Screen nominal wall space, then build a contract manufacturing RFQ. Use the report below to qualify tooling, process evidence and supplier terms. Engineering planning only; device performance and facility capability require review.
Prepared by Catheter Braiding OEM (CBOEM). First recorded: · Reviewed: .
Enter OD, ID and length. See nominal jacket space instantly and copy a draft RFQ. Example defaults need engineering review.
1–30
0.008–0.36
10–260
Current liner: 0.0005 in; wire thickness: 0.0005 in. Edit these layers below. 1 mil = 0.001 in. Ranges are tool limits, not supplier capabilities.
Positive nominal clearance — DFM review required
Liner: 0.50 mils · Braid: 1.00 mils · Jacket: 1.78 mils
Single concentric lumen, two undeformed wires at crossover; excludes tolerances, ovality, reflow and shrinkage. A positive result is not proof of manufacturability. Burst, torque, MR safety, sterilization, angle, coverage, machine time, price and delivery are unknown until reviewed.
0.0003–0.0035
0.0003–0.004
0.0008–0.012
15–250
10–50000; whole units
Material, pattern, PPI, carrier count, phase and environment are recorded in the RFQ. They do not establish performance or certification.
Examples are single-lumen arithmetic exercises. Pull wires, hubs and device performance are outside this model.
Treat the tool result as a drawing review prompt. The following are editorial procurement recommendations, grounded in the scope of the linked references; they do not certify a supplier.
| Decision | Evidence boundary | Action before award |
|---|---|---|
| Separate geometry from performance | Nominal clearance cannot demonstrate device performance; S1 and S3 provide scope and reporting context. | Agree tolerance stackup and device-specific bench acceptance criteria. |
| Qualify the quality system | QMSR incorporates ISO 13485:2016; applicability and supplier role still matter (S2). | Check certificate scope/site, audit evidence and quality responsibilities. |
| Define contamination controls | Air particle classification is distinct from sterility and biological contamination (S4). | Review process areas, monitoring and downstream cleaning/packaging scope. |
| Plan risk and change control | Risk management is device-specific (S10). | Assign validation, change notification, transfer and requalification ownership. |
The calculation assumes a concentric, single-lumen shaft and two undeformed wires at a crossover. French OD is a diameter scale: 1 Fr = 1/3 mm. It is not a circumference measurement. All dimensions below use inches after conversion.
| Output | Formula | Limit |
|---|---|---|
| OD | OD_mm = Fr / 3; OD_in = OD_mm / 25.4 | Use finished OD, not usable lumen size. |
| Radial wall | (OD_in − ID_in) / 2 | Excludes eccentricity and dimensional tolerances. |
| Crossover envelope | 2 × wire thickness or round-wire diameter | No ribbon rollover, compression or extra strands modeled. |
| Remaining jacket | Radial wall − liner wall − crossover envelope | Positive space is not proof of encapsulation or release readiness. |
| Thin-jacket trigger | Remaining jacket < 0.0009 in | Illustrative tool warning only; not a qualified minimum. |
Changing PPI, pattern or material does not change this radial arithmetic. These choices are retained in the brief for supplier evaluation. Angle, coverage and line speed remain unknown without a defined braid/machine model.
A carrier count alone cannot establish torque, size range or productivity. Ask the supplier to return an explicit braid specification and a representative trial plan. Half-load also requires the actual loaded-carrier count; it is not interchangeable with a fully loaded braid.
| Input to resolve | Why it changes the review | Evidence to request |
|---|---|---|
| Loaded carriers and strands per carrier | Changes wire population and local stacking. | Machine setup sheet and braid sample. |
| PPI definition and measurement location | Different pitch conventions cannot be compared directly. | Count convention, gauge length and zoned pitch drawing. |
| Pattern and wire tension | Changes crossover arrangement and handling. | Pattern image, tension window and dimensional observations. |
| Target mechanical behavior | Cannot be inferred from count alone. | Finished-shaft torque, bending and pressure test plan. |
At the dimensions in the example below, the arithmetic radial saving is 0.0016 in (1.6 mils). This comparison says nothing about equal coverage, equivalent strength or clinical suitability.
| Factor | Flat ribbon example | Round wire example | Decision check |
|---|---|---|---|
| Wire dimension | 0.0007 in thick × 0.003 in wide | 0.0015 in diameter | Confirm actual material grade, condition and tolerance. |
| Two-wire envelope | 0.0014 in | 0.0030 in | Compare radial space without assuming equivalent mechanics. |
| Handling | Review edge rollover and twist | Review seating and tension | Inspect cross sections after reflow. |
| Cost and availability | Supplier quote required | Supplier quote required | Compare stocked sizes, MOQ, scrap and setup. |
| MR safety | Unknown for complete assembly | Unknown for complete assembly | Assess intended MR environment and labeling (S6). |
Specify the finished geometry and bond requirements first. Resin grade, moisture, shrink sleeve, stackup, equipment heat transfer and traverse motion determine the development window. No temperature, shrink pressure, speed or scarf length is prescribed here.
| Observation | Candidate causes to investigate | Evidence for the next decision |
|---|---|---|
| Exposed wire or voids | Available polymer, wire seating, thermal exposure and sleeve behavior | Cross sections and surface inspection along the shaft. |
| Liner/jacket separation | Surface condition, treatment age, material pair and thermal history | Qualified bond test, aging and relevant functional tests. |
| Lumen restriction | Core support, polymer flow, shrink behavior and cooling | ID/patency check and local sections at transitions. |
| Transition kink or weak joint | Zone geometry, overlap and material pairing | Bending and tensile verification for the intended design. |
ASTM D2578 is scoped to PE/PP film wetting tension; it is not evidence for a universal PTFE adhesion threshold. A screening method needs qualification and correlation to assembly performance [S5].
The core supports the lumen during processing. A stretch-removable core, a reusable rigid core and a release-coated core each require a material- and process-specific trial. Shaft size alone is insufficient to select a mandrel.
| Core approach | Potential tradeoff | What to verify |
|---|---|---|
| Stretch-removable core | May create removal clearance; adds sacrificial material and handling | Tensile behavior, coating integrity, liner damage and cleanliness. |
| Rigid reusable core | May spread tooling cost across runs; requires extraction and reuse controls | Pull force trace, surface condition, dimensional reinspection and reuse limits. |
| Release-coated core | May change interface friction; introduces coating controls | Coating wear, residue transfer and qualified cleaning. |
Request documented trial results at the full working length. Do not assume a fixed extraction-force limit, Poisson neckdown value or number of reuse cycles.
For a conservative jacket-space screen, use minimum finished OD, maximum ID, maximum liner thickness and maximum wire thickness. Remaining space = (OD_min − ID_max)/2 − liner_max − 2 × wire_max. This is a geometric bound, not a process capability study.
Illustrative sensitivity: a 0.0005 in decrease in OD removes 0.00025 in radial space. A 0.0001 in increase in liner wall removes another 0.0001 in. These values are arithmetic examples, not proposed manufacturing tolerances. The tool currently uses nominal values only.
Agree measurement resolution, uncertainty and sampling before interpreting capability. An external laser OD gauge does not directly establish lumen ID; qualify a suitable ID/patency method.
The Class 7/8 selector records a requested environment; it does not establish a facility’s classification or a required room class for every catheter. ISO 14644-1 concerns airborne particles and does not characterize their biological nature [S4].
| Question | Evidence to inspect | Remaining boundary |
|---|---|---|
| Which operations and rooms are covered? | Classification report identifying rooms, operating state, dates and monitoring | A room class alone does not cover every process or product. |
| How are contamination risks controlled? | Process-specific cleaning, handling and environmental control plan | Particle class alone is not a bioburden or endotoxin result. |
| Who owns sterile release? | Agreed packaging, sterilization and release responsibilities | A shaft supplier may deliver nonsterile subassemblies. |
QMSR took effect February 2, 2026 and incorporates ISO 13485:2016 by reference [S2]. Review the supplier’s scope and your quality agreement. The roadmap below is editorial planning guidance; applicability, sample sizes and acceptance criteria must be justified for the process.
| Stage | Question to resolve | Reviewable output |
|---|---|---|
| IQ | Is the installed equipment/configuration documented and suitable? | Approved installation and calibration evidence. |
| OQ | What process limits and failure modes need challenging? | Justified process window and executed challenge results. |
| PQ | Can routine production meet the agreed requirements? | Risk-based lots, samples and evidence against the approved protocol. |
| Lot release | Who reviews conformance and authorizes shipment? | Traceability, inspection/test records and release authorization. |
This page establishes no universal three-lot rule, Cpk/Ppk target or Gage R&R acceptance limit. Include the rationale in the approved protocol.
Prepare a supplier evidence requestFDA’s bench guidance addresses report content [S3]. ISO 10555-1 has a sterile single-use intravascular catheter scope [S1]. Select applicable requirements from the actual device and intended use; the checklist below does not reproduce normative clauses or acceptance thresholds.
| Property | Protocol detail to agree | Decision evidence |
|---|---|---|
| Tensile / joint integrity | Test segment, conditioning, fixtures, pull rate and failure definition | Measured distribution and failure location versus approved limits. |
| Pressure / leak / burst | Fluid, temperature, ramp or cycling, dwell and failure definition | Observed performance before and after relevant conditioning. |
| Bend / kink / patency | Path geometry, support, lumen load and collapse definition | Patency and recovery over representative use conditions. |
| Torque response | Path, friction, rotation history, hub/tip measurement | Lag, windup and sudden release observations against justified limits. |
| Particles and surface integrity | Simulated use, collection method and detection limits | Device-specific risk assessment and justified acceptance criteria. |
ASTM F2606 concerns stents/stent systems, not a general catheter kink test [S9]. MR marking is a separate topic [S6]. No braid count, wire profile or PPI alone establishes a burst rating or eliminates torque windup.
Confirm whether the contracted scope is a nonsterile shaft or a sterile finished device. EO process development/validation and EO/ECH residual evaluation are separate evidence questions [S7] [S8]. No method is approved for an assembly merely by selecting its liner and jacket.
| Route under consideration | Questions to resolve | Evidence before release |
|---|---|---|
| Ethylene oxide | Cycle, packaging, absorption, aeration and residual limits | Validated cycle, residual evaluation and post-process functional evidence. |
| Gamma / electron beam | Actual resin grades, dose distribution and aging effects | Material supplier data plus finished-device testing at the qualified conditions. |
| Moist heat | Thermal/moisture exposure and geometry retention | Compatibility evidence and validated finished-device process. |
As of 2026-10-25, ISO lists ISO 10993-7:2026 as published and the 2008 edition as withdrawn. Confirm market recognition and the edition in your protocol. Do not infer a fixed 48-hour aeration period, a universal residual dose, or complete property retention.
Use the gates below to negotiate scope and spending. Timing and quantities remain quote-dependent; material availability, tooling changes and validation review can dominate the schedule.
| Gate | Sponsor input | Evidence to approve before progressing |
|---|---|---|
| DFM and scope | Drawing revision, tolerances, application, CTQs and forecasts | Stackup review, open risks, assumptions and itemized quote. |
| Engineering build | Approved materials and prototype acceptance plan | First article evidence and observations; identify redesign needs. |
| Verification and validation | Frozen design and approved protocols where applicable | Executed reports, deviations and agreed disposition. |
| Routine supply | Quality agreement, purchase orders and change controls | Approved release records, capacity and delivery commitment. |
No public price, MOQ or delivery benchmark has been established for these examples. Request a quote that separates recurring unit cost, NRE and validation. A single nominal geometry cannot price a manufacturing program.
| Cost / schedule driver | Ask the supplier | Action if unresolved |
|---|---|---|
| Material and tooling availability | Grade, size, minimum buys, lead time and ownership | Quote alternatives with explicit requalification consequences. |
| Setup and yield | Setup allocation, expected scrap, inspection and accepted output | Compare cost per accepted shaft, with yield assumptions stated. |
| Validation and testing | Included deliverables, destructive samples and approval dependencies | Price development and validation as separate milestones. |
| Capacity and logistics | Reserved capacity, shipment terms and milestone dates | Obtain a dated schedule and change-notification commitment. |
This register is an editorial starting point, not a risk assessment of a particular device. Assign owners and verify mitigations within the sponsor’s risk process [S10].
| Risk | Consequence | Minimum mitigation / alternative |
|---|---|---|
| Using nominal clearance as design approval | Missed tolerance or encapsulation failure | Require worst-case stackup and sample evidence; revise geometry when needed. |
| Applying the single-lumen model to a steerable shaft | Pull-wire channels or local structures consume unmodeled wall | Request a local assembly drawing and specialist DFM review. |
| Ignoring setup, scrap or test samples | Budget or quantity shortfall | Compare quotes on accepted output and ask for an NRE/validation breakdown. |
| Assuming tooling or recipes transfer automatically | Supplier lock-in or transfer delay | Negotiate ownership, background IP, access and transfer deliverables. |
| Substituting a resin without assessment | Unexpected processing, aging or test behavior | Use approved change control and justified requalification. |
These are arithmetic exercises using the first four tool presets, not customer cases, measured test results or approved devices. Load a preset above, subtract liner + twice the wire thickness from radial wall, and compare the result below. Names describe scale only; anatomical suitability is unverified.
| Scenario | OD / ID inputs | Layer inputs | Calculated result | Next action |
|---|---|---|---|---|
| Micro-profile example | 2.1 Fr / 0.021 in ID | 0.0005 in liner; 0.0005 in wire thickness | 3.280 mils total; 1.780 mils jacket | Positive nominal space: request DFM and test evidence. |
| Guide-shaft example | 6 Fr / 0.071 in ID | 0.0008 in liner; 0.0012 in wire thickness | 3.870 mils total; 0.670 mils jacket | Thin-jacket trigger: request tolerance review. |
| Larger single-lumen example | 8.5 Fr / 0.098 in ID | 0.001 in liner; 0.0008 in wire thickness | 6.774 mils total; 4.174 mils jacket | Positive nominal space: request DFM and test evidence. |
| Large-bore example | 14 Fr / 0.165 in ID | 0.0015 in liner; 0.0012 in wire thickness | 9.364 mils total; 5.464 mils jacket | Positive nominal space: request DFM and test evidence. |
Source scope and links checked: 2026-10-25. Public catalog pages support scope summaries, not a full normative compliance review. The geometry model and procurement checklists are editorial aids. Full standards, device-specific evidence and applicable market requirements must be reviewed before approving a design or supplier. No private validation data or supplier capability evidence is supplied here.
Applies to sterile, single-use intravascular catheters.
Boundary: The public catalog does not establish this tool’s jacket threshold, joint recipe or device-specific performance limits.
Effective February 2, 2026; incorporates ISO 13485:2016 by reference into the amended 21 CFR Part 820.
Boundary: Applicability depends on the manufacturer’s role. This page and an RFQ do not establish compliance or facility certification.
Describes information for bench test protocols, summaries and complete reports in premarket submissions.
Boundary: It is reporting guidance, not a universal burst, torque, kink or sample-size specification.
Classifies cleanroom air by particle concentration.
Boundary: Air classification alone does not establish sterility, bioburden, endotoxin control or suitability for this device.
Its stated scope concerns polyethylene and polypropylene films.
Boundary: It is not a PTFE catheter bond qualification standard; no dyne threshold is adopted here.
Addresses safety assessment and labeling of devices that may enter the MR environment.
Boundary: Selecting PEEK or Nitinol alone cannot establish finished-device MR safety.
Addresses development, validation and routine control of EO sterilization processes.
Boundary: It does not validate a generic temperature or aeration duration for this shaft. Check edition and market requirements when agreeing a protocol.
Published April 2026; addresses residual EO/ECH limits, measurement and conformity for device release.
Boundary: The 2008 edition is withdrawn. Confirm applicable editions and recognition with regulatory specialists; no single dose limit or fixed aeration time is inferred here.
Its stated scope is balloon-expandable vascular stents and stent systems.
Boundary: It is not used here as a general catheter kink-radius test or particulate acceptance standard.
Describes a device lifecycle risk management process.
Boundary: Product-specific risk acceptability and verification plans require sponsor decisions; there is no universal acceptable risk score.
It converts French OD to millimeters and inches, calculates nominal radial wall, subtracts liner thickness and a two-wire crossover envelope, and creates a preliminary RFQ brief. Other inputs record the requested scope.
No. It omits tolerances, ovality, wire deformation, reflow, polymer flow and shrinkage. Use it to frame DFM questions, then qualify the actual construction.
This is an illustrative editorial review trigger, not an ISO requirement or a supplier minimum. A value above it is not a qualified design; a value below it needs explicit tolerance and encapsulation review.
PPI conventions, loaded carriers, strands per carrier, pattern and machine kinematics must be defined first. The tool records requested PPI and pattern without presenting an unverified geometric or throughput prediction.
Compare crossover thickness at specified dimensions, ribbon handling, availability and finished-shaft test results. Neither profile alone guarantees torque, burst pressure or column strength.
No. Document the complete device configuration and intended MR conditions, and plan the safety assessment and labeling. Nonmetallic reinforcement alone is not a finished-device MR designation; see S6.
No range is established here. Ask the supplier to review diameter, loaded carriers, strands, pattern, pitch definition and equipment capability together, with a representative build.
No. It models a single concentric lumen. Steerable assemblies, pull-wire channels, markers, tips and hubs need a separate local stackup and functional assessment.
Agree environmental controls from the process, contamination risk and finished-device requirements. Class 7 or 8 is an RFQ request, not proof of capability or sterility; ISO 14644-1 addresses airborne particle classification (S4).
FDA states that the rule effective February 2, 2026 incorporates ISO 13485:2016 into the amended quality system regulation. Confirm the supplier’s role, applicable obligations and quality agreement (S2).
This page adopts neither as a universal rule. The validation protocol must justify lots, samples, process challenges, measurement capability and acceptance criteria for the actual risk and process.
No release criterion is established here. ASTM D2578 concerns PE/PP film wetting tension. Qualify any adapted screening method and correlate it with finished assembly bond evidence (S5).
Paste the brief into the inquiry form or email, then provide drawing revision, tolerances, intended use, functional CTQs, quantities, annual forecast and delivery location. Agree a secure drawing exchange if needed.
Ownership is a negotiated contract term. Identify paid tooling, storage, maintenance, background IP, process know-how, transfer rights and return/disposal obligations before the award.
None. Request an itemized quote covering NRE, materials, yield assumptions, setup, inspection, validation and delivery milestones. A nominal wall calculation cannot establish cost or schedule.
Correct the highlighted inputs or reset defaults. A geometric conflict can be copied as a redesign request. If clipboard access fails, use the displayed text area to copy manually; the contact form and email remain available.
Copy your specification brief from the tool, then send your drawing revision, tolerances and contract scope for engineering review. Agree a secure exchange for confidential drawings before sharing them.