(90 days)
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.
The provided document is a 510(k) Premarket Notification from the FDA for the Arrow® Nitinol Wire. It details the device description, indications for use, comparison to a predicate device, and various performance and biocompatibility tests conducted to support its substantial equivalence.
The document does NOT describe the acceptance criteria and study that proves the device meets the acceptance criteria for a software or AI/ML-driven medical device.
Instead, it pertains to a physical medical device – a guide wire – and the testing focuses on its physical properties, material compatibility, and engineering performance. Therefore, many of the requested points, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this type of device submission.
However, I can extract the relevant information from the document regarding the acceptance criteria and performance studies for the Arrow® Nitinol Wire.
Acceptance Criteria and Device Performance (for a Physical Medical Device)
1. Table of Acceptance Criteria and the Reported Device Performance:
The document provides two tables: one for Biocompatibility and one for Performance Data.
Biocompatibility Testing:
| Test Name | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - L 929 Proliferation | The test article will meet the requirements of the test if it obtains a Grade of 0,1,or 2 (not more than 50% of the cells are round, devoid of intracytoplasmic granules, and no extensive cell lysis) | Acceptable |
| Sensitization - Kligman Maximization Assay | The test article will be considered a non-irritant if the difference between the test article mean score and the vehicle control mean score is 1.0 or less. | Acceptable |
| Intracutaneous Reactivity Test (Polar and Non-Polar (ISO)) | The test article will meet the requirements of the test if it receives a Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Acute Systemic Toxicity - Systemic Injection Test | The test article will meet the requirements of the test if it does not induce a significantly greater biological reaction than the control. | Acceptable |
| Acute Systemic Toxicity - Material Mediated Test | The test article will meet the requirements of the test if no rabbit shows an individual rise in temperature of 0.50C or more above the baseline temperature. | Acceptable |
| Hemocompatibility – Rabbit Blood Hemolysis (Complete) ASTM Test | The test article will meet the requirements of the test and is not considered to have hemolytic activity potential, if the hemolytic index above the negative control article and negative control article extract is <5%. | Acceptable |
Performance Testing:
| Test Name | Acceptance Criteria | Result |
|---|---|---|
| Dimensional Verification | All dimensions shall be statistically inside tolerance limits according to the drawing with assurance of 95%. | Pass |
| Visual Inspection / Surface | When examined by normal or corrected-to-normal vision with minimum 2.5x magnification, the external surface of the effective length of the device shall appear free from extraneous matter. | Pass |
| Tensile Strength / Peak Tensile Force | When tested in accordance with the method given in BS EN ISO 11070, Annex H, the minimum peak tensile force of the guidewire and any critical junctions shall be: - 2 N for diameters <0.55mm (0.022") - 5 N for diameters ≥0.55mm (0.022") - <0.75 mm (0.030") - 10 N for spring wire guides with diameter ≥0.75 mm (0.030"). | Pass |
| Tip Pull | When tested in accordance with the method given in BS EN ISO 11070, Annex H, the minimum peak tensile force of the guidewire and any critical junctions shall be: - 2 N for diameters <0.55mm (0.022") - 5 N for diameters ≥0.55mm (0.022") - <0.75 mm (0.030") - 10 N for spring wire guides with diameter ≥0.75 mm (0.030"). | Pass |
| Torque Strength | Torque strength of subject device is substantially equivalent to the predicate device. | Pass |
| Corrosion Resistance | When tested in accordance with the method given in BS EN ISO 11070, Annex B, metallic components of the device shall show no visible signs of corrosion that can affect functional performance or biocompatibility test results. | Pass |
| Kink Resistance (Fracture test) | When tested in accordance with BS EN ISO 11070, Annex F, the spring wire guide shall not fracture, loosen, or fail in such a manner that:a. any section of the coil is left free to stretchb. a sharp, or potentially traumatic fracture surface is exposed, orc. any part of the device becomes separated such that it would not be removable by withdrawing the device from use. | Pass |
| Kink Resistance (Flexing test) | When tested in accordance with BS EN ISO 11070, Annex G, Neither the distal end of the guide wire nor the remaining portion of the guide wire shall show signs of defects or damage. | Pass |
| Kink Resistance (Comparison to predicate) | Test samples after being subjected to the test with pin gauge of particular radius did not show worse kink or plastic deformation or/and fracture compared to the predicate device. | Pass |
| Tip Flexibility | The tip shall visually exhibit higher flexibility than the rest of the wire. | Pass |
| Radiopacity | The spring wire guide has to be clearly visible on X-ray picture in its full length despite of shadowing by the water tank or human body. | Pass |
The following points are not applicable to this 510(k) submission for a physical medical device, as they relate specifically to AI/ML or software-driven devices, or human-in-the-loop studies. However, I will address them to confirm their non-applicability based on the provided document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable in the context of AI/ML or software test sets. For this physical device, "test set" refers to the tested physical units of the guide wire. The documentation does not specify the number of units tested for each performance or biocompatibility test, nor does it specify data provenance in the sense of clinical data (e.g., country of origin or retrospective/prospective). The testing is laboratory-based on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. "Ground truth" in this context would refer to objective, measurable physical properties, or standard biological responses, not expert interpretation of diagnostic images. The performance and biocompatibility tests are based on established ISO standards and
in-vitro/in-vivo laboratory methods, not human expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging by multiple readers. The testing for a guide wire is objective and measurable against predefined physical and biological criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical device, not an AI or software product. MRMC studies are for assessment of reader performance, typically with diagnostic imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device. There is no algorithm or software component being submitted for standalone performance evaluation in this 510(k).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the AI/ML context. For physical device testing, the "ground truth" equates to the objective acceptance criteria derived from engineering specifications and relevant ISO standards (e.g., BS EN ISO 11070 for guidewires, ISO 10993-1 for biocompatibility).
8. The sample size for the training set:
- Not Applicable. This concept is only relevant for machine learning models.
9. How the ground truth for the training set was established:
- Not Applicable. This concept is only relevant for machine learning models.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2024
Teleflex Medical Madison Snyder Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K241784
Trade/Device Name: Arrow® Nitinol Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 25, 2024 Received: June 20, 2024
Dear Madison Snyder:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Lydia S. Digitally signed
Lydia S. Lydia S. Glaw -S Digitally signed by Glaw 7 2 Date: 2024.09.18
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241784
Device Name Arrow® Nitinol Wire
Indications for Use (Describe)
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY Arrow® Nitinol Wire K241784
Name, Address, Phone and Fax Number of Applicant
Arrow International LLC Subsidiary of Teleflex Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919.433.4932 Fax: 919.433.4996
Contact Person
Madison Snyder madison.snyder@teleflex.com Regulatory Affairs Specialist
Date Prepared
June 13, 2024
Device Name
Device Trade Name: Arrow® Nitinol Wire Device Common Name: Catheter Guide Wire Device Classification Name: Wire, Guide, Catheter FDA Classification Regulation: 21 CFR 870.1330 FDA Classification: Class II FDA Product Code: DQX Classification Panel: Cardiovascular FDA Panel Number: 74
Predicate Device
Predicate™ III Guidewire (Lake Region Medical)
Device Description
The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the
Teleflex Medical, Inc.
{5}------------------------------------------------
vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.
| Core Material | Nitinol |
|---|---|
| Coil Material | Stainless Steel |
| Coil length | Full length |
| Joining Agent | Weld |
| Tip Type | Straight or J-shaped |
| Overall Lengths | 30cm to 68cm |
| Overall Diameters | 0.018" to 0.035" |
| Sterilization Method | Ethylene Oxide |
The guidewire family is bound by the following parameters:
Intended Use Statement
The Arrow Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
Patient Population
The guidewires are intended for use in patients undergoing central or peripheral vascular access procedures where use of a guidewire to aid insertion is indicated. There are no restrictions on the target patient population. Guidewire choice is per clinician expertise and consideration of guidewire size and patient habitus.
Environment of use
The device is to be used in a hospital and sub-acute facility environment as directed by a physician.
Contraindications
There are no known contraindications for this device.
Substantial Equivalence
The proposed device is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k)Number | Date Cleared |
|---|---|---|---|
| PREDICATE III GUIDEWIRE | Lake RegionMedical | K142393 | November 25, 2014 |
Comparison to Predicate Device
The proposed device has the same or equivalent indications for use, operating principles, classification, sterilization and general design as the predicate device. The subject and predicate devices are both intended to introduce and place vascular devices. In this
Teleflex Medical, Inc.
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application, the words "coronary vasculature" used for the predicate device means the same as "central circulatory system" used for the subject device. The guidewire is designed for peripheral applications and does not navigate beyond the superior vena cava into further coronary vasculature. Biocompatibility testing and performance testing has been performed on the proposed device in order to establish substantial equivalence to the predicate device. The proposed changes below do not impact the safety or effectiveness of the Arrow Nitinol Wire. The subject device is therefore substantially equivalent to the predicate device identified within this submission.
| Predicate DeviceK142393Predicate III Guidewire | ProposedArrow Nitinol Wire | Equivalence | |
|---|---|---|---|
| ClassificationName | wire, guide, catheter | wire, guide, catheter | Identical |
| Common Name | CATHETER GUIDEWIRE | CATHETER GUIDEWIRE | Identical |
| Product Code | DQX | DQX | Identical |
| Classification | Class II | Class II | Identical |
| RegulationNumber | 870.1330 | 870.1330 | Identical |
| Indications for Use | PREDICATE III GUIDEWIRE areindicated to facilitate theplacement of devices inangiographic procedures | The Arrow Nitinol Wires areindicated to facilitate theplacement of devices for diagnosticand interventional procedures. | EQUIVALENT |
| Intended Use | The guidewires are intended foruse in angiographic procedures tointroduce and position cathetersand interventional devices withinthe coronary and peripheralvasculature | The guidewires are intended tofacilitate the placement of centralcirculatory system or peripheralvascular devices for diagnostic andinterventional procedures. | EQUIVALENT |
| Device Use | Single Use | Single Use | Identical |
| Prescription | Yes | Yes | Identical |
| Contraindications | There are no knowncontraindications for this device | There are no knowncontraindications for this device | Identical |
| Shelf Life | 36 months from date ofmanufacture | 60 months from date ofmanufacture | Similar* |
| Design | A solid nitinol core wire welded atboth ends to SS coil. | A solid nitinol core wire weldedat both ends to SS coil | Identical |
| Tip Type | J-end, straight | J-end, straight | Identical |
| Coating | None | None | Identical |
| Core Material | NiTinol | NiTinol | Identical |
| Coil Material | Stainless steel | Stainless steel | Identical |
| Diameter | 0.018" to 0.038" | 0.018" - 0.035" (0.46 - 0.89 mm) | EQUIVALENT |
| Length | 30cm to 500cm | 17-3/4" - 23-5/8" (45 – 68 cm) | EQUIVALENT |
| Biocompatibility | Biocompatible materials used(per ISO 10993-1) | Biocompatible materials used(per ISO 10993-1) | Identical |
| SterilizationMethod | EO | EO | Identical |
Teleflex Medical, Inc.
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*Shelf life was established via performance testing of accelerated-aged products.
Materials
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - L 929 Proliferation | The test article will meet the requirements of the test if it obtains a Grade of 0,1,or 2 (not more than 50% of the cells are round, devoid of intracytoplasmic granules, and no extensive cell lysis) | Acceptable |
| Sensitization - KligmanMaximization Assay | The test article will be considered a non-irritant if the difference between the test article mean score and the vehicle control mean score is 1.0 or less. | Acceptable |
| Intracutaneous Reactivity Test(Polar and Non- Polar (ISO) | The test article will meet the requirements of the test if it receives a Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Acute Systemic Toxicity- Systemic Injection Test | The test article will meet the requirements of the test if it does not induce a significantly greater biological reaction than the control. | Acceptable |
| Acute Systemic Toxicity -Material Mediated Test | The test article will meet the requirements of the test if no rabbit shows an individual rise in temperature of 0.50C or more above the baseline temperature. | Acceptable |
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| Hemocompatibility – RabbitBlood Hemolysis (Complete)ASTM Test | The test article will meet the requirements ofthe test and is not considered to havehemolytic activity potential, if the hemolyticindex above the negative control article andnegative control article extract is <5%. | Acceptable |
|---|---|---|
| ----------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------ |
Performance Data
Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs.
| Test | Acceptance Criteria | Result |
|---|---|---|
| DimensionalVerification | All dimensions shall be statistically inside tolerance limitsaccording to the drawing with assurance of 95%. | Pass |
| Title: Visual Inspection /Surface | When examined by normal or corrected-to-normal visionwith minimum 2.5x magnification, the external surface ofthe effective length of the device shall appear free fromextraneous matter. | Pass |
| Tensile Strength / PeakTensile Force | When tested in accordance with the method given in BS ENISO 11070, Annex H, the minimum peak tensile force of theguidewire and any critical junctions shall be 2 N for diameters <0.55mm (0.022") 5 N for diameters ≥0.55mm (0.022") - <0.75 mm (0.030") 10 N for spring wire guides with diameter ≥0.75 mm (0.030"). | Pass |
| Tip Pull | When tested in accordance with the method given in BS ENISO 11070, Annex H, the minimum peak tensile force of theguidewire and any critical junctions shall be 2 N for diameters <0.55mm (0.022") 5 N for diameters ≥0.55mm (0.022") - <0.75 mm (0.030") 10 N for spring wire guides with diameter ≥0.75 mm (0.030"). | Pass |
| Torque Strength | Torque strength of subject device is substantially equivalentto the predicate device. | Pass |
| Corrosion Resistance | When tested in accordance with the method given in BS ENISO 11070, Annex B, metallic components of the device shallshow no visible signs of corrosion that can affect functionalperformance or biocompatibility test results. | Pass |
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| Kink Resistance | Fracture test:When tested in accordance with BS EN ISO 11070, Annex F,the spring wire guide shall not fracture, loosen, or fail insuch a manner thata. any section of the coil is left free to stretchb. a sharp, or potentially traumatic fracture surface is exposed, orc. any part of the device becomes separated such that it would not be removable by withdrawing the device from use. | Pass |
|---|---|---|
| Kink Resistance | Flexing test:When tested in accordance with BS EN ISO 11070, Annex G,Neither the distal end of the guide wire nor the remaining portion of the guide wire shall show signs of defects or damage. | Pass |
| Kink Resistance | Kink Resistance Test:Characterization and comparison with predicate device.Test samples after being subjected to the test with pin gauge of particular radius did not show worse kink or plastic deformation or/and fracture compared to the predicate device. | Pass |
| Tip Flexibility | The tip shall visually exhibit higher flexibility than the rest of the wire. | Pass |
| Radiopacity | The spring wire guide has to be clearly visible on X-ray picture in its full length despite of shadowing by the water tank or human body. | Pass |
Conclusion
Based on the performance and comparative test results, the proposed Arrow Nitinol Wire is substantially equivalent to the predicate device cleared to market in K142393 The modifications made to the Nitinol Wire do not introduce any new issues of safety and effectiveness.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.