Arrow® Nitinol Wire

K241784 · Teleflex Medical · DQX · Sep 18, 2024 · Cardiovascular

Device Facts

• Record ID: K241784
• Device Name: Arrow® Nitinol Wire
• Applicant: Teleflex Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Arrow Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.

Device Story

Arrow Nitinol Wire consists of a coil wire wrapped around a solid nitinol core; designed to fit inside percutaneous catheters to direct them through blood vessels. Used in hospital and sub-acute facilities by physicians to guide and control catheter advancement through a single puncture site. Facilitates vascular access for diagnostic and interventional procedures. Provides clinician with tactile control for catheter placement; benefits patient by enabling minimally invasive vascular access. Provided as spring wire guide assemblies including accessories like straighteners and advancers for handling. Output is the physical guidance of the catheter; clinician visualizes device position via X-ray (radiopaque).

Clinical Evidence

Bench testing only. Performance testing included dimensional verification, tensile strength, tip pull, torque strength, corrosion resistance, kink resistance, tip flexibility, and radiopacity per BS EN ISO 11070. Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and hemocompatibility. All tests passed.

Technological Characteristics

Core: Nitinol; Coil: Stainless steel. Tip: Straight or J-shaped. Dimensions: 30-68cm length, 0.018-0.035" diameter. Sterilization: Ethylene Oxide. Design: Solid core wire welded to coil. Biocompatibility: ISO 10993-1 compliant. Mechanical testing: BS EN ISO 11070.

Indications for Use

Indicated for patients undergoing central or peripheral vascular access procedures where use of a guidewire to aid insertion is indicated. No restrictions on target patient population; choice per clinician expertise based on size and patient habitus.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Predicate™ III Guidewire (K142393)

Submission Summary (Full Text)

{0}------------------------------------------------

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"

{1}------------------------------------------------

(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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}------------------------------------------------

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

{3}------------------------------------------------

# 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

## 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: [phone] Fax: [phone]

#### Contact Person

Madison Snyder [e-mail] 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

K142393

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)<br>Number | Date Cleared |
|-------------------------|------------------------|------------------|-------------------|
| PREDICATE III GUIDEWIRE | Lake Region<br>Medical | 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.

{6}------------------------------------------------

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 Device<br>K142393<br>Predicate III Guidewire | Proposed<br>Arrow Nitinol Wire | Equivalence |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Classification<br>Name | 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 |
| Regulation<br>Number | 870.1330 | 870.1330 | Identical |
| Indications for Use | PREDICATE III GUIDEWIRE are<br>indicated to facilitate the<br>placement of devices in<br>angiographic procedures | The Arrow Nitinol Wires are<br>indicated to facilitate the<br>placement of devices for diagnostic<br>and interventional procedures. | EQUIVALENT |
| Intended Use | The guidewires are intended for<br>use in angiographic procedures to<br>introduce and position catheters<br>and interventional devices within<br>the coronary and peripheral<br>vasculature | The guidewires are intended to<br>facilitate the placement of central<br>circulatory system or peripheral<br>vascular devices for diagnostic and<br>interventional procedures. | EQUIVALENT |
| Device Use | Single Use | Single Use | Identical |
| Prescription | Yes | Yes | Identical |
| Contraindications | There are no known<br>contraindications for this device | There are no known<br>contraindications for this device | Identical |
| Shelf Life | 36 months from date of<br>manufacture | 60 months from date of<br>manufacture | Similar* |
| Design | A solid nitinol core wire welded at<br>both ends to SS coil. | A solid nitinol core wire welded<br>at 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<br>(per ISO 10993-1) | Biocompatible materials used<br>(per ISO 10993-1) | Identical |
| Sterilization<br>Method | EO | EO | Identical |

Teleflex Medical, Inc.

{7}------------------------------------------------

*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 - Kligman<br>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<br>(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<br>- 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 -<br>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 |

{8}------------------------------------------------

| Hemocompatibility – Rabbit<br>Blood Hemolysis (Complete)<br>ASTM Test | The test article will meet the requirements of<br>the test and is not considered to have<br>hemolytic activity potential, if the hemolytic<br>index above the negative control article and<br>negative 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 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Dimensional<br>Verification | All dimensions shall be statistically inside tolerance limits<br>according to the drawing with assurance of 95%. | Pass |
| Title: Visual Inspection /<br>Surface | When examined by normal or corrected-to-normal vision<br>with minimum 2.5x magnification, the external surface of<br>the effective length of the device shall appear free from<br>extraneous matter. | Pass |
| Tensile Strength / Peak<br>Tensile Force | When tested in accordance with the method given in BS EN<br>ISO 11070, Annex H, the minimum peak tensile force of the<br>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<br>ISO 11070, Annex H, the minimum peak tensile force of the<br>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<br>to the predicate device. | Pass |
| Corrosion Resistance | When tested in accordance with the method given in BS EN<br>ISO 11070, Annex B, metallic components of the device shall<br>show no visible signs of corrosion that can affect functional<br>performance or biocompatibility test results. | Pass |

{9}------------------------------------------------

| Kink Resistance | Fracture test:<br>When tested in accordance with BS EN ISO 11070, Annex F,<br>the spring wire guide shall not fracture, loosen, or fail in<br>such a manner that<br>a. any section of the coil is left free to stretch<br>b. a sharp, or potentially traumatic fracture surface is exposed, or<br>c. 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:<br>When tested in accordance with BS EN ISO 11070, Annex G,<br>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:<br>Characterization and comparison with predicate device.<br>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.