Worker Guidewire

K160785 · Argon Medical Devices, Inc. · DQX · Dec 8, 2016 · Cardiovascular

Device Facts

• Record ID: K160785
• Device Name: Worker Guidewire
• Applicant: Argon Medical Devices, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.

Device Story

WORKER Guidewire is a sterile, disposable medical device used to facilitate catheter placement within coronary and peripheral vasculature. The device consists of a fixed stainless steel core with a PTFE-coated stainless steel spring wire to reduce friction during navigation. It is available in diameters of 0.035" or 0.038" and lengths ranging from 80 to 260 cm, with Standard, Amplatz, and Bentson iterations. The device is operated by a clinician in a clinical setting. It functions as a mechanical guide for catheters; the clinician manually manipulates the guidewire to navigate the vasculature, providing a path for the subsequent insertion of a catheter. This facilitates minimally invasive procedures, potentially reducing trauma and improving procedural efficiency.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, catheter compatibility, particulate testing, and radiopacity. Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity, hemocompatibility, and irritation/intracutaneous reactivity per ISO 10993-1.

Technological Characteristics

Materials: Stainless steel core, PTFE-coated stainless steel spring wire. Dimensions: 0.035" or 0.038" diameter; 80-260 cm length. Tip styles: J and Straight. Sterilization: Ethylene Oxide (ISO 11135-1). Mechanical device; no software or energy source.

Indications for Use

Indicated for facilitating catheter placement within coronary and peripheral vasculature in patients requiring percutaneous vascular access.

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

• Bard PTFE Coated Guidewires (K082094)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 8, 2016

Argon Medical Devices, Inc. Beckie Ellis Vice President, Regulatory Affairs/Quality Assurance 1445 Flat Creek Road Athens. Texas 75751

Re: K160785

Trade/Device Name: WORKER Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 3, 2016 Received: November 7, 2016

Dear Ms. Ellis:

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 (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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K160785

Device Name WORKER™ Guidewire

Indications for Use (Describe)

WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.

Type of Use (Select one or both, as applicable)

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

| Date Prepared: | October 10, 2016 |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Argon Medical Devices, Inc.<br>1445 Flat Creek Road Athens,<br>Texas 75751<br>Facility Registration number: 1625425 |
| Contact: | Suzanne Cheang<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device trade name: | WORKER™ Guidewire |
| Device Common Name: | Guidewire |
| Device classification: | Catheter guide wire<br>Product code, DQX<br>21 CFR 870.1330<br>Class II |
| Legally marketed device to which the device is substantially equivalent: | K082094<br>Bard PTFE Coated Guidewires |
| Description of the device: | WORKER™ Guidewires have a fixed stainless steel core with<br>polytetrafluoroethylene (PTFE) coated stainless steel spring wire to<br>reduce friction. The WORKER™ Guidewires have a diameter of either<br>0.035" or 0.038" and range in length from 80 to 260 cm. Guidewires<br>are marketed in Standard, Amplatz and Bentson iterations. |
| Indications for Use: | WORKER™ Guidewires are for use in facilitating the placement of<br>catheters within the coronary and peripheral vasculature. |
| Technological Characteristics: | Comparisons of the WORKER™ Guidewire and predicate devices<br>show that the technological characteristics such as product<br>performance, design and intended use are substantially equivalent to<br>the current marketed predicate devices.<br>The WORKER™ Guidewire is similar in design - device dimensional<br>specifications, intended use, shelf life, materials and sterilization<br>process of that of the predicate devices. Below is the summarized<br>technological characteristics comparison: |

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| Feature | WORKER™<br>Guidewire | Bard PTFE (Teflon®) Coated<br>Guidewires |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | WORKER™Guidewires are<br>for use in facilitating the<br>placement of catheters<br>within the coronary and<br>peripheral vasculature. | Bard PTFE Coated Guide Wires<br>are indicated for percutaneous<br>entry of a guiding catheter into<br>a vessel using standard<br>percutaneous methods<br>(Seldinger's Technique) |
| Sizes | 0.035" & 0.038" | 0.035" & 0.038" |
| Tip Styles | J & Straight | J & Straight |
| Materials | Stainless steel, PTFE | Stainless steel, PTFE |
| Disposable | Yes | Yes |

Performance tests (Non-Clinical):

No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

Where appropriate, the tests were based on the requirements of the following documents:

- FDA guidance Coronary and Cerebrovascular Guidewire . Guidance January 1995.
- ISO 11135-1Sterilization of heath care products- Ethylene ● Oxide - Part 1: Requirements for the development. validation and routine control of a sterilization process for medical devices.
- ISO 10993-1, Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process.

The WORKER™ Guidewire is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:

- · Tensile Strength
- · Torque Strength
- · Torqueability
- · Tip Flexibility
- · Coating Adherence/Integrity
- · Catheter Compatibility
- · Particulate Testing
- · Radiopacity

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Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:

- · Cytotoxicity
- · Sensitization
- Acute systemic toxicity
- · Hemocompatibility
- Irritation/intracutaneous reactivity

The results of this testing demonstrates that the WORKERTM Guidewire, is substantially equivalent to the predicate devices and did not raise new safety or performance questions.

Based on the Indication for Use, design safety and performance testing, the subject WORKER™ Guidewire meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate devices.

Substantial Equivalence: