Spring Coil Guidewire

K143135 · Neometrics, Inc. · DQX · Feb 20, 2015 · Cardiovascular

Device Facts

• Record ID: K143135
• Device Name: Spring Coil Guidewire
• Applicant: Neometrics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To facilitate the placement of devices during diagnostic or interventional procedures.

Device Story

Spring Coil Guidewire; non-steerable; manually inserted into vessel; advanced to target region to facilitate placement of diagnostic or interventional devices. Constructed of stainless steel and nickel titanium alloys. Available in single or dual tip, retracted or fixed core, and straight or J-tipped configurations. Packaged with J-straightener for needle insertion. Used by clinicians in interventional settings.

Clinical Evidence

Bench testing only. Testing included dimensional verification, tensile strength, tip flexibility, packaging, kink resistance, fracture resistance, flex resistance, corrosion resistance, biocompatibility, and radiopacity.

Technological Characteristics

Materials: stainless steel, nickel titanium alloys. Non-steerable. Configurations: single/dual tip, retracted/fixed core, straight/J-tipped. Includes J-straightener. Mechanical device.

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures requiring device placement.

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

• Cardiovascular Spring Guides (K770977)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Public Health Service

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

February 20, 2015

Neometrics, Inc. Mr. Gene Champeau CEO 2605 Fernbrook Lane, Suite J Plymouth, Minnesota 55447

Re: K143135 Trade/Device Name: Spring Coil Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 27, 2015 Received: January 28, 2015

Dear Mr. Champeau,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Kenneth J. Cavanaugh -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)

K143135

Device Name Spring Coil Guidewire

Indications for Use (Describe)

To facilitate the placement of devices during diagnostic or interventional procedures.

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

| Submitter: | NeoMetrics, Inc.<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447<br>763-559-4440<br>763-559-7676 |
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| Contact Person: | Eugene Champeau, CEO<br>2605 Fernbrook Lane North, Suite J<br>Plymouth, MN 55447 |
| Date Prepared: | January 27, 2015 |
| Device Name: | Spring Coil Guidewire |
| Device Common<br>Name: | Catheter Guide Wire |
| Classification: | Class II<br>Regulation Number: 21 CFR 870.1330. |
| Product Code: | DQX |
| Predicate Device: | Company Name: Lake Region Medical.<br>Brand Name: Cardiovascular Spring Guides<br>510(k) number: K770977 |
| Device<br>Description: | NeoMetrics guidewires are constructed using stainless steel and<br>nickel titanium alloys. Configurations include a single tip or dual<br>tip, retracted core or fixed core, and straight or J-tipped. The<br>guidewire is packaged in a spiral hoop fitted with a "J"-<br>Straightener, where applicable to aid in insertion of the guidewire<br>into the puncture needle. |
| Indication for Use: | To facilitate the placement of devices during diagnostic or<br>interventional procedures. |
| Principle of<br>Operation: | The Spring Coil Guidewire is manually inserted into a vessel and<br>advanced to the target region; it is a non-steerable guidewire. |
| Device<br>Characteristics<br>Compared to the<br>Predicate: | The Spring Coil Guidewire has the same technological<br>characteristics as the predicate guidewires. |

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Performance Data: To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances.

Performance Testing:

- . Dimensional Verification
- . Tensile Strength
- Tip Flexibility .
- . Packaging Study
- Kink Resistance .
- . Fracture Resistance
- Flex Resistance ●
- Corrosion Resistance .
- Biocompatibility Testing ●
- Radiopacity Testing ●

These data demonstrates that the Spring Coil Guidewire is equivalent to the predicate.

Conclusion: NeoMetrics Inc. considers the Spring Coil Guidewire to be equivalent to the predicate device. This conclusion is based upon the fact that device has an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.