ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE

K991898 · Microvena Corp. · DQX · Jun 16, 1999 · Cardiovascular

Device Facts

• Record ID: K991898
• Device Name: ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
• Applicant: Microvena Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The 0.035" and 0.025" Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

Device Story

HyTek Guidewire is a medical device designed to fit inside a catheter to facilitate navigation through blood vessels. The device consists of a Nitinol core with a distal helical coiled wire tip and a hydrophilic coating to reduce friction. It is available in diameters ranging from 0.014" to 0.035" and lengths from 80 cm to 300 cm. The device is used by clinicians in a clinical setting to direct catheters during vascular procedures. By providing a track for the catheter, the guidewire assists the physician in reaching target sites within the peripheral or coronary vasculature, potentially improving procedural success and patient outcomes.

Clinical Evidence

Bench testing only. Performance characteristics, including torque, flexibility, and coating adherence, were evaluated and found to be comparable to the predicate devices.

Technological Characteristics

Core material: Nitinol. Distal tip: Helical coiled wire. Coating: Hydrophilic. Dimensions: 0.014" to 0.035" diameter; 80 cm to 300 cm length. Mechanical device; no software or energy source.

Indications for Use

Indicated for use in peripheral vasculature (all sizes) and coronary vasculature (0.014", 0.016", and 0.018" sizes).

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

• K943390
• K991194

Submission Summary (Full Text)

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K991898

## Special 510(k) Summary

# HyTek™ Guidewire (Prepared in accordance with 21 CFR part 807.92)

#### 510(k) Number: This application

- Submitter: Prepared and Submitted by: 1. MICROVENA Corporation Angela Mallery Sr. Regulatory Affairs Associate 651-7777-6700 1861 Buerkle Road White Bear Lake, MN 55110
- Device Name: Guidewire 2. Trade Name: HyTek Guidewire Classification Name: Wire, Guide, Catheter Classification Code: 74 DQX
- Substantial Equivalency: The HyTek guidewire is substantially equivalent 3. to K943390 and K991194.
- Device Description and Intended Use: 4. The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for the purpose of directing the catheter through a blood vessel.

The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to help facilitate smoother passage.

The HyTek Guidewire is available in diameters of .014" to .035, and in lengths from 80 cm to 300 cm.

- Technological Characteristics ഗ് MICROVENA's HyTek guidewire have the same indications for use and are otherwise technically the same as the predicate device.
- 6. Non-Clinical Tests

The results of these tests demonstrated the functionality and performance characteristics of the guidewire are comparable to the currently marketed device. These tests included: torque, flexibility, and coating adherence.

- 7. Conclusions Based on information presented in this 510(k) premarket notification, MICROVENA guidewires are considered substantially equivalent to the currently marketed predicate device.
HyTek 510(k) Special 510(k) Summary - 1

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

JUN 16 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Angela Mallery Sr. Regulatory Affairs Associate MICROVENA Corporation 1861 Buerkle Road White Bear Lake, MN 55110

Re: K991898 HyTek™ Guidewire Trade Name: Requlatory Class: II Product Code: DQX Dated: June 3, 1999 Received: June 4, 1999

Dear Ms. Mallery:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ms. Angela Mallery

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application

HyTek Guidewire

The 0.035" and 0.025" Hytek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>for Callahan</i> |
|-----------------------------------|---------------------|
| (Division Sign-Off) | |
| F of Cardiovascular, Respiratory, | |
| logical Devices | |
| K(k) Number | K991898 |

| Prescription Use<br>(Per 21 CRF 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|

HyTek 510(k)Indications for Use - 1