TECHDEVICE GUIDEWIRE

K053251 · Techdevice Corporation · DQX · Mar 8, 2006 · Cardiovascular

Device Facts

• Record ID: K053251
• Device Name: TECHDEVICE GUIDEWIRE
• Applicant: Techdevice Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use

Device Story

The TechDevice Guidewire is a peripheral vascular guidewire used to facilitate catheter and instrument placement/exchange. It consists of a stainless steel core wire with a stainless steel or platinum coil; may include PTFE coating or jacket; platinum marker bands for visualization; and proximal exit markers for depth determination. Used by physicians in clinical settings. The device is a mechanical tool; no electronic or software components. Benefit is improved navigation and positioning of interventional devices within the peripheral vasculature.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel core wire; stainless steel or platinum coil; PTFE spray or jacket coating; platinum marker bands. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for facilitating placement and exchange of catheters and other instruments in the peripheral vasculature. Not indicated for neuro or cardiac use.

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

• Guidewire (K943737)
• Guidewire (K935997)
• Guidewire (K933334)

Submission Summary (Full Text)

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TechDevice Corporation November 15, 2005

510(k) Premarket Notification (Traditional)

# 510(k) Summary

Vascular Guidewire
K053251

## General Company Information

| Name | TechDevice Corporation | MAR 8 2006 |
|----------------------------|------------------------------------------------------------------------|------------------|
| Address | 650 Pleasant Street<br>Watertown, MA 02472 | |
| Contact: | Leigh Hayward | |
| Telephone: | 617-972-5808 | |
| General Device Information | | |
| Product Name: | TechDevice Guidewire | |
| Common Name: | Guidewire | |
| Classification: | DQX, Catheter guide wire | 21 CFR 870. 1330 |
| Predicate Devices | Guidewire K943737<br>Boston Scientific Corporation<br>Natick, MA 01760 | |
| | Guidewire K935997<br>Boston Scientific Corporation<br>Natick, MA 01760 | |
| | Guidewire K933334<br>Boston Scientific Corporation<br>Natick MA 01760 | |

## Product Description:

The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.

#### Indications for Use:

The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use

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#### Safety and Performance:

Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate device, as well as on the results of comparative bench testing. Comparative performance testing included:

- Tensile Strength A.
- Torque Strength B.
- ്. Torqueability
- Tip Flexibility D.
- ட். Coating Integrity

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the TechDevice Guidewire has been shown to be safe and effective for its intended use.

160

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DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 8

TechDevice Corporation c/o Mr. Leigh Hayward Director of Technical Operations 650 Pleasant Street Watertown, MA 02472

Re: K053251

TechDevice Guidewire 1 cent20.100 Sula01722 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: February 10, 2006 Received: February 14, 2006

## Dear Mr. Hayward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for abound in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered province may 2011 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Leigh Hayward

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any it cacal statutes und regaranents, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)01); good manufacturing practice requirements as set CFR Part 8077, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product lanation control pro holens (s seting your device as described in your Section 510(k) This letter will anow yours of substantial equivalence of your device of your device to a legally prematics notification. The station 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), please If you desire specific advice 101-10-101-01-240) 276-0120. Also, please note the regulation entitled, Connact the Orition of Compullier in (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna R. Vidmer

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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TechDevice Corporation

Page

510(k) Number (if known): K053251

TechDevice Guidewire Device Name:

Indications for Use:

The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. de Juney

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 5 12 5 1