RADIUS COUGAR WIRE

K032899 · Radius Medical Technologies, Inc. · DQX · Oct 17, 2003 · Cardiovascular

Device Facts

• Record ID: K032899
• Device Name: RADIUS COUGAR WIRE
• Applicant: Radius Medical Technologies, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Modified Radius Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Modified Radius Cougar Wires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an 014 guidewire.

Device Story

The Radius Cougar Wire is a cardiovascular guidewire used to facilitate the placement of balloon dilatation catheters during PTCA and PTA procedures. It consists of a composite stainless steel and Nitinol core with a tapered distal section attached to a coil. The proximal section features a PTFE coating, while the distal coil is hydrophilic coated. The device is used by clinicians in a clinical setting to navigate the vasculature for catheter placement. It is provided sterile via ETO gas sterilization. The device functions as a mechanical guide for interventional equipment.

Clinical Evidence

Bench testing only. Testing included tensile strength, accelerated age testing, coating adherence/integrity, and biocompatibility.

Technological Characteristics

Composite stainless steel and Nitinol core; PTFE proximal coating; hydrophilic distal coil coating; ETO gas sterilization; compatible with .014 guidewire systems.

Indications for Use

Indicated for facilitating the placement of balloon dilatation catheters during PTCA and/or PTA procedures in patients requiring such interventions.

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

• Radius PTCA Guidewire (K970466)
• Radius Cougar Wire (K011287)

Submission Summary (Full Text)

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OCT 17 2003

# Attachment 6 510(k) Summary of Safety and Effectiveness September 15, 2003

## GENERAL INFORMATION A.

| Submitter's Name: | Radius Medical Technologies, Inc. | |
|----------------------|-------------------------------------|--|
| Address: | 15 Craig Road<br>Acton, MA 01720 | |
| Contact Person: | Maureen A. Finlayson | |
| Device Generic Name: | PTCA Guidewire | |
| Device Trade Name: | Radius Cougar Wire | |
| Classification Name: | Wire, Guide, Cardiovascular (74DOX) | |

#### B. INDICATIONS

The Modified Radius Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Modified Radius Cougar Wires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an 014 guidewire.

#### ட் DESCRIPTIVE CHARACTERISTICS

The Modified Radius Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

### COMPARATIVE INFORMATION D.

The Modified Radius Cougar Wire is substantially equivalent to the currently marketed Radius PTCA Guidewire (K970466) and the Radius Cougar Wire (K011287).

#### PERFORMANCE TESTING E.

The following in vitro performance tests were performed on the Modified Radius Cougar Wire: 1. Tensile Strength

- 2. Accelerated Age Testing
- 3. Coating Adherence/Integrity
- 4. Biocompatability

# CONCLUSION:

Based on the indications for use, technological characteristics, and safety and performance testing, the proposed modifications to the Radius Cougar Wire meets the minimum requirements that are considered adequate for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness.

OCT 17 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radius Medical Technologies, Inc. c/o Ms. Debbie Iampietro 7 Tiffany Trail Hopkinton, MA 01748

Re: K032899

Trade Name: Radius Cougar Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: September 15, 2003 Received: September 18, 2003

Dear Ms. Iampietro:

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. Ilsting 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.

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

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Page 2 – Ms. Debbie Iampietro

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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mefan Mup
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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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Radius Cougar Wire

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Indications For Use:

______________________________________________________________________________________________________________________________________________________________________________

Radius Cougar Wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

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

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|--------------------------------------------------------|----------------------|
| (Division Sign-Off) | | |
| Division of Cardiovascular Devices | | |
| 510(k) Number | K032899 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |