RADIUS 018 COUGAR WIRE

K032129 · Radius Medical Technologies, Inc. · DQX · Jul 17, 2003 · Cardiovascular

Device Facts

• Record ID: K032129
• Device Name: RADIUS 018 COUGAR WIRE
• Applicant: Radius Medical Technologies, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.

Device Story

Radius .018 Cougar Wire is a cardiovascular guidewire used to facilitate placement of balloon dilatation catheters during PTCA or PTA procedures. Device consists of composite stainless steel and Nitinol core with attached distal coil. Proximal section features PTFE coating; distal coil features hydrophilic coating. Used in clinical settings by physicians; device provides mechanical guidance for balloon catheters through vasculature. Benefits include improved trackability and catheter delivery. Device is sterile, single-use, and packaged in protective hoop.

Clinical Evidence

No clinical data. Bench testing only: tensile strength, torque strength, torqueability, tip flexibility, and coating adherence/integrity.

Technological Characteristics

Composite stainless steel and Nitinol core; distal coil; proximal PTFE coating; distal hydrophilic coating. Sterilized via ETO gas. Dimensions: .018 diameter.

Indications for Use

Indicated for patients undergoing PTCA or PTA procedures requiring the placement of balloon dilatation catheters compatible with .018 guidewires.

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 Cougar Guidewire (K011287)

Submission Summary (Full Text)

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# JUL 1 7 2003

## Attachment 6 510(k) Summary of Safety and Effectiveness July 9, 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 .018 Cougar Wire |
| Classification Name: | Wire, Guide, Cardiovascular (74DQX) |

#### INDICATIONS B.

The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.

#### DESCRIPTIVE CHARACTERISTICS C.

The Radius .018 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 Radius .018 Cougar Wire is substantially equivalent to the currently marketed Radius Cougar Guidewire (K011287).

#### E. PERFORMANCE TESTING

The following in vitro performance tests were performed on the Radius .018 Cougar Wire:

- 1. Tensile Strength
- 2. Torque Strength
- 3. Torqueability
- 4. Tip Flexibility
- 5. Coating Adherence/Integrity

## CONCLUSION:

Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Radius .018 Cougar Wire meets the minimum requirements that are considered adequate for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

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

Re: K032129

Radius 018 Cougar Wire Regulation Number: 870.1330 Regulation Name: Cardiovascular Guidewire Regulatory Class: Class II Product Code: DQX Dated: July 9, 2003 Received: July 10, 2003

Dear Ms. Iampiedro:

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.

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 - 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 (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. 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]. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

Bram D. Zuckerman, M.D.

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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Radius .018 Cougar Wire Device Name:

Indications For Use:

Radius .018 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) 510(k