CPS COURIER GUIDEWIRE

K073082 · Brivant, Ltd. · DQX · Jan 9, 2008 · Cardiovascular

Device Facts

• Record ID: K073082
• Device Name: CPS COURIER GUIDEWIRE
• Applicant: Brivant, Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.

Device Story

Disposable, single-use guidewire; 0.014" diameter stainless steel core; distal end reduced via centreless grinding for variable stiffness; polymer-coated body; distal tip features 0.010" platinum/tungsten alloy coil for x-ray visibility; attached via solder joints. Used by physicians in clinical settings (coronary/peripheral vasculature) to facilitate catheter placement. Provides tactile feedback and radiopaque visualization to assist navigation through vasculature.

Clinical Evidence

Bench testing only. Performance testing included tensile strength, torque strength, torque response, coating performance, radiopacity, tip flexibility, catheter compatibility, accelerated aging, and biocompatibility (ISO 10993-1). Results demonstrated device performs within design parameters and is equivalent to predicate.

Technological Characteristics

0.014" stainless steel core; platinum/tungsten alloy distal coil; polymer coating. Dimensions vary by model (stiffness/tip shape). Sterilization and packaging consistent with predicate. No software or electronic components.

Indications for Use

Indicated for use in coronary and peripheral vasculature for patients requiring guidewire navigation during interventional procedures.

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

• Brivant Guidewire (K073082)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Brivant Medical Engineering. The word "BRIVANT" is in large, bold, sans-serif font. Below "BRIVANT" is the phrase "MEDICAL ENGINEERING" in a smaller, sans-serif font. There is a line separating the two phrases.

CPS Courier Guidewire Special 510(k)

# K073082

1/2

### 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

(1) Submitter's Name / Contact Person: Brivant Limited,

Parkmore West Business Park Galway. Ireland

JAN - 9 2008

Contact Person:

Tomas Furey, Vice President Regulatory Affairs Tel: [phone] Fax: [phone]

(2) Summary Preparation Date:

October 25, 2007

(3) Device Name and Classification:

Trade Name:

Common Name:

Classification Name:

Device Classification:

CPS Courier Guidewire, Extra Firm, Straight Tip. Catalogue Number: 901008-01

CPS Courier Guidewire, Extra Firm, J Tip. Catalogue Number: 901008-02

CPS Courier Guidewire, Firm, Straight Tip. Catalogue Number: 901008-03

CPS Courier Guidewire, Firm, J Tip. Catalogue Number: 901008-04

CPS Courier Guidewire, Medium, Straight Tip. Catalogue Number: 901008-05

CPS Courier Guidewire, Medium, J Tip. Catalogue Number: 901008-06

CPS Courier Guidewire, Soft, Straight Tip. Catalogue Number: 901008-07

CPS Courier Guidewire, Soft, J Tip. Catalogue Number: 901008-08

CPS Courier Guidewire, Extra Soft, Straight Tip. Catalogue Number: 901008-09

CPS Courier Guidewire, Extra Soft, J Tip. Catalogue Number: 901008-10

Guidewire

Catheter, Guidewire

Class II, 21 CFR §870.1330

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "BRIVANT" in large, bold letters. Below "BRIVANT" is the text "MEDICAL ENGINEERING" in a smaller font. There is a line separating the two texts.

## CPS Courier Guidewire Special 510(k)

K073082

Pg 2/2

#### (4) Summary of Substantial Equivalence

The CPS Courier quidewires have minor design differences with the predicate Brivant guidewire. The Brivant Guidewire has the same intended use and fundamental technology as the predicate Brivant Guidewire. The technical features are closely similar and where there are differences these differences are minor such that they do not affect safety or effectiveness and there is also supporting data to demonstrate that the new technical features have not diminished safety or effectiveness - as a result the CPS Courier Guidewire is substantially equivalent to the Brivant Guidewire predicate.

#### (5) Description of the Device:

The Courier Guide wire is a disposable medical device designed for single use only. It consists of a 0.014" diameter stainless steel core wire, the distal end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. The quide wire comes in 5 unique base models distinguished by their distal flexibility portions, the profile varied to provide a range of products of mixed stiffness. This reduced section is covered with a polymer coating of equivalent diameter to the main core body. Underneath the polymer at the distal tip there is a 0.010" platinum/tungsten alloy platinum coil attached to the distal tip of the core by means of solder joints. This provides greater visibility on x-ray equipment.

#### (6) Statement of Intended Use:

The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.

#### (7) Technological Characteristics.

Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are substantially equivalent to the currently marketed device.

#### (8) Summary of Testing:

Performance testing involving the following testing has been completed tensile strength, torque strength, torque response, coating performance, radiopacity, tip flexibility, catheter compatibility testing, accelerated aging and biocompatibility testing in compliance with ISO 10993-1 has been successfully completed. The successful tests demonstrated the CPS Courier Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices.

{2}------------------------------------------------

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

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Brivant, LTD c/o Mr. Thomas Furey Vice President Regulatory Affairs Parkmore West Business Park Galway, Ireland

Re: K073082

> Trade Name: CPS Courier Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: December 18, 2007 Received: December 20, 2007

Dear Mr. Furey:

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 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

{3}------------------------------------------------

Page 2 - Mr. Thomas Furey

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Dina R. Vuchner

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

Enclosure

{4}------------------------------------------------

દ્વાર)

Image /page/4/Picture/1 description: The image shows the logo for Brivant Medical Engineering. The word "BRIVANT" is in large, bold, sans-serif font. Below that, in a smaller font, are the words "MEDICAL ENGINEERING". A horizontal line is above the words "MEDICAL ENGINEERING" and below the word "BRIVANT".

## CPS Courier Guidewire Special 510(k)

#### Indications for Use

510(k) Number (if known): K073082

Device Name: CPS Courier Guidewire

Indications for Use:

The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. Richter
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K073082