GUIDEWIRES

K042264 · Rocket Medical Plc · DQX · Nov 24, 2004 · Cardiovascular

Device Facts

• Record ID: K042264
• Device Name: GUIDEWIRES
• Applicant: Rocket Medical Plc
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

Device Story

Guidewires function as mechanical aids for percutaneous catheter placement. Device inserted into catheter lumen to provide structural support and steerability during navigation through vasculature or natural body channels. Operated by clinicians in clinical settings. Device facilitates catheter advancement to target site; aids in procedural success. Excludes coronary and neurovascular applications.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by the device's long-standing commercial history (over 10 years) and absence of reported complaints.

Technological Characteristics

Mechanical guidewire for catheter navigation. Class II device (21 CFR 870.1330). Product code DQX.

Indications for Use

Indicated for use as a guidewire to direct percutaneous catheters through blood vessels or natural channels. Contraindicated for use in coronary arteries and the neurovasculature.

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.

Submission Summary (Full Text)

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#### Rocket Medical plc - 510(k) Notification IR™ Guidewires

# NOV 2 4 2004

K042264

### Summary of Safety and Effectiveness

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

Guidewires have been in commercial use for over 10 years and been found to be safe and effective for the application for which they are intended. No complaints have been reported to Rocket Medical Plc regarding the use or application of the guidewires.

Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

#### CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

16/8/04

Date

Tradura

Signed by Tracy Charlton Regulatory Affairs Manager Rocket Medical plc Wear Industrial Estate, Washington Tyne & Wear, England. NE38 9BZ

Image /page/0/Picture/13 description: The image contains the logo for Rocketmedical. The logo consists of a stylized letter "R" with a plus sign incorporated into its design, positioned above the word "Rocketmedical". The text is in a simple, sans-serif font.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

NOV 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rocket Medical Plc. c/o Ms. Tracy Charlton RA Manager Factories 2-4, Sedling Road Wear Industrial Estate Washington, Tyne, & Wear NE38 9BZ UNITED KINGDOM

Re: K042264

Trade Name: IR Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire. Regulatory Class: II (two) Product Code: DQX Dated: August 13, 2004 Received: August 23, 2004

#### Dear Ms. Charlton:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have and have 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.

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Page 2 - Ms. Tracy Charlton

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 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,

Duna R. Wehner

A/\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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## Indications for Use

510(k) Number (if known): KD42264

Device Name: Guidewires

Indications for Use:

The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

Prescription Use V (Part 21 CFR 801 Subpart D)

and / or

Over-The-Counter Usc (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Duna R. Vachner
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K642264