BACK-UP MEIER STEERABLE GUIDEWIRE

K020283 · Boston Scientific Corp · DQX · Feb 11, 2002 · Cardiovascular

Device Facts

• Record ID: K020283
• Device Name: BACK-UP MEIER STEERABLE GUIDEWIRE
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Back-Up Meier Steerable Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures.

Device Story

The Back-Up Meier Steerable Guidewire is a sterile, single-use device designed to assist clinicians in navigating and exchanging catheters during diagnostic or interventional procedures, specifically AAA endovascular graft procedures. The device features a radiopaque distal segment to allow for visualization under fluoroscopy. It is available in various tip shapes and lengths ranging from 185cm to 300cm. The guidewire is operated by a physician in a clinical setting (e.g., interventional suite). By providing a steerable path, the device facilitates the precise placement of catheters, which aids in the successful completion of endovascular procedures and potentially improves patient outcomes by enabling minimally invasive access.

Clinical Evidence

Bench testing and biocompatibility testing only. No clinical data provided.

Technological Characteristics

Sterile, single-use guidewire. Features radiopaque distal segment for fluoroscopic visualization. Available in multiple tip shapes and lengths (185cm-300cm). Class II device (Product Code DQX).

Indications for Use

Indicated for facilitating catheter placement and exchange during diagnostic or interventional procedures, including AAA endovascular graft 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

• Back-Up Meier Steerable Guidewire (K011906)

Submission Summary (Full Text)

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KO20283
January 25, 2002

### ATTACHMENT H

FEB 1 1 2002

## SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the proposed Back-Up Meier Steerable Guidewire is as follows:

| Trade Name: | Back-Up Meier Steerable Guidewire |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation<br>8600 NW 41st Street<br>Miami, Florida 33166-3355 |
| Device Generic Name: | Guidewire |
| Classification: | According to Section 13 of the Federal Food, Drug and<br>Cosmetic Act, the device classification is Class II,<br>Performance Standards. |
| Predicate Devices: | The following device is referenced in this premarket<br>notification as the predicate device for the Back-Up Meier<br>Steerable Guidewire: |
| | Boston Scientific Corporation -- Back-Up Meier Steerable<br>Guidewire (K011906) |
| | The device mentioned above has been determined<br>substantially equivalent by FDA. |

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The proposed Back-Up Meier Steerable Guidewires are Device Description: intended to facilitate catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. The Back-Up Meier Steerable Guidewires are sterile, single-use wirres and are available in different tip shapes with overall wire lengths of 185cm - 300cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy. The Back-Up Meier Steerable Guidewire facilitates catheter Indications for Use: placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. Safety and Performance: Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen. Based on the Indication for Use, technological Conclusion: characteristics and safety and performance testing, the Back-Up Meier Steerable Guidewire has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 1 2002

Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Re: K020283

Trade Name: Back-Up Meier Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: January 25, 2002 Received: January 28, 2002

Dear Ms. Bolton:

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.

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Page 2 - Ms. Jennifer Bolton, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issualled or our device complies with other requirements of the Act that IDA has made a decormination administered by other Federal agencies. You must or ally it edelal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr K Fatt 607), labeling (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (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) I hils letter will anow you to ogen mailing of substantial equivalence of your device to a legally prematication. The PDF intembers 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 and If you desire specific acrise for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 007.10 101 11:10 Till Times on the promotion and advertising of Compliance at (301) 594-610. Ticalationship, tions of [phone]. Also, please note the your device, prease connervanding by reference to premarket notification" (21CFR Part 807.97). Tegulation chitteed, "Wilsoranang of responsibilities under the Act may be obtained from the Outer general information on your respectional 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,

Kalle Mell
O. Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| <b>510(k) Number (if known):</b> | New Application |
|----------------------------------|-----------------|
|----------------------------------|-----------------|

Device Name:

Back-Up Meier Steerable Guidewire

Indications for Use:

The Back-Up Meier Steerable Guidewire facilitates catheter placement and exchange The Buok Op Molor Stockentional procedures including AAA endovascular graft procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020283

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)