BACK-UP MEIER GUIDEWIRE

K011906 · Boston Scientific Corp · DQX · Aug 13, 2001 · Cardiovascular

Device Facts

• Record ID: K011906
• Device Name: BACK-UP MEIER GUIDEWIRE
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Back-Up Meier Guidewires are intended to facilitates placement of a catheter during diagnostic or interventional intravascular procedures The Back-Up Meier Guidewires are sterile, single-use wires and are available in different tip shapes with overall wire lengths of 185 cm - 300 cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy.

Device Story

Back-Up Meier Guidewire is a sterile, single-use intravascular device; facilitates catheter placement during diagnostic or interventional procedures. Distal segment is radiopaque for fluoroscopic visualization. Available in various tip shapes; lengths 185 cm - 300 cm. Used by physicians in clinical settings (e.g., cath lab) during intravascular interventions. Device provides mechanical support and guidance for catheter navigation through vasculature; aids in successful delivery of diagnostic or therapeutic tools.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Sterile, single-use guidewire; radiopaque distal segment for fluoroscopy. Available in multiple tip shapes; lengths 185-300 cm. Biocompatibility per ISO 10993.

Indications for Use

Indicated for facilitating catheter placement during diagnostic or interventional intravascular procedures in patients requiring such 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

• Platinum Plus Guidewire
• Amplatz Super Stiff Guidewire

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Back-Up Meier Guidewire<br>Classification Name: Wire, Guide |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Platinum Plus Guidewire<br>Amplatz Super Stiff Guidewire |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Back-Up Meier Guidewires are intended to facilitates placement of a<br>catheter during diagnostic or interventional intravascular procedures The<br>Back-Up Meier Guidewires are sterile, single-use wires and are available in<br>different tip shapes with overall wire lengths of 185 cm - 300 cm. The distal<br>segment of the wire is radiopaque to aid in visualization of the device under<br>fluoroscopy. |
| Biocompatibility | The Back-Up Meier Guidewires have been tested for biocompatibility per<br>ISO 10993. All data demonstrate this device is biocompatible for its intended<br>use. |
| Summary of<br>Substantial<br>Equivalence | The Back-Up Meier Guidewires have been tested and compared to the<br>predicate devices. All data gathered demonstrate this device as substantially<br>equivalent. No new issues of safety or efficacy have been raised. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing-like shapes, symbolizing health, services, and human needs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2001

Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Re: K011906 Back-Up Meier Steerable Guidewire Regulation Number: 870.1330 Regulatory Class: II (two) Product Code: 74 DQX Dated: June 18, 2001 Received: June 19, 2001

Dear Ms. Greenizen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your beedon Fre(is) hostantially equivalent (for the indications for use stated in and we nave decemmiou the aboved redicate devices marketed in interstate commerce prior to the enclosure) to regally marketed producato accass or to devices that have been May 26, 1970, the Chaomicit date of the Federal Food, Drug, and Cosmetic Act (Act). Teclassified in accordance market the device, subject to the general controls provisions of the Act. The Tourmay, therefore, market the Act include requirements for annual registration, listing of general controls profisions of actice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your do round the may be subject to such additional controls. Existing major regulations affecting your Apployal), it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 10gulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 Dri) 111 vertir varily cadition, FDA may publish further announcements concerning may rount in regulater, as Register. Please note: this response to your premarket notification your dovioe in the Pouch any obligation you might have under sections 531 through 542 of the submission does not arroer any overgised your and and provisions, or other Federal laws or regulations.

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Page 2 - Ms. Jodi Lynn Greenizen

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

J. E. Dillard, III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

| 510(k) Number (if known) | Unknown |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | K011906 |
| Device Name: | Back-Up Meier Guidewire |
| Indications for Use | The Back-Up Meier Guidewire is intended to facilitate placement of a catheter during diagnostic or interventional intravascular procedures. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Regulatory Devices
510(k) Number

| Prescription Use (Per 21 CFR 801.109) | <span></span> |
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OR

| Over-The Counter Use (Optional Format 1-2-96) | <span></span> |
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