MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM

K014223 · Medtronic Percusurge, Inc. · NFA · Jan 25, 2002 · Cardiovascular

Device Facts

• Record ID: K014223
• Device Name: MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
• Applicant: Medtronic Percusurge, Inc.
• Product Code: NFA · Cardiovascular
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to: - Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures. - To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion. - The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

Device Story

PercuSurge GuardWire Plus is a temporary occlusion and aspiration system used during coronary saphenous vein bypass graft interventions. Device functions as an embolic protection system; utilizes a distal occlusion balloon to block vessel flow; allows for aspiration of thrombus/debris and infusion of therapeutic agents. Operated by physicians in a catheterization lab/interventional setting. Provides embolic protection to reduce distal embolization risks during angioplasty or stenting. Output is mechanical containment of debris and localized delivery of agents.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on device design and intended use.

Technological Characteristics

Percutaneous catheter system; includes distal occlusion balloon for vessel occlusion and aspiration lumen. Designed for coronary saphenous vein bypass graft access. Class II device (Product Code NFA).

Indications for Use

Indicated for patients undergoing angioplasty or stenting in coronary saphenous vein bypass grafts. Used for containment/aspiration of embolic material and delivery of diagnostic/therapeutic agents. Not indicated for cerebral, carotid, or peripheral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Mr. Matthew Moon Regulatory Manager Medtronic PercuSurge, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

Re: K014223

> Percusurge GuardWire Plus Temporary Occlusion and Aspiration System Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: NFA Dated: December 21, 2001 Received: December 26, 2001

Dear Mr. Moon:

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 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.

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Page 2 - Mr. Matthew Moon

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 and additionally 21 CFR Part 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 Part 807.97). 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 vours.

N. Orellana Tiller

Bram 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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510(k) Number K014223

Device Name

Device Name

## Indications for Use

The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

- Contain and aspirate embolic material (thrombus/debris) while performing . Somain and aspenary angioplasty or stenting procedures.
- To subselectively infuse/deliver diagnostic or therapeutic agents with or . without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)