GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

K023878 · Medtronic Vascular · NFA · Jan 24, 2003 · Cardiovascular

Device Facts

• Record ID: K023878
• Device Name: GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
• Applicant: Medtronic Vascular
• Product Code: NFA · Cardiovascular
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GuardWire 3-6 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 percutaneous transluminal coronary 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

GuardWire 3-6 Temporary Occlusion & Aspiration System provides temporary vascular occlusion and embolic protection during coronary saphenous vein bypass graft interventions. System components include GuardWire Temporary Occlusion Catheter, EZ Adapter (actuator), Export Aspiration Catheter, and EZ Flator Inflation Device. Device used by physicians in clinical settings during angioplasty or stenting. Occlusion catheter balloon inflated via EZ Flator to contain embolic debris; aspiration catheter removes thrombus/debris. System also enables subselective infusion of diagnostic or therapeutic agents. Modification involves replacing MicroSeal Adapter with EZ Adapter, which maintains identical mechanical functions: holding catheter in fixed position, actuating MicroSeal plug via linear movement, and facilitating balloon inflation/deflation. Benefits include reduced risk of distal embolization during coronary procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes occlusion catheter, aspiration catheter, inflation device, and adapter. EZ Adapter provides mechanical actuation of the MicroSeal plug via linear movement and fluid communication for balloon inflation. Materials and manufacturing processes are equivalent to the predicate MicroSeal Adapter. Device is a percutaneous catheter system (21 CFR 870.1250).

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty or stenting in coronary saphenous vein bypass grafts. Contraindicated for use in 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.

Predicate Devices

• GuardWire Temporary Occlusion and Aspiration System (K023878)

Submission Summary (Full Text)

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K023878

JAN 2 4 2003

# Section 6 Summary of Safety and Effectiveness

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)

### 1. ldentifying Information: Submitters Name: Medtronic AVE, Inc. 1.1. 37A Cherry Hill Drive Danvers, MA 01923 1.2. Contact Person: Fred L. Boucher R.A.C. [phone] 2. Classification Name: Device, Coronary Saphenous Vein Graft, Temporary, for Embolization Protection (21 CFR Part 870.1250) 3. Proprietary Name: GuardWire Temporary Occlusion and Aspiration System 4. Name of Predicate Devices: GuardWire Temporary Occlusion and

#### 5. Description:

The GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in coronary saphenous bypass grafts. The system is used to contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures and is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal® Adapter and the Export® Aspiration Catheter and the EZ Flator Inflation Device. The GuardWire may also be used during these procedures alone or in conjunction with the Export Catheter to locally infuse diagnostic or therapeutic agents with or without vessel occlusion.

Aspiration System

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The modification to the GuardWire system addressed with this submission entails the introduction of the EZ-Adapter as a replacement for the MicroSeal Adapter (MSA), as the device that actuates the MicroSeal of the GuardWire device.

Both the EZ Adapter and the MicroSeal Adapter provide the same mechanical functions:

- hold the GuardWire in a static fixed position, ●
- actuate, through linear movement, the MicroSeal plug system of the . GuardWire, and
- provide direct communication from the EZ Flator inflation device to the . GuardWire balloon to facilitate inflation or deflation of the GuardWire balloon.

### Intended-Use:

The GuardWire 3-6 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 percutaneous transluminal coronary 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.

## Technology:

The EZ Adapter is manufactured under the same conditions, using the similar processes and equivalent materials, as the MicroSeal Adapter that is contained in the GuardWire Temporary Occlusion and Aspiration System; the leqally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.

The EZ Adapter has been subjected to performance testing and it has been determined that the EZ Adapter is substantially equivalent to the MicroSeal Adapter.

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JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fred L. Boucher, R.A.C. Sr. Regulatory Affairs Manager Medtronic AVE 37A Cherry Hill Drive Danvers, MA 01923

Re: K023878

> Trade/Device Name: GuardWire 3-6 Temporary Occlusion and Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NFA Dated: December 24, 2002 Received: December 26, 2002

Dear Mr. Boucher:

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

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Page 2 -- Mr. Fred Boucher

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 procéed 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 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 yours,

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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510(k) Number: K023878

Device Name: GuardWire Temporary Occlusion and aspiration System

Indications for Use:

The GuardWire 3-6 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 percutaneous transluminal coronary 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)

OR

Over-The-Counter -

Noleth

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K023878