GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID

K072990 · Medtronic, Inc. · NTE · Oct 31, 2007 · Cardiovascular

Device Facts

• Record ID: K072990
• Device Name: GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
• Applicant: Medtronic, Inc.
• Product Code: NTE · Cardiovascular
• Decision Date: Oct 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to: . Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures. . Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter. . To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion. . The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.

Device Story

System comprises GuardWire Temporary Occlusion Catheter, EZ Adaptor, Export Catheter, and EZ Flator inflation device. GuardWire features distal elastomeric occlusion balloon on hypotube wire with lubricious coating and radiopaque tip. EZ Flator provides controlled volumetric inflation/deflation of balloon using diluted contrast. Export Catheter facilitates aspiration of embolic material (thrombus/debris) during carotid angioplasty or stenting. Used by physicians in clinical settings to contain debris, facilitate catheter placement, or locally deliver therapeutic agents. System benefits patients by reducing risk of distal embolization during carotid interventions.

Clinical Evidence

Safety and performance supported by MAVErIC I & II clinical trials.

Technological Characteristics

Balloon-on-a-hypotube-wire catheter; distal elastomeric occlusion balloon; lubricious coating; radiopaque tip markers; manual inflation/deflation via EZ Flator device using diluted contrast; Luer-lock connections.

Indications for Use

Indicated for patients undergoing carotid artery angioplasty or stenting requiring embolic protection; specifically for vessels with diameters between 3 and 6 mm.

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® 3-6 Temporary Occlusion and Aspiration System (K023878)
• 6F Export® Catheter (K030201)
• Export® XT Catheter (K061958)
• RX ACCUNET™ Embolic Protection System (K052166)
• SpideRX® Embolic Protection Device (K052659)
• The Emboshield® Embolic Protection System (K052454)

Submission Summary (Full Text)

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### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 3 3 1 2017 (Pursuant to Section 12, Safe Medical Devices Act of 1990)

#### 1. Identifying Information:

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923 |
|-----------------|---------------------------------------------------------------------|
| Contact Person: | Karen A. Brozowski.<br>Regulatory Affairs Manager<br>[phone] |

- Classification Name: Catheter, carotid, temporary, for embolization capture (21 2. CFR Part 870.1250) Product Code NTE
- GuardWire® Temporary Occlusion and Aspiration System 3. Proprietary Name:

#### Name of Predicate Devices: 4.

| GuardWire® 3-6 Temporary Occlusion and Aspiration System | K023878 |
|----------------------------------------------------------|---------|
| 6F Export® Catheter | K030201 |
| Export® XT Catheter | K061958 |
| RX ACCUNET™ Embolic Protection System | K052166 |
| SpideRX® Embolic Protection Device | K052659 |
| The Emboshield® Embolic Protection System | K052454 |

### 5. Description:

The GuardWire® Temporary Occlusion and Aspiration System is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the EZ Adaptor device, the Export® Catheter, and the EZ Flator Inflation device.

The GuardWire Temporary Occlusion Catheter is a "balloon-on-a-hypotube-wire" catheter with a distal elastomeric occlusion balloon. It has a lubricious coating and a flexible radiopaque tip. The GuardWire Temporary Occlusion Catheter is packaged

## CONFIDENTIAL

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with an Introducer Sheath, an EZ Adaptor device, and an EZ Flator Inflation Device. The EZ Adaptor device is used exclusively with the GuardWire Temporary Occlusion Catheter for the purpose of controlled volumetric inflation and deflation of the temporary occlusion balloon.

The EZ Flator device is used exclusively with the GuardWire Temporary Occlusion Catheter during catheter preparation, inflation and deflation of the balloon. The EZ Flator device delivers a controlled volume when inflating the balloon to each occlusion size. It has an integrated deflation syringe used for catheter preparation and balloon deflation and has a reservoir for diluted contrast solution.

The Export Catheter is compatible with the GuardWire Temporary Occlusion Catheter and has a distal radiopaque tip marker and proximal Luer-lock port.

### 6. Intended-Use:

ﺎ ﻓﻲ

The GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to:

- . Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures.
- . Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter.
- . To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- . The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.

#### 7. Summary Of Substantial Equivalence:

The GuardWire 3-6 Temporary Occlusion and Aspiration System for carotid artery use is manufactured under the same conditions, using the same processes and materials as the legally marketed GuardWire predicate devices, K023878, In addition to being technologically equivalent to the GuardWire K030201. predicate devices, the indications for use are substantially equivalent the predicated devices described in K052454, K052659 and K052166. The safety and

## INFIDENTIAL

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performance of the GuardWire 3-6 Temporary Occlusion and Aspiration System for use in carotid arteries is supported by the MAVErIC I & II clinical trials.

.

# CONFIDENTIAL

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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2007

Medtronic Vascular, Inc. c/o Ms. Karen A. Brozowski Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923

Re: K072990

Trade/Device Name: GuardWire Temporary Occlusion and Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: NTE Dated: April 23, 2007 Received: October 24, 2007

Dear Ms. Brozowski:

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. Karen A. Brozowski

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Dune R. Volmer

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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# CONFIDENTIAL

### Indications for Use

### 510(k) Number: Ko72990

Device Name: GuardWire® Temporary Occlusion and Aspiration System

### Indications for Use:

The GuardWire Temporary Occlusion and Aspiration System is indicated for use in carotid arteries to:

- . Contain and aspirate embolic material (thrombus/debris) while performing angioplasty or stenting procedures.
- . Facilitate placement and use of diagnostic or therapeutic catheters using the GuardWire Temporary Occlusion Catheter.
- . To locally infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- . The diameter of the artery where the occlusion balloon is placed should be between 3 and 6 mm.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Duna R. Holmes

ision Sign-Off) sion of Cardiovascular Devices

510(k) Number_K072990