GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

K081454 · Possis Medical, Inc. · MJN · Jun 13, 2008 · Cardiovascular

Device Facts

• Record ID: K081454
• Device Name: GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
• Applicant: Possis Medical, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jun 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended Use

The GuardDOG® Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.

Device Story

GuardDOG Occlusion System comprises an occlusion guidewire and a CO2 inflation device. Used in peripheral vasculature to facilitate localized infusion of therapeutic or diagnostic fluids; enables vessel occlusion via balloon inflation. Operated by clinicians in clinical settings. Inflation device seals guidewire once positioned. Benefits include targeted delivery of fluids to specific vascular sites.

Clinical Evidence

Bench testing including mechanical testing, biocompatibility, and sterility; animal testing performed. No human clinical data provided.

Technological Characteristics

System consists of an occlusion guidewire and a CO2 inflation device. Mechanical device; no software or electronic components. Tested for biocompatibility and sterility.

Indications for Use

Indicated for use in peripheral vasculature to facilitate localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. Not indicated for coronary, cerebral, or carotid vasculature.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• GuardDOG Occlusion System (K062220)

Submission Summary (Full Text)

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K081454
p. 1 of 1

## Section 5 – 510k Summary Information

:

:

## JUN 1 3 2008

| Applicant: | Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003<br>Tel: [phone]<br>Fax: [phone] ERN: 2183460 |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside<br>Sr. Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | May 22, 2008 |
| Trade Name: | GuardDOG® Occlusion System |
| Common Name of<br>Device/ Classification<br>and Code: | Vascular Clamp Product Code: MJN<br>Class II/21 CFR 870.4450 Cardiovascular |
| Predicate Device: | The GuardDOG Occlusion System - K062220<br>Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003 |
| Device Description: | The GuardDOG System consists of two components: An Occlusion<br>Guidewire and a carbon dioxide (CO2) Inflation Device. The<br>GuardDOG Inflation Device is used to inflate the occlusion balloon<br>and seal the guidewire once it is in position. |
| Intended Use: | The GuardDOG® Occlusion System is indicated for use in the<br>peripheral vasculature to facilitate the localized infusion of therapeutic<br>or diagnostic fluids, with or without vessel occlusion. |
| | The safety and effectiveness of this device have not been established<br>in the coronary, cerebral, or carotid vasculature. |
| Summary of<br>Technological<br>Characteristics: | Representative samples of the device underwent testing including but<br>not limited to mechanical testing, biocompatibility, sterility, and<br>animal testing. |
| Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to be<br>substantially equivalent to the predicate device listed above. This<br>conclusion is based upon the devices' similarities in functional design,<br>materials, indications for use, and principles of operation. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 13 2008

Possis Medical, Inc. c/o Mr. Mike Burnside Sr. Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433

Re: K081454

Trade/Device Name: GuardDOG Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: MJN Dated: May 22, 2008 Received: May 23, 2008

Dear Mr. Burnside:

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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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 promarket 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 vours.

R. verhner

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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### Indication for Use

# 510(k) Number (if known): K 08 1454

Device Name: The GuardDOG® Occlusion System

### Indications for Use:

The GuardDOG Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.

The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.

Prescription Use
(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Umma R. Vachner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_608)454