(21 days)
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.
The GuardDOG System consists of two components: An Occlusion Guidewire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guidewire once it is in position.
I am sorry, but the provided text only refers to mechanical, biocompatibility, sterility, and animal testing without going into the specifics of the acceptance criteria or how the device performance was measured against them. Consequently, I cannot provide an answer following the requested template as it would require information not present in the given document.
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K081454
p. 1 of 1
Section 5 – 510k Summary Information
:
:
JUN 1 3 2008
| Applicant: | Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003Tel: (612) 780-4555Fax: (612) 780-2227 ERN: 2183460 |
|---|---|
| Contact Person: | Mike BurnsideSr. Regulatory Affairs AssociatePhone: (763) 780-4555Fax: (763) 780-2227Email: mike.burnside@possis.com |
| Date Prepared: | May 22, 2008 |
| Trade Name: | GuardDOG® Occlusion System |
| Common Name ofDevice/ Classificationand Code: | Vascular Clamp Product Code: MJNClass II/21 CFR 870.4450 Cardiovascular |
| Predicate Device: | The GuardDOG Occlusion System - K062220Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003 |
| Device Description: | The GuardDOG System consists of two components: An OcclusionGuidewire and a carbon dioxide (CO2) Inflation Device. TheGuardDOG Inflation Device is used to inflate the occlusion balloonand seal the guidewire once it is in position. |
| Intended Use: | The GuardDOG® Occlusion System is indicated for use in theperipheral vasculature to facilitate the localized infusion of therapeuticor diagnostic fluids, with or without vessel occlusion. |
| The safety and effectiveness of this device have not been establishedin the coronary, cerebral, or carotid vasculature. | |
| Summary ofTechnologicalCharacteristics: | Representative samples of the device underwent testing including butnot limited to mechanical testing, biocompatibility, sterility, andanimal testing. |
| Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to besubstantially equivalent to the predicate device listed above. Thisconclusion is based upon the devices' similarities in functional design,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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).