(21 days)
Not Found
No
The summary describes a mechanical device for occlusion and fluid infusion, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for facilitating the localized infusion of therapeutic fluids in the peripheral vasculature.
No
The device is indicated to "facilitate the localized infusion of therapeutic or diagnostic fluids." While it helps in the delivery of diagnostic fluids, its primary function is not to diagnose conditions itself.
No
The device description explicitly states the system consists of two hardware components: an Occlusion Guidewire and a CO2 Inflation Device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion" within the peripheral vasculature. This describes a device used in vivo (within the body) for delivering substances or occluding vessels, not for testing samples in vitro (outside the body).
- Device Description: The description details a guidewire and an inflation device used to inflate a balloon within a blood vessel. This is consistent with an interventional medical device used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the GuardDOG® Occlusion System is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MJN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Representative samples of the device underwent testing including but not limited to mechanical testing, biocompatibility, sterility, and animal testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 55433-8003
Tel: (612) 780-4555
Fax: (612) 780-2227 ERN: 2183460 |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside
Sr. Regulatory Affairs Associate
Phone: (763) 780-4555
Fax: (763) 780-2227
Email: mike.burnside@possis.com |
| Date Prepared: | May 22, 2008 |
| Trade Name: | GuardDOG® Occlusion System |
| Common Name of
Device/ Classification
and Code: | Vascular Clamp Product Code: MJN
Class II/21 CFR 870.4450 Cardiovascular |
| Predicate Device: | The GuardDOG Occlusion System - K062220
Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003 |
| Device Description: | 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. |
| 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. |
| Summary of
Technological
Characteristics: | Representative samples of the device underwent testing including but
not limited to mechanical testing, biocompatibility, sterility, and
animal testing. |
| Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to be
substantially equivalent to the predicate device listed above. This
conclusion is based upon the devices' similarities in functional design,
materials, indications for use, and principles of operation. |
1
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
2
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
3
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