(9 days)
Not Found
No
The device description focuses on mechanical components and CO2 inflation, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The intended use of the device is to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion, meaning it's an accessory to deliver therapeutic fluids, not a therapeutic device itself.
No
The document states "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." This indicates the device is used to facilitate the infusion of diagnostic fluids, not to perform the diagnosis itself. Its function is to inflate a balloon to occlude a vessel and/or deliver fluids, which are mechanical actions rather than diagnostic measurements.
No
The device description clearly outlines two physical components: an Occlusion Guide Wire and a CO2 Inflation Device. These are hardware components, not software.
Based on the provided information, the GuardDOG™ Occlusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion" in the peripheral vasculature. This describes a device used in vivo (within the body) for delivering substances or occluding vessels, not for examining specimens in vitro (outside the body).
- Device Description: The description details a guide wire and an inflation device used to manipulate the guide wire within the body. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro testing.
Therefore, the GuardDOG™ Occlusion System is an interventional medical device used within the body, not an IVD.
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 (comma separated list FDA assigned to the subject device)
MJN
Device Description
The GuardDOG System consists of two components: an Occlusion Guide Wire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guide Wire once it is in position.
The GuardDOG Guide wire is 0.035" in size; 300cm in length (260cm working length); is compatible with a 0.038, or larger, guide catheter; has a shapeable tip; a radiopaque marker proximal and distal to the inflatable balloon; and a crimp zone that can be sealed to maintain balloon inflation on the proximal end.
The GuardDOG Inflation device is used to inflate the occlusion balloon and seal the guide wire once it is in position. The GuardDOG Inflation device is a disposable CO2 delivery device with two integrated syringes and a gauge. One syringe contains 20cc of CO2 and the second syringe is used to evacuate air from the Occlusion Guide Wire. The gauge is used to measure pressure of CO2 delivered. The GuardDOG Inflation device is packaged in Tyvek pouch for sterilization and then into a sealable can to maintain the CO2 environment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of the device underwent testing including but not limited to mechanical testing, biocompatibility, sterility, and animal testing.
Representative samples of the device underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility to demonstrate safety and effectiveness and appropriate functional and performance characteristics. Animal testing was conducted to demonstrate performance characteristics only.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section 3 – 510k Summary Information
AUG 1 1 2006
| Applicant: | Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003
Tel: (612) 780-4555
Fax: (612) 780-2227 ERN: 2183460 | Applicant: | Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003
Tel: (612) 780-4555
Fax: (612) 780-2227
Establishment Registration Number: 2183460 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark D. Stenoien
Director of Worldwide Regulatory Affairs
P. 763.717.1092
Email: mark.stenoien@possis.com | Contact Person: | Mark D. Stenoien
Director of World Wide Regulatory Affairs
P. 763.717.1092
Email: mark.stenoien@possis.com |
| Date Prepared: | 31 July 2006 | Date Prepared: | 31 July 2006 |
| Trade Name: | GuardDOG® Occlusion System | Contract Manufacture: | Synovis Interventional Solutions Inc.
475 Apollo Dr.
Lino Lakes, MN 55104
ERN #3004594493 |
| Common Name of
Device/ Classification
and Code: | Vascular Clamp Product Code: MJN
Class II/21 CFR 870.4450 Cardiovascular | Sterilizer Contractor: | Guide Wire:
STERIS Isomedix Services
380 90th Ave. NW, Coon Rapids, MN 55433
ERN#2183744
Inflation Device:
STERIS Isomedix Services
7828 Nagle Avenue Morton Grove, IL 60053
ERN#1450253 |
| Predicate Device: | The GuardDOG Occlusion System - K031357
Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003 | Trade Name: | GuardDOG™ Occlusion System |
| Device Description: | The GuardDOG System consists of two components: an Occlusion
Guide Wire and a carbon dioxide (CO2) Inflation Device. The
GuardDOG Inflation Device is used to inflate the occlusion balloon
and seal the guide Wire once it is in position. | Common Name of
Device/Product
Classification and
Code: | Vascular Clamp
Product Code: MJN
Class II/21 CFR 870.4450
Cardiovascular |
| 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. | Predicate Device: | The GuardDOG Occlusion System - K031357
Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433-8003 |
| | The safety and effectiveness of this device have not been established
in the coronary, cerebral, or carotid vasculature. | Device Description: | The GuardDOG System consists of two components: an Occlusion
Guide wire and a carbon dioxide (CO2) Inflation Device. The
GuardDOG Guide wire is 0.035" in size; 300cm in length (260cm
working length); is compatible with a 0.038, or larger, guide catheter;
has a shapeable tip; a radiopaque marker proximal and distal to the
inflatable balloon; and a crimp zone that can be sealed to maintain
balloon inflation on the proximal end.
The GuardDOG Inflation device is used to inflate the occlusion
balloon and seal the guide wire once it is in position. The GuardDOG
Inflation device is a disposable CO2 delivery device with two |
| 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 and
demonstrate appropriate safety and efficacy of the GuardDOG
Occlusion System for use in the peripheral vasculature to facilitate the
localized infusion of therapeutic or diagnostic fluids, with or without
vessel occlusion. | | |
1
Section 4 -- General Information
:
:
.
2
| | integrated syringes and a gauge. One syringe contains 20cc of CO2
and the second syringe is used to evacuate air from the Occlusion
Guide Wire. The gauge is used to measure pressure of CO2 delivered.
The GuardDOG Inflation device is packaged in Tyvek pouch for
sterilization and then into a sealable can to maintain the CO2
environment. |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 bench testing,
including but not limited to mechanical testing, biocompatibility,
sterility to demonstrate safety and effectiveness and appropriate
functional and performance characteristics. Animal testing was
conducted to demonstrate performance characteristics only. |
| Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to be
substantially equivalent to the predicate device listed above and
demonstrate appropriate safety and efficacy of the GuardDOG—
Occlusion System for use in the peripheral vasculature to facilitate the
localized infusion of therapeutic or diagnostic fluids, with or without
vessel occlusion.
This conclusion is based upon the devices' similarities in functional
design, materials, indications for use, and principles of operation. |
:
and the comments of the country of
:
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Possis Medical, Inc. c/o Mr. Mark Stenoien Director of Worldwide Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K062220
GuardDog Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II (Two) Product Code: MJN Dated: July 31, 2006 Received: August 2, 2006
Dear Mr. Stenoien:
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). and ooometherefore, 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.
4
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 that i Drederal 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 Office of Compliance at (240) 276-0120. 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 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 yours,
Duna R. Lochner
( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 2 - Indications For Use Statement
510(k) Number (if known): K O6 2220
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 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 OF NEEDED)
Duna R. Vicker
cm
ision Sian-Off Division of Cardiovascular Devices
510(k) Number 40622 0
Possis Special 510k for the GuardDOG Occlusion System
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