(9 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 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.
The provided text describes a 510(k) submission for the GuardDOG® Occlusion System (K062220). This submission focuses on demonstrating substantial equivalence to a predicate device (K031357), rather than proving device performance against specific acceptance criteria through a clinical study or a standalone algorithm study.
Therefore, the requested details regarding acceptance criteria, study findings against those criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not present in this document. The submission relies on non-clinical testing and comparison to a previously cleared device.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (mechanical, biocompatibility, sterility) and animal testing for performance characteristics, rather than reporting against specific, quantified acceptance criteria for overall device performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The document mentions "Representative samples of the device underwent testing," but does not specify sample sizes or data provenance for a "test set" in the context of clinical or algorithm performance. The animal testing was for "performance characteristics only."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not available in the provided document. The submission does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document. No such adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not available in the provided document. The device is a physical medical device (occlusion system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not available in the provided document. The submission discusses "bench testing" and "animal testing" to demonstrate "safety and effectiveness and appropriate functional and performance characteristics" and "performance characteristics only," respectively. This suggests engineering and pre-clinical data, not ground truth in the context of clinical outcomes or expert labels.
8. The sample size for the training set:
This information is not available in the provided document. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is not available in the provided document. The device is not an AI algorithm requiring a training set with established ground truth.
Summary of available information from the document related to substantiation:
The GardDOG Occlusion System (K062220) establishes substantial equivalence to its predicate device (K031357) based on:
- Technology Characteristics: Representative samples underwent bench testing, including mechanical testing, biocompatibility, and sterility.
- Animal Testing: Conducted to demonstrate performance characteristics only.
- Conclusion Basis: Similarities in functional design, materials, indications for use, and principles of operation between the proposed device and the predicate device.
The document is a 510(k) summary for a physical medical device and therefore does not contain the types of studies or data points typically associated with AI/algorithm-based devices.
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Section 3 – 510k Summary Information
AUG 1 1 2006
| Applicant: | Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003Tel: (612) 780-4555Fax: (612) 780-2227 ERN: 2183460 | Applicant: | Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003Tel: (612) 780-4555Fax: (612) 780-2227Establishment Registration Number: 2183460 |
|---|---|---|---|
| Contact Person: | Mark D. StenoienDirector of Worldwide Regulatory AffairsP. 763.717.1092Email: mark.stenoien@possis.com | Contact Person: | Mark D. StenoienDirector of World Wide Regulatory AffairsP. 763.717.1092Email: 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 55104ERN #3004594493 |
| Common Name ofDevice/ Classificationand Code: | Vascular Clamp Product Code: MJNClass II/21 CFR 870.4450 Cardiovascular | Sterilizer Contractor: | Guide Wire:STERIS Isomedix Services380 90th Ave. NW, Coon Rapids, MN 55433ERN#2183744Inflation Device:STERIS Isomedix Services7828 Nagle Avenue Morton Grove, IL 60053ERN#1450253 |
| Predicate Device: | The GuardDOG Occlusion System - K031357Possis 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 OcclusionGuide Wire and a carbon dioxide (CO2) Inflation Device. TheGuardDOG Inflation Device is used to inflate the occlusion balloonand seal the guide Wire once it is in position. | Common Name ofDevice/ProductClassification andCode: | Vascular ClampProduct Code: MJNClass II/21 CFR 870.4450Cardiovascular |
| 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. | Predicate Device: | The GuardDOG Occlusion System - K031357Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433-8003 |
| The safety and effectiveness of this device have not been establishedin the coronary, cerebral, or carotid vasculature. | Device Description: | The GuardDOG System consists of two components: an OcclusionGuide wire and a carbon dioxide (CO2) Inflation Device. TheGuardDOG Guide wire is 0.035" in size; 300cm in length (260cmworking length); is compatible with a 0.038, or larger, guide catheter;has a shapeable tip; a radiopaque marker proximal and distal to theinflatable balloon; and a crimp zone that can be sealed to maintainballoon inflation on the proximal end.The GuardDOG Inflation device is used to inflate the occlusionballoon and seal the guide wire once it is in position. The GuardDOGInflation device is a disposable CO2 delivery device with two | |
| 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 anddemonstrate appropriate safety and efficacy of the GuardDOGOcclusion System for use in the peripheral vasculature to facilitate thelocalized infusion of therapeutic or diagnostic fluids, with or withoutvessel occlusion. |
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Section 4 -- General Information
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:
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| integrated syringes and a gauge. One syringe contains 20cc of CO2and the second syringe is used to evacuate air from the OcclusionGuide Wire. The gauge is used to measure pressure of CO2 delivered.The GuardDOG Inflation device is packaged in Tyvek pouch forsterilization and then into a sealable can to maintain the CO2environment. | |
|---|---|
| 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 bench testing,including but not limited to mechanical testing, biocompatibility,sterility to demonstrate safety and effectiveness and appropriatefunctional and performance characteristics. Animal testing wasconducted to demonstrate performance characteristics only. |
| Conclusion: | Possis Medical, Inc. considers the GuardDOG Occlusion System to besubstantially equivalent to the predicate device listed above anddemonstrate appropriate safety and efficacy of the GuardDOG—Occlusion System for use in the peripheral vasculature to facilitate thelocalized infusion of therapeutic or diagnostic fluids, with or withoutvessel occlusion.This conclusion is based upon the devices' similarities in functionaldesign, materials, indications for use, and principles of operation. |
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and the comments of the country of
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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.
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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
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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
Page 6
§ 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).