(384 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: a carbon dioxide (CO2) Inflation Device and a balloon Occlusion Guide Wire. The GuardDOG Inflation Device is a disposable syringe assembly, which is prepackaged with carbon dioxide and is used to inflate the Occlusion Guide Wire. The GuardDOG Occlusion Guide Wire is a 200 or 300cm long by 0.014" outside diameter Catheter with an inflatable balloon on the distal end. The guide wire is inflated via a detachable hub, which is connected to the Inflation Device.
The Possis Medical, Inc.'s GuardDOG™ Occlusion System (K031357) was evaluated for its safety and effectiveness for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. The acceptance criteria and the study performance are summarized below:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it demonstrates equivalency to predicate devices and appropriate safety and efficacy through functional, mechanical, biocompatibility, and animal studies. The table below summarizes the comparison to predicate devices and the outcomes of the non-clinical tests.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Technical Characteristics Equivalence | Demonstrate equivalent technical characteristics to legally marketed predicate devices (PercuSurge™ GuardWire Temporary Occlusion Balloon System - K972777 and Equinox™ Occlusion Balloon – K990487). | - Indication/Intended Use: Identical to predicate device K972777. |
| - Major Components: Similar (Occlusion Guide Wire, Inflation Device). | ||
| - Number of lumens: Single lumen, same as predicate devices. | ||
| - Outer Diameter: 0.014 inch, same as predicate device K972777. | ||
| - Inflated balloon: 3-6 mm, comparable to 4, 4.5, 5 mm (K972777) and 4 mm (K990487). | ||
| - Balloon Material: Compliant elastomer, same as predicate devices. | ||
| - Sterility: Sterile, intended for single use, same as predicate devices. | ||
| - The GuardDOG Occlusion System is equivalent to the predicate devices in technical characteristics. | ||
| Functional and Mechanical Integrity | Verify equivalency to predicate devices and appropriate safety and efficacy for the intended use. Ensure the device functions as intended within specified parameters (e.g., burst diameter). | - Functional and mechanical integrity testing performed. Results verify equivalency to predicate devices and appropriate safety and efficacy. |
| - Rated burst diameter of 9.26 mm provides acceptable margin of error over the recommended 3-6 mm vessel occlusion range. | ||
| Inflation Medium Safety | Demonstrate safe use of CO2 as an inflation medium, with exposure limits and purity. | - CO2 is an accepted contrast agent in peripheral vasculature. |
| - Literature search showed CO2 doses of 5-250cc are safe in peripheral vasculature. | ||
| - GuardDOG System limits potential CO2 exposure to 5 cc or less. | ||
| - Packaged with CO2 maintained at high purity (>95%), mitigating air embolism risk upon balloon failure. | ||
| Biocompatibility | Meet ISO 10993-1 for external communicating, blood contact of short duration devices. | - Evaluated in compliance with GLP (21 CFR Part 58) and ISO 10993-1. |
| - Results demonstrate GuardDOG materials and manufacturing methods are appropriate and safe. | ||
| Vessel Safety (Acute Injury) | Incidence of acute vessel injury comparable to or better than predicate devices. | - Animal study compared incidence of acute vessel injury with GuardDOG vs. Equinox Occlusion Balloon Catheter in a canine model. |
| - GuardDOG performed well regarding vessel occlusion and did not cause significant vessel injury compared to the predicate device. | ||
| Device Integrity and Performance | Maintain device integrity, track to target, and deliver infusion catheter. Compatibility with standard interventional devices. | - Additional animal studies evaluated device integrity, tracking, and delivery of an infusion catheter. |
| - GuardDOG Occlusion System is compatible with standard interventional devices (introducers, guide catheters, infusion catheters) and is equivalent to predicate devices based on acceptable test results. | ||
| Sterilization & Packaging | Sterilized according to industry standards and packaging maintains sterile barrier and device integrity. | - Sterilized according to industry standard procedures. |
| - Packaged appropriately to maintain sterile barrier and device integrity. |
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical laboratory tests and animal studies.
- Test Set Sample Size: Not explicitly stated as a number of devices for specific tests (e.g., mechanical, functional). For the "Vessel Safety Animal Study," it involved a "canine model," but the precise number of animals is not provided. "Additional animal studies" are also mentioned without specific numbers.
- Data Provenance: The studies are non-clinical, involving laboratory testing and animal models (canine model).
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: These would be prospective studies, as they involve testing the device in controlled laboratory and animal settings specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the submission. For non-clinical device testing, "ground truth" is typically established by engineering specifications, validated test methods, and in animal studies, by veterinary and pathology assessments. The document mentions "results, reported in the Biocompatibility tab" and "a Vesscl Safety Animal Study... concluded that the GuardDOG performed well," implying expert interpretation by relevant specialists (e.g., toxicologists, pathologists, veterinarians), but their number or specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of non-clinical device testing and animal studies, adjudication methods like 2+1 or 3+1 are typically not applicable in the same way as human reader studies for image analysis. Findings would be based on objective measurements, observation, and pathological examination by qualified personnel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices where human interpretation of medical images is involved. The GuardDOG™ Occlusion System is an interventional medical device, not a diagnostic imaging device. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not performed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone "algorithm only" performance study was not done. The GuardDOG™ Occlusion System is a physical medical device (an occlusion guide wire and inflation device), not a software algorithm. Therefore, this type of study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device evaluation was established through:
- Engineering Specifications and Bench Testing: For functional and mechanical integrity (e.g., burst diameter, material properties).
- Biocompatibility Standards: Adherence to ISO 10993-1, evaluated via standardized test methods.
- Pathology/Veterinary Assessment: For the Vessel Safety Animal Study, acute vessel injury would be assessed by veterinary pathologists.
- Literature Review: For the safety of CO2 as an inflation medium, existing scientific literature served as a basis for safety.
8. Sample Size for the Training Set
This information is not applicable as the GuardDOG™ Occlusion System is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the GuardDOG™ Occlusion System is a physical medical device and does not involve a "training set" in the context of AI/ML algorithms.
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KO31354 11/4
GUARDDOG™ OCCLUSION SYSTEM MAY 1 8 2004 510(K) SUMMARY
| SUBMITTER'SINFORMATION | Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433 |
|---|---|
| Tel: (612) 780-4555Fax: (612) 780-2227 | |
| CONTACT | Mark D. StenoienManager, Regulatory & Clinical Affairs |
| SUMMARY DATE | 29 April 2003 |
| DEVICE TRADE NAME | GuardDOG™ Occlusion SystemGuardDOG Occlusion Guide Wire, 300 cmGuardDOG Occlusion Guide Wire, 200 cmGuardDOG Inflation Device |
| COMMON NAME | Temporary Occlusion Catheter |
| DEVICE CLASS | Catheter, Intravascular Occluding, Temporary(MJN, 21 CFR 870.4450) Class II |
| LEGALLY MARKETEDPREDICATE DEVICES | PercuSurge Temporary Occlusion Balloon System- K972777Medtronic PercuSurge Inc.540 Oakmead ParkwaySunnyvale, CA 94086 |
| Equinox Occlusion Balloon - K990487Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618 |
DEVICE DESCRIPTION
The GuardDOG System consists of two components: a carbon dioxide (CO2) Inflation Device and a balloon Occlusion Guide Wire. The GuardDOG Inflation Device is a disposable syringe assembly, which is prepackaged with carbon dioxide and is used to inflate the Occlusion Guide Wire. The GuardDOG Occlusion Guide Wire is a 200 or 300cm long by 0.014" outside diameter Catheter with an inflatable balloon on the distal end. The guide wire is inflated via a detachable hub, which is connected to the Inflation Device.
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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.
COMPARISON TO PREDICATE DEVICE:
Table 1 summarizes key technical characteristics and physical properties of the Perma-Pass Graft and the predicate device. This information is provided for two graft sizes denoted as follows: thin wall 6mm internal diameter (6T), and standard wall 6mm internal diameter (6S).
| GuardDOG™Occlusion System | PercuSurge™GuardWire TemporaryOcclusion BalloonSystem - K972777 | MicroTherapeutics,Inc. Equinox™Occlusion Balloon –K990487 | |
|---|---|---|---|
| Indication / IntendedUse | The GuardDOGOcclusion System isindicated for use inthe peripheralvasculature tofacilitate the localizedinfusion of therapeuticor diagnostic fluids,with or without vesselocclusion.The safety andeffectiveness of thisdevice have not beenestablished in thecoronary, cerebral, orcarotid vasculature. | The PercuSurgeTemporary OcclusionBalloon System isindicated for use inthe peripheralvasculature tofacilitate the localizedinfusion of therapeuticor diagnostic fluids,with or without vesselocclusion.The safety andeffectiveness of thisdevice have not beenestablished in thecoronary, cerebral, orcarotid vasculature. | TheMicroTherapeutics,Inc. Occlusion BalloonCatheter is designedfor use in bloodvessels wheretemporary occlusion isdesired. The MTIOcclusion BalloonCatheter offers avessel selectivetechnique oftemporary vascularocclusion which isuseful in selectivelystopping or controllingblood flow. |
| Major Components | GuardDOG OcclusionGuide Wire, GuardDOGInflation Device | GuardWire TemporaryOcclusion Catheter,MicroSeal® Adapter,(optional: Export®Catheter) | Equinox OcclusionBalloon Catheter,SilverSpeed 0.010"Guidewire, and arotating hemostaticvalve |
| Accessories Included | Scissors, introducer | Fixed volume syringe,introducer | |
| Balloon Catheter | |||
| Number of lumens | Single lumen | Single lumen | Single lumen |
| Outer Diameter | 0.014 inch | 0.014 inch | 2.8-2.2 French(0.037-0.029 inch) |
| Length | 200 or 300 cm | 175 cm | 150 cm |
| Inflated balloon | 3-6 mm | 4, 4.5, and 5 mm | 4 mm |
| Balloon Material | Compliant elastomer | Compliant elastomer | Compliant elastomer |
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KC 3135 + T = 1 1-
| Inflation Medium | CO2 | 1:1 solution of 60%contrast with saline | 1:1 solution of 60%contrast with saline |
|---|---|---|---|
| Sterility | Sterile, intended forsingle use. | Sterile, intended forsingle use. | Sterile, intended forsingle use. |
| Biocompatibility | Biocompatible inaccordance with ISO10993-1 BiologicalEvaluation of MedicalDevices for externalcommunicating, bloodcontact of short durationdevice. | Biocompatible inaccordance with ISO10993-1 BiologicalEvaluation of MedicalDevices for externalcommunicating, bloodcontact of short durationdevice. | Biocompatible inaccordance with ISO10993-1 BiologicalEvaluation of MedicalDevices for externalcommunicating, bloodcontact of short durationdevice. |
The GuardDOG Occlusion System is equivalent to the predicate devices in technical characteristics.
Functional and mechanical integrity testing has been performed. The results verify equivalency to the predicate devices and appropriate safety and efficacy of the GuardDOG Occlusion System for the intended use.
One difference is that the GuardDOG Occlusion System uses CO2 gas as the inflation medium; both predicate devices use a 1:1 mixture of 60% contrast in saline. However, CO2 is an accepted contrast agent for use in the peripheral vasculature. A literature search was done to evaluate the effects of CO2 in the circulatory system. The results demonstrate that CO2 doses of 5-250cc are safe in the peripheral vasculature. The design of the GuardDOG System limits the potential exposure to CO2 to 5 cc or less. In addition, the GuardDOG is packaged such that CO2 is maintained at high purity (greater than 95%) and thus potential balloon failure will expose the patient to CO2 rather than to air embolism. Finally, the rated burst diameter of the GuardDOG Occlusion Guide Wire balloon is 9.26 mm and provides an acceptable margin of error over the recommended 3-6 mm vessel occlusion range. These results, individually and taken together, demonstrate equivalency to the predicate devices and appropriate safety and efficacy of the GuardDOG Occlusion System for the intended use.
NON-CLINICAL TESTS
Biocompatibility of the GuardDOG system was evaluated in compliance with Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, 21 CFR Part 58 and according to the recommendations in ISO 10993-1 Biological Evaluation of Medical Devices - Part One. The results, reported in the Biocompatibility tab, demonstrate that the GuardDOG materials and manufacturing methods are appropriate and safe for the intended use. In addition, the GuardDOG System is sterilized according to industry standard procedures and is packaged appropriately in packaging that maintains a sterile barrier and device integrity as reported in the Packaging and Sterilization tab.
A Vesscl Safety Animal Study was performed to compared the incidence of acute vessel injury between the GuardDOG Occlusion System and the Equinox Occlusion Balloon Catheter in a canine model. The study concluded that the GuardDOG performed well with regard to vessel occlusion and does not cause any significant vessel injury compared
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to the predicate device. These results demonstrate appropriate safety of the GuardDOG Occlusion System for the intended use and equivalence to the predicate device.
Additional animal studies were conducted to evaluate device integrity, track to a targeted vascular site and deliver an infusion catheter device the intended vascular territory. The GuardDOG Occlusion System is compatible with standard interventional devices such as introducers, guide catheters, and infusion catheters and is equivalent to the predicate devices based on acceptable results in these tests.
CONCLUSION
The data presented in this Premarket Notification establish that the GuardDOG Occlusion System is equivalent to the predicate devices 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.
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Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2004
Possis Medical, Inc. c/o Mr. Mark D. Stenoien Manager, Clinical and Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K031357
Trade Name: GuardDOG Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II (two) Product Code: MJN Dated: February 17, 2004 Received: February 18, 2004
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). 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 classificd (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
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Page 2 - Mr. Mark D. Stenoien
or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 odetar bather and st 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. product radiation oonal of provesin marketing your device as described in your Section 510(k) I mis letter will and will be of substantial equivalence of your device to a legally premation of neation. "The 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), plcase 11 you deem e epecific and Compliance at (301) 594-4659. 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 other general mionmational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. bo chines
G/\ 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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GUARDDOG™ OCCLUSION SYSTEM INDICATION FOR USE STATEMENT
APRIL 2003
The GuardDOG™ Occlusion System is indicated for use in the peripheral vasculature to The GualdDOO - Occalized 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 _
Mark R. Vachner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ko 31357
§ 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).