(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.
§ 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).