(94 days)
The Genadyne A4 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.
The provided 510(k) summary for the Genadyne A4 Wound Vacuum System (K082676) describes a substantial equivalence determination to a predicate device, the BlueSky VISTA™ Wound Vacuum System (K061367). This type of submission does not typically involve extensive clinical studies with acceptance criteria as one might find for novel devices or PMAs. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an analysis of the available information regarding acceptance criteria and the supporting study, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) generally compares the new device's technical specifications and intended use against the predicate device to argue substantial equivalence, rather than setting and meeting specific performance acceptance criteria for a new clinical outcome. The acceptance criteria essentially boil down to aligning with or being acceptably similar to the predicate device’s established characteristics.
| Acceptance Criterion (Implicit) | Reported Device Performance (Genadyne A4) | Comparison to Predicate Device (BlueSky VISTA™) |
|---|---|---|
| Suction Capacity (Functional equivalence) | 5 liters per minute | Predicate: 8 liters per minute (Difference noted, but not explicitly stated as non-equivalent for safety/effectiveness) |
| Max Vacuum (Functional equivalence) | 230 mmHg | Predicate: 200 mmHg (Difference noted, but not explicitly stated as non-equivalent for safety/effectiveness) |
| Power Requirements (Technical equivalence) | 24 VDC, 1A | Predicate: 100-240 V AC, 60 Hz (Difference noted, but not explicitly stated as non-equivalent for safety/effectiveness) |
| Battery Type (Component equivalence) | Ni-MH | Predicate: Ni-MH (Equivalent) |
| Dimensions and Weight (Physical characteristics) | 200 x 180 x 80 mm / 1.36 Kg | Predicate: 260 x 250 x 106 mm / 1.9 Kg (Genadyne A4 is lighter; noted as a difference that "does not affect safety and effectiveness") |
| Canisters (Accessory compatibility) | 800 ml disposable with hydrophobic shut off filter | Predicate: 250 ml or 800 ml disposable (Similar capacity, added filter in Genadyne A4) |
| Reusable (Operational characteristic) | Yes | Predicate: Yes (Equivalent) |
| Sterile (Operational characteristic) | Non Sterile | Predicate: Non Sterile (Equivalent) |
| Accessory Kit Components (Functional equivalence) | Non-adherent gauze, Anti-Microbial gauze, Transparent film dressing, Silicone flat drain | Predicate: Non-adherent gauze, Anti-Microbial gauze, Transparent film dressing, Silicone flat drain (Equivalent) |
| Indications for Use (Clinical equivalence) | "indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris." | Predicate: "indicated for patients who would benefit from a suction device particularly as the device may promote wound healing." (Stated as identical) |
| Contraindications (Safety equivalence) | Necrotic tissue, Untreated osteomyelitis, Malignancy (with exception to enhance quality of life), Untreated malnutrition, Exposed arteries, veins, or organs | Predicate: Necrotic tissue, Untreated osteomyelitis, Malignancy (with exception to enhance quality of life), Untreated malnutrition, Exposed arteries, veins, or organs (Equivalent) |
| Precautions (Safety equivalence) | Patients receiving anticoagulant therapy, suffering from difficult hemostasis, untreated for malnutrition, non-complaint or combative | Predicate: Patients receiving anticoagulant therapy, suffering from difficult hemostasis, untreated for malnutrition, non-complaint or combative (Equivalent) |
| Compliance (Electrical Safety) | UL 60601-1, CAN/CSA C22.2 No. 601-1-M90, IEC 60601-1-2, FCC part 15 Class B, EN 55011, IEC 61000-4-2, IEC 61000-4-3 | Predicate: UL 60601-1, IEC 0601-1-2, CAN/CSA C22.2 No. 601.1 (Similar standards, Genadyne lists additional EMC/EMI tests) |
| Storage/Transport and Operation Conditions (Environmental Tolerance) | Similar temperature and humidity ranges | Similar temperature and humidity ranges (Differences noted, but within acceptable operating ranges for device type) |
The study proving the device meets these (implicit) acceptance criteria is a bench testing and comparative analysis study. The 510(k) states: "Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4 Wound Vacuum System for the intended use." and "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use." This is primarily a comparison of technical specifications and claimed indications for use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned in terms of patient numbers or specific datasets. For a mechanical device like a wound vacuum system, "test set" typically refers to the physical devices undergoing various engineering and performance tests, rather than a clinical patient cohort. The testing appears to be focused on the device itself and its components (e.g., suction capacity, maximum vacuum, battery life, compliance with electrical safety standards, kit component performance).
- Data Provenance: The nature of the testing (bench testing, comparison of specifications) indicates that the "data" would be generated from laboratory tests of the device itself. There's no mention of country of origin for any clinical data, as this is not a clinical study in the traditional sense, but a demonstration of substantial equivalence based on technical and performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of submission. "Ground truth" in this context refers to established engineering standards, existing scientific understanding of wound therapy mechanisms, and the performance of the predicate device. No expert panel was involved in creating a "ground truth" for a test set of data in a clinical trial model.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a technical equivalence submission, not a clinical study requiring adjudication of outcomes or diagnoses.
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
Not applicable. This is a medical device for wound therapy (a physical pump), not an imaging or diagnostic AI device that involves human "readers" or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device. It's a pump that provides negative pressure. The "standalone" performance here refers to the device's ability to meet its technical specifications (e.g., suction rate, maximum vacuum) independent of a human operator, which would have been covered by the performance testing mentioned.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is primarily:
- Predicate Device Performance: The established safety and effectiveness profile and technical specifications of the BlueSky VISTA™ Wound Vacuum System (K061367).
- Engineering Standards: Compliance with recognized international and national standards for medical devices (e.g., UL 60601-1, IEC 60601-1-2, FCC part 15 Class B, EN 55011, IEC 61000-4-x series).
- Scientific Principles: The understanding of how negative pressure wound therapy works and the role of suction in removing exudates, infectious material, and tissue debris.
8. The Sample Size for the Training Set
Not applicable. There is no AI/algorithm being trained described in this 510(k) submission.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/algorithm or training set.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.