(301 days)
Genadyne UNO 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 low to moderate exudates and infectious material.
Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
Genadyne UNO is a single patient use device.
The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Genadyne UNO Negative Pressure Wound Therapy System:
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical trial. As such, detailed human clinical study data proving the device meets acceptance criteria in the same way a new drug or novel device might is not typically included in these summaries. The "acceptance criteria" here largely refer to comparison against the predicate device's characteristics and meeting relevant safety standards.
Acceptance Criteria and Reported Device Performance
The core of the "acceptance criteria" for this 510(k) submission is demonstrating that the Genadyne UNO is substantially equivalent to the predicate device, the Pico Single Use Negative Pressure Wound Therapy System (K151436), and that it meets applicable safety and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (based on predicate or standards) | Reported Device Performance (Genadyne UNO) |
|---|---|---|
| Intended Use/Indications | Indications for negative pressure wound therapy, promoting healing via removal of low to moderate exudates and infectious material for specified wound types (chronic, acute, traumatic, subacute/dehisced, partial-thickness burns, ulcers, flaps/grafts). | "Similar" to predicate: Indicated for negative pressure wound therapy, promoting healing via removal of low to moderate exudates and infectious material for same specified wound types. Single patient use. |
| Max Vacuum | 100 mmHg (Predicate: Pico) | 125 mmHg (Higher than predicate, but within expected therapeutic range for NPWT, no new safety/effectiveness concerns indicated). |
| Battery Type | Lithium AA (L91) (Predicate: Pico) | Alkaline-Manganese Dioxide AA (QU1500) (Different type, but likely deemed equivalent in function/safety for the application). |
| Power (Battery) | 3V DC (Predicate: Pico) | 3V DC (Matches predicate) |
| Canisters | N/A (Predicate: Pico did not use separate canisters, assumed to be integrated into dressing) | Two 70 ml disposable canisters with built-in hydrophobic shut-off filter for overflow protection (A functional difference from predicate but addresses exudate management effectively). |
| Reusable | No (Predicate: Pico) | No (Matches predicate) |
| Sterility | Pump, dressing, secondary fixation strips are sterile (Predicate: Pico) | Dressings provided are sterile (Implies the pump itself might not be sterile, but the critical patient-contact components are. This is a common arrangement). |
| Dressings | Various sizes (10x20, 10x30, 15x15, 15x20) (Predicate: Pico) | A wider range of sizes (10x20, 10x30, 10x40, 15x15, 15x20, 15x30, 20x20, 20x25, 25x25) (More options, but fundamentally similar in type/function). |
| Contraindications | Same as predicate: Necrotic tissue with Eschar, untreated osteomyelitis, malignancy (except palliation), exposed arteries/veins/organs, non-enteric/unexplored fistulas, anastomotic sites, emergency airway aspiration, pleural/mediastinal/chest tube drainage, surgical suction. | "Similar" to predicate, with minor phrasing differences but substantively the same list. |
| Biocompatibility | Meet biocompatibility standards for patient-contact materials. | Dressings (silicone foam, PU film strips) met acceptance criteria for biocompatibility testing. |
| Electrical Safety/EMC | IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), UL 60601-1, Can/CSA C22.2. | Pump met acceptance criteria for all applicable IEC testing (specific clauses not detailed beyond general standards). |
| Bench Testing (Performance) | Ensure expected performance and outcome when used as a system. | Bench testing was done with in-house protocol to ensure performance and outcome. |
| Storage/Transport Temps | 5°C to +25°C (Predicate: Pico) | -18°C to +43°C (Broader range than predicate, indicating robust design for storage/transport). |
| Operation Temps | 5°C to 35°C (Predicate: Pico) | 18°C to 34°C (Slightly narrower range than predicate, but within typical clinical environment). |
Study Details:
The document primarily describes non-clinical testing to support substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for individual tests. For the non-clinical testing, sample sizes would typically refer to the number of units tested per bench test (e.g., n=3, n=5, n=10 devices). The document states "Bench testing was done with in house protocol to establish ensure the performance and outcome."
- Data Provenance: The testing appears to be prospective bench testing conducted in-house by Genadyne Biotechnologies, Inc., and potentially by third-party labs for standards compliance (e.g., biocompatibility, IEC). The country of origin for the data generation would likely be the USA, as this is a US-based company submitting to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For bench/non-clinical testing, "ground truth" is typically established by engineering specifications, recognized standards (e.g., ISO, IEC), and scientific principles, not by expert medical consensus on individual cases.
4. Adjudication method for the test set:
- This is not applicable to the type of non-clinical, bench testing described. Adjudication methods like 2+1 or 3+1 are used for reviewing patient cases, often in diagnostic studies to establish a consensus ground truth.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The Genadyne UNO is a therapeutic negative pressure wound therapy system, not a diagnostic imaging device with AI interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The Genadyne UNO is a medical device (a powered suction pump) used directly on patients for wound therapy, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is its functional operation (e.g., maintaining negative pressure, managing exudate).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing described, the "ground truth" or reference standards used would be:
- Engineering specifications for device function (e.g., vacuum pressure, battery life).
- International standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility).
- Predicate device characteristics as a benchmark for comparison.
8. The sample size for the training set:
- Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm.
Summary of Device Meeting Acceptance Criteria:
The document concludes that the Genadyne UNO meets its acceptance criteria by demonstrating substantial equivalence to the predicate device and by passing relevant safety and performance non-clinical tests.
- Biocompatibility Testing: The dressing kit (silicone foam dressing, PU film strips) met accepted criteria.
- Electrical Safety & EMC Testing: The pump successfully met acceptance criteria for all applicable IEC testing.
- Bench Testing: In-house protocols were used to ensure the device's performance and outcome were as expected.
- Design & Function Comparison: While some technical specifications differ (e.g., max vacuum, battery type, canister use), these differences are highlighted and determined not to raise new issues of safety or effectiveness. The fundamental intended use, indications, and contraindications are presented as similar to the predicate.
The basis for acceptance is that the device is as safe and effective as a legally marketed predicate device, as evidenced by these non-clinical comparisons and standard compliance.
§ 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.