(168 days)
Genadyne UNO Negative Pressure Wound Therapy System is 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
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed Surgical Incision
Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.
The Genadyne UNO Negative Pressure Wound Therapy System is a single patient use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO Negative Pressure Wound Therapy System has a pre-determined lifespan. The unit has an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and has selections of Continuous Mode at 80mmHg/ 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Negative Pressure Wound Therapy System Therapy Kits include a therapy unit. 200 ml and 300 mL canisters, and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO Negative Pressure Wound Therapy System can be provided separately. The dressing is intended to be used for a maximum of 3 days. Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes. Disposable components of the Genadyne UNO Negative Pressure Wound Therapy System, including the foam dressing and drape, are packaged sterile (Ethylene Oxide) and not made with natural rubber latex. All disposable components of the Genadyne UNO Negative Pressure Wound Therapy System are for single use only. The Genadyne UNO Negative Pressure Wound Therapy System dressings are to be used only with the Genadyne UNO Negative Pressure Wound Therapy System.
This document is a 510(k) Summary for the Genadyne UNO Negative Pressure Wound Therapy System, seeking FDA clearance for a modified version of an existing device (K190028). The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with detailed performance metrics. Instead, it relies on demonstrating compliance with recognized electrical safety and electromagnetic compatibility standards, and on a comparison of technical specifications with a legally marketed predicate device.
However, based on the non-clinical testing mentioned and the comparison table, we can infer the acceptance criteria are met by demonstrating conformity to relevant standards and maintaining equivalent performance to the predicate device for critical specifications.
| Feature/Specification | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Passed IEC 60601-1 reports submitted |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Passed IEC 60601-1-2 reports submitted |
| Max Vacuum | 125 mmHg (matching predicate) | 125 mmHg (matches predicate) |
| Battery Type | Rechargeable Lithium Ion Battery (modified from predicate) | Lithium Ion Battery (new, tested for safety) |
| Charger | Presence of charger (new feature) | Yes, Input: 100VAC-240VAC, 50-60Hz; Output: 5V DC, 2A, 10W |
| Power Battery | 3.6V, 1700mAh (modified from predicate) | 3.6V, 1700mAh (new) |
| Dimensions | Physically compatible with intended use (modified from predicate) | 4 3/8" x 3" x 1 5/8" (modified) |
| Accessories (Canisters/Dressings) | Identical to predicate | Identical to predicate (70ml, 10cm x 10cm, etc.) |
| Reusability | Non-reusable (identical to predicate) | No (matches predicate) |
| Sterility | Dressings provided sterile (identical to predicate) | Dressings are provided Sterile (matches predicate) |
| Indications for Use | Identical to predicate | Identical to predicate |
| Contraindications | Identical to predicate | Identical to predicate |
| Storage/Transport Temperature | -18°C to +43°C (0°F to 109.4°F) (identical to predicate) | -18°C to +43°C (0°F to 109.4°F) (matches predicate) |
| Storage/Transport Relative Humidity | 15% to 95 % (identical to predicate) | 15% to 95 % (matches predicate) |
| Storage/Transport Atmospheric Pressure | 700 - 1060 mbar (identical to predicate) | 700 - 1060 mbar (matches predicate) |
| Operation Temperature | 18°C to 34°C (65°F to 93.2°F) (identical to predicate) | 18°C to 34°C (65°F to 93.2°F) (matches predicate) |
| Operation Relative Humidity | 10% to 95 % (identical to predicate) | 10% to 95 % (matches predicate) |
| Operation Atmospheric Pressure | 700 - 1060 mbar (identical to predicate) | 700 - 1060 mbar (matches predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for performance. The testing involved compliance with IEC standards for electrical safety and EMC. These standards typically involve a defined set of tests on representative units of the device rather than a "sample size" in the statistical sense for clinical studies. The number of devices used for these engineering tests is not disclosed.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are described as "non-clinical" and implicitly prospective as they were performed on the new device model to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission relies solely on non-clinical testing (electrical safety, EMC) and comparison to a predicate device's specifications. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there was no clinical study with a test set requiring adjudication of findings. The assessment was based on engineering test results against established compliance standards.
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 applicable. No MRMC comparative effectiveness study was performed as this is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic imaging device. The changes relate to the pump's power source and housing, not its interaction with clinical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a Negative Pressure Wound Therapy System, which is a physical medical device, not an algorithm or software. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically understood in the context of diagnostic AI or clinical studies (e.g., pathology, expert consensus) is not applicable to this submission. The "ground truth" for the non-clinical tests would be the established requirements and limits defined by the IEC 60601-1 and IEC 60601-1-2 standards. The device's performance (e.g., maintaining 125 mmHg vacuum) is directly measured and compared against its own specifications and the predicate device's specifications.
8. The sample size for the training set:
This information is not applicable. This device is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
§ 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.