(54 days)
The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate and infectious materials. Appropriate wound types include:
- Chronic
- Acute
- · Traumatic
- Sub-acute and dehisced wounds
- · Ulcers (such as pressure or diabetic)
- Partial-thickness burns
- · Flaps
- · Grafts
When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
The RENASYS EDGE device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.
RENASYS EDGE can be operated by either a mains power supply or internal battery. The RENASYS EDGE device is compatible with Smith & Nephew RENASYS Dressing Kits.
The provided document is a 510(k) Premarket Notification for the RENASYS EDGE device, a negative pressure wound therapy (NPWT) system. Based on the document, here's an analysis of the acceptance criteria and the study performed:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance in a quantitative manner as typically seen for diagnostic devices. Instead, it lists various verification activities conducted to demonstrate the overall system performance and substantial equivalence to a predicate device.
The "acceptance criteria" here are implicitly linked to compliance with relevant medical device standards and the successful completion of specific types of testing to ensure the device performs as intended and is safe and effective when compared to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-1-11) | Successful completion of electrical safety testing per IEC 60601-1 (general medical electrical equipment) and IEC 60601-1-11 (for home healthcare environment). |
| Electromagnetic Compatibility (EMC per IEC 60601-1-2) | Successful completion of EMC testing per IEC 60601-1-2. |
| Human Factors/Usability (IEC 62366, IEC 60601-1-6, FDA Guidance) | Successful completion of human factors testing per IEC 62366, IEC 60601-1-6, and applicable FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Bench-top Performance (including challenge conditions) | Successful completion of "simulated wound model tests" and other bench-top performance testing under various challenge conditions. This likely includes: |
- Exudate Management: Ability to remove fluids, wound exudate, and infectious materials.
- Therapeutic Pressure Setting: Ability to maintain negative pressure within the 25-200mmHg range.
- Alarm Functionality: Proper functioning of alarms to notify users of therapy loss.
- Auto-restart Function: Effective re-initiation of therapy after pause. |
| Software Verification | Successful completion of software verification testing. |
| Substantial Equivalence | Demonstrated through evaluation of indications for use, principle of operation, materials, technology, product specifications, and energy requirements, alongside performance testing, software verification, EMC, and electrical safety testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical data were provided to support the demonstration of substantial equivalence."
Therefore, there is no sample size for a test set of patients, nor is there any provenance information such as country of origin or retrospective/prospective nature, as no human clinical studies were performed. The testing conducted was entirely non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Since no clinical data was provided and no human test set was used, there were no experts establishing ground truth for a clinical test set. The validation was based on engineering and performance criteria against standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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. The RENASYS EDGE device is a physical medical device (NPWT pump), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. The evaluation focused on the physical device's performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would have been the engineering specifications and established performance parameters defined by the manufacturer and relevant international medical device standards (e.g., specific negative pressure range, exudate removal rates, alarm trigger conditions, electrical safety limits, EMC limits). Compliance with these predefined technical criteria constituted the "ground truth."
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI model.
§ 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.