(427 days)
The RENASYS White Foam NPWT Dressing is a moist, sterile, polyvinyl alcohol (PVA) foam intended to be used in conjunction with Smith & Nephew RENASYS TOUCH and RENASYS GO Negative Pressure Wound Therapy (NPWT) Systems.
The Smith & Nephew RENASYS system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy) as it may promote wound healing via the removal of wound fluids, including irrigation of body fluids, wound exudates 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
RENASYS™-WF White Foam NPWT Dressing for use as a wound filler in conjunction with the RENASYS Touch or GO Negative Pressure Wound Therapy System and compatible components.
The provided FDA 510(k) Premarket Notification is for a medical device (RENASYS™-WF White Foam NPWT Dressing) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to meet explicit quantitative performance acceptance criteria as might be seen for an AI/ML device.
Here's an analysis based on the provided document, addressing the requested points where applicable:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) that an AI/ML device would typically have, because this is not an AI/ML device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device. The performance is assessed through non-clinical testing comparing the subject device to the predicate device in terms of physical characteristics, intended use, indications, contraindications, materials, sterility, and packaging.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Subject device has comparable intended use to the predicate. | Verdict: Yes - The subject device's intended use for open wounds is the same as the predicate device. Closed wounds are not listed for the subject device. Compatible NPWT systems are different (manufacturer specific). |
| Indications for Use Equivalence: Subject device has comparable indications for use to the predicate. | Verdict: Yes - The indicated wound types for the subject device are the same as the predicate device, with the exception that the predicate specifically states "Venous insufficiency ulcers," which is not included for the subject device to align with compatible RENASYS devices. |
| Contraindications Equivalence: Subject device has comparable contraindications to the predicate. | Verdict: Yes - The subject device contains the same contraindications as the predicate device for open wounds. |
| Sterility: Subject device maintains same sterility method as predicate. | Verdict: Yes - Sterilized by Gamma Irradiation (same as predicate). |
| Packaging: Subject device has comparable packaging to the predicate. | Verdict: Yes - Polyethylene inner and Aluminum foil outer pouch (same as predicate). |
| Materials: Subject device uses comparable materials to the predicate. | Verdict: Yes - PVA Foam, moistened with water (same as predicate). |
| Status: Subject device has the same prescription status as predicate. | Verdict: Yes - Rx Only (same as predicate). |
| Environment of Use: Subject device is suitable for comparable environments of use as predicate. | Verdict: Yes - Clinical and Home Environments (same as predicate). |
| Physical Composition & Dimensions: Subject device has comparable physical composition and dimensions. | Verdict: Yes - Both are made of Polyvinyl Alcohol (PVA) foam, moistened with water, sterilized by gamma irradiation, and share the same dimensions (7.5 X 10 X 1 cm and 15 X 10 X 1 cm). |
| Non-clinical Performance: Subject device performs as intended in challenge conditions and comparably to the predicate in wound model testing. | Reported: Wound model testing in challenge conditions using compatible components; Comparative wound model testing between the subject and predicate device; Testing in accordance with relevant parts of ISO 10993. Conclusion: Testing indicates the subject device performs as intended and on an equivalence basis with the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "wound model testing in challenge conditions" and "comparative wound model testing," which suggests non-clinical bench testing rather than human subject data. Therefore, concepts like sample size for a test set (in the context of patient data) and data provenance (country of origin, retrospective/prospective) are not applicable or detailed here.
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)
This is not applicable as the study involved non-clinical wound model testing, not expert-adjudicated patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3.
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 is not applicable as the device is a medical dressing, not an AI/ML diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a medical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be established by the defined parameters and expected outcomes of the wound models, adherence to ISO standards (e.g., ISO 10993 for biocompatibility), and direct comparison of physical and functional properties against the predicate device. This is more akin to engineering and material performance standards than clinical ground truth obtained from patients.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML algorithm requiring a 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.