(196 days)
The RENASYS EZ MAX NPWT is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and 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 and grafts. RENASYS EZ MAX professional healthcare facility model (REF 66801309) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT (Negative Pressure Wound Therapy) systems. Smith & Nephew RENASYS systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and 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 and grafts.
The RENASYS EZ MAX Negative Pressure Wound Therapy NPWT device is a lightweight, suction device intended for wound management via application of continuous or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The technological characteristics of the new device have not changed.
The 800ml and 250ml canisters are non-sterile, single use devices with a lid that is ultrasonically welded on. The canister kits contain a combination of solidifier gel pack, bacterial overflow quard that attaches to the pump and canister tubing that attaches to the Soft Port assembly. The 800ml canister without solidifier is a non-sterile, single use device with a lid that is ultrasonically welded on. The canister kit contains a bacterial overflow guard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.
The RENASYS Foam and Gauze Wound Dressing Kits with Soft Port consist of the following components: Foam Kits: Polyurethane foam wound filler, a Soft Port assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes: small, medium and large. Gauze Kits: Antimicrobial gauze wound filler, a Soft Port assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile and kitted in a non-sterile kit package. The kit is single use. The Soft Port assembly attaches to an exudate canister to deliver negative pressure wound therapy. The foam and gauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters.
The provided document is a 510(k) premarket notification for a medical device. It details the device description, indications for use, comparison with predicate devices, and non-clinical tests conducted to demonstrate substantial equivalence. However, it does not contain information about the device's performance in terms of specific acceptance criteria, corresponding study results, or aspects typically associated with an AI/ML medical device such as sample sizes for test/training sets, data provenance, expert adjudication, or MRMC studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present quantitative performance results against such criteria for the device. Instead, it states that "comprehensive verification was completed which demonstrated acceptable device performance" or that certain aspects are "substantially equivalent" to predicate devices.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no ground truth determination by experts is described.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, as this is not an AI/ML device.
- The type of ground truth used: Not applicable in the context of this device's testing. Testing focused on device functionality, materials, and safety (e.g., pumping capacity, alarm functionality, biocompatibility).
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding testing and "acceptance" (or rather, verification of design specifications and substantial equivalence):
The document details various non-clinical (bench) tests conducted to verify that modifications to the RENASYS EZ MAX NPWT device and the RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port meet design specifications and demonstrate substantial equivalence to predicate devices. These tests relate to the functional performance, safety, and material characteristics of the device.
Table summarizing verification activities (from the "Verification Testing Performed" column):
| Modification | Verification Testing Performed (Indicative of "Acceptance") |
|---|---|
| Addition of RENASYS EZ MAX 800ml S-Canister without Solidifier | Comprehensive verification was completed which demonstrated acceptable device performance. |
| Modification to half of the bacterial overflow guard housing material to a softer resin | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability. |
| Qualification of a replacement resin for the RENASYS EZ PLUS/EZ MAX 250ml S-Canister | Qualification studies demonstrated acceptable replacement of the resin. |
| Reduction in the amount of solidifier in the RENASYS EZ PLUS/EZ MAX 800ml S-Canister | Comprehensive verification was completed which demonstrated acceptable device performance. |
| Qualification of a replacement resin for the RENASYS EZ PLUS/EZ MAX 800ml S-Canister (including lid) and the RENASYS EZ PLUS/EZ MAX 250ml S-Canister lid | Qualification studies demonstrated acceptable replacement of the resin. |
| Modification to the release paper liner of the Soft Port assembly to add an additional slit | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability. |
| Modification to increase the Soft Port aperture size | Comprehensive verification was completed which demonstrated acceptable device performance. |
| Modification of the hole size and geometry in the mid and bottom poly sheet layers of the Soft Port Assembly | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability. |
| Qualification of an alternate Controlled Leak Path (CLP) adhesive material | Qualification studies demonstrated acceptable criteria met. |
| Extension of the shelf-life of the RENASYS Foam and Gauze NPWT Dressing Kits with Soft Port from 9 months to 24 months | Comprehensive verification demonstrated acceptable extension of shelf-life. |
| Addition of RENASYS G Sterile Gauze Dressing Kit with Soft Port | Comprehensive verification was completed which demonstrated acceptable device performance. |
Specific Non-Clinical Tests for RENASYS EZ MAX Negative Pressure Wound Therapy Device:
- Pumping capacity is equivalent to the predicate device.
- Device provides negative pressure at individual pressure settings, identical to the predicate device.
- Verification that the device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device.
- Verification of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate.
- Verification of system performance in foreseeable fault conditions.
- Verification of system performance when running with high air peaks at the dressing site.
- Verification of system performance in worst-case scenarios with ranges of exudate viscosity and protein content.
Specific Non-Clinical Tests for RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port:
- Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and NPWT wound dressings by transmitting negative pressure and collecting exudate flows.
- Verification that the Soft Port functions throughout the recommended maximum elapsed time of 72 hours between dressing changes.
- Verification of system performance with a full range of indicated disposable kits, spanning the range of wound sizes.
- Biocompatibility testing on the new foam in accordance with ISO 10993 (Cytotoxicity, Skin Irritation, Skin Sensitization, System Toxicity).
The document concludes that these tests demonstrate substantial equivalence to the predicate devices for the intended use.
§ 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.