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510(k) Data Aggregation
(30 days)
RENASYS-G Gauze Dressing Kits with Soft Port
The RENASYS-G Gauze Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT 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 Gauze Wound Dressing Kit with Soft Port consists of the following components:
- . Antimicrobial gauze wound filler
- Soft Port assembly
- Non-adherent wound contact layer ●
- RENASYS Transparent film ●
- . Saline bullet
- . No Sting Skin Prep
- . Wound ruler
The RENASYS-G Gauze kits are offered in four sizes: small, medium, large and extralarge. The components of the kit are individually packaged and sterilized 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 to the wound. The qauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters.
This document is a 510(k) summary for the RENASYS-G Gauze Dressing Kits with Soft Port. It describes the device, compares it to a predicate device, and outlines the non-clinical tests performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the device's performance in terms of wound healing efficacy or similar outcomes. Instead, the study focuses on verifying the substantial equivalence of the modified device to its predicate. The "acceptance criteria" are implied by the successful completion of the verification tests, ensuring the modifications do not compromise the device's performance or safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintenance of package seal integrity during transit | Transit testing was conducted to assure the sterile barrier of the RENASYS Transparent Film remains intact in the flat configuration. |
| Individually packaged and sterilized components meet criteria for 24-month shelf life | Stability testing and simulated wound model testing on aged product has been conducted to assure acceptance criteria are met. |
| Device complies with applicable standards (e.g., ISO 10993 for biocompatibility) | All components comply with ISO 10993. The device complies with listed standards (EN ISO 13485:2003, EN 1041:2008 +A1, ISO 15223-1:2012, EN ISO 14971:2012, EN ISO 10993-1:2009, EN 62366:2008). |
| Indications for Use are substantially equivalent | Substantially equivalent (to predicate device). |
| Materials are substantially equivalent | Substantially equivalent (to predicate device). |
| Soft Port Assembly is substantially equivalent | Substantially equivalent (to predicate device). |
| Sterilization method is identical | Identical (to 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)
The document does not explicitly state the sample sizes for the "transit testing" or "stability testing" or provide details on the data provenance (country of origin, retrospective/prospective). These are non-clinical (bench) tests, not typically subject to the same patient data collection requirements.
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 information is not applicable. The tests performed are non-clinical bench tests (transit testing, stability testing), which do not involve expert interpretation or ground truth establishment in the way clinical studies with expert reviewers would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as there are no expert adjudications in these non-clinical bench tests.
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
There was no MRMC comparative effectiveness study. This document describes the substantial equivalence of a medical device (wound dressing kit), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical wound dressing kit, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Transit testing: The "ground truth" for package seal integrity would be based on validated physical testing methods and established criteria for package integrity.
- Stability testing: The "ground truth" for shelf life and performance specifications would be based on validated laboratory testing methods to assess material degradation, sterilization maintenance, and functional performance over time.
8. The sample size for the training set
This information is not applicable. The tests performed are non-clinical bench tests for device modifications, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an algorithm in this context.
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