(107 days)
The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport 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. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components:
Foam Kits: Polyurethane foam wound filler, a Softport 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 qauze wound filler, a Softport 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 Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375.
This submission describes the RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™, which adds a Softport assembly to existing Negative Pressure Wound Therapy (NPWT) dressing kits. The evaluation focuses on demonstrating that the new Softport assembly maintains the safety and effectiveness of the previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on functional performance and biocompatibility of the new Softport component, ensuring it performs comparably to the predicate device and does not introduce new risks.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The Softport shall serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows. | The device was evaluated under a number of verification and validation tests to ensure performance requirements were met, demonstrating the Softport's ability to transmit negative pressure and collect exudate. |
| The Softport shall function throughout the recommended maximum elapsed time of 72 hours between dressing changes. | Verification and validation tests confirmed the Softport's functionality for the specified 72-hour duration. |
| The Softport will continue to serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows when compressed at its terminal end (atop the wound dressing). | Verification and validation tests established that the Softport maintains its conduit function even when compressed at its terminal end. |
| The Softport shall incorporate a controlled leak path that does not contribute to RENASYS EZ and RENASYS GO NPWT therapy devices false blockage or leak alarms. | Verification and validation tests demonstrated that the Softport's leak path design does not cause false blockage or leak alarms in the associated NPWT devices. |
| Biocompatibility of all components, including the new Softport assembly, shall comply with ISO 10993. | Biocompatibility testing for the Softport assembly was successfully completed per applicable parts of ISO 10993, including Cytotoxicity, Skin Irritation, and Skin Sensitization. All other existing components were already compliant with ISO 10993. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "verification and validation tests" conducted for the Softport. It mentions that these tests were performed to ensure performance requirements were met.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of the tests (functional and biocompatibility), they are typically conducted in a controlled laboratory or testing environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No information is provided regarding the use of "experts" to establish ground truth for this device's testing. The ground truth for functional performance is established by engineering specifications and objective measurements against those specifications. For biocompatibility, the ground truth is established by adherence to recognized international standards (ISO 10993) and the results of laboratory tests.
4. Adjudication Method for the Test Set
No adjudication method for a "test set" is mentioned, as the testing described is primarily objective performance and safety testing, not human-read evaluation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a critical component. This submission is for wound dressing kits, and the testing focuses on the functional performance and biocompatibility of the device itself.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the described testing is akin to standalone performance. The verification and validation tests evaluate the physical device's ability to meet its functional specifications and biocompatibility requirements independently, without human interaction as part of the evaluated performance metric.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Engineering Specifications and Performance Standards: For functional aspects (negative pressure transmission, exudate collection, leak path control, 72-hour functionality, and performance under compression).
- International Biocompatibility Standards: Specifically, ISO 10993 for Cytotoxicity, Skin Irritation, and Skin Sensitization.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device, as it is a physical medical device (wound dressing kit) undergoing traditional engineering and biological compatibility testing, not an artificial intelligence/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no training set for this type of medical device submission.
§ 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.