(265 days)
RENASYS EZ MAX 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.
RENASYS AB Abdominal Kit with Soft Port 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 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 EZ MAX Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction device intended for wound management via application of continuous or intermittent neqative 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 guard 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 quard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.
RENASYS AB Abdominal Dressing Kit with Soft Port consists of the following components:
- Two large hydrophobic, reticulated polyurethane foam dressings that incorporate several ● cuts to facilitate custom sizing, if needed.
- One organ protection layer made of non-adherent clear polyurethane film perforated with slits. The slits in the organ protection layer facilitate fluid removal under negative pressure wound therapy.
- . Six 12" x 8" polyurethane transparent film drapes with acrylic adhesive backing. The drapes are placed over the foam and surrounding intact skin to create an airtight seal for the application of negative pressure wound therapy.
- . One Soft Port suction assembly with tubing that attaches to the exudate collection canister. The Soft Port assembly is placed over a hole cut in the drape to facilitate application of negative pressure wound therapy to the wound.
The abdominal kit is designed specifically for use with the RENASYS EZ MAX negative pressure wound therapy devices and canisters.
Here's a breakdown of the acceptance criteria and study information for the RENASYS™ EZ MAX Negative Pressure Wound Therapy Device and RENASYS™ AB Abdominal Dressing Kit with Soft Port, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for improved performance. The acceptance criteria are implicitly defined by the predicate device's performance and the successful completion of various verification tests to show that modifications do not negatively impact device function and usability, and that the new device performs identically or equivalently to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| RENASYS EZ MAX Negative Pressure Wound Therapy Device: | |
| Pumping capacity is equivalent to predicate device. | Pumping capacity is equivalent to the predicate device. |
| Device provides negative pressure wound therapy at individual pressure settings, identical to the predicate device. | Device provides negative pressure wound therapy 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 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 simulated wound fluid. | Verification of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate (successfully completed). |
| Verification of system performance in foreseeable fault conditions. | Verification of system performance in foreseeable fault conditions (successfully completed). |
| Verification of system performance with high air leaks at the dressing site. | Verification of system performance when running with high air leaks at the dressing site (successfully completed). |
| Verification of system performance in worst-case scenarios with ranges of exudate viscosity and protein content. | Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content (successfully completed). |
| RENASYS AB Abdominal Dressing Kit with Soft Port: | |
| Soft Port serves as a conduit between NPWT device and dressing kit by transmitting negative pressure and collecting exudate flows. | Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and RENASYS AB Abdominal Dressing Kit with Soft Port by transmitting negative pressure wound therapy and collecting exudate flows (successfully completed). |
| Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes. | Verification that the Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes (successfully completed). |
| Biocompatibility | All components comply with ISO 10993. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the "test set" in terms of number of devices or number of tests performed. It refers to "testing" and "verification" but doesn't provide specific quantitative sample sizes for each test.
The data provenance is implied to be bench testing conducted by the manufacturer, Smith & Nephew, Inc. There is no mention of clinical data, human subjects, or country of origin for any experimental data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a bench testing study for substantial equivalence, not a study involving expert-established ground truth for clinical diagnosis or outcome. The "ground truth" for the tests described would be the physical properties and performance characteristics being measured by the testing equipment and protocols.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. There was no adjudication method described as this was not a human reader or diagnostic accuracy study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (Negative Pressure Wound Therapy Device and Dressing Kit) and focuses on engineering and performance characteristics, not diagnostic interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (pump and dressing kit), not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for these tests was engineering and performance specifications based on the predicate devices and relevant industry standards (e.g., ISO, IEC). For instance, pumping capacity was compared to the predicate, and alarm functionality was verified against expected operational parameters using simulated wound fluid.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning study.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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.