(423 days)
The RENASYS GO 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
The RENASYS GO NPWT device is a modification to predicate device K088375. It is a lightweight suction pump 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 RENASYS GO NPWT device is designed to deliver negative pressure wound therapy to a closed environment over a wound in order to drain exudates from the wound site to help promote wound healing.
The closed environment over the wound is created by applying a sterile foam or gauze wound dressing to the wound site and connecting the sealed wound to the suction pump via a tube that connects to the disposable canister. The suction pump delivers negative pressure wound therapy and removes the exudates from the wound site to the disposable canister.
The device provides negative pressure wound therapy to the wound at a range of pressure settings between 40-200mmHg. The device can operate either by a mains power supply or internal battery.
RENASYS GO uses an integral waste canister that is supplied non-sterile, single-use with a volume capacity of 300ml or 750ml. The waste canister is attached to the pump device by two clips on either side of the canister. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Safety features include a 1.0 micron filter in the top of the canister to resist fluid penetration into the device, as well as a 0.2 micron bacterial filter to prevent the passage of airborne bacteria. Each sealed canister contains a solidifier which acts as a gelling agent to the exudate.
A tube is permanently attached to the bottom of the waste canister through an inlet port. A connector attached to the distal end of the canister tube attaches to the corresponding tubing included in each Smith & Nephew NPWT dressing kit.
The RENASYS GO device is compatible with RENASYS Foam and Gauze dressing kits with Soft Port which were cleared under 510(k) K142979.
The provided text describes modifications to an existing negative pressure wound therapy (NPWT) device, the RENASYS GO, and the testing conducted to demonstrate its substantial equivalence to a predicate device (K083375). As this is a 510(k) submission, the focus is on substantial equivalence rather than establishing novel acceptance criteria for a new device. Therefore, the "acceptance criteria" here largely refer to demonstrating that the modified device performs comparably to the predicate and meets relevant safety and performance standards.
Here's an analysis based on your request, understanding that "acceptance criteria" are implied by the scope of a 510(k) modification rather than explicitly listed as performance targets in the same way a new device might have:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) and testing) | Reported Device Performance |
|---|---|
| Pumping capacity equivalent to predicate device. | Verification completed: Pumping capacity is equivalent to the predicate device. |
| Delivers negative pressure wound therapy (continuous/intermittent) identical to predicate. | Verification completed: Device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device. |
| Complete Blockage/Canister Overcapacity alarm functionality. | Verification completed: Alarm functionality tested using wound fluid simulating real exudate chemistry and protein. |
| System performance in foreseeable fault conditions. | Verification completed: System performance evaluated in foreseeable fault conditions. |
| System performance with high air leaks at the dressing site. | Verification completed: System performance evaluated with high air leaks at the dressing site. |
| System performance in worst-case scenarios with ranges of exudate viscosity and protein. | Verification completed: System performance evaluated in worst-case scenarios with ranges of exudate viscosity and protein content. |
| Blockage/Canister Over-capacity & Leak Alarm assertion in vertical orientation. | Verification completed: Alarm assertion verified in vertical orientation. |
| Blockage/Canister Over-capacity & Leak Alarm assertion in horizontal face up orientation. | Verification completed: Alarm assertion verified in horizontal face up orientation. |
| Blockage/Canister Over-capacity & Leak Alarm assertion in horizontal face down orientation. | Verification completed: Alarm assertion verified in horizontal face down orientation. |
| Performance at increased heights above the wound. | Verification completed: Performance evaluated at increased heights above the wound. |
| O-Ring durability. | Verification completed: O-Ring durability verified. |
| Compliance with IEC 60601 3rd Edition (Electrical safety, usability, alarm systems, home care). | Verification completed: Electrical safety testing in accordance with IEC 60601 3rd Edition standards successfully completed. Software verification and usability studies demonstrated acceptable device performance and compliance. |
| Software validation for alarm functionality improvements. | Verification completed: Software validation and comprehensive verification testing completed, demonstrating acceptable device performance. Software documentation assembled per FDA guidance for Moderate Level of Concern. |
| Performance of 750ml canister. | Verification completed: Comprehensive verification completed which demonstrated acceptable device performance for the 750ml canister. |
| Robustness of canister and alternate materials of construction. | Verification completed: Comprehensive verification completed which demonstrated acceptable device performance for the modified canister design and materials. |
| Usability/clarity of canister markings for change indicator. | Verification completed: Usability studies completed to verify labeling changes (markings on canister for change indicator). |
| Compliance with relevant medical device standards (ISO 14971, ISO 15223, IEC 62366, ANSI/AAMI, etc.). | Declared Compliance: Device complies with listed standards: ISO 14971, ISO 15223-1, ISO 15223-2, IEC 60601-1 (3rd Ed.), IEC 60601-1-6 (3rd Ed.), IEC 60601-1-8 (2nd Ed.), IEC 60601-1-11 (1st Ed.), IEC 62366, ANSI/AAMI ES60601-1, RTCA/DO-160G, ANSI/AAMI HE75, IEC CISPR-25, EN 50121-3-2. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing ("Non-Clinical Tests (Bench)") and verification testing. It does not specify sample sizes (e.g., number of devices tested for each condition). The testing appears to be conducted by the manufacturer, Smith & Nephew, Inc., and therefore the "data provenance" would be internal company testing. There is no mention of external data sources or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This document pertains to bench and verification testing for a device modification, demonstrating substantial equivalence. The "ground truth" for these tests relates to engineering specifications and performance against known standards or the predicate device, not expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
N/A. As the testing mentioned is bench and verification testing against engineering specifications and standards, there is no mention or need for a medical expert adjudication method like 2+1 or 3+1.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states that "Non-Clinical Tests (Bench)" were performed. It does not describe any human reader studies or MRMC comparative effectiveness studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a negative pressure wound therapy pump, not an AI/algorithm-based diagnostic or therapeutic device. The "performance" described is the functioning of the pump and its alarm systems, which is inherently standalone in its operation (i.e., the pump operates without continuous human "in-the-loop" interaction for its core function, though it is used by a human).
7. The Type of Ground Truth Used
The "ground truth" for the tests described is primarily:
- Engineering specifications and design requirements: For aspects like pumping capacity, negative pressure range, O-ring durability, and performance in various conditions.
- Predicate device performance: To demonstrate equivalence in core functionalities.
- Regulatory and consensus standards: Such as IEC 60601 series for electrical safety, usability, and alarm systems, and ISO standards for risk management.
- Simulated wound fluid chemistry: For testing alarm functionality.
8. The Sample Size for the Training Set
N/A. This document describes a medical device (a pump) and its modifications, not a machine learning or AI algorithm that requires a training set. The "software modifications" mentioned relate to alarm functionality and compliance with standards, implying traditional software engineering and testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
N/A. 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.