(255 days)
RENASYS TOUCH 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 fluids 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
When used with the RENASYS AB Abdominal Kit with Soft Port, RENASYS TOUCH 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 Y-Connector can only be used with the RENASYS TOUCH system. RENASYS TOUCH 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.
The following wound types may be used with a RENASYS system that is utilizing a RENASYS Y-connector:
- Flaps and grafts (only in one wound configuration)
- Open abdomen (only in one wound configuration & only with RENASYS TOUCH and RENASYS AB Abdominal Kit)
- Chronic
- Acute
- Traumatic
- Sub-Acute and dehisced wounds
- Ulcers (such as pressure or diabetic)
- Partial-thickness burns
When the RENASYS Y-Connector is used with the RENASYS AB Abdominal Kit with Soft Port (only in one wound configuration), it 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.
RENASYS TOUCH device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.
RENASYS TOUCH device can be operated by either a mains power supply or internal battery.
RENASYS TOUCH device contains integrated global cellular technology that allows device location, billing and maintenance data to be sent wirelessly to a secure Internet website providing Health Care Professionals access to device information.
The RENASYS TOUCH device is compatible with Smith & Nephew RENASYS Foam, RENASYS Gauze and RENASYS Abdominal dressing kits previously cleared under K152163, K153209 and K143133.
RENASYS TOUCH has also demonstrated compatibility with RENASYS Y-Connector. The RENASYS Y-connector is only intended to be used in conjunction with RENASYS Negative Pressure Wound Therapy (NPWT) systems. The RENASYS Y-Connector can be used to connect one or two wounds through two RENASYS Soft Ports to a single RENASYS TOUCH device. The Y-Connector is constructed of PVC tubing and is compatible with Smith & Nephew RENASYS Foam, RENASYS Gauze and RENASYS Abdominal dressing kits with Soft Port.
Here's an analysis of the acceptance criteria and supporting study for the RENASYS TOUCH and RENASYS Y-Connector, based on the provided FDA 510(k) summary:
This device is not an AI/ML device. The provided document does not describe the acceptance criteria and study proving an AI/ML device meets them. The document is for a Negative Pressure Wound Therapy (NPWT) device, the RENASYS TOUCH, and its accessory, the RENASYS Y-Connector. It describes non-clinical performance testing rather than an AI/ML study.
Therefore, many sections of your requested output, particularly those related to AI/ML specific criteria (like sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance), cannot be answered from the provided text.
However, I can extract information related to the device's performance testing and general regulatory details.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a formal table format, nor does it provide specific numerical performance results. Instead, it summarises the types of performance testing conducted to verify the device meets design specifications and demonstrates substantial equivalence to the predicate. The "reported device performance" is generally stated as having "successfully completed" the tests.
| Acceptance Criteria (Inferred from Test Types) | Reported Device Performance |
|---|---|
| Maintain pressure at all settings (25-200mmHg) in simulated wound models | Successfully completed simulated wound model testing; maintains pressure. |
| Battery life and verification over duration of battery life | Successfully completed battery verification over the duration of its life. |
| Functionality with integrated global cellular technology (SIM activation/deactivation) | Successfully completed activation and deactivation of the SIM card. |
| Compatibility with RENASYS Y-Connector in simulated wound models | Successfully completed RENASYS TOUCH compatibility testing with RENASYS Y-Connector in simulated wound models. |
| Electrical safety, Electromagnetic compatibility (EMC), and mechanical/environmental performance for various use environments (transportation, ambulatory, home healthcare) | Successfully completed electrical safety, EMC, and mechanical/environmental testing. |
| Compliance with Home Healthcare requirements (IEC 60601-1-11) | Demonstrated compliance with Home Healthcare requirements of IEC 60601-1-11. |
| Software functionality (wireless technology, GUI, video playback for alarms/canister changes) | Software updated to facilitate wireless technology, updated GUI screen wording, includes video playback. |
| Compatibility with additional Class I Power Supply and Power Cords | Device includes compatibility with an additional Class I Power Supply and Power Cords. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states that performance testing was "performed in triplicate" for the RENASYS TOUCH device (implying 3 devices were tested) and that this was done for "simulated wound model testing." It doesn't specify how many simulated wound models or test scenarios were run for each triplicate.
- Data Provenance: The testing was non-clinical performance testing conducted by the manufacturer, Smith & Nephew Medical Limited. The country of origin for the data generation would likely be the UK (where Smith & Nephew Medical Limited is located) or another internal testing facility. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involved non-clinical performance testing using simulated wound models and engineering measurements, not expert-adjudicated clinical data or ground truth from human experts.
4. Adjudication Method for the Test Set
Not applicable, as there was no human adjudication of results in this non-clinical performance testing.
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
Not applicable. This is a medical device (NPWT pump) and not an AI/ML diagnostic tool. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The device's "standalone" performance refers to its ability to perform its intended function of negative pressure wound therapy, which was assessed through the non-clinical performance testing described.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing consists of:
- Engineering specifications and design requirements: The device's ability to maintain specific pressure ranges, battery life, and proper function of its components (e.g., SIM card, software GUI).
- Predicate device performance: The new device was tested to verify it performs comparably to its legally marketed predicate device (K153209 RENASYS TOUCH System).
- Relevant standards: Compliance with standards like IEC 60601-1-11 for home healthcare environments.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no "training set," there is no ground truth to establish for one.
§ 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.