(78 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.
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
The RENASYS EZ MAX Professional Healthcare Facility model (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.
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 negative 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 primary changes made are in relation to compliance with the IEC 60601-1 electrical safety standards. The predicate device complies with the IEC 60601-1 200 edition series while the RENASYS EZ MAX NPWT complies with the IEC 60601-1 3rd Edition series of electrical safety standards
RENASYS EZ MAX NPWT is compatible with existing Smith & Nephew wound dressing kits currently on the market.
The provided document describes the K132466 submission for the RENASYS™ EZ MAX Negative Pressure Wound Therapy Device. This submission is for a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission primarily relies on non-clinical (bench) testing to show equivalence in performance, safety, and technological characteristics rather than extensive clinical studies on human subjects.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Pumping capacity is equivalent to the predicate device. | Pumping capacity is equivalent to the predicate device. |
| Device provides negative pressure at individual pressure settings of 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180 and 200mmHg, identical to the predicate device. | Device provides negative pressure at individual pressure settings of 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180 and 200mmHg, identical to the predicate device. |
| The device delivers negative pressure in a continuous and intermittent operating mode identical to the predicate device. | The device delivers negative pressure in a continuous and intermittent operating mode identical to the predicate device. |
| The device including canisters interface with existing RENASYS NPWT wound dressing kits. | The device including canisters interface with existing RENASYS NPWT wound dressing kits. |
| Device pressure setting remains unchanged when the device is locked and actuation of the Therapy Knob is attempted. | Device pressure setting remains unchanged when the device is locked and actuation of the Therapy Knob is attempted. |
| Device has a protection feature/mechanism to maintain the intended functional state (Continuous ON, OFF, Intermittent ON). | Device has a protection feature/mechanism to maintain the intended functional state (Continuous ON, OFF, Intermittent ON). |
| Device attaches to IV poles ranging in diameter from 1/2 inches. | Device attaches to IV poles ranging in diameter from 1/2 inches. |
| Device bed rail clamp attaches to a bed rail (or equivalent) up to 3 inches in diameter. | Device bed rail clamp attaches to a bed rail (or equivalent) up to 3 inches in diameter. |
| Device canister bracket withstands side impact load simulating a worst case failure mode for clinical use. | Device canister bracket withstands side impact load simulating a worst case failure mode for clinical use. |
| Device complies with specified electrical safety standards (IEC 60601-1-2:2007, IEC 60601-1:2005, ANSI/AAMI ES60601-1:2005, IEC 60601-1-8:2006, IEC 60601-1-6:2010, IEC 62366:2007). | Device complies with the following standards: IEC 60601-1-2:2007(3rd edition), IEC 60601-1:2005 (3rd edition), ANSI/AAMI ES60601-1:2005 Version (R2012), IEC 60601-1-8:2006 (2nd edition), IEC 60601-1-6:2010 (3rd Edition), IEC 62366:2007 (1st edition). |
2. Sample size used for the test set and the data provenance
The document details non-clinical bench testing. Therefore, there isn't a "test set" in the sense of patient data. The testing involved physical devices and components to verify performance and compliance with standards. The data provenance is derived from these bench tests, conducted by the manufacturer (Smith & Nephew, Inc.). No specific country of origin for patient data is relevant here, nor is it retrospective or prospective in the clinical study context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For bench testing of a medical device's physical and electrical performance, "ground truth" is established by engineering specifications, validated test protocols, and compliance with recognized standards. It does not involve human experts in the way clinical studies often do for image interpretation or diagnosis.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. Bench testing directly measures device performance against predefined engineering criteria.
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 submission concerns a physical medical device (Negative Pressure Wound Therapy pump), not an AI-powered diagnostic tool requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. Its performance is measured directly through bench tests as a standalone physical product.
7. The type of ground truth used
The ground truth used for these bench tests is engineering specifications, established performance parameters of the predicate device, and recognized international and national electrical safety and medical device standards. The goal was to prove the RENASYS EZ MAX performs identically to the predicate and complies with updated safety standards.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning 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.
§ 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.