Search Results

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

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

The RENASYS™ - F/-AB Abdominal Wound Dressing Kit 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.

This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic or AI-powered device would.

The document is a 510(k) summary for a medical device called the RENASYS™ -F/AB Abdominal Dressing Kit. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes details about:

• Biocompatibility testing: This confirms the materials used are safe for contact with the body. The table lists various tests (Cytotoxicity, Irritation, Sensitization, Implantation, Sub-acute Toxicity, Genotoxicity) completed for each kit component. These are safety standards, not performance criteria in the sense of accuracy, sensitivity, or specificity.
• Design verification testing: The document states this was conducted "to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates." However, it does not provide:
  • A table of actual "performance specifications" or acceptance criteria.
  • Specific results from this design verification testing.
  • Details on the sample size, data provenance, ground truth establishment, or expert involvement for this testing.
  • Any information about a comparative effectiveness study (MRMC) or a standalone (algorithm only) study.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, or study types as they are typically described for devices with measurable diagnostic or analytical performance claims.

The document concludes that the device "has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use." This is the general statement required for a 510(k) clearance, indicating that it meets the regulatory bar for market entry, but not detailing specific performance metrics.

Ask a specific question about this device