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Found 6 results
510(k) Data Aggregation
(265 days)
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft
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.
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(59 days)
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
The RENASYS EZ PLUS NPWT 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 PLUS professional healthcare facility model (REF 66800697) 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 PLUS 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 provided text describes a 510(k) premarket notification for a medical device called the RENASYS™ EZ PLUS Negative Pressure Wound Therapy Device. This notification aims to demonstrate substantial equivalence to a predicate device, the RENASYS EZ MAX Negative Pressure Wound Therapy Device (K142979).
The document details the device description, indications for use, and a summary comparison between the subject and predicate devices. It also outlines the non-clinical (bench) tests conducted to verify that the modifications to the RENASYS EZ PLUS NPWT meet design specifications and demonstrate substantial equivalence.
Important Note: The provided text does not include information about acceptance criteria, reported device performance in a statistical table, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device studies. This document is a regulatory submission for a non-AI/ML medical device where the primary goal is demonstrating substantial equivalence to a predicate device through bench testing, not through clinical or AI performance metrics.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of the available information and, where information is not present, an explanation of why:
1. Table of Acceptance Criteria and Reported Device Performance
Rationale: The provided text describes the regulatory clearance of a Negative Pressure Wound Therapy (NPWT) device. This is a traditional medical device, not an AI/ML powered device. The "acceptance criteria" and "reported device performance" in the context of this document refer to the successful completion of a series of non-clinical (bench) tests designed to demonstrate that the device meets its design specifications and is substantially equivalent to a predicate device. These are functional and safety performance metrics, not diagnostic accuracy metrics typically reported for AI/ML.
Since this is not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" as typically presented for AI/ML devices (e.g., sensitivity, specificity, AUC) is not applicable here. The document focuses on demonstrating substantial equivalence to an existing predicate device rather than meeting specific performance thresholds in a clinical study for a novel AI algorithm.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Successful Testing) | Reported Device Performance (Summary from Text) |
|---|---|---|
| Functional Equivalence | - Pumping capacity equivalent to predicate device. |
- Delivers negative pressure at individual pressure settings, identical to predicate device.
- Delivers continuous and intermittent NPWT identical to predicate device. | - "Pumping capacity is equivalent to the predicate device."
- "Device provides negative pressure 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." |
| Alarm Functionality | - Canister Full alarm functions correctly using simulated wound fluid. | - "Verification of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate." (Implies successful verification) |
| Robustness & Safety | - System performance in foreseeable fault conditions is maintained. - System performance with high air leaks at the dressing site is maintained.
- System performance in worst-case scenarios (exudate viscosity/protein) is maintained. | - "Verification of system performance in foreseeable fault conditions." (Implies successful verification)
- "Verification of system performance when running with high air leaks at the dressing site." (Implies successful verification)
- "Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content." (Implies successful verification). The overall conclusion states: "Performance testing has been successfully completed to demonstrate that the RENASYS EZ PLUS NPWT device and canisters are substantially equivalent to the predicate devices for the intended use." |
| Standards Compliance | - Compliance with relevant ISO, IEC, BS EN, and UL standards (e.g., ISO13485, ISO 14971, IEC 60601-1-2). | - "Device complies with the following standards: ISO13485:2003, ISO 14971:2012, ISO 15223-1:2012, ISO 15223-2:2010, BS EN 980:2008, BS EN 1041:2008 +A1:2013, IEC 60601-1-2:2007, IEC 60601-1: :1988 + A1:1991 + A2:1995, UL 60601-1." |
2. Sample size used for the test set and the data provenance
Sample Size for Test Set: Not applicable in the context of this type of device. The "test set" here refers to the conditions and samples used in the bench testing. The document states "wound fluid designed to simulate chemistry and protein content of real exudate" and mentions "worst case scenarios with ranges of exudate viscosity and protein content", but does not specify numerical sample sizes for these test materials.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The data provenience is from non-clinical bench testing conducted to verify design specifications and substantial equivalence, not from clinical patient data. The manufacturer is Smith & Nephew, Inc., located in St. Petersburg, FL, USA, suggesting the testing was likely overseen by them, but the specific location of the bench testing is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated labels for patient data. For this device, the "truth" is established by engineering and performance specifications and comparison to the predicate device, not by expert interpretation of patient data.
Qualifications of Experts: Not applicable. The verification and validation of such a device are typically performed by engineers, quality assurance personnel, and regulatory affairs specialists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of ground truth in AI/ML studies. This is not relevant for bench testing of a physical medical device.
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
MRMC Study: No. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Standalone Study: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Type of Ground Truth: For the bench testing, the "ground truth" equates to the established engineering specifications, performance parameters of the predicate device, and compliance with recognized industry standards. For example, the "ground truth" for pumping capacity would be the specified output pressure range, and the "truth" for alarm functionality would be the correct activation of alarms under specific fault conditions as per design. It is not clinical "ground truth" such as pathology or outcomes data.
8. The sample size for the training set
Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or a training set.
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(196 days)
RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze
The RENASYS EZ MAX NPWT 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.
The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT (Negative Pressure Wound Therapy) systems. Smith & Nephew RENASYS 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. 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 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 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 quard 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 guard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.
The RENASYS Foam and Gauze Wound Dressing Kits with Soft Port consist of the following components: Foam Kits: Polyurethane foam wound filler, a Soft Port 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 gauze wound filler, a Soft Port 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 Soft Port assembly attaches to an exudate canister to deliver negative pressure wound therapy. The foam and gauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters.
The provided document is a 510(k) premarket notification for a medical device. It details the device description, indications for use, comparison with predicate devices, and non-clinical tests conducted to demonstrate substantial equivalence. However, it does not contain information about the device's performance in terms of specific acceptance criteria, corresponding study results, or aspects typically associated with an AI/ML medical device such as sample sizes for test/training sets, data provenance, expert adjudication, or MRMC studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present quantitative performance results against such criteria for the device. Instead, it states that "comprehensive verification was completed which demonstrated acceptable device performance" or that certain aspects are "substantially equivalent" to predicate devices.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no ground truth determination by experts is described.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, as this is not an AI/ML device.
- The type of ground truth used: Not applicable in the context of this device's testing. Testing focused on device functionality, materials, and safety (e.g., pumping capacity, alarm functionality, biocompatibility).
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding testing and "acceptance" (or rather, verification of design specifications and substantial equivalence):
The document details various non-clinical (bench) tests conducted to verify that modifications to the RENASYS EZ MAX NPWT device and the RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port meet design specifications and demonstrate substantial equivalence to predicate devices. These tests relate to the functional performance, safety, and material characteristics of the device.
Table summarizing verification activities (from the "Verification Testing Performed" column):
| Modification | Verification Testing Performed (Indicative of "Acceptance") |
|---|---|
| Addition of RENASYS EZ MAX 800ml S-Canister without Solidifier | Comprehensive verification was completed which demonstrated acceptable device performance. |
| Modification to half of the bacterial overflow guard housing material to a softer resin | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability. |
| Qualification of a replacement resin for the RENASYS EZ PLUS/EZ MAX 250ml S-Canister | Qualification studies demonstrated acceptable replacement of the resin. |
| Reduction in the amount of solidifier in the RENASYS EZ PLUS/EZ MAX 800ml S-Canister | Comprehensive verification was completed which demonstrated acceptable device performance. |
| Qualification of a replacement resin for the RENASYS EZ PLUS/EZ MAX 800ml S-Canister (including lid) and the RENASYS EZ PLUS/EZ MAX 250ml S-Canister lid | Qualification studies demonstrated acceptable replacement of the resin. |
| Modification to the release paper liner of the Soft Port assembly to add an additional slit | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability. |
| Modification to increase the Soft Port aperture size | Comprehensive verification was completed which demonstrated acceptable device performance. |
| Modification of the hole size and geometry in the mid and bottom poly sheet layers of the Soft Port Assembly | Comprehensive verification was completed which demonstrated acceptable device performance and improved usability. |
| Qualification of an alternate Controlled Leak Path (CLP) adhesive material | Qualification studies demonstrated acceptable criteria met. |
| Extension of the shelf-life of the RENASYS Foam and Gauze NPWT Dressing Kits with Soft Port from 9 months to 24 months | Comprehensive verification demonstrated acceptable extension of shelf-life. |
| Addition of RENASYS G Sterile Gauze Dressing Kit with Soft Port | Comprehensive verification was completed which demonstrated acceptable device performance. |
Specific Non-Clinical Tests for RENASYS EZ MAX Negative Pressure Wound Therapy Device:
- Pumping capacity is equivalent to the predicate device.
- Device provides negative pressure 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 of Canister Full alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate.
- Verification of system performance in foreseeable fault conditions.
- Verification of system performance when running with high air peaks at the dressing site.
- Verification of system performance in worst-case scenarios with ranges of exudate viscosity and protein content.
Specific Non-Clinical Tests for RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port:
- Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and NPWT wound dressings by transmitting negative pressure and collecting exudate flows.
- Verification that the Soft Port functions throughout the recommended maximum elapsed time of 72 hours between dressing changes.
- Verification of system performance with a full range of indicated disposable kits, spanning the range of wound sizes.
- Biocompatibility testing on the new foam in accordance with ISO 10993 (Cytotoxicity, Skin Irritation, Skin Sensitization, System Toxicity).
The document concludes that these tests demonstrate substantial equivalence to the predicate devices for the intended use.
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(78 days)
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
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.
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(22 days)
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
The RENASYS EZ PLUS 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 PLUS NPWT device is a lightweight, suction device intended for wound management via application of continual 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. Renasys EZ PLUS is suitable for use in either a hospital or homecare setting. Renasys EZ PLUS is compatible with existing Smith & Nephew wound dressing kits currently on the market.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Renasys™ EZ PLUS Negative Pressure Wound Therapy device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety: Compliance with UL 60601-1 and IEC 60601-1 | Testing in accordance with UL 60601-1 and IEC 60601-1 was conducted and found satisfactory. |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2 | Testing in accordance with IEC 60601-1-2 was conducted and found satisfactory. |
| Design Specifications: Meeting design specifications | Testing was conducted to verify the changes in the Renasys EZ PLUS met design specifications. |
| Substantial Equivalence: To predicate device (K091470 - Renasys™ EZ) for intended use. | Performance testing and electrical safety testing successfully demonstrated substantial equivalence to the marketed predicate device and safety and effectiveness for intended use. The FDA concurred with this determination. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The conducted testing appears to be primarily non-clinical bench testing.
- Data Provenance: The data provenance is from bench testing conducted by the manufacturer, Smith & Nephew, Inc. No information on country of origin for clinical or patient data is provided, as no clinical study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the provided document describes non-clinical (bench) testing, not a clinical study involving human patients where "ground truth" would be established by experts. The "ground truth" in this context is adherence to established engineering and safety standards.
4. Adjudication Method for the Test Set
- This question is not applicable as there is no human adjudication process described for the non-clinical bench testing. The evaluation is against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC study was done. This device is a negative pressure wound therapy (NPWT) device, which is a physical medical device, not an AI or imaging-related diagnostic tool. Therefore, the concept of "human readers" and "AI assistance" does not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical medical device for wound therapy, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" in this context refers to established engineering standards and design specifications (e.g., UL 60601-1, IEC 60601-1-2, internal design specifications) rather than clinical ground truth like pathology or outcomes data. The primary "ground truth" for substantial equivalence is the performance and safety profile of the predicate device (Renasys™ EZ).
8. The Sample Size for the Training Set
- This question is not applicable as this device is a physical medical device and does not involve machine learning algorithms with a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no "training set" for this type of device.
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RENASYS EZ
The Renasys EZ is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
The Renasys EZ is a powered suction pump with accessory wound dressing kits, disposable canister and filter designed for Negative Pressure Wound Therapy (NPWT). The Renasys EZ is designed for use with various Smith & Nephew wound dressing kits to deliver a recommended therapeutic range of 40-80 mmHg of continuous or internittent topical negative pressure to a wound site for the purposes of wound healing.
The provided text is a 510(k) Summary for the Renasys™ EZ Negative Pressure Wound Therapy system. This document focuses on establishing substantial equivalence to a predicate device based on indications for use, materials, technology, product specifications, and energy requirements. It does not contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement in a clinical effectiveness study that would typically be associated with performance claims for AI-driven devices.
Therefore, I cannot provide a response that includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details of standalone algorithm performance studies.
- Sample size for training sets or how ground truth for training sets was established.
This is because the provided document is a regulatory submission for a medical device (a suction pump), not an AI/ML-driven device, and thus the type of performance evaluation information requested is not relevant or present in this context.
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