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510(k) Data Aggregation
(291 days)
The V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system 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.
When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The V.A.C. GranuFoam Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
When used on closed surgical incisions, it is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System, model number 60600, is a therapy unit capable of providing Negative Pressure Wound Therapy for up to four wounds simultaneously with individual wound channel controls and feedback. The device is intended to be used only in acute care.
The V.A.C.Rx4™ NPWT System consists of a four-channel therapy unit, disposable exudate canisters and dressings. The V.A.C.Rx4™ NPWT System utilizes the same KCI dressing systems and canisters that have been cleared for use with the predicate device system.
The software-controlled therapy unit applies a selectable range of negative pressure wound therapy to the wound bed or incision site. It can provide continuous or intermittent application of negative pressure wound therapy to the wound in the selectable range of 50mmHg to 200mmHg (in increments of 25mmHg). The dressing, to which the therapy unit is connected, enables distribution of the negative pressure wound therapy across the surface of the wound or incision, while the tubing transfers accumulated fluids such as wound exudates and infectious material to a disposable canister. The device can operate either by a mains power supply or internal battery.
For the KCI USA, Inc. V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System, the provided document details bench testing and a usability study rather than a traditional study with acceptance criteria for device performance related to treatment efficacy. The substantial equivalence determination is based on the device's functional similarity to a predicate device and successful verification of its engineering and usability aspects.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative table format for treatment efficacy. Instead, it relies on demonstrating substantial equivalence to the predicate device through various tests. The reported performance relates to the device's ability to deliver negative pressure wound therapy as intended and its usability.
| Aspect Tested | Acceptance Criteria (Implied by Substantial Equivalence and Bench Testing) | Reported Device Performance |
|---|---|---|
| Delivery of Negative Pressure (50, 125, 200 mmHg) | Substantially equivalent to the InfoV.A.C. Therapy Unit in delivering negative pressure at specified levels and conditions. | Bench testing demonstrated that the V.A.C.Rx4™ is substantially equivalent to the InfoV.A.C. Therapy Unit in the delivery of negative pressure wound therapy at 50, 125, and 200 mmHg under an air leak rate of 1.4 lpm in both continuous and intermittent modes and under both wet and dry conditions. |
| Performance with Dressing Configurations | Ability to provide NPWT within specification to each of the cleared dressing configurations for each channel. | The ability of the V.A.C. Rx4™ Therapy Unit to provide NPWT within specification to each of the dressing configurations was confirmed for each channel. |
| Control of Negative Pressure, Fluid Management, Alarms | Ability to control negative pressure wound therapy, manage fluid, and not generate false or unexpected alerts or alarms during normal operation. | The ability of the therapy unit to control negative pressure wound therapy, manage fluid and not generate false or unexpected alerts or alarms during normal operation was confirmed. |
| Usability (Safety & Effectiveness) | Intended users can safely and effectively perform critical tasks for intended use in the expected use environment, and no use errors leading to unacceptable risk of harm are likely to occur. Risk levels (occurrence/severity) reduced as far as possible. | Summative usability evaluation with 15 subjects from three user groups (Surgeon/Physician, Surgical Scrub/Theatre Nurse, and Acute Care Nurse) performing approximately 50 usability tasks in a simulated use environment demonstrated that intended users could safely and effectively perform critical tasks, and identified no use errors likely to lead to unacceptable harm. Risk levels were determined to be reduced to as low as reasonably practicable. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document does not specify a numerical "sample size" for the bench testing beyond stating that the V.A.C.Rx4™ was tested under various conditions and configurations (continuous/intermittent modes, wet/dry conditions, different pressure levels, and with various dressing configurations for each of the four channels). Data provenance is internal (KCI USA, Inc.) and prospective, as it describes the testing performed for this specific device for its 510(k) submission.
- Usability Evaluation (Simulated-Use Testing):
- Sample Size: 15 subjects.
- Data Provenance: Prospective, generated specifically for this device submission within a simulated use environment. The country of origin is not explicitly stated but can be inferred as the USA, given the submitting company's location and FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Bench Testing: Not applicable in the sense of expert-established ground truth for clinical outcomes. The "ground truth" here is the established scientific and engineering principles for negative pressure wound therapy and the performance of the predicate device.
- Usability Evaluation: The "ground truth" or reference for safe and effective use during the usability study would have been the defined critical tasks and expected user interactions established by human factors engineering principles and potentially validated by subject matter experts in negative pressure wound therapy usage. The subjects themselves were representative users from key healthcare professional groups: Surgeon/Physician, Surgical Scrub/Theatre Nurse, and Acute Care Nurse. The number of experts involved in the design or evaluation protocol of the usability study, or in interpreting the results, is not specified, but the users involved were qualified practitioners.
4. Adjudication Method for the Test Set
- Bench Testing: Not applicable. Performance was measured against predefined engineering specifications and compared to the predicate device.
- Usability Evaluation: Not explicitly stated as a formal adjudication method. However, "Multiple formative evaluations led to the selection of an optimal user interface design," indicating an iterative design and evaluation process. The summative evaluation involved observing user performance on critical tasks, and a "residual risk analysis" was performed. This implies direct observation and assessment of user interaction against safety and effectiveness criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The V.A.C. Rx4™ is a hardware device for wound therapy, not an imaging or diagnostic AI device where reader performance is typically assessed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The V.A.C. Rx4™ System is a medical device that assists in wound management through applied negative pressure, not an AI algorithm performing diagnostic or predictive functions. The "algorithm" here refers to the software controlling the pump, which was tested during bench testing within the context of the device's functionality. The usability study evaluated the human-device interaction.
7. Type of Ground Truth Used
- Bench Testing: Engineering specifications, physical measurements of pressure, flow rates, alarm functionality, and comparison to the predicate device's established performance.
- Usability Evaluation: Defined critical tasks, user safety and effectiveness criteria, and human factors engineering principles.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would have been its design and development process, informed by engineering principles and previous device designs like the predicate.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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(29 days)
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Negative pressure wound therapy system for application to surgically closed incisions.
The provided document is a 510(k) Summary for the Prevena Incision Management System with Customizable Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance, sample sizes for test and training sets, expert ground truthing, and MRMC studies is not present in this document.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 | Met (stated in "Summary of non-clinical tests") |
| Equivalency in delivery of negative pressure wound therapy | Met (stated in "Summary of non-clinical tests") |
| Safety | Substantially equivalent to predicate (K121883) |
| Efficacy | Substantially equivalent to predicate (K121883) |
| Conformance to design specifications | Met (stated in "Summary of non-clinical tests") |
| Functional components | Equivalent to predicate |
| Indicated wound types | Same as predicate (Closed surgical incisions) |
| Dressing | Same as predicate (Multiple dressing components) |
| Therapy unit | Same as predicate (Single patient use only; battery powered) |
Study Proving Acceptance Criteria:
The document states: "The Prevena Incision Management System with Customizable Dressing was evaluated under a number of design verification and validation tests to assure safety, efficacy, conformance to design specifications and equivalence to the predicate device."
Specifically, the following tests were conducted:
- Biocompatibility testing according to ISO 10993-1.
- Equivalency testing with respect to delivery of negative pressure wound therapy.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document only mentions "design verification and validation tests" and "non-clinical tests."
- Data provenance: Not specified. As these were non-clinical tests, the concept of "country of origin" for patient data isn't directly applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. The tests mentioned are non-clinical (biocompatibility and functional equivalency) and do not involve human interpretation or ground truthing by medical experts in the way an AI diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The tests mentioned are non-clinical and do not require expert adjudication.
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
- No. The document explicitly states: "No clinical tests were necessary." This device is not an AI diagnostic tool that would typically involve MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (negative pressure wound therapy system), not an algorithm or AI. The "performance" refers to its mechanical and biological functionality, not an analytical algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Ground truth would be established by validated laboratory assays and compliance with ISO 10993-1 standards.
- For equivalency in negative pressure delivery: Ground truth would be established by engineering specifications and direct measurement/comparison to the predicate device's performance.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device that requires a training set.
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