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510(k) Data Aggregation
(294 days)
The V.A.C. DERMATACTM Drape is an accessory to the:
· ACTIV.A.C.™, INFOV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.
· V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems 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, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing 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.
When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudates via the application of negative pressure wound therapy.
The V.A.C. DERMATAC Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C. Therapy System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site.
The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound and the silicone layer primarily provides a seal for negative pressure.
The V.A.C. Therapy System is comprised of the following:
- . Software controlled neqative pressure therapy unit
- . Disposable canister which collects wound exudate
- . Polyurethane foam dressing
- Semi-occlusive wound drape
The provided text describes the V.A.C. DERMATAC Drape, an accessory for Negative Pressure Wound Therapy (NPWT) Systems, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested (e.g., performance metrics like sensitivity, specificity, AUC, or comparative effectiveness with human readers).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a human factors assessment. The "study" mentioned is a set of engineering and biocompatibility tests, not a clinical trial or an AI performance study with ground truth established by experts.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, or training set details as that information is not present in the provided text.
Here's what I can extract based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
| Biocompatibility | Met requirements according to ISO 10993 series testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, Chemical Characterization, Leachable Substances). |
| Shelf Life (Packaging Integrity) | Met all requirements after 3 cycles of EtO sterilization and simulated shipping, for an accelerated aged equivalent of 2 years real time (shelf life stated as 1 year). |
| Adhesive Peel Test (Force required to remove drape) | Met specification requirements. |
| Moisture Vapor Transmission Rate (MVTR) | Met minimum requirements when using ASTM E96/E96M (Upright Cup Method at 38°C and 10%RH). |
| Negative Pressure Maintenance System Test (Maintain negative pressure with simulated wound exudate, maximum air leak, worst-case dressing, max use life, re-application cycling) | Capable of maintaining negative pressure within specification, including after re-application cycling. |
| Peel Adhesion with Re-Application Cycling Testing (Peel force after multiple re-applications) | Capable of meeting specification for peel adhesion after multiple re-applications and removals. |
| Human Factors (Safe and effective use by representative users) | 30 representative users found the new user interface could be safely and effectively used. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Biocompatibility: Not specified, but involved testing according to ISO standards.
- Shelf Life: Not specified for unit count.
- Adhesive Peel Test: Not specified for unit count.
- Moisture Vapor Transmission Rate Test: Not specified for unit count.
- Negative Pressure Maintenance System Test: Not specified for unit count.
- Peel Adhesion with Re-Application Cycling Testing: Not specified for unit count.
- Human Factors: 30 representative users.
- Data Provenance: The tests described are laboratory/engineering tests conducted to assess physical and biological properties. A "country of origin for data" is not applicable in the context of these non-clinical tests. These are considered prospective tests performed on the device to prove its characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests, not studies requiring expert-adjudicated ground truth. The human factors study involved "representative users" but didn't establish ground truth for a diagnostic task.
4. Adjudication method for the test set:
- This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests.
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, an MRMC comparative effectiveness study was not done. The device is a wound drape, not an AI diagnostic tool for human readers.
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 wound drape, not an algorithm or AI system.
7. The type of ground truth used:
- Not applicable in the context of diagnostic ground truth. The "ground truth" for these tests was established by meeting engineering specifications and ISO standards (e.g., passing a biocompatibility test means no cytotoxic effect, maintaining negative pressure within a specified range).
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
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(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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