(123 days)
The V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation 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.
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. Uta Negative Pressure Wound Therapy System with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The V.A.C. VeraFlo Cleanse Choice Dressing System is intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System to deliver negative pressure wound therapy (NPWT) as well as facilitate the instillation of fluid to the wound.
The V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing cleared under K103156. The only difference between the two systems is the configuration of the dressing.
The subject system has a dressing that is designed with 3 separate layers. The predicate dressing, on the other hand, is a single spiral shaped rod configuration. The materials of the dressing are the same.
The provided document is a 510(k) premarket notification for the V.A.C. VeraFlo Cleanse Choice Dressing System, which is a modification of an existing device, the V.A.C. VeraFlo Cleanse Dressing System (K103156). The document focuses on demonstrating substantial equivalence to the predicate device, rather than providing a detailed clinical study report with extensive statistical analysis of performance metrics. Therefore, some of the requested information, particularly regarding specific performance metrics for acceptance criteria and human superiority studies, is not explicitly available in the document in the format requested.
However, I can extract and infer information about the acceptance criteria and the study conducted to prove the device meets these criteria based on the provided text.
Acceptance Criteria and Reported Device Performance
The document states that the new device is "substantially equivalent" to the predicate device, implying that its performance should be comparable. The key performance aspects tested relate to the mechanical properties of the dressing and its ability to function within the V.A.C. Ulta Negative Pressure Wound Therapy (NPWT) System for both negative pressure delivery and instillation.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (V.A.C. VeraFlo Cleanse Choice Dressing System) |
|---|---|---|
| Mechanical Properties (Tensile Strength) | For the dressing material (polyurethane ester foam with 0.1% w/v carbon black colorant), the tensile strength should be ≥230kPa, matching the predicate device. | Pass (Implies ≥230kPa) |
| Negative Pressure Delivery | The dressing, as part of the V.A.C. Ulta NPWT System, must effectively create negative pressure within the sealed wound bed. (Implied: similar efficacy to predicate device). | Confirmed (by bench verification testing) |
| Instillation Solution Distribution | The dressing must effectively distribute instillation solution throughout the wound surface when used with the V.A.C. Ulta NPWT System. (Implied: similar efficacy to predicate device). | Confirmed (by bench verification testing) |
| Biocompatibility | Given the same materials as the predicate, it is implied that the device meets biocompatibility standards. (Not explicitly stated as an "acceptance criterion" in this section, but a fundamental requirement for medical devices). | Not explicitly stated, but implied by "Same as predicate" in materials. |
| Sterilization | Must achieve a Sterility Assurance Level (SAL) of 10-6. | Same as predicate (Gamma Irradiation to SAL of 10-6) |
| Packaging | Sterile packaging. | Same as predicate (Thermoformed tray of PETG with a Tyvek lid) |
| Shelf Life | Must demonstrate a shelf life of 2 years. | Same as predicate (2 years) |
| Overall Functionality | The system, with the new dressing configuration, should function identically to the predicate device in terms of delivering NPWT and controlled delivery of topical wound treatment solutions/suspensions, for the same indications for use. This is the overarching goal of demonstrating "substantial equivalence" despite the change in dressing configuration. | Confirmed (by bench and animal testing, demonstrating substantial equivalence) |
Study Details
The study described is a bench verification testing and animal testing conducted to demonstrate substantial equivalence to a legally marketed predicate device.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact numerical sample sizes for the bench or animal testing. It states "Bench Verification testing was performed" and "Bench and animal testing have demonstrated."
- Data Provenance: The document does not explicitly state the country of origin of the data. Given KCI USA, Inc. is based in San Antonio, Texas, it is highly likely the testing was conducted in the USA or by labs commissioned by them. The studies are prospective in nature, as they were conducted to verify the performance of the new device configuration.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of verification study for a device modification (dressing configuration) typically relies on engineering specifications and established biological response models, rather than expert human interpretation of images or patient outcomes for "ground truth." The "ground truth" here is adherence to mechanical and functional specifications derived from the predicate device's performance and general wound healing principles. Therefore, it's unlikely a panel of experts established "ground truth" in the way it would for AI/diagnostic studies. Engineers and scientists involved in the testing would have evaluated the results against pre-defined success criteria.
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Adjudication method for the test set:
- Not applicable in the context of this type of engineering and animal testing. Adjudication methods like "2+1" are relevant for expert consensus in diagnostic or clinical trial settings. Here, data would be analyzed against quantitative or qualitative pass/fail criteria.
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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. This study concerns a medical device, specifically a wound dressing system, not an AI or diagnostic imaging system that would involve human readers or AI assistance in interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the test set was based on engineering specifications and functional performance criteria derived from the predicate device and established medical device standards. For instance, the tensile strength has a hard numerical "ground truth" (≥230kPa). For negative pressure and instillation distribution, the ground truth is successful operation mimicking the predicate device in controlled bench and animal models.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning system that requires a "training set."
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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.