(26 days)
The ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.
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 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.
When used on closed surgical incisions, they are 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.
V.A.C. Therapy Wound Dressings for use with KCI's V.A.C. NPWT System.
This 510(k) summary is for V.A.C.® Therapy Wound Dressings, which are components of the V.A.C.® Negative Pressure Wound Therapy System. This submission appears to be for a modification to the dressings, as it compares the "Modified Device" to a "Predicate" and states that "The V.A.C. ® Dressing System was evaluated to ensure conformance to the design specifications."
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format with specific pass/fail thresholds. Instead, it lists the types of non-clinical tests performed to ensure conformance to design specifications and that the modified device meets user requirements. The "reported device performance" is implicitly that the device conformed to these specifications and met user requirements.
| Test Type | Reported Device Performance |
|---|---|
| Peel adhesion testing | Device was evaluated to ensure conformance to design specifications. (Implied: Conformed) |
| Moisture vapor transmission rate (MVTR) testing | Device was evaluated to ensure conformance to design specifications. (Implied: Conformed) |
| Biocompatibility testing (ISO 10993-1) | Device was evaluated to ensure conformance to design specifications. (Implied: Conformed) |
| Study on healthy human volunteers | Conducted to ensure that the proposed modified device meets user requirements, as there is no reliable method for measuring these requirements on the bench. (Implied: Device met user requirements) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "study conducted on healthy human volunteers" but does not specify the sample size for this study. The data provenance (country of origin, retrospective/prospective) is also not specified.
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)
This is not applicable as the described study was on "healthy human volunteers" to assess user requirements, not to establish a "ground truth" for a diagnostic or AI-driven system. There is no mention of experts establishing a ground truth in the context of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as no adjudication method is mentioned for the study on healthy human volunteers. The study's purpose was to assess user requirements, not to evaluate diagnostic accuracy requiring 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 MRMC comparative effectiveness study was done. The document explicitly states: "There was no clinical study conducted." The nature of the device (wound dressings) and the described tests do not suggest a need for such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound dressing system, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the traditional sense of a diagnostic or AI device. The "ground truth" or reference for the healthy human volunteer study would have been the user requirements themselves, which the device was designed to meet.
8. The sample size for the training set
This is not applicable as this is a medical device (wound dressings) and not an AI/algorithm-based product requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above (not an AI/algorithm-based product).
§ 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.