(56 days)
The KCI Wound Cell Transparent Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Dressing may also be used as a secondary fixation device for other topical wound treatments such as antimicrobial and enzymatic debriding solutions and suspensions, alginates, gels and foams.
The KCI Wound Cell Transparent Dressing is indicated for:
- Non-exudating to minimally exuding wounds
- Pressure sores
- Lacerations/abrasions
- Partial and full thickness wounds
- Surgical incisions
- Second degree burns
- Donor sites
- IV sites
Occlusive Wound Dressing (21 CFR 878.4020)
The KCI occlusive wound dressings differ in that the Wound Cell includes an injection port. This injection port facilitates the application of topical wound care products after the wound dressing has been placed over the wound to serve as a secondary fixation device in addition to its other intended uses.
This 510(k) summary (K02078) is for a labeling revision of the KCI Wound Cell Transparent Wound Dressing, not for a new device requiring performance studies to demonstrate substantial equivalence based on acceptance criteria. The original device, KCI Wound Cell Transparent Wound Dressing, was already determined to be exempt from 510(k) requirements. The current submission only addresses modifications to the labeling regarding the application of topical wound treatment products through the injection port.
Therefore, the provided document does not contain information regarding traditional acceptance criteria and device performance studies of the kind requested.
Here's why and what can be extracted:
- Device Type: This is a wound dressing, which are typically evaluated for biocompatibility, sterility, integrity, and sometimes moisture vapor transmission rates (MVTR) or adherence.
- Nature of Submission: This is a labeling revision for an already-exempt device. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the manufacturer is essentially confirming that the label changes do not alter the substantial equivalence or safety/effectiveness of the device.
- Lack of Performance Data: There is no mention of clinical trials, technical performance tests, or comparative studies against specified acceptance criteria in this document. The argument for substantial equivalence rests on the fact that the changes are minor (labeling for drug application) and do not alter the previously established (or exempt) characteristics of the device.
Given this, I cannot fill out the requested table or answer most of the questions because the information is not present in the provided text.
However, I can provide what is available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not specified or discussed in the context of this labeling update. The previous exemption implies the device met initial safety and efficacy requirements, likely based on general controls for wound dressings.
- Reported Device Performance: Not reported in this document. The submission focuses on the lack of change in performance due to labeling revision.
2. Sample size used for the test set and the data provenance: Not applicable. No test set usage discussed. Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No experts for ground truth establishment are mentioned.
4. Adjudication method for the test set: Not applicable. No test set adjudication mentioned.
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 device is a passive wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established for device performance in this document.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.
In summary, this 510(k) pertains to regulatory modifications for labeling an already available and exempt device rather than demonstrating the device's technical performance against specific criteria through a study.
§ 878.4020 Occlusive wound dressing.
(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.