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

Device Description

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.

AI/ML Overview

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.

Summary

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K02078

MAY 0 6 2002

510(k) Summary

Device Trade Name: KCI Wound Cell Transparent Wound Dressing

Classification Name: Occlusive Wound Dressing (21 CFR 878.4020)

510(k) Applicant: Kinetic Concepts, Inc. (KCI) 8023 Vantage Drive San Antonio, TX 78265-8508 Contact: Judith Harbour 1-800-275-4524
Predicate Devices; KCI Wound Cell Transparent Wound Dressing [510(k) Exempt] KCI Wet Cell Transparent Wound Dressing [510(k) Exempt] SimpliCare Transparent Wound Dressing (K991214) Innovative Technologies' Transparent Film Dressing (K973312)

FDA Regulatory Status:

A final order published in the October 5, 1999 Federal Register exempted occlusive wound dressing from the premarket notification requirements when intended to cover a wound, provide or support a moist wound environment, and allow the exchange of gases such as oxygen and water vapor through the device. This classification regulation does not include occlusive wound dressings that contain added drugs or are composed of materials derived from animal sources.

Indication for Use:

FDA review of previous KCI 510(k) submissions for the KCI Wet Cell and Wound Cell Transparent Wound Dressings determined that both were exempt from the 510(k) requirements. Their indications for use are similar to the cited predicate devices (SimpliCare Transparent Wound Dressing and Innovative Technologies' Transparent Wound Dressings) granted FDA marketing clearance before the 510(k) exemption went into effect. They are intended to cover a wound, provide or support a moist wound environment, and allow the exchange of gases through the device. In addition, they may be used as a secondary fixation device for other wound care products such as alginates, gels and foams. 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.

The KCI Wound Cell Transparent Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Wound Cell Dressing may also be used as a secondary fixation device for other topical wound treatment products such as antimicrobial and enzymatic debriding solutions and suspensions, alginates, gels and foams.

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Purpose of This 510(k) Submission:

Labeling revision to provide directions for using a sterile syringe with an appropriately gauged needle to topically apply legally marketed topical wound treatment solutions, suspensions, alginates, gels and foams on the treatment site through the injection port of a previously applied KCI Wound Cell Transparent Wound Dressing.

KO207

age 2 of 2

Substantial Equivalence:

The FDA review of the previous 510(k) notification for the KCI Wound Cell Transparent Wound Dressing with the injection port for introducing sterile saline, alginates, gels and foams determined that this occlusive wound dressing was exempt from the 510(k) requirements. The present 510(k) submission for the labeling revisions also includes the labeling for several legally marketed topical wound treatment drugs (antimicrobial agent and debriding ointments). The revised labeling does not constitute a major change or modification in the intended use of the KCI Wound Cell Transparent Wound Dressing. No changes in the technological characteristics of this device were necessitated by this labeling revision. Applying the topical wound treatment drugs in this manner does not result in a change in their route of administration, dosage, or intended use. KCI concludes that the KCI Wound Cell Transparent Wound Dressing, as modified by this revised labeling, is substantially equivalent to the cited predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

MAY 0 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kinetic Concepts, Inc. Ms. Judith A. Harbour 8023 Vantage Drive San Antonio, Texas 78230-4726

Re: K020781

Trade Name: KCI Wound Cell Transparent Wound Dressing Regulation Number: 878.4020 Regulation Name: Occlusive wound dressing Regulatory Class: I Product Code: NAD Dated: February 28, 2002 Received: March 11, 2002

Dear Ms. Harbour:

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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Judith Harbour

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis ictier will and w you'ls ough finding of substantial equivalence of your device to a legally promatics notication: "The Presults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific aart 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F Furt 6011 o additionally, for questions on the promotion and advertising of Compinatee at (301) 07 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionination sturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost
for S. M. Witter, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): K020781

Device Name: The Wound Cell

Indications For Use:

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 ◆

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

miriam C.

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020781

Regulation Number and Section

§ 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.