WET CHAMBER

K020781 · Kinetic Concepts, Inc. · NAD · May 6, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020781
• Device Name: WET CHAMBER
• Applicant: Kinetic Concepts, Inc.
• Product Code: NAD · General, Plastic Surgery
• Decision Date: May 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4020
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Transparent occlusive wound dressing; features integrated injection port. Applied to wound site to maintain moist healing environment; serves as secondary fixation for topical treatments (antimicrobial/enzymatic solutions, suspensions, alginates, gels, foams). Injection port allows clinician to apply topical agents through dressing after placement. Used in clinical settings; operated by physicians or healthcare professionals. Benefits patient by facilitating normal healing process and enabling targeted topical treatment delivery without removing primary dressing.

Clinical Evidence

No clinical data. Substantial equivalence based on technological similarity to legally marketed predicate devices and the nature of the labeling revision.

Technological Characteristics

Occlusive transparent wound dressing; includes integrated injection port for topical agent delivery. Materials and construction unchanged from exempt predicate. Sterile, single-use device.

Indications for Use

Indicated for non-exudating to minimally exuding wounds, pressure sores, lacerations/abrasions, partial and full thickness wounds, surgical incisions, second degree burns, donor sites, and IV sites. Federal law restricts device to sale by or on the order of a physician.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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 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 ◆

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