CUTICOVER SKIN BARRIER DEVICE

K042955 · D & D Holdings, LLC · KMF · Jun 19, 2006 · General Hospital

Device Facts

• Record ID: K042955
• Device Name: CUTICOVER SKIN BARRIER DEVICE
• Applicant: D & D Holdings, LLC
• Product Code: KMF · General Hospital
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces.

Device Story

CUTICOVER™ SKIN is a barrier film applied to the skin to protect against moisture, urine, or feces. The device is formulated identically to the predicate NUVO Barrier Film. It functions as a topical protective layer. It is intended for use by patients or clinicians to prevent skin irritation or breakdown caused by exposure to bodily fluids.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical formulation to the predicate device.

Technological Characteristics

Liquid barrier film; identical formulation to predicate device (K980117).

Indications for Use

Indicated for use as a skin barrier to protect skin from moisture, urine, or feces. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• NUVO Barrier Film (K980117)

Submission Summary (Full Text)

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## EXHIBIT 3 - CUTICOVER™ SKIN BARRIER DEVICE - REVISED 510(K) SUMMARY

K042955
Page 1 of 1

## 10.0 510(K) Summary

10.1 Device Name/Sponsor CUTICOVER™ SKIN Barrier Device D & D Holdings, LLC Contact: Robert Conway Telephone: [phone]

- Predicate Device/Company Name and Addresses 10.2
000

NUVO Barrier Film (K980117) EPIKEIA, INC. 500 Sandau, Suite 200 San Antonio, TX 78216-3636

- 10.3 Description of Device CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device.
- 10.4 Intended Use INDICATIONS: "CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces."
- 10.5 Safety The formulation is identical to that currently used in the marketed device, NUVO Barrier Film.
- 10.6 Basis of Substantial Equivalence The design, composition, indications and packaging are equivalent to similar devices currently marketed.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

JUN 19 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

D&D Holdings, LLC % R.G. Conway & Associates Consulting Services, Inc. Mr. R.G. Conway President Six Edison Road White House Station, New Jersey 08889

Re: K042955

Trade/Device Name: CUTICOVER™ SKIN Barrier Device Regulatory Number: 21 CFR 880.5090 Regulatory Name: Liquid bandage Regulatorv Class: I Product Code: KMF Dated: May 17, 2006 Received: May 19, 2006

Dear Mr. Conway:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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

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Page 2 - Mr. R.G. Conway

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Hucker Lemon no

Radiological Health

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and

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## 510(K) Number (if known): K042955

Device Name: CUTICOVER™ SKIN Barrier Device

## INDICATIONS FOR USE:

Skin barrier for protection against the detrimental effects of moisture, urine, or feces.

Prescription Use (Per 21 CFR 801.109) -OR-

Over-the-Counter Use

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Hebert Turner

Division of General, Restorative, and Neurological Devices

**510(k) Number** *K042935*