ARGLAES FILM DRESSING

K970566 · Maersk Medical, Ltd. · FRO · Jul 29, 1997 · SU

Device Facts

• Record ID: K970566
• Device Name: ARGLAES FILM DRESSING
• Applicant: Maersk Medical, Ltd.
• Product Code: FRO · SU
• Decision Date: Jul 29, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U

Intended Use

ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.

Device Story

ARGLAES Film Dressing is a sterile, transparent, self-adherent wound dressing. Used for local management of various dermal wounds (pressure sores, incisions, donor sites, minor burns, abrasions, lacerations, leg ulcers) and for securing intravenous catheters. Applied by clinicians to protect wound sites and catheter insertion points. Provides a barrier function. Not for use on third-degree burns; not a treatment or cure for wounds; not for long-term/permanent use or as synthetic skin.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, transparent, self-adherent film dressing. Form factor: film. No electronic components or software.

Indications for Use

Indicated for local management of pressure sores, incisions, donor sites, minor burns, abrasions, lacerations, superficial leg ulcers, and other dermal ulcers; also for securing and protecting intravenous catheters. Contraindicated for third-degree burns.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL 29 1997

Maersk Medical Ltd.
c/o Evan Dick, Ph.D.
E.G. Dick & Associates
7527 Westmoreland Avenue
St. Louis, Missouri 63105

Re: K970566
ARGLAES-AB Antimicrobial Barrier Film Dressing
Regulatory Class: Unclassified
Product Code: MGP
Dated: May 29, 1997
Received: May 30, 1997

Dear Dr. Dick:

We have reviewed your Section 510(k) 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

1. This device may not be labeled for use on third degree burns.
2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual

{1}

Page 2 - Evan Dick, Ph.D.

registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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

Enclosure

{2}

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K970566

Device Name: ARGLAES FILM DRESSING

Indications For Use:

ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers.

ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (per 21 CFR 01.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)