CALGITROL AG SILVER ALGINATE WOUND DRESSING

K011618 · Adri · FRO · Nov 15, 2002 · SU

Device Facts

• Record ID: K011618
• Device Name: CALGITROL AG SILVER ALGINATE WOUND DRESSING
• Applicant: Adri
• Product Code: FRO · SU
• Decision Date: Nov 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites

Device Story

Calgitrol Ag Silver Alginate Foam and Gel Foam Dressings are wound care products designed for management of various skin lesions. Dressings incorporate silver for antimicrobial properties and may include maltodextrin. Applied topically by clinicians to wound sites to provide a moist healing environment and manage exudate. Device functions as a physical barrier and therapeutic dressing; no electronic or software components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Wound dressing composed of alginate foam and gel foam; contains silver for antimicrobial action; may contain maltodextrin. Non-electronic, passive medical device.

Indications for Use

Indicated for patients with pressure ulcers (Stages I-IV), dermal lesions/secreting skin injuries, venous ulcers, stasis ulcers, 1st and 2nd degree burns, and donor sites.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles, creating a sense of unity and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2002

ADRI · George H. Scherr Director P. O. Box 134 Park Forest. Illinois 60466

Re: K011618

Trade/Device Name: Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings, with or without Maltodextrin

Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 22, 2002 Received: August 23, 2002

Dear Dr. Scherr:

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. Drue, 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. Iisting 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 (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,

{1}------------------------------------------------

Page 2 – Dr. George H. Scherr

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Muram C. Phurst

(cl 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

{2}------------------------------------------------

K011618

Page 1 of 1

510(k) Number (if known); ' K011618

Device Name: CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin

Indications for Use:

Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1* and 2nd degree burns; donor sites

..

uriam C. Thorst

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

510(k) Number K011618

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.108) જ્ઞર

Over-The Counter Use

(Optional: Format 1-2-96);