ISLAND WOUND DRESSING WITH MICROBAN

K010951 · Island Dressing, LLC · FRO · Jun 11, 2001 · SU

Device Facts

• Record ID: K010951
• Device Name: ISLAND WOUND DRESSING WITH MICROBAN
• Applicant: Island Dressing, LLC
• Product Code: FRO · SU
• Decision Date: Jun 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Island Wound Dressing™ with Microban® is indicated for local management of superficial wounds. Wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions, and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). The dressing should be changed as frequently as needed for proper management of the wound.

Device Story

Island Wound Dressing™ with Microban® is a wound dressing designed for the local management of superficial wounds. It incorporates Microban® antimicrobial technology. The dressing is applied topically to the wound site to provide protection and management of exudate. It is intended for use by healthcare professionals in clinical settings for various wound types, including surgical incisions, pin sites, and chronic ulcers. The dressing is changed as needed based on wound status. It functions as a physical barrier to the environment while managing the wound microenvironment.

Technological Characteristics

Wound dressing containing Microban® antimicrobial agent. Form factor is an island-style dressing. No specific materials or ASTM standards provided in the document.

Indications for Use

Indicated for local management of superficial wounds, including vascular access/peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor/graft sites, incisions), and partial to full-thickness dermal ulcers (Stage I-IV pressure sores, venous stasis, arterial, and diabetic ulcers).

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 2, 2024

Island Dressing, LLC.
John A. Dobos, D.D.S.
President
300 Corporate Parkway
Suite 116N
Amherst, New York 14226

Re: K010951
Trade/Device Name: Island Wound Dressing™ With Microban®
Regulatory Class: Unclassified
Product Code: FRO

Dear John A. Dobos, D.D.S.:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 11, 2001. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FRO.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, [e-mail].

Sincerely,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 11 2001

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

John A. Dobos, D.D.S.
President
Island Dressing, LLC
300 Corporate Parkway
Suite 116N
Amherst, New York 14226

Re: K010951
Trade/Device Name: Island Wound Dressing™ with Microban®
Regulatory Class: Unclassified
Product Code: MGP
Dated: March 27, 2001
Received: March 28, 2001

Dear Dr. Dobos:

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 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). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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Page 2 - John A. Dobos, D.D.S.

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" (21CFR 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,


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 1 of 1

510(k) Number (if known): K010951.

Device Name: Island Wound Dressing™ with Microban®

Indications For Use:

Island Wound Dressing™ with Microban® is indicated for local management of superficial wounds.

Wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions, and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). The dressing should be changed as frequently as needed for proper management of the wound.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Millburn
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K010951

(Optional Format 3-10-98)