(75 days)
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.
Not Found
The provided FDA letters for the "Island Wound Dressing With Microban®" are administrative and regulatory documents related to its 510(k) clearance. They announce an administrative change in the product code and confirm substantial equivalence to a predicate device.
These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the input text. The letters explicitly state that the 510(k) submission was not re-reviewed in the December 2, 2024 letter, and the June 11, 2001 letter confirms substantial equivalence but does not detail the specific studies or data used to establish that equivalence.
FDA Letters - Island Wound Dressing With Microban®
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.04
Silver Spring, MD 20993
www.fda.gov
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, YuChieh.Chiu@fda.hhs.gov.
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
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, Yu-Chieh.Chiu@fda.hhs.gov.
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
Page 2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
JUN 11 2001
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.
Page 3
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 (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
[Signature]
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
Page 4
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)
[Signature]
Division of General, Restorative
and Neurological Devices
(Optional Format: 3-10-98)
510(k) Number K010951
N/A