HYDROFERA BACTERIOSTATIC WOUND DRESSING

K023138 · Hydrofera, LLC · FRO · Jan 17, 2003 · SU

Device Facts

• Record ID: K023138
• Device Name: HYDROFERA BACTERIOSTATIC WOUND DRESSING
• Applicant: Hydrofera, LLC
• Product Code: FRO · SU
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin. Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have. Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.

Device Story

Hydrofera Bacteriostatic Wound Dressing is an external wound management device. It functions as a dressing to cover and manage various wound types, including ulcers, burns, and surgical incisions. Used in both home settings (OTC for minor wounds) and clinical settings (under professional care for complex wounds). The dressing provides a physical barrier and bacteriostatic environment to support wound healing. Healthcare providers apply the dressing to the wound site to facilitate local management. Benefits include protection of the wound bed and assistance in the healing process for a wide range of acute and chronic external wounds.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bacteriostatic wound dressing; form factor is a topical dressing; intended for external application. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for management of minor skin wounds (cuts, scalds, abrasions, lacerations, irritations) for OTC use, and under professional care for pressure, venous stasis, arterial, and diabetic ulcers, donor sites, superficial burns, post-surgical incisions, and traumatic wounds.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Hydrofera, LLC. Heather S. Bond 322 Main Street, Suite 1101 Willimantic, Connecticut 06226

Re: K023138 Trade/Device Name: Hydrofera Bacteriostatic Wound Dressing Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 31, 2002 Received: January 2, 2003

Dear Ms. Bond:

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 forth in

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Page 2 – Ms. Heather S. Bond

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]. 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 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,

Muriam C. Provost

for 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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## 510(K) NUMBER (IF KNOWN): 023138

DEVICE `NAME : _HYDROFERA BACTERIOSTATIC WOUND DRESSING

## INDICATIONS FOR USE:

Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin.

Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have.

Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.

(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 801.109) OR

Over-The-Counter-Use √
(Optional Format 1-2-96)

Muriam C. Provost

eneral. Restorative

Number K623138