POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS

K092348 · Polyremedy, Inc. · FRO · Apr 8, 2010 · SU

Device Facts

• Record ID: K092348
• Device Name: POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
• Applicant: Polyremedy, Inc.
• Product Code: FRO · SU
• Decision Date: Apr 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PolyFIT+ High Hydrating Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ High Hydrating Antimicrobial Dressings are indicated for use under a healthcare professional's orders as adjunctive treatment to maintain a moist wound environment in the management of dry wounds or wounds with minimal to no exudate, in the care of partial or full-thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone and for 3rd degree byrns.

Device Story

PolyFIT+ High Hydrating Antimicrobial Dressing functions as a physical barrier to inhibit microbial proliferation and penetration. Applied by healthcare professionals to maintain a moist wound environment for dry or minimally exuding wounds. Device supports wound healing by providing moisture and antimicrobial protection. Used in clinical settings for various wound types; aids clinical decision-making by facilitating wound management and infection control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrating antimicrobial dressing; functions as a physical barrier. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for management of dry or minimally exuding partial or full-thickness wounds, including pressure ulcers (Stages II-IV), venous/arterial lower extremity ulcers, diabetic foot ulcers, and surgical/traumatic wounds. Contraindicated for 3rd degree burns and wounds with exposed tendon or bone.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 8 2010

Poly Remedy, Inc. % Mr. Gary Mocnik 2637 Marine Way, Suite 100 Mountain View, California 94043

Re: K092348

Trade/Device Name: Poly Fit Hydrating Antimicrobial Dressings Regulatory Class: Unclassified Product Code: FRO Dated: March 28, 2010 Received: March 30, 2010

Dear Mr. Mocnik:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gary Mocnik

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark McMullen

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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- 5. Indications for Use Statement
l0092348.111

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K092340

Device Name: PolyFIT™+ High Hydrating Antimicrobial Dressings

Indications for Use:

PolyFIT+ High Hydrating Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ High Hydrating Antimicrobial Dressings are indicated for use under a healthcare professional's orders as adjunctive treatment to maintain a moist wound environment in the management of dry wounds or wounds with minimal to no exudate, in the care of partial or full-thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone and for 3rd degree byrns.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krane for MXM
(Division Sign Off)

Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K092348

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