(247 days)
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.
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The provided text is related to an FDA 510(k) clearance for a medical device called "PolyFIT+ High Hydrating Antimicrobial Dressings." It does not contain any information about acceptance criteria, study details, or performance metrics in the context of an AI/ML device.
The document is a clearance letter and an indications for use statement for a wound dressing. It declares the device substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance, as the provided text does not contain this type of data.
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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 (800) 638-2041 or (301) 796-7100 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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- Indications for Use Statement
l0092348.111
- Indications for Use Statement
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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