(247 days)
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use under a healthcare professional's orders as adjunctive treatment in the management of exudating wounds, partial and 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, for 310 degree burns or for dry wounds.
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This document is a 510(k) clearance letter from the FDA for a medical device called "PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings."
The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this type of document (a 510(k) clearance letter) does not contain acceptance criteria or the details of a study proving the device meets those criteria.
510(k) clearance is based on demonstrating substantial equivalence to a predicate device, usually through performance testing, material characterization, and sometimes limited clinical data summarized in the 510(k) submission. The FDA letter itself is the final communication of that decision, not the submission document.
Therefore, I cannot provide the requested information based solely on the provided text. The information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications would be found in the original 510(k) submission filed by Poly Remedy, Inc., not in this clearance letter.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
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: K092351
Trade/Device Name: PolyFIT"+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings Regulatory Class: Unclassified Product Code: FRO Dated: March 26, 2010 Received: March 29, 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 idence on 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 Amendmants, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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 libility warranties. We remind you; however, that device labeling must be truthful and not mileding,
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 vours.
Much M Millen
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 5.
K092351 1.1/
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K09123S(
PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ Device Name: High Absorbing Antimicrobial Dressings
Indications for Use:
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use under a healthcare professional's orders as adjunctive treatment in the management of exudating wounds, partial and 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, for 310 degree burns or for dry wounds.
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 Krone
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K09235(
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