(35 days)
Not Found
No
The device description focuses on the material composition and physical mechanism of action of the dressing, with no mention of AI or ML.
Yes.
The device is a wound dressing designed to absorb exudate, inhibit microbial proliferation, and kill bacteria, all of which contribute to the healing process of various types of wounds, thus providing therapeutic benefit.
No
The device description clearly states that PolyFIT+ Absorbing Antimicrobial Dressings are soft, sterile dressings designed for the management of exudating wounds. It functions by absorbing wound exudate and inhibiting microbial proliferation through the embedded PHMB. These are functions of a treatment device (dressing), not a diagnostic device which primarily identify or detect a disease, condition, or other health status.
No
The device description clearly describes a physical dressing made of synthetic fibers with embedded PHMB, intended for wound management. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a dressing applied to wounds on the body. It absorbs exudate and acts as a barrier, but it does not analyze or test biological samples taken from the body.
- The mechanism of action is physical and chemical interaction with the wound and bacteria. The dressing absorbs exudate and the PHMB embedded in the fibers directly interacts with bacteria on contact. This is a topical treatment, not an in vitro diagnostic test.
- The intended use is for wound management and treatment. The indications for use describe the types of wounds the dressing is intended to be applied to for healing and protection. This is a therapeutic purpose, not a diagnostic one.
Therefore, the PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings are considered medical devices, specifically wound dressings, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For Over-the-Counter Use, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
Under the supervision of a healthcare professional, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for the management of:
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 as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers 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, or for 30 degree burns.
Product codes
FRO
Device Description
PolyFIT+ Absorbing Antimicrobial Dressings are soft, sterile dressings designed for the management of exudating wounds and are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are made of synthetic, hvdrophilic, fibers embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB).
PolyRemedy employs an electrospinnng process to manufacture the ingredients: polyethylene oxide (PEO), polyethylene-co-vinyl-alcohol (EVOH), polycaprolactone (PCL) and PHMB into fibers, forming consistent and congruent dressings. Within the PolyFIT+ Absorbing Antimicrobial Dressings, the PEO gelling fibers are supported by the EVOH and PCL fibers for structural integrity. While absorbing wound exudate, the fibers transform from a dry dressing into a fiber gelling dressing that rapidly absorbs excess exudate away from the wound surface and retains it in the dressing. When exudate is absorbed into the PolyFIT+ Absorbing Antimicrobial Dressing, the PHMB embedded in the fibers ensures that when bacteria come in contact with the PHMB molecule the outer cell wall of the bacteria is disrupted, resulting in leakage of cytoplasm and cell death. As a consequence, bacterial numbers decrease, replication ceases and mutation cannot occur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use, Under the supervision of a healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This submission does not rely on clinical data to determine substantial equivalency to the predicate devices. All necessary verification and validation testing has been performed for the PolyFIT+ Absorbing Antimicrobial Dressings to assure substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Section 6
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being sub accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | PolyRemedy, Inc. |
|---|---|
| TRADE NAME: | Poly FIT™+ Absorbing Antimicrobial Dressings (OTC) |
| Poly FIT™+ High Absorbing Antimicrobial Dressings (OTC) | |
| COMMON NAME: | Wound Dressing |
| CLASSIFICATION NAME: | Dressing, Wound, Drug |
| DEVICE CLASSIFICATION: | Unclassified (preamendment) |
| PRODUCT CODE | FRO |
| PREDICATE DEVICES: | Poly FIT™+ High Absorbing Antimicrobial Dressings |
| (K092351) | |
| Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC) | |
| (K070653) | |
| Convatec Aquacel Ag Hydrofiber Antimicrobial Dressings | |
| (K080383) |
Substantially Equivalent To:
PolyFIT+ Absorbing Antimicrobial Dressings are substantially equivalent in intended use, principal of operation and technological characteristics to the legally marketed PolyFIT Absorbing Antimicrobial Wound Dressing (K092351) and the Kendall Kerlix AMD Antimicrobial Wound Dressing (K070653) and the Convatec Aquacel Ag Hydrofiber Antimicrobial Dressings (K080383).
Description of the Device Subject to Premarket Notification:
PolyFIT+ Absorbing Antimicrobial Dressings are soft, sterile dressings designed for the management of exudating wounds and are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are made of synthetic, hvdrophilic, fibers embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB).
PolyRemedy employs an electrospinnng process to manufacture the ingredients: polyethylene oxide (PEO), polyethylene-co-vinyl-alcohol (EVOH), polycaprolactone (PCL) and PHMB into fibers, forming consistent and congruent dressings. Within the PolyFIT+ Absorbing Antimicrobial Dressings, the PEO gelling fibers are supported by the EVOH and PCL fibers for structural integrity. While absorbing wound exudate, the fibers transform from a dry dressing into a fiber gelling dressing that rapidly absorbs excess exudate away from the wound surface and retains it in the dressing. When exudate is absorbed into the PolyFIT+ Absorbing Antimicrobial Dressing, the PHMB embedded in the fibers ensures that when bacteria come in contact with the PHMB molecule the outer cell wall of the bacteria is disrupted,
1
Section 6
resulting in leakage of cytoplasm and cell death. As a consequence, bacterial numbers decrease, replication ceases and mutation cannot occur.
Indication for Use:
For Over-the-Counter Use, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
Indications for Use:
Under the supervision of a healthcare professional, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for the management of:
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 as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers 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.
Technical Characteristics:
PolyFIT+ Absorbing Antimicrobial Dressings have similar physical and technical characteristics to the predicate devices.
Non-Clinical Performance Data:
All necessary verification and validation testing has been performed for the PolyFIT+ Absorbing Antimicrobial Dressings to assure substantial equivalence to the predicate devices.
Clinical Data:
This submission does not rely on clinical data to determine substantial equivalency to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and effectiveness information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the PolyFIT+ Absorbing Antimicrobial Dressings are determined by PolyRemedy to be substantially equivalent to existing legally marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 7 2012
Polyremedy, Incorporated % Gary Mocnik and Associates Mr. Gary Mocnik 49 Coastal Oak Aliso Viejo, California 92656
Re: K121522
Trade/Device Name: PolyFit™+ Absorbing Antimicrobial Dressings (OTC) Regulation Name: Unclassified Product Code: FRO Dated: May 15, 2012 Received: May 23, 2012
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
3
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
the
Mark N. Melkerson 8 Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 5
Indications for Use Statement
Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 121522
Device Name: PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings
For Over-the-Counter Use, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
Indications for Use:
Under the supervision of a healthcare professional, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for the management of:
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 as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers 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, or for 30 degree burns.
OR
Prescription Use _ X (Per 21 CFR 801 Subpart D) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kramer MM
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121522