(273 days)
For the management of dry to low/moderate exuding wounds such as:
Stage I-IV pressure ulcers Diabetic & foot ulcers Partial and full thickness wounds Graft and donor sites Post-operative surgical wounds Trauma wounds (dermal lesions, trauma injuries and incisions) 1 & 2nd degree burns Abrasions and lacerations
Prescription Use Only (Part 21 CFR 801 Subpart D)
The product is a spreadable amorphous water based wound gel comprising a synthetic clay as the thickening agent. The gel provides for optimal moisture management of the wound bed by donating/absorbing water that in turns aids in wound healing. The presence of active silver compounds within the gel provides preservative action and acts as an effective barrier to microbial penetration by inhibiting the growth of microorganisms within the dressing. The gel is clear to hazy and will not stain tissue when used over a period of 3 days though its potential to stain skin beyond 3 day use is not known.
Even with silver content at 550ppm, the gel is not discolored by incidental exposure to intense light such sunlight or to elevated environment temperatures.
The device is packaged primarily in tamperproof tubes (43g) with screw caps though it may be available in other sizes and containers. The tube is contained in a cardboard box with product insert.
I am sorry, but the provided text describes a medical device, specifically an antimicrobial silver wound gel (MTR550). It does not contain information about the acceptance criteria and study design for an AI/ML powered medical device. Therefore, I cannot extract the information required to answer your request.
The text focuses on:
- Regulatory information: FDA 510(k) clearance, substantial equivalence to predicate devices, and general controls.
- Device description: Composition, packaging, and specific properties of the wound gel.
- Indications for Use and Contraindications.
- Manufacturing and Biocompatibility testing.
- Performance data: Antimicrobial efficacy (preservative challenge test, in vitro assays against microorganisms), animal studies (rat, porcine), non-staining property, and stability.
- Comparison with predicate devices.
There is no mention of AI/ML, test sets, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
Medical Technology Research, Inc. Bhalchandra M. Karandikar, Ph.D Chief Technology Officer 2650 Progress Way Woodburn, OR 97071
Re: K152519
Trade/Device Name: MTR550 (Tentative) Antimicrobial Silver Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 25, 2016 Received: May 5, 2016
Dear Dr. Karandikar:
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 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE
K NUMBER: K152519
DEVICE NAME: MTR550 ANTIMICROBIAL SILVER WOUND GEL
INDICATIONS FOR USE
For the management of dry to low/moderate exuding wounds such as:
Stage I-IV pressure ulcers Diabetic & foot ulcers Partial and full thickness wounds Graft and donor sites Post-operative surgical wounds Trauma wounds (dermal lesions, trauma injuries and incisions) 1 & 2nd degree burns Abrasions and lacerations
Prescription Use Only (Part 21 CFR 801 Subpart D) TYPE OF USE:
{3}------------------------------------------------
510(k) SUMMARY
1. SUBMITTER/OWNER
MEDICAL TECHNOLOGY RESEARCH INC. 2650 PROGRESS WAY WOODBURN, OR 97071
Phone: 503-902-6279 Fax: 503-980-7931
Contact Person: Bhalchandra M. Karandikar, PhD Chief Technology Officer
Date Prepared: April 25, 2016
2. DEVICE
| Name of Device: | MTR550 (Tentative) Antimicrobial Silver Wound Gel |
|---|---|
| Common Name: | Antimicrobial Wound Dressing |
| Classification Name: Dressing Wound, Drug | |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
3. PREDICATE DEVICE
MTR550 gel is substantially equivalent to the following legally marketed predicate devices:
- SilverShield™ Antimicrobial Skin and Wound Gel (# K062212) from Anacapa (i) Technologies of San Dimas, CA and distributed presently under SilverSept® name
- (ii) Silver Antimicrobial Wound Gel from Advanced Medical Solutions of Winsford, UK (#K110458) and marketed by Molynyke under the name Normlgel Ag®
4. DEVICE DESCRIPTION
The product is a spreadable amorphous water based wound gel comprising a synthetic clay as the thickening agent. The gel provides for optimal moisture management of the wound bed by donating/absorbing water that in turns aids in wound healing. The presence of active silver compounds within the gel provides preservative action and acts as an effective barrier to microbial penetration by inhibiting the growth of microorganisms within the dressing. The gel is clear to hazy and will not stain tissue when used over a period of 3 days though its potential to stain skin beyond 3 day use is not known.
{4}------------------------------------------------
Even with silver content at 550ppm, the gel is not discolored by incidental exposure to intense light such sunlight or to elevated environment temperatures.
The device is packaged primarily in tamperproof tubes (43g) with screw caps though it may be available in other sizes and containers. The tube is contained in a cardboard box with product insert.
5. INDICATIONS FOR USE
The device is indicated for use by prescription only. It is indicated for use in the management of dry to low/moderate exuding partial and fullness thickness wounds, stage I-IV pressure ulcers, diabetic and foot ulcers, graft wounds and donor sites, first and second degree wounds, post-operative surgical wounds, trauma wounds (dermal lesions, trauma injuries and incisions), abrasions and lacerations.
Contraindications: The gel should not be used on patients with known sensitivity to silver and s-triazine compounds.
6. MANUFACTURING
The MTR550 gel will be manufactured in a production facility in accordance with good manufacturing practices consistent with US FDA guidelines. The batch production of the gel and packaging will be verified to meet product specifications to ensure the product is safe and effective.
7. BIOCOMPATIBILITY TESTING
The device has been tested for in-vitro cytotoxicity, dermal irritation and sensitization in accordance with ISO 10993 -1 (Biological Evaluation of Medical Devices).
No systemic toxicity was associated with the antimicrobial silver compounds. Animal study employing rats showed no adverse effects on animals due to the device.
8. PERFORMANCE
The antimicrobial efficacy of the device has been demonstrated by 28 days Antimicrobial preservative challenge test in accordance with USP Chapter 51 guidelines. Employing in vitro assays, the antimicrobial barrier property was demonstrated against 17 different micro-organisms that included bacteria, yeast and fungi. The tested microorganisms included, MRSA, VRE, Candida A. and Aspergillus niger. Sustenance of antimicrobial barrier activity was demonstrated for 3 days in a serial transfer assay.
Animal study employing rats showed the device exhibited no adverse effect on animals. In a porcine study examining deep partial thickness burn wound healing. MTR550 device was found to be safe and effective as the predicate device.
{5}------------------------------------------------
Despite its silver content at 550ppm, the device was shown to be non-staining to dermal tissue over 3 days use. The device showed no discoloration despite exposure to intense light or elevated environmental temperatures.
9. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
With respect to its physical and chemical properties, the device is substantially equivalent to the predicate device.
The mechanism of antimicrobial action is also similar. Both device exert toxicity towards micro-organisms as a result of silver ions.
The device is substantially equivalent to legally marketed predicate devices in composition and intended use.
10. CONCLUSIONS
Based on the indications for use, biocompatibility, invivo studies, performance data, the MTR550 gel is substantially similar to SilverShield™ Antimicrobial Skin and Wound Gel (#K062212)
N/A