(42 days)
PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
PerioPatch is a hydrogel wound dressing for use in the oral cavity. It is a hydrogel with an occlusive ethyl cellulose backing to support and help the hydrogel conform to the wound, thereby providing protection and coverage to the wound. The dressing is made entirely of GRAS natural ingredients, commonly used in ingested products, which absorb moisture and become a hydrogel. These materials adhere to the wound for up to 5-6 hours. The patch is self-adhesive after contact with moist tissue and provides an absorptive and flexible barrier over the affected area and as such protects the inflamed areas and lesions in the mouth from contact with the rest of the oral environment, thereby preventing irritation and painful aggravation of the affected area.
The provided 510(k) summary for the PerioPatch does not contain information regarding objective acceptance criteria or a study designed to demonstrate device performance against such criteria.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a common pathway for 510(k) clearances. Substantial equivalence is determined by comparing the new device to a legally marketed predicate device based on intended use, technological characteristics, and performance. In this case, the performance aspect is described in general terms, highlighting the similar hydrophilic characteristics and self-adhesive nature upon contact with moisture.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Specifically, the following information is not available in the document:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned.
- Sample size used for the test set and the data provenance: There is no mention of a test set, clinical trial, or any quantitative testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant in an application focused on substantial equivalence through comparison of characteristics rather than a new performance study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set or clinical study is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This concept is entirely irrelevant to a wound dressing device described here.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study was conducted.
- The sample size for the training set: Not applicable as this is not an AI/ML device, and no training data for a model is mentioned.
- How the ground truth for the training set was established: Not applicable.
The conclusion states: "The evaluation of PerioPatch does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device." This indicates that the regulatory decision was made based on the comparison of the device's characteristics and intended use to an existing, cleared device, rather than on new performance studies with objective acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the word "mis" in a stylized, handwritten font. The "m" is formed by two connected arches, the "i" is a straight vertical line with a dot above it, and the "s" is a curved shape that resembles a backwards "c" with a horizontal line at the bottom. The letters are all connected and appear to be written in a single stroke.
Implants Technologies Ltd.
510(k) Summary:
PerioPatch
Company Name: MIS Implants Technologies Ltd. PO Box 7, Bar Lev Industrial Park, 20156, ISRAEL Telephone: +972-4-9016800 Fax: +972-4-9918623
Establishment Registration Number: 3004203816
Contact Name: Iman Khorshid VP QA & RA Telephone: +972-4-9016800 Fax: +972-4-9918623 E-mail: iman@mis-implants.com
US Agent:
Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: (201) 797-9144 (201) 797-9145 Fax: E-mail: service@misimplants.com
Date prepared: February 13, 2011
Trade Name: PerioPatch
Classification name: Hydrogel wound dressing
Common/usual name: Dressing wound
Product Code: MGQ, FRO
Regulation No.: 878.4022
Class: Unclassified
Panel identification: General & Plastic Surgery
510 (k) PerioPatch Section E - Page 1of 3 APR 2 8 2011
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plants Technologies Ltd.
Predicate Device:
PerioPatch from Izun Pharmaceuticals Corporation, Rockefeller Plaza Center, 7th Floor, 1230 Avenue of the Americas, Manhattan, New York, 10020, USA, cleared under 510(k) K103054.
Description of the device:
PerioPatch is a hydrogel wound dressing for use in the oral cavity. It is a hydrogel with an occlusive ethyl cellulose backing to support and help the hydrogel conform to the wound, thereby providing protection and coverage to the wound. The dressing is made entirely of GRAS natural ingredients, commonly used in ingested products, which absorb moisture and become a hydrogel. These materials adhere to the wound for up to 5-6 hours.
The patch is self-adhesive after contact with moist tissue and provides an absorptive and flexible barrier over the affected area and as such protects the inflamed areas and lesions in the mouth from contact with the rest of the oral environment, thereby preventing irritation and painful aggravation of the affected area.
Indications for Use:
PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
510 (k) PerioPatch Section E - Page 2of 3
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3 of 3
Image /page/2/Picture/1 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font. Below the logo, the words "Substantial Equivalence:" are printed.
110750
Substantial Equivalence:
PerioPatch is equivalent to its predicate device based on a comparison of the intended use, product technical characteristics and performance. Both products become self-adhesive hydrogels upon contact with moisture, exhibiting the same hydrophilic product characteristics.
Conclusion:
The evaluation of PerioPatch does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.
510 (k) PerioPatch Section E - Page 3of 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Iman Khorshid Vice President Quality Assurance & Regulatory Affairs Mis Implants Technologies, Limited Bar Lev Industrial Park P.O. Box 7 Bar Lev Industrial Park Israel 20156
APR 2 8 20:1
Re: K110750
Trade/Device Name: PerioPatch Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: February 13, 2011 Received: March 17, 2011
Dear Mr. Khorshid:
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.
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Page 2- Mr. Khorshid
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.
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/ucm 115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jh
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Implanis Technologies Ltd.
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: PerioPatch
Indications for Use: PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
Prescription Use _ OR X (Part 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)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Device
510(k) Number: K110750
510 (k) PerioPatch Section D- Page 1 of 1
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