PERIOPATCH by IZUN PHARMACEUTICALS CORPORATION

PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingiva and oral mucosa, including stomatitis, minor chaffins and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adharing to and protecting affected tissues from further irritation, thereby allowing healing.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification and not a study on device performance. It focuses on regulatory approval rather than clinical study data and acceptance criteria for a medical device. Therefore, a table of acceptance criteria and device performance cannot be generated from the provided text.

Here's why and what's missing:

Type of Document: This is a letter from the FDA regarding a 510(k) premarket notification. A 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It is not a clinical study report or a summary of a study's findings directly proving efficacy against acceptance criteria.
Focus: The letter confirms that the FDA has reviewed the submission and determined that the device, PerioPatch, is "substantially equivalent" to predicate devices for its stated indications for use. It outlines regulatory requirements that the manufacturer must follow.
Lack of Performance Data: The provided text does not contain any information about:
- Specific acceptance criteria (e.g., pain reduction percentage, healing time)
- Reported device performance metrics (e.g., actual pain reduction observed, healing rates)
- Details of a study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Conclusion: The provided document does not contain the information required to populate the table or answer the questions related to acceptance criteria and a study proving device performance. This information would typically be found in a separate clinical study report or a detailed summary of a clinical trial that was submitted as part of the 510(k), but it is not present in this specific FDA letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular with text around the perimeter. In the center of the seal is a symbol with three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Izun Pharmaceuticals Corporation C/O Mr. Irving Wiesen Law Offices of Irving L. Wiesen 420 Lexington Avenue New York, New York 10170

Re: K103054

Trade/Device Name: Periopatch Regulatory Class: Unclassified Product Code: MGO Dated: January 26, 2011 Received: January 28, 2011

FEB - 7 201

Dear Mr. Wiesen:

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. Wiesen

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/ucml 15809.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.

Wh for

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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K103054

Section 6: Statement of Indications for Use

510K number (if known):

Device Name: PerioPatch

Indications for Use:

Prescription Use X

Non-Prescription Use _________________________________________________________________________________________________________________________________________________________

Susan Burns
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103054

Regulation Number and Section

N/A