PERIOPATCH

K110750 · Mis Implants Technologies , Ltd. · OLR · Apr 28, 2011 · SU

Device Facts

• Record ID: K110750
• Device Name: PERIOPATCH
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: OLR · SU
• Decision Date: Apr 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

PerioPatch is a hydrogel wound dressing for oral cavity use. It consists of a hydrogel layer with an occlusive ethyl cellulose backing to support conformation to the wound. Upon contact with moist oral tissue, the patch becomes self-adhesive, providing an absorptive, flexible barrier. This barrier protects inflamed areas and lesions from the oral environment, preventing irritation and reducing pain to facilitate healing. The patch remains adhered for 5-6 hours. It is intended for use by patients or clinicians to manage various oral mucosal injuries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrogel wound dressing; materials consist of GRAS (Generally Recognized As Safe) natural ingredients; features an occlusive ethyl cellulose backing; self-adhesive upon contact with moisture; flexible, absorptive barrier; non-electronic; no software.

Indications for Use

Indicated for patients with oral wounds, injuries, or ulcerations of the gingival and oral mucosa, including stomatitis, minor chaffing, traumatic ulcers, abrasions from braces or dentures, and post-oral surgery lesions.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Predicate Devices

• PerioPatch (K103054)

Submission Summary (Full Text)

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K110756

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Implants Technologies Ltd.

# 510(k) Summary:

PerioPatch

Company Name: MIS Implants Technologies Ltd. PO Box 7, Bar Lev Industrial Park, 20156, ISRAEL Telephone: [phone] Fax: [phone]

Establishment Registration Number: 3004203816

Contact Name: Iman Khorshid VP QA & RA Telephone: [phone] Fax: [phone] E-mail: [e-mail]

US Agent:

Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: [phone] [phone] Fax: E-mail: [e-mail]

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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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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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 [phone] or [phone] 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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