EPIGUARD

K050188 · Episafe Medical Devices, Ltd. · JXL · Apr 27, 2005 · Neurology

Device Facts

• Record ID: K050188
• Device Name: EPIGUARD
• Applicant: Episafe Medical Devices, Ltd.
• Product Code: JXL · Neurology
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.

Device Story

EpiGuard is a single-use, biocompatible silicone oral protective device; functions as a physical barrier to prevent tongue and cheek damage during epileptic tonic-clonic seizures. Device maintains open airway; allows free flow of air and vomit. Design features include grip under palatals and teeth; held in front by interior surface of lips to prevent swallowing. Dimensions based on dental impressions of men and women over age 10. Device is provided clean (non-sterile).

Clinical Evidence

Observational study conducted on 10 subjects using 3 devices (30 total trials). Subjects graded 13 performance aspects on a 1-5 scale. Results indicated no objectionable performance.

Technological Characteristics

Biocompatible silicone construction; single-use; non-sterile. Dimensions based on dental impressions of individuals >10 years old. Mechanical bite block design; no energy source or software components.

Indications for Use

Indicated for prevention of oral soft tissue damage during epileptic tonic-clonic seizures preceded by an aura in patients aged 10 and older.

Regulatory Classification

Identification

A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.

Predicate Devices

• Ventil-A Bite Block (K992269)
• MouthGuard Bite Block (K864181)
• Sage Bite Block (Pre-Amendment)

Submission Summary (Full Text)

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## KOSO 188 510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. (a) Submitter Address: | MedicSense, Ltd.<br>Galdani Bldg<br>58b Amal St.<br>Kiriat Arie, Petach Tikya, Israel<br>www.medicsense.com |
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| 1. (b) Manufacturer Address: | EpiSafe Medical Devices, Ltd.<br>84 Yitzhak Rabin Rd.<br>Givataym, Israel 53483<br>972-3-571-0768 |
| Mfg. Phone: | Eran Lavi, CEO |
| Contact Person: | |
| Date: | January 19, 2005 |
| 2. Device & Classification Name: | Bite Block, Class 2, Product Code 84JXL, 21 CFR 882.5070<br>EpiGuard |
| 3. Predicate Devices: | Ventil-A Bite Block K992269<br>MouthGuard Bite Block K864181<br>Sage Bite Block Pre-Amendment |
| 4. Description: | The EpiGuard is a single use oral protective device manufactured from<br>biocompatible silicone. It is provided clean (non-sterile). Besides providing a<br>physical barrier to prevent tongue and cheek damage of the user, the device<br>will maintain an open airway in the mouth cavity and allow the free flow of air<br>and vomit. In addition, the device is griped under the palatals and teeth of<br>the user while also being held in front by the interior surface of the lips. This<br>allows the EpiGuard to be fixed to the necessary position to prevent it from<br>being swallowed. |
| 5. Intended Use: | The EpiGuard is intended for the prevention of oral soft tissue damage<br>during epileptic tonic-clonic seizures proceeded by an aura. |
| 6. (a) Comparison of Technological Characteristics: | With respect to technology, the EpiGuard is substantially equivalent to its<br>predicate devices of being a bite block in terms of design principles. Its<br>dimensions were based upon the measurements from dental impressions of<br>men and women above the age of 10. The biocompatible material has the<br>necessary tensile strength properties to prevent degradation when utilized. |
| 6. (b) Clinical Testing: | An observational study was conducted on 10 subjects with 3 devices (30<br>trials total) to evaluate 13 specific aspects of the EpiGuard. The subjects<br>graded the performance of the device on a scale of 1-5. The outcome of this<br>study did not indicate any objectionable performance of the device |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, symbolizing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EpiSafe Medical Devices, LTD. C/o Mr. George J. Hattub, RAC & CQE Senior Staff Consultant MedicSense, Ltd. 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K050188 Trade/Device Name: EpiGuard Regulation Number: 21 CFR 882.5070 Regulation Name: Bite block Regulatory Class: II Product Code: JXL Dated: April 13, 2005 Received: April 15, 2005

Dear Mr. Hattub:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 – Mr. George J. Hattub

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Minos O. Perez

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: EpiGuard

Indications For Use: The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eun Citta

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