(90 days)
The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.
The EpiGuard is a single use oral protective device manufactured from biocompatible silicone. It is provided clean (non-sterile). Besides providing a physical barrier to prevent tongue and cheek damage of the user, the device will maintain an open airway in the mouth cavity and allow the free flow of air and vomit. In addition, the device is griped under the palatals and teeth of the user while also being held in front by the interior surface of the lips. This allows the EpiGuard to be fixed to the necessary position to prevent it from being swallowed.
This document describes the acceptance criteria and the study that proves the device meets those criteria for the EpiGuard bite block.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No objectionable performance aspects across 13 specific criteria | The observational study indicated no objectionable performance of the device. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 10 subjects.
- Data Provenance: The study was an observational study conducted by the manufacturer, EpiSafe Medical Devices, Ltd., in Israel. The nature (retrospective/prospective) is not explicitly stated, but "observational study" typically implies prospective data collection for the specific evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study involved subjects grading the device's performance, not experts establishing ground truth for a diagnostic output.
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Adjudication method for the test set:
- Not applicable. The study involved subject self-grading (scale of 1-5) on device performance, not expert adjudication of a classification.
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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:
- No MRMC comparative effectiveness study was done. This device is a physical bite block, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical bite block, not an algorithm.
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The type of ground truth used:
- Subjective assessment of device performance by the users (subjects) themselves, graded on a scale of 1-5 for 13 specific aspects.
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The sample size for the training set:
- Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set in the conventional sense. The "dimensions were based upon the measurements from dental impressions of men and women above the age of 10," which might be considered analogous to "training data" for design, but it's not a computational training set.
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How the ground truth for the training set was established:
- Not applicable as it's not an AI/ML algorithm. The design of the device was based on "measurements from dental impressions of men and women above the age of 10." The "ground truth" for the design would be anatomical averages and variations within the target user population.
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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.Galdani Bldg58b Amal St.Kiriat Arie, Petach Tikya, Israelwww.medicsense.com |
|---|---|
| 1. (b) Manufacturer Address: | EpiSafe Medical Devices, Ltd.84 Yitzhak Rabin Rd.Givataym, Israel 53483972-3-571-0768 |
| Mfg. Phone: | Eran Lavi, CEO |
| Contact Person: | |
| Date: | January 19, 2005 |
| 2. Device & Classification Name: | Bite Block, Class 2, Product Code 84JXL, 21 CFR 882.5070EpiGuard |
| 3. Predicate Devices: | Ventil-A Bite Block K992269MouthGuard Bite Block K864181Sage Bite Block Pre-Amendment |
| 4. Description: | The EpiGuard is a single use oral protective device manufactured frombiocompatible silicone. It is provided clean (non-sterile). Besides providing aphysical barrier to prevent tongue and cheek damage of the user, the devicewill maintain an open airway in the mouth cavity and allow the free flow of airand vomit. In addition, the device is griped under the palatals and teeth ofthe user while also being held in front by the interior surface of the lips. Thisallows the EpiGuard to be fixed to the necessary position to prevent it frombeing swallowed. |
| 5. Intended Use: | The EpiGuard is intended for the prevention of oral soft tissue damageduring epileptic tonic-clonic seizures proceeded by an aura. |
| 6. (a) Comparison of Technological Characteristics: | With respect to technology, the EpiGuard is substantially equivalent to itspredicate devices of being a bite block in terms of design principles. Itsdimensions were based upon the measurements from dental impressions ofmen and women above the age of 10. The biocompatible material has thenecessary tensile strength properties to prevent degradation when utilized. |
| 6. (b) Clinical Testing: | An observational study was conducted on 10 subjects with 3 devices (30trials total) to evaluate 13 specific aspects of the EpiGuard. The subjectsgraded the performance of the device on a scale of 1-5. The outcome of thisstudy 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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 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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§ 882.5070 Bite block.
(a)
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.(b)
Classification. Class II (performance standards).