(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of the device, with no mention of AI or ML algorithms.
Yes
The device is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures and to maintain an open airway, which are therapeutic functions.
No
The device is a protective measure used during epileptic seizures to prevent oral soft tissue damage and maintain an open airway. It does not perform any diagnostic function such as identifying a disease, condition, or its severity.
No
The device description clearly states it is a physical oral protective device made from silicone, which is a hardware component.
Based on the provided information, the EpiGuard is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- EpiGuard's Function: The EpiGuard is a physical device that is placed in the mouth to prevent injury during seizures. It does not analyze any biological specimens or provide diagnostic information. Its function is purely mechanical and protective.
The description clearly states its purpose is to prevent physical damage and maintain an open airway, which are not functions of an IVD.
N/A
Intended Use / Indications for Use
The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.
Product codes (comma separated list FDA assigned to the subject device)
84JXL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue, mouth cavity
Indicated Patient Age Range
men and women above the age of 10.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
An observational study was conducted on 10 subjects with 3 devices (30 trials total) to evaluate 13 specific aspects of the EpiGuard. The subjects graded the performance of the device on a scale of 1-5.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An observational study was conducted on 10 subjects with 3 devices (30 trials total) to evaluate 13 specific aspects of the EpiGuard. The subjects graded the performance of the device on a scale of 1-5. The outcome of this study did not indicate any objectionable performance of the device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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 Bldg
58b Amal St.
Kiriat Arie, Petach Tikya, Israel
www.medicsense.com |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) Manufacturer Address: | EpiSafe Medical Devices, Ltd.
84 Yitzhak Rabin Rd.
Givataym, Israel 53483
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
EpiGuard |
| 3. Predicate Devices: | Ventil-A Bite Block K992269
MouthGuard Bite Block K864181
Sage Bite Block Pre-Amendment |
| 4. Description: | 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. |
| 5. Intended Use: | The EpiGuard is intended for the prevention of oral soft tissue damage
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
predicate devices of being a bite block in terms of design principles. Its
dimensions were based upon the measurements from dental impressions of
men and women above the age of 10. The biocompatible material has the
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
trials total) to evaluate 13 specific aspects of the EpiGuard. The subjects
graded the performance of the device on a scale of 1-5. The outcome of this
study did not indicate any objectionable performance of the device |
1
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.
2
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
3
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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