(86 days)
Not Found
No
The description focuses on the mechanical function of the device as an oral protector and does not mention any AI/ML components or capabilities.
No
The device is described as an "oral protector" designed to prevent injury to the mouth during seizures or stimulation, rather than to treat a disease or condition. Its function is protective, not therapeutic.
No
The device description clearly states its purpose is "protection of the teeth, lips, tongue, and buccal mucosa" during seizures or stimulation, and it performs "Bite Force Testing," "Displacement Testing," and "Testing with Endotracheal Tubes" to ensure its protective function. There is no indication that the device is used to identify or analyze a condition.
No
The device description clearly states it is a physical, disposable oral protector designed to be placed in the patient's mouth, indicating it is a hardware device.
Based on the provided information, the SurgeoBite® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- SurgeoBite's Function: The SurgeoBite is a physical device placed inside the mouth to protect tissues during seizures or other procedures. It does not analyze any biological samples or provide diagnostic information. Its function is purely mechanical protection.
The description clearly states its purpose is to protect the teeth, lips, tongue, and buccal mucosa from damage during specific events. This is a protective function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
Product codes
JXL
Device Description
The SurgeoBite is designed to be an easy to use and safe device for use in the patient's mouth. The shape of the device allows for easy positioning into the mouth and provides a biting surface between the teeth making sure that the tongue and cheeks are not between the biting surfaces. During seizures induced by electroconvulsive therapy, neuromonitoring stimulation, spontaneous seizures, and circumstances requiring protection, the jaw muscles can contract and cause potential damage to the teeth and mouth tissues. By placing the oral protector in the patient's mouth, it will provide protection of the teeth, lips, tongue, and buccal mucosa. The SurgeoBite is sold nonsterile, single use, and is discarded after use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth, teeth, lips, tongue, buccal mucosa
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 biocompatibility requirements. The silicone rubber material as manufactured is compliant under ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. Performance testing completed for SurgeoBite included Bite Force Testing, Displacement Testing, and Testing with Endotracheal Tubes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2017
Surgovations LLC % Julie Stephens President/Consultant Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, Georgia 30004
Re: K172978
Trade/Device Name: SurgeoBite Regulation Number: 21 CFR 882.5070 Regulation Name: Bite Block Regulatory Class: Class II Product Code: JXL Dated: September 27, 2017 Received: September 27, 2017
Dear Julie Stephens:
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.
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2017.12.22 08:39:24 -05'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172978
Device Name SurgeoBite®
Indications for Use (Describe)
The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
| Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 201.5 Subject Drug) ☐ Over-The-Counter Use (21 CFR 201.6 Subject Drug) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Surgovations LLC Traditional 510(k) - SurgeoBite®
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | Surgovations LLC
110 Fairway Run
Forsyth, GA 31029
Phone: (478) 254-1707 |
|-----------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens - Regulatory Resources Group, Inc.
Regulatory Consultant
Phone: (678) 513-0693 |
| Date Submitted: | September 27, 2017 |
Device Name and Classification:
| Trade/Proprietary Name: | SurgeoBite® |
|---|---|
| Common Name: | Bite Block |
| Classification Name: | Bite Block |
| Regulation: | 21 CFR 882.5070 |
| Class: | II |
| Product Code: | JXL |
Legally Marketed Predicate Device:
Ventil-A - Somatics, LLC - 510(k) # K992269
Device Description:
The SurgeoBite is designed to be an easy to use and safe device for use in the patient's mouth. The shape of the device allows for easy positioning into the mouth and provides a biting surface between the teeth making sure that the tongue and cheeks are not between the biting surfaces. During seizures induced by electroconvulsive therapy, neuromonitoring stimulation, spontaneous seizures, and circumstances requiring protection, the jaw muscles can contract and cause potential damage to the teeth and mouth tissues. By placing the oral protector in the patient's mouth, it will provide protection of the teeth, lips, tongue, and buccal mucosa. The SurgeoBite is sold nonsterile, single use, and is discarded after use.
Indications for Use:
The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
4
Surgovations LLC Traditional 510(k) - SurgeoBite®
510(k) SUMMARY
Similarities and Differences to the Predicate Devices:
Similarities
The SurgeoBite (proposed device) has the same basic technology characteristics as they are both one piece, single use bite blocks and the indications for use are the same as the Ventil-A (predicate device).
Differences
The SurgeoBite (proposed device) uses a different profile and does not use the same material as the Ventil-A (predicate device). The material used by the SurgeoBite is a medical grade silicone rubber. The material used by the Ventil-A is a closed-cell foam. The addition of neuromonitoring stimulation into the indications for the SurgeoBite delineates a current usage that meets the definition of "circumstance requiring protection of the teeth, lips, tonque, and buccal mucosa".
Summary of Testing:
The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 biocompatibility requirements. The silicone rubber material as manufactured is compliant under ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. Performance testing completed for SurgeoBite included Bite Force Testing, Displacement Testing, and Testing with Endotracheal Tubes.
Substantial Equivalence Conclusions:
All of the testing results for SurgeoBite passed within the acceptance parameters and demonstrated a safe and reliable device for providing protection of the teeth, lips, tongue, and buccal mucosa. The completion of the testing demonstrates that the SurgeoBite has the same principles of operation, indications for use, and technological characteristics as the predicate device.