The PATI device is a single-use (disposable) oral protector for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. The PATI is indicated for use with any individual aged 12 or older who suffers from seizures and can be used in a clinical or non-clinical environment.

Device Description

The Protector Against Tongue Injury (PATI) device is a symptom-management, oral device technology that helps to protect against oral injury during seizures, while also allowing fluids to naturally drain or be suctioned. The device will be administered by the patient, an assistant, or medical personnel, (such as hospital staff, EEG technicians, or first responders, including EMTs and paramedics), prior to full onset of a seizure. The device is single use and disposable.

AI/ML Overview

This document is a 510(k) summary for the NeuroVice PATI (Protector Against Tongue Injury) device. It describes the device, its intended use, and how it is substantially equivalent to a predicate device.

Here's the breakdown of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way one might expect for a quantitative AI/ML study. Instead, it demonstrates substantial equivalence through a direct comparison of attributes with a predicate device and by reporting on various non-clinical and human factors tests.

However, based on the provided text, we can infer some "acceptance criteria" through the lens of establishing substantial equivalence and the reported performance as a confirmation of meeting these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: Provide oral protection during seizures and other circumstances requiring protection of oral tissues.	Met: Both PATI and the predicate (Surgovations SurgeoBite) are described as "oral protectors for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa."
Design and Principles of Operation Equivalence: General design features (mouth guard walls, bite pads, salivary drainage opening).	Met: Both devices have "mouth guard walls that reside in the space between the buccal tissues and the teeth, bite pads to cushion teeth during biting or clenching, and an opening in the front of the device for salivary drainage."
Biocompatibility: Safe for patient contact based on type and duration of contact.	Met: PATI underwent biocompatibility testing (Cytotoxicity, Sensitization, and Irritation) according to ISO 10993-1 and FDA Guidance, similar to the predicate device.
Performance (Mechanical/Functional): Ability to function as a bite protection device.	Met: "Simulated Use Bite Force and Displacement Testing" was conducted to support the premarket notification. While specific metrics are not provided, the inclusion implies successful performance.
Human Factors: Safe and effective use by various user groups.	Met: "Summative Human Factors testing was performed using 30 users across adolescent and adult user groups to demonstrate that the subject device promotes safe and effective use across all user groups."
Indications for Use (Specific Patient Population/Environment): Protection for individuals aged 12 or older, in clinical or non-clinical environments.	Met: This was addressed through "design, risk analysis, product labeling, and the Summative Human Factors Testing" to ensure safety and effectiveness for the adolescent and non-clinical user populations.
Sterilization: Non-sterile.	Met: Both PATI and the predicate are "Non-sterile."
Reuse: Single use.	Met: Both PATI and the predicate are "Single use."
Prescription Status: RxOnly.	Met: Both PATI and the predicate are "RxOnly."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Human Factors Testing: 30 users across adolescent and adult user groups.
Data Provenance: Not explicitly stated, but Human Factors testing is typically prospective, involving participants performing tasks with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This device is not an AI/ML algorithm that relies on expert interpretation of data to establish ground truth. Therefore, this question is not directly applicable. The "ground truth" for the performance and human factors testing would be derived from direct observation and measurement of device function and user interaction.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML study involving diagnostic imaging or similar data requiring expert adjudication. The "ground truth" for human factors testing would be objective data collected on device usability and safety, not expert consensus on interpretations.

5. 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

Not applicable. This device is a physical medical device (bite block), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the tests described:

Biocompatibility: Laboratory test results (e.g., cytotoxicity, sensitization, irritation) against established ISO standards.
Performance Testing (Simulated Use Bite Force and Displacement): Objective physical measurements of the device's mechanical properties.
Human Factors Testing: Objective observations and data collected from user interactions with the device, and potentially subjective feedback, to assess usability, safety, and effectiveness. The "ground truth" here is whether users can safely and effectively use the device as intended.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI/ML system.

Summary

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February 22, 2023

NeuroVice, LLC % John Hayes Manager, Product Development Gilero, LLC 635 Davis Drive, Suite 100 Morrisville, North Carolina 27560

Re: K221469

Trade/Device Name: PATI (Protector Against Tongue Injury) Regulation Number: 21 CFR 882.5070 Regulation Name: Bite block Regulatory Class: Class II Product Code: JXL Dated: January 23, 2023 Received: January 23, 2023

Dear John Hayes:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Kang -S

for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221469

Device Name

PATI (Protector Against Tongue Injury)

Indications for Use (Describe)

The PATI device is a single-use (disposable) oral protector for use during spontaneous seizures and any croumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. The PATI is indicated for use with any individual aged 12 or older who suffers from seizures and can be used in a clinical or non-clinical environment.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the text "NEUROVICE" in a sans-serif font. The text is arranged in two lines, with "NEURO" on the top line and "VICE" on the bottom line. The color of the text is a light blue. The letters are bold and evenly spaced.

5.0 510k Summary

Company Name:	NeuroVice, LLC
Company Address:	7928 Woodcross WayWake Forest, NC 27587
Company Phone:	+1 (919) 260-5023
Official Contact:	Amanda Schaffers
Phone:	+1 (919) 595-8225
E-mail:	aschaffers@gilero.com
Submission Date:	May 19, 2022
Device Identification:
Trade Name:	Protector Against Tongue Injury (PATI)
Device Class:	2
Regulation Number:	21 CFR 882.5070

Regulation Number:	21 CFR 882.5070
Regulation Name:	Block. Bite
Product Code:	JXL
Review Panel:	Neurology

Predicate Device:

Manufacturer:	Surgovations, LLC
Trade Name:	SurgeoBite
510(k):	K172978

Device Description:

Indications for Use:

Technological Characteristics and Substantial Equivalence:

The following chart presents an overview of comparisons between the subject device (PATI) and the predicate device (Surgovations LLC Surgeobite):

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Image /page/4/Picture/1 description: The image shows the word "NEUROVICE" in a sans-serif font. The letters are a light blue color. The letters are stacked on top of each other, with "NEURO" on top and "VICE" on the bottom.

DeviceAttribute	SUBJECT: [NeuroVice] PATI	PREDICATE: [Surgovations] SurgeoBite(K172978)
Device Class	II	II
DeviceClassificationName	Block, Bite	Block, Bite
RegulationNumber	882.5070	882.5070
Product Code	JXL	JXL
Intended Use	The PATI device is a single-use (disposable) oralprotector for use during spontaneous seizures andany circumstances requiring the protection of theteeth, lips, tongue, and buccal mucosa.	The SurgeoBite device is a single-use (disposable)oral protector for use during spontaneous seizuresand any circumstances requiring the protection ofthe teeth, lips, tongue, and buccal mucosa.
Indications forUse	The PATI device is a single-use (disposable) oralprotector for use during spontaneous seizures andany circumstances requiring the protection of theteeth, lips, tongue, and buccal mucosa.The PATI is indicated for use with any individualaged 12 or older who suffers from seizures and canbe used in a clinical or non-clinical environment.	The SurgeoBite device is single-use (disposable)oral protector for use during seizures induced byelectroconvulsive therapy, spontaneous seizures,neuromonitoring stimulation, and anycircumstances requiring protection of the teeth,lips, tongue, and buccal mucosa.
Materials	Medical grade thermoplastic elastomer (TPE):VersalloyTM HC 9210-55N ThermoplasticElastomer with TPV Sky Blue 278C Colorant	Medical grade silicone rubber
Principles ofOperation	The device is positioned into the mouth andprovides a biting surface between the teeth makingsure that the tongue and cheeks are not between thebiting surfaces. The device protects the teeth, lips,tongue, and buccal mucosa.	The device is positioned into the mouth andprovides a biting surface between the teeth makingsure that the tongue and cheeks are not between thebiting surfaces. The device protects the teeth, lips,tongue, and buccal mucosa.
Technology andDesign	General design: one piece, single-use bite block	General design: one piece, single-use bite block
	Profile: Mouth guard walls that reside in the spacebetween the buccal tissues and the teeth. Bite padsto cushion teeth during biting or clenching.Opening in the front of the device for salivarydrainage.	Profile: Mouth guard walls that reside in the spacebetween the buccal tissues and the teeth. Bite padsto cushion teeth during biting or clenching.Opening in the front of the device for salivarydrainage.
	The PATI is not designed for feature compatibilitywith endotracheal tubes.	Designed for feature compatibility withendotracheal tubes.
	The subject device additionally features a handle tohelp facilitate device placement while allowing thefingers of the individual placing the device toremain outside of the mouth during placement foradditional protection and safety of the user.
Biocompatibility	The subject device has been evaluated throughbiocompatibility testing (ISO 10993 Cytotoxicity,Sensitization, and Irritation) to ensure device safetyfor patient contact in accordance with theindications for use.	The predicate device material as manufactured iscompliant under ISO 10993-1 for Cytotoxicity,Sensitization, and Irritation.
Sterilization	Non-sterile	Non-sterile
DeviceAttribute	SUBJECT: [NeuroVice] PATI	PREDICATE: [Surgovations] SurgeoBite(K172978)
Prescription	RxOnly	RxOnly
Reuse	Single use	Single use

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Image /page/5/Picture/1 description: The image shows the word "NEUROVICE" in a sans-serif font. The letters are a light blue color. The word is split into two lines, with "NEURO" on the top line and "VICE" on the bottom line. The "V" in "VICE" is directly below the "R" in "NEURO".

Substantial Equivalence:

The PATI is substantially equivalent to the predicate: Surgovations LLC Surgeobite.

Both devices are oral protectors for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. Both devices are single-use (disposable) and are non-sterile. The devices are very similar in their design and principles of operation in that they both feature mouth guard walls that reside in the space between the buccal tissues and the teeth, bite pads to cushion teeth during biting or clenching, and an opening in the front of the device for salivary drainage.

While the subject PATI has different indications for use compared to the available information for the predicate device, the devices have the same intended use.

The differences in the indications for use of the PATI as compared to the predicate device include:

1. The use circumstances indicated for the subject PATI device are a subset of the predicate device, as the subject device is not indicated for use during seizures induced by electroconvulsive therapy or neuromonitoring stimulation, where the predicate Surgeobite is.
1. Clarification of the patient population to include adolescents and adults
1. Clarification of the permissible use environment to include clinical and non-clinical environments

The use considerations of the adolescent population of (2) and the lay users associated with the non-clinical use of the device of (3) above have been adequately addressed through design, risk analysis, product labeling, and the Summative Human Factors Testing.

Finally, the subject PATI and the predicate SurgeoBite utilize different materials for their constructions, but the subject device was appropriately evaluated for biological safety consistent with its patient contact and duration of use.

Discussion of Non-clinical Tests:

The following non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device.

Biocompatibility:

The PATI, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (type and duration), in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific testing included:

· Cytotoxicity

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Image /page/6/Picture/0 description: The image shows the word "NEUROVICE" in a sans-serif font. The letters are a light blue color. The letters are arranged in a slightly staggered fashion, with the "NEURO" part of the word slightly above the "VICE" part. The "I" in "VICE" is extended upwards to connect with the "O" in "NEURO".

Sensitization
Irritation or Intracutaneous Reactivity ●

Performance Testing:

The following performance data were provided in support of this Premarket Notification:

. Simulated Use Bite Force and Displacement Testing

Human Factors Testing

Summative Human Factors testing was performed using 30 users across adolescent and adult user groups to demonstrate that the subject device promotes safe and effective use across all user groups.

Conclusion

The information in this submission supports the safety and efficacy of the subject device for its intended use and demonstrates substantial equivalence with the predicate device. The PATI's differences in material, technology and operation from the predicate device do not raise new questions about safety and effectiveness.

Regulation Number and Section

§ 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).