(278 days)
Not Found
No
The provided text describes a physical oral device for seizure protection and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as a "symptom-management" device that protects against oral injury during seizures, rather than intending to treat or cure a medical condition.
No
The device description clearly states it is a "symptom-management, oral device technology that helps to protect against oral injury during seizures," and not to diagnose conditions.
No
The device description clearly states it is an "oral device technology" and a "single-use (disposable) oral protector," indicating a physical, hardware component.
Based on the provided information, the PATI 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.
- PATI's Function: The PATI device is an oral protector used during seizures to prevent physical injury to the mouth. It does not perform any tests on bodily samples to diagnose, monitor, or predict a medical condition.
- Intended Use: The intended use clearly states its purpose is protection during seizures and circumstances requiring oral protection, not diagnostic testing.
- Device Description: The description focuses on its physical function as a protective oral device.
Therefore, the PATI device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JXL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity (teeth, lips, tongue, and buccal mucosa)
Indicated Patient Age Range
12 or older
Intended User / Care Setting
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. Can be used in a clinical or non-clinical environment.
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)
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
- Sensitization
- Irritation or Intracutaneous Reactivity
Performance Testing: - 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.
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.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Way |
| Wake 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:
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.
Indications for Use:
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.
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):
4
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.
| Device
Attribute | SUBJECT: [NeuroVice] PATI | PREDICATE: [Surgovations] SurgeoBite
(K172978) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| Device
Classification
Name | Block, Bite | Block, Bite |
| Regulation
Number | 882.5070 | 882.5070 |
| Product Code | JXL | JXL |
| Intended Use | 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 SurgeoBite 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. |
| Indications for
Use | 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. | 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. |
| Materials | Medical grade thermoplastic elastomer (TPE):
VersalloyTM HC 9210-55N Thermoplastic
Elastomer with TPV Sky Blue 278C Colorant | Medical grade silicone rubber |
| Principles of
Operation | The device is positioned into the mouth and
provides a biting surface between the teeth making
sure that the tongue and cheeks are not between the
biting surfaces. The device protects the teeth, lips,
tongue, and buccal mucosa. | The device is positioned into the mouth and
provides a biting surface between the teeth making
sure that the tongue and cheeks are not between the
biting surfaces. The device protects the teeth, lips,
tongue, and buccal mucosa. |
| Technology and
Design | General design: one piece, single-use bite block | General design: one piece, single-use bite block |
| | Profile: Mouth guard walls that reside in the space
between the buccal tissues and the teeth. Bite pads
to cushion teeth during biting or clenching.
Opening in the front of the device for salivary
drainage. | Profile: Mouth guard walls that reside in the space
between the buccal tissues and the teeth. Bite pads
to cushion teeth during biting or clenching.
Opening in the front of the device for salivary
drainage. |
| | The PATI is not designed for feature compatibility
with endotracheal tubes. | Designed for feature compatibility with
endotracheal tubes. |
| | The subject device additionally features a handle to
help facilitate device placement while allowing the
fingers of the individual placing the device to
remain outside of the mouth during placement for
additional protection and safety of the user. | |
| Biocompatibility | The subject device has been evaluated through
biocompatibility testing (ISO 10993 Cytotoxicity,
Sensitization, and Irritation) to ensure device safety
for patient contact in accordance with the
indications for use. | The predicate device material as manufactured is
compliant under ISO 10993-1 for Cytotoxicity,
Sensitization, and Irritation. |
| Sterilization | Non-sterile | Non-sterile |
| Device
Attribute | SUBJECT: [NeuroVice] PATI | PREDICATE: [Surgovations] SurgeoBite
(K172978) |
| Prescription | RxOnly | RxOnly |
| Reuse | Single use | Single use |
5
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:
-
- 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.
-
- Clarification of the patient population to include adolescents and adults
-
- 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
6
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.