(133 days)
The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
The Mouth Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's teeth after the guard has been heated via submersion in boiled water. The fully occlusive guard is worn on the upper teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding.
This document is a 510(k) summary for a Mouth Guard device, not a typical diagnostic AI or image analysis device that would be evaluated with specific metrics like sensitivity, specificity, or improvement with AI assistance. Therefore, many of the requested points regarding acceptance criteria and study details (e.g., ground truth, MRMC study, sample size for test/training sets, number of experts, adjudication methods) are not applicable to the information provided in this document.
The Mouth Guard is a physical device, and its acceptance criteria and performance are based on bench testing (non-clinical) rather than clinical studies or the analysis of medical images by AI.
Here's an analysis of the provided text based on the questions, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with specific numerical thresholds and corresponding performance values for the Mouth Guard. Instead, it states that "Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling."
It lists the types of performance tests conducted:
- Hardness
- Tear strength
- Impact and rebound
- Water absorption
- Impression test
- Separation test
- Stability test
It also lists biocompatibility tests:
- Cytotoxicity
- Oral Mucosa Irritation
- Skin Sensitization
- Acute systemic toxicity
- Sub chronic systemic toxicity
- Genotoxicity
The reported performance is a qualitative statement: "The non-clinical testing of Mouth Guard demonstrates the device's performance in providing including hardness, tear strength, impact and rebound, and water absorption, which supports its substantial equivalence to the predicate device." And for biocompatibility: "The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence to the predicate."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because the submission did not include a clinical study or a "test set" in the context of AI/ML evaluation. The testing was non-clinical (bench testing) and biocompatibility testing. No mention of data provenance like country of origin or retrospective/prospective nature is made for these types of tests in this document.
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)
Not applicable. As this is a physical device measured through bench tests and biocompatibility, there are no "experts" establishing ground truth in the sense of medical image interpretation. Performance is measured against physical standards and parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process described for the evaluation of this physical device.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established physical standards, material specifications, and validated test methods for properties like hardness, tear strength, and biocompatibility. It's not "expert consensus" or pathology outcomes as would be seen in diagnostic claim evaluations.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this kind of physical device submission.
9. How the ground truth for the training set was established
Not applicable. There is no concept of a "training set" for this kind of physical device submission.
In summary, the provided document is a 510(k) clearance letter for a non-AI/ML medical device (a mouth guard). The substantial equivalence determination is based on a comparison to predicate devices and non-clinical bench testing. The nature of the device and the submission means that most of the questions relating to AI/ML device evaluation criteria are not applicable.
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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.
November 6, 2023
Reazeal Corp % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA
Re: K231865
Trade/Device Name: Mouth Guard (ATG0603R) Regulatory Class: Unclassified Product Code: OBR Dated: June 26, 2023 Received: June 26, 2023
Dear Ivy Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known) K231865
Device Name Mouth Guard (ATG0603R)
Indications for Use (Describe)
The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
K231865
Prepared date: 11/03/2023 A. Applicant: REAZEAL CORP Address: 1226 NORTH KING ST. #485 WILMINGTON DELAWARE 19801 Contact Person: Fuhua Liu Tel: +8613014295243 Email: carolanmanthey564@gmail.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Mouth Guard Common Name: Over-the-Counter Dental Guard Model: ATG0603R
Regulatory Information Classification Name: Mouthguard, Over-the Counter Regulation Number: N/A Product Code: OBR Device Class: Unclassified Review Panel: Dental
C. Predicate device:
Predicate - K180933 DenTek Ultimate Dental Guard Medtech Products Inc.
Reference device – K183315 CustMBite Dental Guard Dental Choice Holdings, LLC
D. Indications for use of the device:
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The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
E. Device Description:
The Mouth Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's teeth after the guard has been heated via submersion in boiled water. The fully occlusive guard is worn on the upper teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding.
The Mouth Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| Device | Proposed Device | Predicate Device | Reference Device | Result |
| 510K number | K231865 | K180933 | K183315 | - |
| Model name | Mouth Guard | DenTek UltimateDental Guard | CustMBite DentalGuard | - |
| Classification | Unclassified | Unclassified | Unclassified | Same |
| Regulation | N/A | N/A | N/A | Same |
| Product code | OBR | OBR | OBR | Same |
| Indications for use | The Mouth Guard isindicated for protectionagainst bruxism ornighttime teeth grinding.It is intended to reducedamage to the teeth andreduce the noiseassociated with bruxing orgrinding. | The DenTekUltimate™ DentalGuard is indicated forprotection againstbruxism or nighttimeteeth grinding. It isintended to reducedamage to the teethand reduce the noiseassociated withbruxing or grinding. | The CustMBiteDental Guard is anover-the-counterdental guardindicated for theprotection againstbruxism - thenighttime clenchingand grinding of theteeth.It is intended for usein the mouth at nightto reduce damage tothe teeth and toprevent the noiseassociated with teethgrinding.The CustMBiteDental Guard isintended forindividuals age 18and older. | Samewithpredicatedevice |
| Intended use | Keep upper and lowerteeth separated duringsleep. | Keep upper andlower teeth separatedduring sleep. | Keep upper andlower teethseparated duringsleep. | Same |
| OTC use | Yes | Yes | Yes | Same |
| Target population | Adults 18 and older | Adults 18 and older | Adults 18 and older | Same |
| Technologicalcharacteristics | Flexible, moldable guardused as a barrier betweenteeth. | Flexible, moldableguard used as abarrier between teeth. | Flexible, moldableguard used as abarrier between | Same |
| Material | Ethylene-vinyl acetatecopolymer | Ethylene-vinylacetate copolymer | Propylene-basedelastomer | Samewithpredicatedevice. |
| Design | Full occlusion,boil-and-fit dental guard | Posterior occlusion,boil-and-fit dentalguard | Full occlusion,boil-and-fit dentalguard | Samewithreferencedevice. |
| Methodofmanufacture | Injection molding | Injection molding | Injection molding | Same |
| Method of cleaning | Scrub with toothbrush,liquid soap and cold water | Toothpaste ormouthwash, brushfollowed by coolwater rinse. | Scrub withtoothbrush,toothpaste and coldwater | Similar |
| Fit | One size fits all viatraditional heat and bite. | One size fits all viatraditional heat andbite. | One size fits all viatraditional heat andbite. | Same |
| Multiple use device | Yes | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Leaflet included | Yes | Yes | Yes | Same |
| Accessories | Storage case | Storage case | Storage case | Same |
| Use environment | Home | Home | Home | Same |
| Anatomical site ofuse | Oral cavity | Oral cavity | Oral cavity | Same |
F. Comparison with predicate device
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Discussion:
The table above identifies a few minor differences between the proposed device and the predicate device.
The design of the proposed device and reference device is full occlusion while the predicate device is posterior occlusion. Both of the two structures can achieve the intended use. This difference will not affect the safety and performance of the device.
The cleaning method of the two devices are slightly different, but both of them use toothbrush to scrub the devices and rinse with water. This difference will not affect the safety and effectiveness of
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the proposed device.
The dimension of the proposed device is different with the predicate device, since it is a full occlusion design, which will not affect the safety and effectiveness of the proposed device.
G. Non-Clinical Test Conclusion
Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling. Performance testing was performed to the proposed device including hardness, tear strength, impact and rebound, water absorption, impression test, separation test, stability test to demonstrate its effectiveness.
The non-clinical testing of Mouth Guard demonstrates the device's performance in providing including hardness, tear strength, impact and rebound, and water absorption, which supports its substantial equivalence to the predicate device.
Additionally, the following tests for biocompatibility were conducted on the Mouth Guard.
- Cytotoxicity
- Oral Mucosa Irritation ●
- Skin Sensitization
- Acute systemic toxicity
- Sub chronic systemic toxicity
- Genotoxicity
The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence to the predicate.
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K180933.
N/A