(60 days)
The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.
The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.
The provided text is a 510(k) Pre-market Notification for a medical device called "Anti Grinding Guard." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new, independent set of clinical efficacy studies. Therefore, much of the requested information about acceptance criteria, detailed study designs, sample sizes, and expert adjudication for proving efficacy is not typically found in these documents.
However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table with specific target values and reported performance for each criterion in the way a clinical trial might. Instead, it states that "The non-clinical testing of Anti Grinding Guard demonstrates the device's performance in providing including hardness, water absorption and solubility testing, boiling/cooling water testing, impression test, separation test, and comparative wear test, which supports its substantial equivalence to the predicate device."
It implies that the "acceptance criteria" for these tests were met if the results demonstrated performance comparable to the predicate device and compliance with "pertinent standards and specifications."
| Test Performed | Reported Device Performance |
|---|---|
| Hardness | Demonstrated performance to support substantial equivalence |
| Water Absorption and Solubility Testing | Demonstrated performance to support substantial equivalence |
| Boiling/Cooling Water Testing | Demonstrated performance to support substantial equivalence |
| Impression Test | Demonstrated performance to support substantial equivalence |
| Separation Test | Demonstrated performance to support substantial equivalence |
| Comparative Wear Test | Demonstrated performance to support substantial equivalence |
| Biocompatibility: Cytotoxicity | Met the requirements of the study protocols; considered non-toxic |
| Biocompatibility: Oral Mucosa Irritation | Met the requirements of the study protocols; not an intracutaneous irritant |
| Biocompatibility: Skin Sensitization | Met the requirements of the study protocols; considered non-sensitizing |
| Biocompatibility: Acute systemic toxicity | Met the requirements of the study protocols |
| Biocompatibility: Sub chronic systemic toxicity | Met the requirements of the study protocols |
| Biocompatibility: Genotoxicity | Met the requirements of the study protocols |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide specific sample sizes for the non-clinical tests. It doesn't specify the country of origin of the data or whether the tests were retrospective or prospective; these details are typically not included in a 510(k) summary for non-clinical testing unless directly relevant to a specific regulatory standard.
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 information is not applicable to the non-clinical bench testing described. "Ground truth" and "experts" are concepts usually associated with clinical studies or performance evaluation where human interpretation of data is involved (e.g., image analysis, diagnosis). The non-clinical tests focus on material properties and physical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to the non-clinical bench testing. Adjudication methods are typically used in clinical studies where multiple human evaluators assess outcomes that may be subjective.
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:
This is not applicable. The device is a physical "Anti Grinding Guard," not an AI diagnostic or assistance tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable, as the device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" would be established by objective measurements and standardized testing procedures to determine material properties and performance characteristics according to relevant international standards (e.g., ISO 10993 for biocompatibility) and engineering principles. The document states that the testing demonstrated compliance with "pertinent standards and specifications" and met "the requirements of the study protocols."
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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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.
May 24, 2024
Xiamen Yizhou Imp. & Exp. Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 CHINA
Re: K240810 Trade/Device Name: Anti Grinding Guard Regulatory Class: Unclassified Product Code: OBR Dated: March 25, 2024 Received: March 25, 2024
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"
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(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).
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).
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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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Anti Grinding Guard
Indications for Use (Describe)
The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.
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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K240810 510(K) Summary
Prepared date: 2024-03-18 A. Applicant: Xiamen Yizhou Imp. & Exp. Co., Ltd. Address: 2F, 1#, Huli Industrial Park, Meixi Road, Tong An District, Xiamen City, Fujian, China Contact Person: Elaine Huang Tel: + 86 13859990367 Email: xmyizhou@hotmail.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: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
B. Device:
Trade Name: Anti Grinding Guard Common Name: Over-the-Counter Dental Guard Model: YZ9003
Regulatory Information Classification Name: Mouthguard, Over-the Counter Regulation Number: N/A Product Code: OBR Unclassified Device Class: Review Panel: Dental
C. Predicate device:
510(k) Number: K181099 Trade Name: Bright Guard Manufacturer: Koncept Innovators, LLC.
D. Indications for use of the device:
The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.
E. Device Description:
The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental
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mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.
| Table 1 General Comparison | |||
|---|---|---|---|
| Device | Proposed Device | Predicate Device | Result |
| 510K number | - | K181099 | - |
| Model name | Anti Grinding Guard | Bright Guard | - |
| Classification | Unclassified | Unclassified | Same |
| Regulation | N/A | N/A | Same |
| Product code | OBR | OBR | Same |
| Indications for use | The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching. | Bright Guard is a mouth guard intended to protect against grinding and clenching. | Same |
| Intended use | Keep upper and lower teeth separated during sleep. | Keep upper and lower teeth separated during sleep. | Same |
| OTC use | Yes | Yes | Same |
| Target population | Adults 18 and older | Adults 18 and older | Same |
| Technological characteristics | Flexible, moldable guard used as a barrier between teeth. | Flexible, moldable guard used as a barrier between teeth. | Same |
| Molding Method | Boil and Bite Method (Heat & Bite Self-Fit) | Boil and Bite Method (Heat & Bite Self-Fit) | Same |
| Material | Ethylene-vinyl acetate copolymer | Ethylene-vinyl acetate copolymer | Same |
| Location of Use | Upper Arch Teeth | Upper Arch Teeth | Same |
| Method of manufacture | Injection molding | Injection molding | Same |
| Molding time | In hot water time: 15-20 secondsMouth molding time: 20-25 seconds | In hot water time: 15-20 secondsMouth molding time:20-25 seconds | Same |
| Wear Time | Four (4) months wear time until replacement with new mouth guard | Four (4) months wear time until replacement with new mouth guard | Same |
| Worn during sleeping for nomore than twelve (12) hours perday. | Worn during sleeping for nomore than twelve (12) hoursper day. | ||
| Sterility | Non-Sterile | Non-Sterile | Same |
| Anatomical site ofuse | Oral cavity | Oral cavity | Same |
| Biocompatibility | ISO 10993 complies | ISO 10993 complies | Same |
F. Comparison with predicate device
2
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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, water absorption and solubility testing, boiling/cooling water testing, impression test, and comparative wear test to demonstrate its effectiveness.
The non-clinical testing of Anti Grinding Guard demonstrates the device's performance in providing including hardness, water absorption and solubility testing, boiling/cooling water testing, impression test, separation test, and comparative wear test, 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 K181099.
N/A