(286 days)
The POD® is for the amelioration of clenching associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
The POD® is a prescription only, removable dental mouthguard worn on the mandibular arch during sleep. The one-piece device is fabricated for the mandibular arch and can be customized for each patient based on the clinician prescription. The dentist obtains a dental impression, prescribes the design, and once laboratory fabricated, delivers the custom-made device at the dental office to be used in the home setting.
Materials: Polymethyl methacrylate (PMMA Acrylic Resin - Orthocryl®) and medical grade stainless steel wire. Only the PMMA has body contact as the SS wire is embedded within the PMMA and does not contact the body.
Duration and type of contact: Surface device with a limited duration (<24 h) contact of the skin and of mucosal membranes.
The subject device provides a disocclusion that protects the teeth and restorations while helping to reduce symptoms of pain and headaches.
Here's an analysis of the provided text regarding the device's acceptance criteria and studies, organized by your requested information:
Device: The POD® (K182820)
Indication for Use: Amelioration of clenching and bruxing associated with TMD, and to aid in the relief of symptoms of TMD/TMJ.
1. Table of Acceptance Criteria and Reported Device Performance
This device appears to be a medical device, and the provided document is a 510(k) summary for premarket notification. The "acceptance criteria" here refers to the performance benchmarks the device needed to meet to demonstrate substantial equivalence to a predicate device, rather than patient outcomes. The acceptance criteria for this device are primarily based on non-clinical testing against recognized standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Physical Properties | Flexural strength (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria |
| Flexural modulus (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Maximum stress intensity factor (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Fracture toughness (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Water sorption (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Water solubility (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Residual monomer (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Meets predetermined pass/fail criteria |
| Sensitization (ISO 10993-10) | Meets predetermined pass/fail criteria | |
| Mucosal Irritation (ISO 10993-10) | Meets predetermined pass/fail criteria | |
| Risk Management | Risk Analysis (ISO 14971) | No new concerns found for the subject device |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical tests were performed. These typically involve material samples rather than a "test set" of patients. Therefore, information about patient sample size, country of origin, or retrospective/prospective nature is not applicable as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set involving human subjects requiring expert ground truth establishment was performed. The evaluation was based on non-clinical bench testing against established standards.
4. Adjudication method for the test set
Not applicable. As no clinical test set was used, there was no need for an adjudication method by experts.
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. No MRMC study was mentioned or performed. This device is a physical dental appliance, 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, not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was based on established international standards (e.g., ISO 20795-2:2013 for physical properties, ISO 10993-5 and -10 for biocompatibility). The device's materials were tested to ensure they met the specifications outlined in these standards.
8. The sample size for the training set
Not applicable. As no AI or machine learning component is involved, there is no training set in the conventional sense. The "training" for this device's development would be in material science and engineering, not data processing.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth to establish for it.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 17, 2019
Advanced Facialdontics LLC Scott Simonetti President 325 Lake Ave. Unit 759 St. James, New York 11780
Re: K182820
Trade/Device Name: The POD® Regulatory Class: Unclassified Product Code: MQC Subsequent Product Code: OCO Dated: April 10, 2019 Received: April 18, 2019
Dear Scott Simonetti:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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,
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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
510(k) Number (if known) K182820
Device Name The POD®
Indications for Use (Describe)
The POD® is for the amelioration of clenching associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
Type of Use (Select one or both, as applicable)
| X 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/1 description: The image shows the logo for Advanced Facialdontics. The logo consists of a stylized DNA helix symbol to the left of the text "Advanced Facialdontics" in a bold, sans-serif font. A registered trademark symbol is present to the right of the text.
510(k) Summary
1. Owner Information
| Owner's Name: | Advanced Facialdontics LLC |
|---|---|
| Owner's Address: | 325 Lake Ave, Unit 759St James, NY 11780 |
| Telephone: | (631) 379-3902 |
| Fax: | (631) 277-4849 |
| Contact Person: | Dr Scott Simonetti |
| Email: | ssimonettidds@yahoo.com |
| Date Prepared: | 7/15/2019 |
2. Device Name
| Trade Name: | The POD® |
|---|---|
| Common Name: | Mouthguard, Prescription |
| Classification: | Unclassified, Pre-Amendment |
| Product Code: | MQC |
| Subsequent Product Code: | OCO |
| Review Panel: | Dental |
| 510(k) Number: | K182820 |
3. Predicate Devices
| Primary Predicate: | Urbanek Device (K170985) |
|---|---|
| Reference Devices: | Luco Hybrid OSA Appliance (K160477) |
| NTI Clenching Suppression System (K981546) |
4. Device Description
The POD® is a prescription only, removable dental mouthguard worn on the mandibular arch during sleep. The one-piece device is fabricated for the mandibular arch and can be customized for each patient based on the clinician prescription. The dentist obtains a dental impression, prescribes the design, and once laboratory fabricated, delivers the custom-made device at the dental office to be used in the home setting.
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Materials: Polymethyl methacrylate (PMMA Acrylic Resin - Orthocryl®) and medical grade stainless steel wire. Only the PMMA has body contact as the SS wire is embedded within the PMMA and does not contact the body.
Duration and type of contact: Surface device with a limited duration (<24 h) contact of the skin and of mucosal membranes.
The subject device provides a disocclusion that protects the teeth and restorations while helping to reduce symptoms of pain and headaches.
-
- Indications for Use: The POD® is for the amelioration of clenching and bruxing associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
6. Comparison to Predicate Device
Technological Characteristics: The predicate and the subject device have the exact same following technological characteristics:
- Principle of Operation
- Indications of Use
- Prescription Device
- Custom fabricated
- Environment of Use: Home
- Removable by patient and reusable
- Provided Non-sterile
- No external energy, software or EMR
- Medical grade stainless steel
The following technological differences exist between the subject device and predicate device:
- Specific Type of acrylic used
- Location the device sits within the oral cavity
- Location of disocclusion mechanism
The Indications of Use statement is identical, the intended use of the devices are the same and the fundamental scientific technology of the subject device is the same as the previously cleared predicate and reference devices as shown in Table 1. Each previously cleared device utilizes a slightly different design to perform the same intended use.
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| Table 1: Comparison of Subject, Predicate and Reference Devices | |||
|---|---|---|---|
| -- | -- | -- | ----------------------------------------------------------------- |
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| Device | The POD®K182820 | Urbanek DeviceK170985 | Luco Hybrid OSAApplianceK160477 | NTI ClenchingSuppression SystemK981546 |
| ProductCode | MQC, OCO | MQC, OCO | MQC, OCO | MQC, OCO |
| Indicationsfor Use | The POD® is for theamelioration ofclenching andbruxing associatedwith TMD and is tobe used to aid inthe relief ofsymptoms ofTMD/TMJ. | The Urbanek Deviceis for theamelioration ofclenching andbruxing associatedwith TMD and is tobe used to aid inthe relief ofsymptoms ofTMD/TMJ. | 1. A device to beused for thetreatment of sleepbruxism and2. As an aid in thetreatment ofassociatedtension/migrainetype headaches inadults. | For the prevention ofchronic tension andtemporal mandibularjoint syndrome that iscaused by chronicclenching of theposterior mandibularand maxillary teeth bythe temporalis muscle.The device is custommade for the individual. |
| DesignFeatures | Prescription DeviceCustom fit | Same | Same | Same |
| Intraoral Device | Same | Same | Same | |
| Provided Non-sterile | Same | Same | Same | |
| Removable bypatient andreusable | Same | Same | Same | |
| Environmentof Use | Home | Same | Same | Same |
| Principle ofOperation | Disocclusion | Disocclusion | Disocclusion | Disocclusion |
| Location ofDevice | Mandibular arch | Maxillary arch | Mandibular andMaxillary arch | Central Incisors |
| DisocclusionMechanismLocation | 1st molar and 2ndPremolar | Canines andIncisors | 1st Premolars | Central Incisors |
| Materials | Methylmethacrylate,medical gradestainless steel | Thermoplasticacrylic resin,medical gradestainless steel | Methylmethacrylate,chrome cobalt,medical gradestainless steel | Thermoplastic acrylicresin |
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7. Non-Clinical Tests Performed
Bench Testing: The submission includes test data regarding the physical properties of the subject device including flexural strength, flexural modulus, maximum stress intensity factor, fracture toughness, water sorption, water solubility, and residual monomer. The physical properties comply with the pre-defined pass/fail criteria listed in the Recognized Standard ISO 20795-2:2013 Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers, without any deviations, modifications or exclusions.
Biocompatibility Testing: Biocompatibility testing was conducted in accordance with the FDA guidance document "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The submission includes full test reports regarding Cytotoxicity, Sensitization, and Mucosal Irritation according to ISO 10993-5 and ISO 10993-10. The subject device meets the predetermined pass/fail criteria.
In addition, a risk analysis was performed as per ISO 14971 and found no new concerns for the subject device.
8. Clinical Tests Performed
Clinical testing has not been performed.
9. Conclusion
Based upon the comparative analysis of features, materials and design, the subject device has the same intended use, similar technological characteristics and the same mechanism of action as the predicate device. Performance data shows that the subject device meets the requirements specified in the applicable standards. It is concluded that The POD® is substantially equivalent to the previously cleared device.
N/A