(232 days)
The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.
The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains.
The provided text is an FDA 510(k) summary for the Serena Sleep Night Guard, a medical device. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based diagnostic or prognostic system.
The submission is for a physical medical device (a night guard), and the "performance testing" section refers to bench testing for physical properties like flexural strength, water sorption, and durability, and states that no clinical testing was deemed necessary due to the similarity to the predicate device.
Therefore, I cannot extract the information required to answer your prompt from the provided text, as it specifically asks for details related to AI/algorithm performance and clinical validation studies common in the context of AI-driven medical devices.
Here's why and what's missing:
- Acceptance Criteria for AI Performance: The document does not mention any AI, algorithms, or software intended for diagnostic or prognostic purposes. Thus, there are no acceptance criteria related to sensitivity, specificity, AUC, or other metrics typically used for assessing AI performance in a clinical setting.
- Study Proving Device Meets Criteria: Since there's no AI component, there's no study described that evaluates AI performance against clinical outcomes or expert labels. The document explicitly states "no Clinical Testing were deemed necessary."
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size/Ground Truth: All these points are relevant to the validation of AI/ML models in medical devices. As the Serena Sleep Night Guard is a physical device analogous to a 3D-printed appliance, these concepts do not apply to its regulatory submission as described.
In summary, the provided document is a 510(k) for a physical medical device and does not contain the information required to address your prompt about AI/algorithm acceptance criteria and validation studies.
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October 13, 2023
Meris Investment Group % Janice Farris Regulatory Affairs Consultant Prime Path Medtech 811 Lakeview Dr. Shoreview, Minnesota 55126
Re: K230495
Trade/Device Name: Serena Sleep Night Guard Regulatory Class: Unclassified Product Code: MQC, OCO Dated: September 14, 2023 Received: September 14, 2023
Dear Janice Farris:
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 QS 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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., COIA 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
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Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Serena Sleep Night Guard
Indications for Use (Describe)
The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate tomporomandibular joint, jaw, and muscle and tension headache pains.
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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Section 5. 510(k) Summary K230495
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Serena Sleep | |
|---|---|---|
| Company Contact Person:Phone:Email: | Gary Maas, President98 St. Croix Trail N PO Box 98 Lakeland, MN 55043(800) 654-9842Gary.Maas@serenasleep.com | |
| SubmissionCorrespondent: | Janice Farris, Regulatory Affairs Consultant | |
| Address:Phone: | 811 Lakeview Dr. Shoreview, MN 55126(754) 237-8344 | |
| Email: | jfarris@primepathmedtech.com | |
| Date Prepared: | September 12, 2023 | |
| Proprietary Name: | Serena Sleep Night Guard | |
| Common Name: | Mouthguard, Prescription | |
| Product Code: | MQC | |
| Subsequent ProductCode: | OCO | |
| Device Classification: | Unclassified | |
| Predicate Device: | Panthera Occlusal Appliance (K203596) |
Device Description:
The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains.
Indications for Use:
The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains
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| Specification | Serena Sleep Night Guard | Panthera Occlusal(Predicate Device) | Comparison Result |
|---|---|---|---|
| 510(k) Number | K230495 | K203596 | |
| Device Photo | Image: Serena Sleep Night Guard | Image: Panthera Occlusal | |
| Indication for Use | The Serena Sleep NightGuard/Occlusal Appliance is aremovable medical devicethat is fitted to the patient'smouth and is intended toprotect teeth andrestorations against theforces of bruxism andalleviate temporomandibularjoint, jaw, and muscle andtension headache pains. | The Panthera OcclusalAppliance is indicated forprotection of teeth andrestorations from the forcesand damage ofparafunctions like bruxism,prevention of noiseassociated with bruxism, andfor alleviation oftemporomandibular joint,muscle and tensionheadache pains associatedwith temporomandibulardisorders | Equivalent |
| Product Code | MQC, OCO | MQC, OCO | Equivalent |
| Class | Unclassified | Unclassified | Equivalent |
| Mechanism ofAction | Disocclusion | Disocclusion | Equivalent |
| Use of Device | Removable intraoral device. Singlepatient multiple use. Prescriptionuse only. | Removable intraoral device.Single patient multiple use.Prescription use only. | Equivalent |
| Target Population | Adult patients | Adult patients | Equivalent |
| Design | Computer-aided design(CAD) from patient dentalmodel or stl file | Computer-aided design(CAD) from patient dentalmodel or stl file | Equivalent |
| Materials | Polyamide 12 (PA 2200) | Made from polymers(polyamide type 12), metal-free | Equivalent |
| Manufacturing | Computer-aidedmanufacturing (CAM) | Computer-aidedmanufacturing (CAM) | Equivalent |
| SuppliedSterile/Non-Sterile | Non-sterile | Non-sterile | Equivalent |
| Biocompatibility:ISO 10993-5 | Not performed as thematerials are identical toSerena Sleep BMA/EMA(K203606) | Not performed as thematerials are identical toPanthera Anti-SnoringDevice (K143244) | Equivalent |
Comparison to Predicate Device: Night Guard
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Non-Clinical Performance Testing (Bench)
The bench testing includes assessment of the physical properties of the Serena Sleep Night Guard/Occlusal Appliance and its ability to achieve its intended use. The submission includes durability testing, manufacturing validation, and testing to the recognized standard ISO 20795-2:2013 Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers (flexural strength, flexural modulus, polishability, water sorption, water solubility, color, freedom from porosity, fracture toughness, max stress intensity factor, and total fracture work).
Clinical Performance Testing
The technological characteristics, indications for use, material, and manufacturing processes are the same or similar to the predicate device and therefore, no Clinical Testing were deemed necessary to demonstrate the safety and effectiveness of the subject device.
Statement of Equivalence
Based on comparison of indications for use, user population, method of manufacturing, non-clinical performance testing, mechanical and technological features, the Serena Sleep Night Guard/Occlusal Appliance has been shown to be substantially equivalent to the legally marketed predicate device. This device does not raise any new safety or effectiveness questions as compared to the predicate device.
N/A