(232 days)
Not Found
No
The summary describes a physical, custom-made intraoral device for bruxism and related pain. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on physical properties and manufacturing validation.
Yes
The device is described as relieving pain and protecting teeth against the forces of bruxism, which directly addresses a medical condition or condition of the body.
No
The device is described as an "Occlusal Appliance" intended to protect teeth and alleviate pain, and its performance studies focus on physical properties and comparison to a predicate device, not on diagnosing medical conditions.
No
The device description clearly states it is a "custom-made intraoral device" and mentions "physical properties," "durability testing," and testing to a standard for "Orthodontic Base Polymers," all of which indicate a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting teeth and alleviating pain related to bruxism and TMJ issues. This is a therapeutic and protective function performed in vivo (within the patient's body), not a diagnostic test performed in vitro (outside the body, on samples).
- Device Description: The description reinforces that it's a custom-made intraoral device used for protection and pain alleviation.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 tomporomandibular joint, jaw, and muscle and tension headache pains.
Product codes (comma separated list FDA assigned to the subject device)
MQC, OCO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth, teeth, temporomandibular joint, jaw, muscle
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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: Not performed as the technological characteristics, indications for use, material, and manufacturing processes are the same or similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Panthera Occlusal Appliance (K203596)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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).
1
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
2
Center for Devices and Radiological Health
Enclosure
3
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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4
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, President | |
| 98 St. Croix Trail N PO Box 98 Lakeland, MN 55043 | ||
| (800) 654-9842 | ||
| Gary.Maas@serenasleep.com | ||
| Submission | ||
| Correspondent: | 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 Product | ||
| Code: | 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 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 Panthera Occlusal
Appliance is indicated for
protection of teeth and
restorations from the forces
and damage of
parafunctions like bruxism,
prevention of noise
associated with bruxism, and
for alleviation of
temporomandibular joint,
muscle and tension
headache pains associated
with temporomandibular
disorders | Equivalent |
| Product Code | MQC, OCO | MQC, OCO | Equivalent |
| Class | Unclassified | Unclassified | Equivalent |
| Mechanism of
Action | Disocclusion | Disocclusion | Equivalent |
| Use of Device | Removable intraoral device. Single
patient multiple use. Prescription
use 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 dental
model or stl file | Computer-aided design
(CAD) from patient dental
model or stl file | Equivalent |
| Materials | Polyamide 12 (PA 2200) | Made from polymers
(polyamide type 12), metal-
free | Equivalent |
| Manufacturing | Computer-aided
manufacturing (CAM) | Computer-aided
manufacturing (CAM) | Equivalent |
| Supplied
Sterile/Non-Sterile | Non-sterile | Non-sterile | Equivalent |
| Biocompatibility:
ISO 10993-5 | Not performed as the
materials are identical to
Serena Sleep BMA/EMA
(K203606) | Not performed as the
materials are identical to
Panthera Anti-Snoring
Device (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.