(90 days)
No
The device description focuses on mechanical mandibular repositioning and custom fitting based on physician prescription and digital scans, with no mention of AI/ML for diagnosis, treatment planning, or device operation.
Yes
The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA), which are medical conditions, and it is a removable medical device fitted in the patient's mouth. Its function of repositioning the jaw to increase pharyngeal space and improve air exchange during sleep directly addresses a health issue.
No
The device is described as a "removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults." This indicates a therapeutic or treatment function, not a diagnostic one.
No
The device description clearly states it is an "intraoral device" consisting of "custom fitted trays" and "positioning blocks" or "exterior pins," which are physical hardware components.
Based on the provided information, the Serena Sleep Appliance is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Serena Sleep Appliance Function: The Serena Sleep Appliance is a physical, intraoral device that is fitted in the patient's mouth. Its function is to mechanically reposition the lower jaw to improve airflow and reduce snoring and sleep apnea. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's a "removable medical device that is fitted in the patient's mouth" and is intended to "reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults." This describes a therapeutic or mechanical intervention, not a diagnostic test performed on a specimen.
Therefore, the Serena Sleep Appliance falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Serena Sleep Block Mandibular Advancement is an intraoral device that treats snoring and sleep apnea through mandibular repositioning the lower jaw forward from its normal location, the patient's pharyngeal space is increased and their ability to exchange air during sleep is improved. This device consists of custom fitted trays which fit over the upper and lower teeth. Based on the physician's prescription, positioning blocks are built into the upper and lower trays The mandibular advancement is achieved through the physician's selection of a specific upper and lower tray that when fitted, sets the optimal mandibular advancement. The separate two-piece construction is desirable for patients that want greater range of motion and lateral movement.
The Elastic Mandibular Advancement model is similar to the Block Mandibular Advancement but has exterior pins that allow for the use of rubber bands rather than the blocks. These bands provide additional treatment options and forces for repositioning the bottom jaw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth
Indicated Patient Age Range
adults.
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)
Performance Testing (Bench)
Testing was conducted to compare the Serena Sleep Block Mandibular Advancement device and Elastic Mandibular Advancement device to mechanical forces found through a literature search of maximum jaw strengths. Compression, Shear, and Bruxism forces were tested, as well as a product durability test for one year of use. The bench testing proved that they devices were able to withstand forces greater than expected jaw forces during nighttime jaw clenching and bruxing.
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.
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.
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
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 10, 2021
Meris Investment Group % Sarah Moss Regulatory Affairs Consultant Medavice, Inc 11218 Zest Ct NE Blaine, Minnesota 55449
Re: K203606
Trade/Device Name: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK Dated: December 10, 2020 Received: December 10, 2020
Dear Sarah Moss:
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.
1
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 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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203606
Device Name
Serena Sleep Block Mandibular Advancement (BMA) Serena Sleep Elastic Mandibular Advancement (EMA)
Indications for Use (Describe)
The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
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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Section 5. 510(k) Summary - K203606
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 | |
| (651) 402-5577 | ||
| Gary.Maas@serenasleep.com | ||
| Submission | ||
| Correspondent: | Address: | |
| Phone: | ||
| Email: | Sarah Moss, Regulatory Affairs Consultant | |
| 11218 Zest Ct. NE, Blaine, MN 55449 | ||
| (281) 795-1812 | ||
| smoss@medavice.com | ||
| Date Prepared: | December 2020 | |
| Proprietary Name: | Serena Sleep Block Mandibular Advancement and Elastic Mandibular | |
| Advancement Devices | ||
| Common Name: | Device, Anti-snoring | |
| Product Code: | LRK | |
| Device Classification: | Class 2 | |
| Predicate Devices: | Block Mandibular Advancement: Prosomnus MicrO2 (Primary | |
| Predicate - K133683) | ||
| Device Description: | Elastic Mandibular Advancement: O2Vent Optima (Reference Device | |
| (K190236)) |
The Serena Sleep Block Mandibular Advancement is an intraoral device that treats snoring and sleep apnea through mandibular repositioning the lower jaw forward from its normal location, the patient's pharyngeal space is increased and their ability to exchange air during sleep is improved. This device consists of custom fitted trays which fit over the upper and lower teeth. Based on the physician's prescription, positioning blocks are built into the upper and lower trays The mandibular advancement is achieved through the physician's selection of a specific upper and lower tray that when fitted, sets the optimal mandibular advancement. The separate two-piece construction is desirable for patients that want greater range of motion and lateral movement.
4
The Elastic Mandibular Advancement model is similar to the Block Mandibular Advancement but has exterior pins that allow for the use of rubber bands rather than the blocks. These bands provide additional treatment options and forces for repositioning the bottom jaw.
Indications for Use:
The Serena Sleep appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
5
| Specification | Serena Sleep
Block Mandibular Advancement | Prosomnus MicrO2
(Predicate Device) | Comparison
Result |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| 510(k) Number | | K133683 | |
| Device Photo | Image: Serena Sleep Device | Image: Prosomnus MicrO2 Device | |
| Indication for
Use | The Serena Sleep Appliance is
a removable medical device
that is fitted in the patient's
mouth and is intended to
reduce or alleviate snoring and
mild to moderate obstructive
sleep apnea (OSA) in adults. | The MICRODENTAL, Inc. MicrO2
device is intended to reduce night
time snoring and mild to moderate
obstructive sleep apnea (OSA) in
adults. | Equivalent |
| Product Code | LRK | LRK | Equivalent |
| Regulations | 21CFR 872.5570 | 21CFR 872.5570 | Equivalent |
| Class | 2 | 2 | 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 | People over 18 of age to
reduce or alleviate snoring
and mild to moderate
obstructive sleep apnea (OSA)
in adults. | Intended to reduce night time
snoring and mild to moderate
obstructive sleep apnea (OSA) in
adults | Equivalent |
| Device | Repositions the lower jaw
forward. | Repositions the lower jaw
forward. | Equivalent |
| Functionality | Acts by increasing the | Acts by increasing the pharyngeal | Equivalent |
| Specification | Serena Sleep
Block Mandibular Advancement | Prosomnus MicrO2
(Predicate Device) | Comparison
Result |
| | pharyngeal space to improve
the patient's ability to
exchange air. | space to improve the patient's
ability to exchange air. | |
| | Retains the top and bottom
teeth using rigid trays (PA
2200). | Retains the top and bottom teeth
using rigid trays (PMMA). | Similar – Different
Material |
| | Upper and lower trays are
separate | Upper and lower trays are
separate | Equivalent |
| Device Design
and Principle or
Operation | Mandibular advancement is
achieved through positioning
blocks that are built into the
upper and lower trays. | Mandibular advancement
achieved through twin-mated
positioning posts built into the
upper and lower trays | Similar – The BMA
uses blocks and the
MicrO2 uses posts |
| Means of
advancing the
mandible | Mandibular advancement
achieved via the use of
interlocking blocks placed on
the trays that are in line with
the teeth. The amount of
mandibular advancement is
based on the location of the
"step" relative to the
centerline of the block. | Mandibular advancement
achieved through twin-mated
positioning posts built into the
upper and lower trays | Equivalent |
| Adjustment | Can be adjusted by the
clinician. | Can be adjusted by the clinician. | Equivalent |
| Design | Serena Sleep devices will be
designed from digital scans of
a patient's dentition. This
baseline model of the
dentition is provided by the
treating dental physician.
Using the 3D image of the
patient's dentition and the
treating physician's indicated
mandibular advancement, the
patient's custom device is
designed by adding blocks.
The device is then 3D printed
using the material Nylon 12
(PA 2200). | CAD/CAM generated specifically
for each prescription and made
with a hard PMMA material | Similar – different
material |
| Specification | Serena Sleep
Block Mandibular Advancement | Prosomnus MicrO2
(Predicate Device) | Comparison
Result |
| Supplied
Sterile/Non-
Sterile | Non-sterile | Non-sterile | Equivalent |
| Materials:
Upper and
Lower Trays | Nylon 12 (PA 2200) | Hard PMMA | Similar — different
material |
| Cleaning
Instructions | Clean the device after use in
water with a soft
toothbrush. Rinse, dry, and
store in the case provided. | Cleaned daily. | Similar |
| Biocompatibility
: ISO 10993-5 | Passed | Not performed as the materials
are identical as in the
Somnomed MAS RXA (K050592). | Equivalent |
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| Comparison to Predicate Devices: Elastic Mandibular Advancement Device | |||
|---|---|---|---|
| ------------------------------------------------------------------------ | -- | -- | -- |
| Specification | Serena Sleep
Elastic Mandibular Advancement | O2Vent Optima
(Predicate Device) | Comparison
Result |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | | K190236 | |
| Device Photo | Image: Serena Sleep Device | Image: O2Vent Optima Device | |
| Indication for
Use | The Serena Sleep Appliance is
a removable medical device
that is fitted in the patient's
mouth and is intended to
reduce or alleviate snoring and
mild to moderate obstructive
sleep apnea (OSA) in adults. | The O2Vent Optima is a
removable medical device that is
fitted in the patient's mouth and
is intended to reduce or alleviate
snoring and mild to moderate
obstructive sleep apnea (OSA).
The device is indicated for use
during sleep to aid in the
treatment of these conditions. | Equivalent |
| Product Code | LRK | LRK | Equivalent |
| Regulations | 21CFR 872.5570 | 21CFR 872.5570 | Equivalent |
| Class | 2 | 2 | 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 | People over 18 of age to
reduce or alleviate snoring
and mild to moderate
obstructive sleep apnea (OSA)
in adults. | People over 18 years of age who
snore and/or have sleep apnea. | Equivalent |
| Device
Functionality | Repositions the lower jaw
forward. | Repositions the lower jaw forward. | Equivalent |
| | Acts by increasing the
pharyngeal space to improve
the patient's ability to
exchange air. | Acts by increasing the pharyngeal
space to improve the patient's
ability to exchange air. | Equivalent |
| Specification | Serena Sleep | O2Vent Optima | Comparison
Result |
| | Elastic Mandibular Advancement | (Predicate Device) | |
| | Retains the top and bottom
teeth using rigid trays (PA
2200). | Retains the top and bottom teeth
using rigid trays (PA 2200). | Equivalent |
| | Upper and lower trays are
separate | Upper and lower trays are separate | Equivalent |
| Device Design
and Principle or
Operation | Mandibular advancement
using exterior pins that allow
for the use of rubber bands
rather than the blocks. These
bands provide additional
treatment options and forces
for repositioning the bottom
jaw. | The trays have protrusions (lugs) at
the side of the upper and lower
parts with a connector between the
upper and lower parts to stabilize
and/or advance the lower jaw. | Equivalent |
| Means of
advancing the
mandible | Lower jaw adjusted by
attaching connectors of
varying lengths | Lower jaw adjusted by attaching
connectors of varying lengths | Equivalent |
| Adjustment | Can be adjusted by the
clinician and patient | Can be adjusted by the clinician and
patient | Equivalent |
| Design | Serena Sleep devices will be
designed from digital scans of
a patient's dentition. This
baseline model of the
dentition is provided by the
treating dental physician.
Using the 3D image of the
patient's dentition and the
treating physician's indicated
mandibular advancement, the
patient's custom device is
designed by adding pins. The
device is then 3D printed
using the material Nylon 12 | Customized for each patient in a
dental laboratory located at the
manufacturing site based on the
dentist prescription Use of computer
aided design (CAD) and computer
aided manufacturing (CAM) and is
made through additive
manufacturing using laser sintering
of Nylon 12 (PA2200) material. The
use of these technologies provides
for customization according to the
unique characteristics of the patient
oral anatomy based on the
prescription provided by the clinician | Equivalent |
| Adjustment
Accessory | Replacement/Re-supply
connectors (13-21 mm) | Replacement/re-supply connectors
(13-21 mm) | Equivalent |
| Supplied
Sterile/Non-
Sterile | Non-sterile | Non-sterile | Equivalent |
| Materials: Upper
and Lower Trays | Nylon 12 (PA2200) | Nylon 12 (PA2200) | Equivalent |
| Specification | Serena Sleep
Elastic Mandibular Advancement | 02Vent Optima
(Predicate Device) | Comparison
Result |
| Materials:
Straps | 100% thermoplastic
Polyurethane/cured
elastomer | 100% thermoplastic
Polyurethane/cured elastomer | Equivalent |
| Cleaning
Instructions | Clean the device after use in
water with a soft
toothbrush. Rinse, dry, and
store in the case provided. | Clean the device daily in lukewarm
water with a soft toothbrush. Rinse,
dry, and store in the case provided. | Equivalent |
| Biocompatibility
: ISO 10993-5 | Passed | Passed | Equivalent |
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Performance Testing (Bench)
Testing was conducted to compare the Serena Sleep Block Mandibular Advancement device and Elastic Mandibular Advancement device to mechanical forces found through a literature search of maximum jaw strengths. Compression, Shear, and Bruxism forces were tested, as well as a product durability test for one year of use. The bench testing proved that they devices were able to withstand forces greater than expected jaw forces during nighttime jaw clenching and bruxing.
A key design advantage of the Serena Sleep products are its ability to customize the amount of mandibular advancement for each patient. This feature allows the doctor the ability to find a setting that is right for each patient.
Therefore, the performance of the Serena Sleep device were shown to be at least equivalent to the predicate devices.
Clinical Testing
No Clinical Testing was required for this product.
Statement of Equivalence
Block Mandibular Advancement
As summarized above, the main differences between the subject (Serena Sleep BMA) and predicate (Prosomnus MicrO2) devices are:
- Predicate device does not use PA2200 in the additive manufacturing process
- Predicate device uses positioning pins instead of positioning blocks
Based on comparison of indications for use, user population, performance testing, mechanical and technological features, the Block Mandibular Advancement device 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.
Elastic Mandibular Advancement
As summarized above, there are no functional differences between the subject (Elastic Mandibular Advancement Device) and predicate (O2Vent Optima) devices.
Based on comparison of indications for use, user population, performance testing, mechanical and technological features, the Elastic Mandibular Advancement device 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.