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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Serena Sleep Block Mandibular Advancement (BMA) and Elastic Mandibular Advancement (EMA) devices. The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria in the traditional sense of a new technology.

Therefore, the "acceptance criteria" here are based on the comparison to the predicate devices, showing that the Serena Sleep devices are as safe and effective as the existing ones. The "study" proving this largely involves bench testing and a detailed comparison of features.

Here's an analysis of the "acceptance criteria" and the "study" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "equivalence" to the predicate devices across various specifications. The "reported device performance" is mainly shown through bench testing results.

Acceptance Criteria (Implicit for Equivalence)	Subject Device Performance (Serena Sleep)	Predicate Device Performance (Prosomnus MicrO2 for BMA, O2Vent Optima for EMA)	Comparison Result
Indications for Use	Reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.	Identical (BMA), Similar (EMA - includes "during sleep to aid in the treatment")	Equivalent
Product Code	LRK	LRK	Equivalent
Regulations	21 CFR 872.5570	21 CFR 872.5570	Equivalent
Device Class	Class II	Class II	Equivalent
Use of Device	Removable intraoral, single patient multiple use, prescription use only.	Removable intraoral, single patient multiple use, prescription use only.	Equivalent
Target Population	Adults (over 18) for snoring and mild to moderate OSA.	Adults (over 18) for snoring and mild to moderate OSA.	Equivalent
Device Functionality	Repositions lower jaw forward, increases pharyngeal space to improve air exchange.	Identical	Equivalent
Teeth Retention Method	Rigid trays (PA 2200)	Rigid trays (PMMA for MicrO2, PA 2200 for Optima)	Similar (BMA - different material), Equivalent (EMA)
Tray Separation	Upper and lower trays are separate.	Upper and lower trays are separate.	Equivalent
Mandibular Advancement Mechanism	BMA: Positioning blocks built into trays. EMA: Exterior pins allowing rubber bands.	MicrO2: Twin-mated positioning posts. Optima: Protrusions/lugs with connector.	Similar (BMA), Equivalent (EMA)
Mandible Adjustment	Clinician adjustable (BMA); Clinician and patient adjustable (EMA).	Identical	Equivalent
Design	Designed from digital scans, 3D printed Nylon 12 (PA 2200).	CAD/CAM generated, PMMA (MicrO2); CAD/CAM, additive manufacturing, Nylon 12 (PA 2200) (Optima).	Similar (BMA-different material), Equivalent (EMA)
Supplied State	Non-sterile	Non-sterile	Equivalent
Materials (Trays)	Nylon 12 (PA 2200)	Hard PMMA (MicrO2); Nylon 12 (PA 2200) (Optima)	Similar (BMA - different material), Equivalent (EMA)
Materials (Straps/Connectors for EMA)	100% thermoplastic Polyurethane/cured elastomer	100% thermoplastic Polyurethane/cured elastomer	Equivalent
Cleaning Instructions	Water with soft toothbrush, rinse, dry, store in case.	Similar (BMA - "Cleaned daily"); Identical (EMA).	Similar/Equivalent
Biocompatibility (ISO 10993-5)	Passed	Passed (Optima); Not performed for MicrO2 as materials were identical to prior cleared device.	Equivalent
Mechanical Performance (Compression, Shear, Bruxism, Durability)	Withstood forces greater than expected jaw forces during nighttime clenching/bruxing for one year of use.	Not explicitly detailed for predicates, but implicit acceptance is that Serena devices meet similar safety/performance.	Met / Comparable

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not mention a "test set" in the context of human subjects or a clinical study. It refers to "Performance Testing (Bench)" which would involve physical device samples.

Sample Size for Bench Testing: Not explicitly stated how many devices were tested for compression, shear, bruxism, and durability.
Data Provenance: The bench testing was conducted internally by the manufacturer (Serena Sleep). The document doesn't specify the country of origin of this testing data. The data is retrospective in the sense that it's reported after the testing completion.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as there was no clinical test set involving human subjects requiring expert ground truth establishment. The ground truth for device performance was established through engineering and mechanical testing methodologies against known maximum jaw forces from literature.

4. Adjudication Method for the Test Set

Not applicable, as no human-in-the-loop clinical test set was conducted that would require adjudication.

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. This device is a physical intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. The core "performance" was physical bench testing of the device for mechanical integrity and durability.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the "ground truth" for mechanical forces was established through:

Literature search of maximum jaw strengths: This implies reliance on established scientific or engineering data regarding biomechanical forces in the human jaw.

For the comparison for substantial equivalence, the "ground truth" was the specifications and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there was no training set.

Summary

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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.

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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

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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)

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) 402-5577Gary.Maas@serenasleep.com
SubmissionCorrespondent:	Address:Phone:Email:	Sarah Moss, Regulatory Affairs Consultant11218 Zest Ct. NE, Blaine, MN 55449(281) 795-1812smoss@medavice.com
Date Prepared:	December 2020
Proprietary Name:	Serena Sleep Block Mandibular Advancement and Elastic MandibularAdvancement Devices
Common Name:	Device, Anti-snoring
Product Code:	LRK
Device Classification:	Class 2
Predicate Devices:	Block Mandibular Advancement: Prosomnus MicrO2 (PrimaryPredicate - K133683)
Device Description:	Elastic Mandibular Advancement: O2Vent Optima (Reference Device(K190236))

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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.

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Specification	Serena SleepBlock Mandibular Advancement	Prosomnus MicrO2(Predicate Device)	ComparisonResult
510(k) Number		K133683
Device Photo	Image: Serena Sleep Device	Image: Prosomnus MicrO2 Device
Indication forUse	The Serena Sleep Appliance isa removable medical devicethat is fitted in the patient'smouth and is intended toreduce or alleviate snoring andmild to moderate obstructivesleep apnea (OSA) in adults.	The MICRODENTAL, Inc. MicrO2device is intended to reduce nighttime snoring and mild to moderateobstructive sleep apnea (OSA) inadults.	Equivalent
Product Code	LRK	LRK	Equivalent
Regulations	21CFR 872.5570	21CFR 872.5570	Equivalent
Class	2	2	Equivalent
Use ofDevice	Removable intraoral device. Singlepatient multiple use. Prescriptionuse only.	Removable intraoral device. Singlepatient multiple use. Prescriptionuse only.	Equivalent
TargetPopulation	People over 18 of age toreduce or alleviate snoringand mild to moderateobstructive sleep apnea (OSA)in adults.	Intended to reduce night timesnoring and mild to moderateobstructive sleep apnea (OSA) inadults	Equivalent
Device	Repositions the lower jawforward.	Repositions the lower jawforward.	Equivalent
Functionality	Acts by increasing the	Acts by increasing the pharyngeal	Equivalent
Specification	Serena SleepBlock Mandibular Advancement	Prosomnus MicrO2(Predicate Device)	ComparisonResult
	pharyngeal space to improvethe patient's ability toexchange air.	space to improve the patient'sability to exchange air.
	Retains the top and bottomteeth using rigid trays (PA2200).	Retains the top and bottom teethusing rigid trays (PMMA).	Similar – DifferentMaterial
	Upper and lower trays areseparate	Upper and lower trays areseparate	Equivalent
Device Designand Principle orOperation	Mandibular advancement isachieved through positioningblocks that are built into theupper and lower trays.	Mandibular advancementachieved through twin-matedpositioning posts built into theupper and lower trays	Similar – The BMAuses blocks and theMicrO2 uses posts
Means ofadvancing themandible	Mandibular advancementachieved via the use ofinterlocking blocks placed onthe trays that are in line withthe teeth. The amount ofmandibular advancement isbased on the location of the"step" relative to thecenterline of the block.	Mandibular advancementachieved through twin-matedpositioning posts built into theupper and lower trays	Equivalent
Adjustment	Can be adjusted by theclinician.	Can be adjusted by the clinician.	Equivalent
Design	Serena Sleep devices will bedesigned from digital scans ofa patient's dentition. Thisbaseline model of thedentition is provided by thetreating dental physician.Using the 3D image of thepatient's dentition and thetreating physician's indicatedmandibular advancement, thepatient's custom device isdesigned by adding blocks.The device is then 3D printedusing the material Nylon 12(PA 2200).	CAD/CAM generated specificallyfor each prescription and madewith a hard PMMA material	Similar – differentmaterial
Specification	Serena SleepBlock Mandibular Advancement	Prosomnus MicrO2(Predicate Device)	ComparisonResult
SuppliedSterile/Non-Sterile	Non-sterile	Non-sterile	Equivalent
Materials:Upper andLower Trays	Nylon 12 (PA 2200)	Hard PMMA	Similar — differentmaterial
CleaningInstructions	Clean the device after use inwater with a softtoothbrush. Rinse, dry, andstore in the case provided.	Cleaned daily.	Similar
Biocompatibility: ISO 10993-5	Passed	Not performed as the materialsare identical as in theSomnomed MAS RXA (K050592).	Equivalent

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Comparison to Predicate Devices: Elastic Mandibular Advancement Device
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Specification	Serena SleepElastic Mandibular Advancement	O2Vent Optima(Predicate Device)	ComparisonResult
510(k) Number		K190236
Device Photo	Image: Serena Sleep Device	Image: O2Vent Optima Device
Indication forUse	The Serena Sleep Appliance isa removable medical devicethat is fitted in the patient'smouth and is intended toreduce or alleviate snoring andmild to moderate obstructivesleep apnea (OSA) in adults.	The O2Vent Optima is aremovable medical device that isfitted in the patient's mouth andis intended to reduce or alleviatesnoring and mild to moderateobstructive sleep apnea (OSA).The device is indicated for useduring sleep to aid in thetreatment of these conditions.	Equivalent
Product Code	LRK	LRK	Equivalent
Regulations	21CFR 872.5570	21CFR 872.5570	Equivalent
Class	2	2	Equivalent
Use ofDevice	Removable intraoral device. Singlepatient multiple use. Prescriptionuse only.	Removable intraoral device. Singlepatient multiple use. Prescriptionuse only.	Equivalent
TargetPopulation	People over 18 of age toreduce or alleviate snoringand mild to moderateobstructive sleep apnea (OSA)in adults.	People over 18 years of age whosnore and/or have sleep apnea.	Equivalent
DeviceFunctionality	Repositions the lower jawforward.	Repositions the lower jaw forward.	Equivalent
	Acts by increasing thepharyngeal space to improvethe patient's ability toexchange air.	Acts by increasing the pharyngealspace to improve the patient'sability to exchange air.	Equivalent
Specification	Serena Sleep	O2Vent Optima	ComparisonResult
	Elastic Mandibular Advancement	(Predicate Device)
	Retains the top and bottomteeth using rigid trays (PA2200).	Retains the top and bottom teethusing rigid trays (PA 2200).	Equivalent
	Upper and lower trays areseparate	Upper and lower trays are separate	Equivalent
Device Designand Principle orOperation	Mandibular advancementusing exterior pins that allowfor the use of rubber bandsrather than the blocks. Thesebands provide additionaltreatment options and forcesfor repositioning the bottomjaw.	The trays have protrusions (lugs) atthe side of the upper and lowerparts with a connector between theupper and lower parts to stabilizeand/or advance the lower jaw.	Equivalent
Means ofadvancing themandible	Lower jaw adjusted byattaching connectors ofvarying lengths	Lower jaw adjusted by attachingconnectors of varying lengths	Equivalent
Adjustment	Can be adjusted by theclinician and patient	Can be adjusted by the clinician andpatient	Equivalent
Design	Serena Sleep devices will bedesigned from digital scans ofa patient's dentition. Thisbaseline model of thedentition is provided by thetreating dental physician.Using the 3D image of thepatient's dentition and thetreating physician's indicatedmandibular advancement, thepatient's custom device isdesigned by adding pins. Thedevice is then 3D printedusing the material Nylon 12	Customized for each patient in adental laboratory located at themanufacturing site based on thedentist prescription Use of computeraided design (CAD) and computeraided manufacturing (CAM) and ismade through additivemanufacturing using laser sinteringof Nylon 12 (PA2200) material. Theuse of these technologies providesfor customization according to theunique characteristics of the patientoral anatomy based on theprescription provided by the clinician	Equivalent
AdjustmentAccessory	Replacement/Re-supplyconnectors (13-21 mm)	Replacement/re-supply connectors(13-21 mm)	Equivalent
SuppliedSterile/Non-Sterile	Non-sterile	Non-sterile	Equivalent
Materials: Upperand Lower Trays	Nylon 12 (PA2200)	Nylon 12 (PA2200)	Equivalent
Specification	Serena SleepElastic Mandibular Advancement	02Vent Optima(Predicate Device)	ComparisonResult
Materials:Straps	100% thermoplasticPolyurethane/curedelastomer	100% thermoplasticPolyurethane/cured elastomer	Equivalent
CleaningInstructions	Clean the device after use inwater with a softtoothbrush. Rinse, dry, andstore in the case provided.	Clean the device daily in lukewarmwater 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.

Regulation Number and Section

§ 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.”