The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

Device Description

The NightBlocks™ appliance consist of two removable, custom fabricated acrylic trays that fit separately over the upper and lower dental arches and engage each other in order to reposition the mandible in a slightly anterior position. They contain stainlesssteel ball clasps for extra retention and stainless-steel orthodontic expansion screws on the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting.

The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea.

Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

AI/ML Overview

This document is a 510(k) summary for "The NightBlocks™ Appliance." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested details, such as a table of acceptance criteria and reported performance, sample sizes for test sets, expert involvement in ground truth, MRMC studies, or standalone algorithm performance, are not applicable as this submission relies on demonstrating similarity to an already cleared device, not on new clinical performance data.

Here's an analysis of the provided information in the context of your questions:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This submission is for substantial equivalence. It does not define new clinical performance acceptance criteria or report new clinical device performance data. The device's performance is inferred to be equivalent to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No clinical test set data was used. The submission states, "Clinical testing has not been performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No clinical test set requiring ground truth establishment was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set requiring adjudication was conducted.

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 or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new clinical ground truth was established as no new clinical testing was performed.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, this is a physical medical device.

Summary of the document's approach:

The manufacturer, Advanced Facialdontics LLC, is seeking 510(k) clearance for "The NightBlocks™ Appliance." Their strategy is to demonstrate substantial equivalence to existing legally marketed predicate devices, primarily the "ATG/SM-OSA Appliances (K130130)."

The core argument for equivalence is based on the following:

Identical Indications for Use: Both the proposed device and the predicate are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults, by supporting the lower jaw in a forward position.
Similar Technological Characteristics:
- Principle of operation (mandibular repositioning)
- Prescription device, custom fabricated, intraoral, removable by patient, reusable.
- Environment of use (home).
- Non-sterile.
- Nearly identical raw materials (Polymethylmethacrylate Polymer and Monomer, medical grade stainless steel wire, orthodontic expansion screws).
- Manufacturing, finishing, and cleaning processes are identical and performed at the same facility (Space Maintainers Laboratory).
Minor Design Differences: The only noted differences are the location of the occluding surface of the upper and lower trays and the inclusion of additional braided stainless-steel supporting wire within the dorsal wings of the proposed device. The submission states these minor differences "do not affect the substantial equivalence" as they don't change the indication, principle of operation, manufacturing/sterilization process, or elevate risk.
Non-Clinical Tests: A risk analysis per ISO 14971 was performed, comparing potential risks (soreness, obstruction, tooth movement, TMD, saliva, breakage) to the predicate device, concluding risks were equivalent or less. Biocompatibility and physical properties were leveraged from the predicate device materials.
Clinical Tests: Explicitly stated that "Clinical testing has not been performed."

In essence, the "study" proving the device meets criteria (or rather, is substantially equivalent) is a comparison and analysis of the device's design, materials, manufacturing, and intended use against a legally marketed predicate device, rather than a novel clinical effectiveness trial. The acceptance criteria are implicitly met if the device is deemed sufficiently similar to a device already cleared by the FDA for the same indications for use.

Summary

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January 28, 2020

Advanced Facialdontics LLC Scott Simonetti President 325 Lake Ave. Unit 759 St James, New York 11780

Re: K192581

Trade/Device Name: The NightBlocks Appliance 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: LOZ, LRK Dated: December 17, 2019 Received: December 19, 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

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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,

for Srinivas "Nandu" Nandkumar, Ph.D. 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) K192581

Device Name The NightBlocks™ Appliance

Indications for Use (Describe)

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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nced Facialdontics®

510(k) Summary

1. Owner Information

Owner's Name:	Advanced Facialdontics LLC
Owner's Address:	325 Lake AveUnit 759St James, NY 11780
FDA Registration #:	3015733038
Telephone:	(631) 379-3902
Fax:	(631) 234-7985
Contact Person:	Dr Scott Simonetti
Email:	ssimonettidds@yahoo.com
Date Prepared:	1/10/2020

2. Device Name

Trade Name:	The NightBlocks™ Appliance
510K Number:	K192581
Common Name:	Device, Jaw Repositioning
Classification:	Class II
Product Code:	LQZ, LRK
Review Panel:	Dental
Regulation:	CFR 872.5570

3. Predicate Devices

Primary Predicate:	ATG/SM-OSA Appliances (K130130)
Reference Devices:	SML-OSA2 Appliances (K162816)Lamberg Sleep Well-Smartrusion, LSW-S (K101709)

4. Device Description

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the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting.

Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

5. Indications for Use:

6. Technological Characteristics Comparison to Predicate Device:

Intended Use: The intended use and the Indications of Use for the proposed device and predicate are identical.

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, intraoral jaw repositioning device for sleep apnea, environment of use: home, removable by patient and reusable, location of advancement mechanism, provided nonsterile, and identical raw materials, manufacturing, finishing and cleaning process.

The only minor design differences between the proposed device and predicate is the location of the occluding surface of the upper and lower trays, and the inclusion of additional braided stainless-steel supporting wire within the dorsal wings.

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	Subject Device	Predicate Device	Reference Device	Reference Device
Device	NightBlocks™Appliance	ATG/SM-OSA,Adjustable DorsalApplianceK130130	SML-OSA2AppliancesK162816	Lamberg SleepWell SmartrusionK101709
Product Codes	LQZ, LRK	LQZ, LRK	LQZ, LRK	LQZ, LRK
Indicationsfor Use	The NightBlocks™Appliance is intendedto reduce nighttimesnoring and mild tomoderate obstructivesleep apnea in adults.The NightBlocks™Appliance is wornwhile sleeping tosupport the lower jawin a forward positionprescribed by thedentist. Thecustomized applianceis inserted andremoved by thepatient and adjustedby the prescribingdentist.	The ATG/SM-OSAAppliances areintended to reducenighttime snoring andmild to moderateobstructive sleepapnea in adults. TheATG/SM-OSAappliances are wornwhile sleeping tosupport the lower jawin a forward positionprescribed by thedentist. Thecustomized applianceis inserted andremoved by thepatient and adjustedby the prescribingdentist.	The SML-OSA2Appliances areintended to reducenighttime snoringand mild tomoderateobstructive sleepapnea in adults. TheSML-OSA2appliances are wornwhile sleeping tosupport the lowerjaw in a forwardposition prescribedby the dentist. Thecustomizedappliance isinserted andremoved by thepatient andadjusted by theprescribing dentist.	For the reductionof nighttimesnoring and mildto moderateobstructive sleepapnea in adults 18years of age orolder. Prescriptionuse only.
TargetPopulation	Adults who snore orhave obstructivesleep apnea.	Same	Same	Same
DesignFeatures	Prescription devicecustom fit	Same	Same	Same
	Intraoral device fittedover upper and lowerdentition	Same	Same	Same
Sterility	Provided Non-sterile	Same	Same	Same
HumanFactors	Removable by patientand reusable	Same	Same	Same
Environmentof Use	Home	Same	Same	Same
Principle ofOperation	MandibularRepositioning withcustom fitted acrylicupper and lowercomponents. Thisadvances themandible anteriorlyto enlarge the airway.	Same	Same	Same
	Expansion mechanismplaced on buccalportions forunobstructed airwaypassage.	Same	Same	Expansionmechanismlocated in anteriorportion of mouth.
	Mandible can beadvanced with twobuccal expansionscrews up to 6mm.	Same	Varyingadvancementmechanisms.	Advancement bydentist addingacrylic material tothe anteriorprotrusive element
Materials	Methyl methacrylate,medical gradestainless steel,OrthodonticExpansion screws	Same, and additionalcolorant	Same	Methylmethacrylate,Stainless steel, andcopolyester.
Biocompatibility	Uses all FDA clearedClass I materials thatare commonly used indentistry.	Same	Same	Same
Compatibilitywith theenvironmentand otherdevices	Does not release anycompounds harmfulto the environmentand pother devices.	Same	Same	Same
Electrical,radiation,chemical, andthermalsafety	The device does notuse electricity,radiation, heat orchemicals to function.	Same	Same	Same

Table 1: Comparison of Intraoral Jaw Repositioning Devices

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7. Non-Clinical Tests Performed

The materials used in the predicate device are identical to those in the subject device, but without the colorant. The three raw materials are obtained from the same manufacturers (Lang Dental Orthodontic Acrylic K141439, medical grade stainless steel orthodontic wire from AJ Wilcock, and stainless-steel orthodontic expansion screws from Leone). Both the predicate device and the subject device are manufactured in the same manufacturing facility (Space Maintainers Laboratory). The manufacturing process and sterilization and cleaning process of the predicate device and the subject device are identical. Biocompatibility and physical properties have been leveraged from the predicate.

A risk analysis was performed as per ISO 14971 which considered intraoral soreness, obstruction of oral breathing, tooth movement or loosening, TMD concerns, excessive saliva and breakage. The subject device was compared to the predicate in each area to show the risks were equivalent or less to the predicate device.

8. Clinical Tests Performed

Clinical testing has not been performed.

9. Conclusion

The subject device has the identical Indications of Use, intended use, materials of construction, sterilization and processing, principle of operation and technological characteristics as the predicate device. The devices are both manufactured, finished and shipped from the same FDA registered facility. Based upon the comparative analysis of features, materials and design, the minor design difference between the subject device and the predicate device does not affect the substantial equivalence of the subject device since: it does not change the Indication of Use of the subject device, it does not change the principle of operation, it does not change the manufacturing or sterilization process, and it does not elevate the risk. It is concluded that the proposed NightBlocks™ Appliance is substantially equivalent to the previously cleared 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.”