The SML OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are 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 SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force.

The SML-OSA2 Appliances are customized, intraoral dental devices designed to reduce snoring and mild to moderate obstructive sleep apnea in adults. The devices fit over the dentition and reposition the mandible in a slightly protrusive position. The SML-OSA2 APPLIANCES consist of 2 arch forms that are linked to advance the mandible, and are 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the SML-OSA2 Appliances device:

This document is a 510(k) Premarket Notification for the SML-OSA2 Appliances. In the context of 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through de novo performance studies. Therefore, the information provided focuses on comparability and known safety/effectiveness of materials and design.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of numerical acceptance criteria and a corresponding table of the device's measured performance in the typical sense of a diagnostic or therapeutic device undergoing a detailed performance study. Instead, substantial equivalence to a predicate device (ATG/SM-OSA Appliances, K130130) is the overarching "acceptance criterion" being met.

Here's how the "acceptance criteria" (implicitly, the characteristics of the predicate) and "reported device performance" (characteristics of the subject device) are presented:

Acceptance Criteria (Predicate Device K130130)	Reported Device Performance (Subject Device SML-OSA2)
K-Number: K130130	K-Number: K162816
Class: II	Class: II
Product Code: LQZ, LRK	Product Code: LQZ, LRK
Regulation Number: 872.5570	Regulation Number: 872.5570
Regulation Name: Intraoral Devices for Snoring and Obstructive Sleep Apnea	Regulation Name: Intraoral Devices for Snoring and Obstructive Sleep Apnea
Indications for Use: Intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. Worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. Customized, inserted/removed by patient, adjusted by dentist.	Indications for Use: Identical to predicate: Intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. Worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. Customized, inserted/removed by patient, adjusted by dentist. (Stated as identical)
Models: Dorsal, Herbst	Models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA), V-force (variations of Dorsal and Herbst designs)
Patient Contact Materials: Acrylic, polymers, and stainless steel	Patient Contact Materials: Acrylic, polymers, elastomers, and stainless steel (Elastomers are a new addition, but justified by prior use/FDA Compendium)
Biocompatibility: External communicating (>30 days), Surface-contacting (mucosa) per ISO 7405 & 10993-1	Biocompatibility: External communicating (>30 days), Surface-contacting (mucosa) (No new tests, justified by predicate and proven use of new materials)
Sterility: Non-sterile	Sterility: Non-sterile
Type of Device: Customized, prescription	Type of Device: Customized, prescription
Scientific Principle: Moves lower mandible forward during sleep	Scientific Principle: Moves lower mandible forward during sleep (Stated as identical)
Design: Upper and lower arches to support jaw	Design: Upper and lower arches to support jaw (Stated as identical principle)
Adjustable or Fixed: Adjustable	Adjustable or Fixed: Adjustable (Stated as identical)
Connection Parts: Stainless steel connectors	Connection Parts: Polyoxymethylene (POM) connectors, acrylic spacers, and orthodontic elastomers (Variations justified by prior use/FDA Compendium)
Performance Standards: ISO 7405, FDA Class II Special Controls Guidance Document	Performance Standards: Compliance addressed by substantial equivalence and material justification.

Study Information & Data Provenance

Sample size used for the test set and the data provenance:
- No specific test set or associated sample size is mentioned. This is a 510(k) submission primarily relying on substantial equivalence to a predicate device, not de novo performance testing.
- The document implies that the "data provenance" for the predicate device's effectiveness would be from its own clearance, but no specific study details are given here for either device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no specific test set or ground truth established for the SML-OSA2 Appliances regarding clinical performance, as no clinical testing was required or performed for this 510(k). The ground truth for the predicate's effectiveness would have been established during its own clearance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no specific test set or clinical study requiring adjudication was performed for the SML-OSA2 Appliances.
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 or assistive tool for human readers. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical intraoral appliance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purposes of this 510(k) submission, the "ground truth" for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device (K130130) for its specified indications for use.
- The "ground truth" for the materials used in SML-OSA2 Appliances (including new ones like POM and latex elastomers) is established by their prior use in cleared dental/intraoral devices or their inclusion in the FDA Biomaterials Compendium.
The sample size for the training set:
- Not applicable. This is not an algorithm or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

In summary: The document from the FDA acknowledges a 510(k) premarket notification for the SML-OSA2 Appliances. It concludes that the device is substantially equivalent to a predicate device (ATG/SM-OSA Appliances, K130130), meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This determination is made based on comparing the indications for use, technological characteristics (design, materials, scientific principle), and performance standards, primarily relying on existing data and prior clearances rather than new, extensive performance studies for the subject device. "No clinical testing is required for these devices."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2017

Selane Products, Inc. % Carolyn Primus Consultant Primus Consulting 7046 Owl's Nest Terrace Bradenton, Florida 34203

Re: K162816 Trade/Device Name: Sml-osa2 Appliances 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: LQZ, LRK Dated: June 25, 2017 Received: June 29, 2017

Dear Ms. Carolyn Primus:

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for

Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162816

Device Name SML-OSA2 Appliances

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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K162816 510(k) Summary

Submitted by:	Space Maintainer Laboratory, Division of Selane products9129 Lurline Ave.Chatsworth, CA 91311
Contact Person:	Mr. John Christian
Date Prepared:	July 25, 2017
Device Trade Name:	SML-OSA2 Appliances
Device Description:	Device, Jaw Repositioning
Device Class:	Class II
Regulation:	872.5570
Classification Panel:	Dental
Product Code:	LQZ, LRK
Predicate Device:	ATG/SM-OSA Appliances (K130130).

Device Description: The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force.

The SML-OSA2 APPLIANCES are made by Appliance Therapy Group/Space Maintainer Laboratory, which is owned/operated by Selane Products, Inc. Appliance Therapy Group/Space Maintainer Laboratory will manufacture these customized, prescription devices. These reusable (repeated use by one patient) devices will be provided to the patient non-sterile.

Indications for Use: The SML-OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized

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appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

TECHNOLOGICAL CHARACTERISTICS:

Intended Use

The Indications for Use for the SML-OSA2A Appliances are identical to the ATG/SM-OSA Appliances' Indications for Use. Both the proposed and predicate devices are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults A more in-depth comparison of the materials of construction is provided in the Substantial Equivalence section.

Design

The SML-OSA2 APPLIANCES are made primarily of dental acrylic. Three modified designs (ASA, Clear Sleep Adjustable Dorsal, and Clear Sleep Adjustable Anterior) are a variation of the Dorsal design. Two modified designs (QNA and V-force) are a variation of the Herbst design. Stainless steel or elastomeric parts are incorporated to allow adjustment of the appliances. These designs may have dual-laminate dental polymers in place of the acrylic. Table S-1 summarizes the design characteristics of the five models of the proposed device.

The function, scientific concept and principle of operation are the same for each device design. The principle of operation is that two connected arch forms maneuver the mandible forward. The position of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be more open, contributing to the reduction in snoring and mild to moderate sleep apnea.

SML-OSA2Appliance	Similarities toK130130	Differences from K130130
Adjustable SleepAppliance (ASA)	Similar to the K130130Dorsal.	Adjustable arch width with midline screw onmaxillary arch; partial anterior coverage.
Clear SleepAdjustable Dorsal	Similar to the K130130Dorsal.	Acrylic wings are replaced with acrylicinterlocking tabs.
Clear SleepAdjustable Anterior	Similar to the K130130Dorsal.	Adjustments in the anterior instead of the buccalcorridor (area between the lateral margin of thelips and the outside of the posterior dental arches).
Quiet NightAppliance (QNA)	Similar to the K130130Herbst.	Stainless steel connectors are replaced with polymer(POM) connectors.
V-force	Similar to the K130130Herbst.	Stainless steel connecting hinges are replaced withorthodontic elastomers and acrylic tabs. Acrylicinterlocking tabs are included to advance themandible.

Table S-1: Five Design Models of the Subject SML-OSA2

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APPLIANCES' Materials

SML-OSA2 Appliances are manufactured of Stainless Steel 304, Stainless Steel 316, Polymethylmethacrylate, SBS/EVA laminate or Polyurethane/copolyester, Polyoxymethylene (POM), and intraoral latex rubber elastomers. Table S-2.1 through Table S-2.5 list the materials of each of the SML-OSA2 Appliances, and indicate that these materials have been used in the predicate device, in previously cleared dental devices, or have otherwise been proven safe for intraoral use.

MATERIAL	DEVICE PART	Predicate DeviceATG/SM-OSA	Subject DeviceSML-OSA2	Acceptable Materialfor Medical Device Use
Stainless Steel 304/316	Connectors	Yes	Yes	K130130
Polymethyl Methacrylate(PMMA Acrylic)	Maxillary & MandibularArch Forms	Yes	Yes	K130130
SBS/EVA laminate orPolyurethane/ copolyester	Maxillary & MandibularArch Forms	Yes	Yes	K130130
Vitallium 2000 partialdenture alloy	Maxillary	Yes	No	K130130
	Table S-2.2: Clear Sleep Adjustable Dorsal Construction
MATERIAL	DEVICE PART	Predicate DeviceATG/SM-OSA	Subject DeviceSML-OSA2	Acceptable Materialfor Medical Device Use
Stainless Steel 304/316	Connectors	Yes	No	K130130
Polymethyl Methacrylate(PMMA Acrylic)	Maxillary & MandibularArch Forms	Yes	Yes	K130130
	Connectors	No	Yes	K130130
SBS/EVA laminate orPolyurethane/ copolyester	Maxillary & MandibularArch Forms	Yes	Yes	K130130
	Table S-2.3: Clear Sleep Adjustable Anterior Construction
MATERIAL	DEVICE PART	Predicate DeviceATG/SM-OSA	Subject DeviceSML-OSA2	Acceptable Materialfor Medical Device Use
Stainless Steel 304/316	Connectors	Yes	No	K130130
Polymethyl Methacrylate(PMMA Acrylic)	Maxillary & MandibularArch Forms	Yes	Yes	K130130
SBS/EVA laminate orPolyurethane/ copolyester	Maxillary & MandibularArch Forms	Yes	Yes	K130130
	Table S-2.4: Quiet Night Appliance (QNA) Construction
MATERIAL	DEVICE PART	Predicate DeviceATG/SM-OSA	Subject DeviceSML-OSA2	Acceptable Materialfor Medical Device Use
Stainless Steel 304/316	Connectors	Yes	No	K130130
Polyoxymethylene (POM)	Connectors	No	Yes	FDA BiomaterialsCompendium (1)
Polymethyl Methacrylate(PMMA Acrylic)	Maxillary & MandibularArch Forms	Yes	Yes	K130130
SBS/EVA laminate orPolyurethane/ copolvester	Maxillary & MandibularArch Forms	Yes	Yes	K130130

1 Polyoxymethylene (POM) is a recognized polymeric thermoplastic in the FDA Biomaterials Compendium.

510(k) Summary of Traditional Premarket Notification for SML-OSA2 APPLIANCES Space Maintainers Laboratory; Division of Selane Products, Inc. K162816 – CONFIDENTIAL TRADE SECRET

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Table S-2.5: V-force Construction

MATERIAL	DEVICE PART	PredicateDeviceATG/SM-OSA	SubjectDevice SML-OSA2	Acceptable Materialfor Medical DeviceUse
Stainless Steel 304/316	Connectors	Yes	No	K130130
Latex Rubber Elastomers	Connectors	No	Yes	FDA BiomaterialsCompendium(1),K935144 (2)
Polymethyl Methacrylate(PMMA Acrylic)	Maxillary & MandibularArch Forms	Yes	Yes	K130130
SBS/EVA laminate orPolyurethane/ copolyester	Maxillary & MandibularArch Forms	Yes	Yes	K130130

ı Natural latex is a recognized polymeric thermoset/elastomer in the FDA Biomaterials Compendium.

2 Latex rubber elastomers will be purchased from Dentaurum GmbH & Co. KG, Registration Number 9611458 or another FDA registered and listed establishment with FDA clearance for intraoral latex elastics.

Substantial Equivalence

Table S-3 has a comparison of the predicate and the subject devices with regard to their substantial equivalence.

	Predicate Device	Subject Device SML-OSA2
	ATG/SM-OSA Appliances	Appliances
510(k) #	K130130	K162816
Class	II	II
Pro Code	LQZ, LRK	LQZ, LRK
Regulation #	872.5570	872.5570
Regulation Name	Intraoral Devices for Snoring andObstructive Sleep Apnea	Intraoral Devices for Snoring andObstructive Sleep Apnea
Indications for Use	The ATG/SM-OSA appliances areintended to reduce nighttime snoring andmild to moderate obstructive sleep apneain adults. The ATG/SM-OSA appliancesare worn while sleeping to support the	The SML-OSA2 appliances are intended toreduce nighttime snoring and mild tomoderate obstructive sleep apnea in adults.The SML-OSA2 appliances are worn whilesleeping to support the lower jaw in a
	lower jaw in a forward position prescribedby the dentist. The customized appliance is	forward position prescribed by the dentist.The customized appliance is inserted and
	inserted and removed by the patient and	removed by the patient and adjusted by the
	adjusted by the prescribing dentist.	prescribing dentist.
	Models	Dorsal Herbst
Patient Contact	Acrylic, polymers, and stainless steel	Acrylic, polymers, elastomers, and stainless steel
Biocompatibility perISO 7405 & 10993-1	External communicating (>30 days)Surface-contacting (mucosa)	External communicating (>30 days)Surface-contacting (mucosa)
Sterility	Non-sterile	Non-sterile
Type of Device	Customized, prescription	Customized, prescription
Scientific Principle	Moves lower mandible forward during sleep	Moves lower mandible forward during sleep
Design	Upper and lower arches to support jaw	Upper and lower arches to support jaw
Adjustable or Fixed	Adjustable	Adjustable
Connection Parts	Stainless steel connectors	Polyoxymethylene (POM) connectors, acrylicspacers, and orthodontic elastomers

Table S-3: Substantial Equivalence Comparison of Devices

510(k) Summary of Traditional Premarket Notification for SML-OSA2 APPLIANCES Space Maintainers Laboratory; Division of Selane Products, Inc. K162816-CONFIDENTIAL TRADE SECRET

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The indications for use are identical for the predicate K130130 and subject K162816 devices. No significant differences exist in technology, intended use, or design between the subject devices and the predicates selected.

Performance Standards:

ISO 7405 Second edition 2008-12-15, dentistry evaluation of biocompatibility of medical . devices used in dentistry as published in the Federal Register (Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036; 07/09/2014).
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." [Nov. 12, 2002]

Biocompatibility:

The predicate and subject devices are considered to be external communicating devices of permanent exposure (>30 days) per ISO 7405 and surface-contacting devices (mucosa) of permanent contact (>30 days) per ISO 10993-1. No changes have been made in the primary materials of construction from the sponsor's own predicate device. In some models, stainless steel connecting parts have been substituted with Polyoxymethylene (POM) or intraoral latex rubber elastomers.

No biocompatibility tests have been performed for the modified devices; the new materials have als o been used in other cleared intraoral devices and implantable devices.

Clinical Testing:

No clinical testing is required for these devices.

Risk Analysis:

A risk analysis including an evaluation of the materials of construction and design was performed. The function of mandibular advancement devices requires that the prescribing dentist be cognizant of the potential for TMJ soreness, soft tissue soreness, and dentition complications (soreness, motion, loosening) by mandibular advancement. The contraindications, warnings, precautions, storage directions, prescription preparation instructions, fitting and adjustment directions are provided to avoid potential problems from arising or persisting with the dentition, tissue, or joints. A risk related to the polymer spacers was addressed. No significant new risks were identified.

Conclusions:

The subject devices have identical indications for use to the predicate devices. The intended use, materials of construction, technology, principle of operation, and designs of the SML-OSA2 Appliances are comparable to the legally marketed predicate. Therefore, the proposed SML-OSA2 Appliances are substantially equivalent to the predicate.

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.”