The Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).

The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).

The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.

The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.

AI/ML Overview

The provided text describes the submission for K170053, a 510(k) premarket notification for the Meridian PM device, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The submission focuses heavily on demonstrating substantial equivalence to predicate devices (SICAT OptiSleep and TheraSom-CAST) rather than presenting a standalone study of the device's clinical performance against specific acceptance criteria for efficacy in reducing snoring or OSA.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not present in the provided document. The performance data presented is entirely non-clinical and relates to the device's material properties and biocompatibility.

Here's a breakdown of the available information:

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

Clinical Performance/Efficacy: The document does not provide specific acceptance criteria or reported performance for clinical outcomes such as reduction in AHI (Apnea-Hypopnea Index) or snoring intensity. The "acceptance criteria" discussed are for non-clinical tests.

Non-Clinical Performance:

Test Category	Test Method	Acceptance Criteria	Reported Performance
Material Properties		"internal requirements, applied national standards, and applied international standards"	Passed
Flexural Properties	ISO 178:2010/Amd.1:2013(E) Method A	(Not specified directly, but implied by "passed")	Passed
Plane-Strain Fracture Toughness	ASTM D5045 -14 (modified notch geometry)	(Not specified directly, but implied by "passed")	Passed
Tensile Properties	ASTM D638-14 - Modified specimen length, test speed and grip separation	(Not specified directly, but implied by "passed")	Passed
Biocompatibility	ISO 10993-1:2009 and FDA guidance document	(Not specified directly, but implied by "passed")	Passed
Cytotoxicity	ISO 10993-5	(Not specified directly, but implied by "passed")	Passed
Irritation and Skin Sensitization	ISO 10993-10	(Not specified directly, but implied by "passed")	Passed
Chemical Characterization	ISO 10993-18	(Not specified directly, but implied by "passed")	Passed
Risk Analysis	ISO 14971	"outcomes of these risks are considered acceptable...all potential risks have been mitigated"	Passed

Regarding the clinical study details, the document does not contain the requested information:

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

Not Provided. There is no mention of a human test set for clinical efficacy.

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 Provided. Not applicable as no clinical test set is described.

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

Not Provided. Not applicable as no clinical test set is described.

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 Provided. This is not relevant for this type of device (intraoral snore/OSA device) and no MRMC study or AI component is mentioned.

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

Not Provided. This is not relevant for this type of device and no algorithm is mentioned for performance assessment.

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

Not Provided. Not applicable as no clinical ground truth is described. The "ground truth" for the non-clinical tests would be the established chemical, physical, and biological properties as per the standards.

8. The sample size for the training set

Not Provided. Not applicable as no clinical training set or machine learning model is described.

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

Not Provided. Not applicable as no clinical training set is described.

Summary

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The Center for Craniofacial & Dental Sleep Medicine % Cheryl Fisher Prinicipal Consultant FisherMed Consulting LLC 260 Howard Drive, Santa Clara California 95051

November 28, 2017

Re: K170053

Trade/Device Name: Meridian PM 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, LQZ Dated: October 2, 2017 Received: October 20, 2017

Dear Cheryl Fisher:

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.

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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); 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. 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) K170053

Device Name Meridian PM

Indications for Use (Describe)

The Meridian PM is intended to reduce nighttime 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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510(k) Summary

Meridian PM

K170053

1. Submission Sponsor

Center for Craniofacial and Dental Sleep Medicine

4545 Sweetwater Blvd.

Sugarland

TX, 77479

United States

Contact: Sam Cress D.D.S.

Title: Director

2. Submission Correspondent

FisherMed Consulting, LLC

820 Civic Center Drive

Santa Clara, CA 95050

Office Phone: (408) 410-5920

Contact: Cheryl Fisher

Title: Principal Consultant, RA/QA

3. Date Prepared

6/15/2017

4. Device Identification

Trade/Proprietary Name:	Meridian PM
Common/Usual Name:	Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
Classification Name:	Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
Regulation Number:	872.5570

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Product Code: LRK, Device, Anti Snoring- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

LQZ, Device, Jaw Repositioning- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea

Device Class: Class II

Dental Classification Panel:

5. Legally Marketed Predicate Device(s)

Main Predicate K153291 OptiSleep Device by SICAT

Secondary Predicate K113516 CAST device by TheraSom

6. Indication for Use Statement

The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

7. Device Description

The Center for Craniofacial & Dental Sleep Medicine wishes to submit their Anti-Snoring & Sleep Apnea Device(s) trade name, Meridian PM, that falls under FDA Regulation Number §872.5570 and Product Codes LRK and LQZ defined as follows:

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.

The summary report is submitted in accordance with FDA's "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Sleep Apnea; Guidance for Industry and FDA."

For discussion purposes only, the Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).

The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).

The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.

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8. Substantial Equivalence Discussion

The following table compares the Meridian PM to the predicate device(s) with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues based on the similarities to the predicate device.

Feature	Meridian PM	SICATOPTISLEEP	TheraSom-CAST	Comparison
510 (k) Number	K170053	K153291	K113516	Same method
Manufacturer	Center forCraniofacial andDental SleepMedicine	SICAT GmbH & Co	Family DentalService PC	NA
Primary Device Similarities to support Substantial Equivalence
Classification #	872-5570	872-5570	872-5570	Same
Product Code	Primary LRKSecondary LQZ	Primary LRKSecondary LQZ	Primary LRKSecondary LQZ	Same
Indications foruse	The Meridian PM isintended to reducenighttime snoring andmild to moderateobstructive sleepapnea (OSA) in adults.	In adultpopulation• To reduce oralleviate snoring• To reduce oralleviate mild tomoderateobstructivesleep apnea(OSA)	The TheraSom-CAST is used toreduce oralleviate theoccurrenceof snoring and/orfor the treatmentof mild tomoderateobstructivesleep apnea(OSA) in patients18 years of ageor older	Similar to bothpredicates theMeridian PMIndications for useis aligned withproduct code LRK
Mode of Action
	These devicesfunction as amandibularrepositioner, whichacts to increase thepatient's pharyngealspace, improving theirability to exchange airduring sleep.	This devicefunctions as amandibularrepositioner,maintaining thelower jaw in aforward positionduring sleep.This mechanicalprotrusion actsto increase thepatient'spharyngealspace,improving theability toexchange airduring sleep byreducingmechanicalobstructions ofthe airway.	The devicefunctions as amandibularrepositioner,which acts toimprove thepatient's abilityto breathewithoutobstruction ofthe pharyngealairway	Similar mode ofaction with slighttechnicaldeviationsdiscussed below,not incurringadditional patientrisks
Material	Acrylic	Milled Acrylic	Cast Metal	The Meridian PMand OptiSleepdevices are madeof an acrylicmaterial while theTheraSom is madeof a dental metalalloy there is nosignificantdifferencebetween theMeridian PM andthe OptiSleepregarding theacrylic basematerial used
	The main parts of thedevice(s) are made ofAcrylic Material,Stainless Steel, andDental Alloy Material	The main partsof the device aremade ofPolymethylmethacrylate. Theexchangeableconnectors aremade ofPolyamide	Dental AlloyMaterial
Mode of Care
Insertion	Adjustable by Dentist or Physician during the duration of use	Adjustable by Dentist or Physician during the duration of use	Adjustable by Dentist or Physician during the duration of use	Same
	the upper and lower appliance to be inserted at the same time	the upper and lower appliance to be inserted at the same time	the upper and lower appliance to be inserted at the same time	Same
Usage	Removable and Reusable by the same patient.Night Time Usage Only for Meridian PM device	Removable and Reusable by the same patient.Night Time Usage Only	Removable and Reusable by the same patient.Night Time Usage Only	Same
Biocompatible	Yes	Yes	Yes	Same
OTC or Rx	Rx	Rx	Rx	Same
Device Technological Differences Difference
Fabrication	Hand made from acrylic and wire formation	Computer generated – milled from acrylic	Hand waxed and metal casted	Hand made component exists in the TheraSom device and a similar acrylic material is used in the OptiSleep device neither of these variations incur additional risk to the patients than are already present in the currently marketed devices.
Retention	Upper appliance has acrylic coverage on the occlusal and mid	Upper and lower appliance has acrylic	Upper appliance has metal casting that are formed	The Meridian PM and OptiSleep both have and acrylic coverage
posterior teeth with	buccal and	height of contour	on commensurate
retention clasp –Lower appliance hascast metal retentionfrom the buccal of theposterior teethwrapping to thelingual with acrylicanterior lingualcoverage	lingual aspect ofthe teeth to thegum line	of the cuspid andbicuspid teeth –Lower applianceand metal castingcovering theocclusal surfaceof the premolarsand molar teeth	dentition on theupper appliancethe Meridian PMand the TheraSomdevice both utilizea metal casting inthe lowerappliance forretentionincurring noadditional risk thepatient than arealready present incurrentlymarketed devices.

Table 5A - Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating the substantial equivalence of Meridian PM to the predicate devices that are subject to this 510(k) submission, The Center for Craniofacial and Dental Sleep Medicine completed a number of non-clinical performance tests, including:

. Determination Of Flexural Properties Test Method : ISO 178:2010/Amd.1:2013(E) Method A
Plane-Strain Fracture Toughness and Strain Energy Release Rate of Plastic Materials Test Method : ASTM D5045 -14 (modified notch geometry)
Tensile Properties Test Method : ASTM D638-14 - Modified specimen length, test speed and grip separation

The Meridian passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device:

Biocompatibility - The biological compatibility of the Meridian PM was evaluated in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016. Under these, for the stated indications for use, each component of the device's biological compatibility was evaluated for in vitro cytotoxicity, skin sensitization, and chemical characterization.

Biocompatibility testing per ISO 10993-1: Passed
. Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
. Biocompatibility testing per ISO 10993-10 Tests for irritation and skin sensitization: Passed
Biocompatibility testing per ISO 10993-18 Chemical Characterization: Passed

Risk Analysis - Formal Risk Assessment of the Meridian PM was performed in accordance with ISO 14971. With respect to perceivable conditions in which the device would be subjected to a worst-case environmental or human error scenario, Center for Craniofacial and Dental Sleep Medicine believes the outcomes of these risks are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.

10. Performance Testing Summary

As part of demonstrating the substantial equivalence of Meridian PM to the predicate devices that are subject to this 510(k) submission, Center for Craniofacial and Dental Sleep Medicine completed a number of tests. The Meridian PM meets all the requirements for overall design, biocompatibility, and performance testing confirm that the output meets the design inputs and specifications. The Meridian PM passed all testing stated above as shown by the acceptable results obtained.

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The Meridian PM complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.

11. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the differences between the Meridian PM and the predicate device do not raise any different questions. The performance testing provided demonstrates that the subject device is substantially equivalent to the predicate devices. The Enter for Craniofacial and Dental Sleep Medicine Meridian PM, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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.”