The Apnea Sciences Corporation "ApneaRx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.

Device Description

The Apnea Sciences Corporation ApneaRx is an intraoral device used at night to reduce mild to moderate obstructive sleep apnea, and/or snoring by advancing the lower jaw (mandibular repositioning) and thereby minimizing air obstruction and turbulence. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ApneaRx device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain explicit performance-based acceptance criteria for the ApneaRx device related to its intended use (reduction of mild to moderate obstructive sleep apnea and/or snoring). Instead, the performance testing focuses on non-clinical evaluations for safety and material characteristics to demonstrate substantial equivalence to predicate devices.

Therefore, the table will reflect the non-clinical tests conducted.

Acceptance Criteria (Implicit from Non-Clinical Tests)	Reported Device Performance (Test Result/Conclusion)
Biocompatibility:
Non-cytotoxicity (ISO MEM Elution Assay)	Passed. Non-cytotoxic
Non-irritancy (ISO Intracutaneous Irritation Test)	Passed. Non-irritant
Non-sensitization (Guinea Pig Maximization)	Passed/Negative for evidence of sensitization
Material Characterization:
Material identity to predicate device	Concluded that materials are identical to listed predicate device.
Dimensional Conformance:	Test conducted to evaluate and characterize performance. (No specific numerical criteria or results provided in this summary).
Visual Inspections:	Test conducted to evaluate and characterize performance. (No specific numerical criteria or results provided in this summary).
Design Verification (Airway Passage Equivalency):	Test conducted to evaluate and characterize performance. (No specific numerical criteria or results provided in this summary).

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

The document states: "Clinical Data: This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."

Therefore, there is no test set of clinical data (patients, images, etc.) to evaluate device performance regarding its effectiveness in reducing sleep apnea or snoring. The tests performed are non-clinical (biocompatibility, material characterization, dimensional conformance, visual inspections, design verification). The sample sizes for these non-clinical tests are not specified in the summary but would typically involve laboratory samples of the device materials.

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

As no clinical data was used and the submission explicitly states no reliance on clinical data for substantial equivalence, no experts were used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set:

Since there was no clinical test set requiring expert evaluation of clinical outcomes, no adjudication method was used. The non-clinical tests have pass/fail criteria based on standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states it does not rely on clinical data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the ApneaRx is a physical oral appliance, not a software algorithm or AI-driven device. Its performance is inherent in its physical design and material properties, rather than an "algorithm-only" functionality.

7. The Type of Ground Truth Used:

The ground truth used for the non-clinical performance data can be described as:

Standard-based criteria for biocompatibility: The "ground truth" for these tests (cytotoxicity, irritation, sensitization) is defined by the passing criteria outlined in the respective ISO 10993 standards.
Reference material comparison: For material characterization, the ground truth is the chemical and physical properties of the materials used in the predicate device.
Engineering specifications/design parameters: For dimensional conformance, visual inspections, and design verification (airway passage equivalency), the ground truth would be the device's design specifications and established engineering parameters.

8. The Sample Size for the Training Set:

This question is not applicable. The ApneaRx is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no training set for a machine learning model.

Summary

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Premarket Notification "ApneaRx" Page 24 of 136

Section 6

510(k) Summary

6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Apnea Sciences CorporationApnea Sciences27071 Cabot Road Building #118Laguna Hills, California. 92653Phone - 949 226 4421Fax - 928 569 5974
CONTACT :	Gary Mocnik49 Coastal Oak, Aliso Viejo, CA 92656949.433.0413949.831.9944 faxgmocnik@cox.net
DATE PREPARED	November 30, 2011
TRADE NAME:	ApneaRx
COMMON NAME:	Oral Appliance for Mild to Moderate Sleep Apnea & Snoring
CLASSIFICATION NAME:	Oral Appliance, 21 CFR, 872.5570
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE	LRK
PREDICATE DEVICES:	Consumer Health Products "SnoreRx" (K112205), RespironicsCustom 1, (K033822) SnoreFree (K955336), OSAP, (K960673),SnoreMaster (PureSleep) (K954128).

Substantially Equivalent To:

The Apnea Sciences Corporation ApneaRx is substantially equivalent in intended use, principal of operation and technological characteristics to the Consumer Health Products "SnoreRx (K112205), Respironics "Custom 1" (K033822), SnoreFree (K955336), OSAP, (K960673), SnoreMaster (PureSleep) (K954128), as well as other predicate devices cleared with an LRK Product Code.

Description of the Device Subject to Premarket Notification:

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the patient's pharyngeal space, improving the ability to exchange air during sleep

Indication for Use:

The Apnea Sciences Corporation "ApneaRx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea, and/or snoring.

Discussion of Technical Characteristics:

The Apnea Sciences Corporation ApneaRx has similar physical and technical characteristics to the predicate devices. The Apnea Sciences Corporation ApneaRx and the identified predicates all provide means for advancing the lower jaw in a predetermined manner. The technical designs and manufacture of the ApneaRx and the predicate devices are very similar, being composed of custom fitted co polymer / trays which fit onto the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism.

Non-Clinical Performance Data:

Performance testing was conducted to evaluate and characterize the performance of the Apnea Sciences Corporation ApneaRx. Preclinical testing conducted included dimensional conformance evaluation, visual inspections, design verification to confirm airway passage equivelancy and biocompatibility testing based on the applicable elements of ISO 10993-1 shown below.

Test Performed	Standard	Test Result/Conclusion
ISO MEM Elution Assay with L-929Mouse Fibroblast Cells	ISO 10993-5	Passed.Non-cytotoxic
ISO Intracutaneous Irritation Test	ISO 10993-10	Passed.Non-irritant
Sensitization: Guinea Pig Maximization	ISO 10993-10	Passed/Negative for evidence ofsensitization

Additionally material characterization testing was performed and concluded that the materials used in the construction of the Consumer Health Products Apnea Rx are identical the listed predicate device.

Clinical Data

This submission does not rely on clinical data to determine substantial equivalency to the predicate devices.

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ﺩﺭ

Basis for Determination of Substantial Equivalence:

Conclusions Drawn:

Product	Intended Use	Principle ofOperation	OverallTechnologicalCharacteristics
Apnea SciencesCorporationApneaRx	The Apnea Sciences Corporation "ApneaRx" isintended for use on adult patients 18 years of age orolder as an aid for the reduction of mild to moderateobstructive sleep apnea, and/or snoring	Provides formandibularrepositioningto increasepharyngealspace	Custom fittedplastic intraoraldevice insertedover the upperand lower dentalarches.
ConsumerHealth ProductsSnoreRx NS 9.0(K112205)	The Consumer Health Products "SnoreRx NS 9.0"is intended for use on adult patients 18 years of ageor older as an aid for the reduction of snoring."	SAME	SAME
SnoreMasterPureSleep(9541285)	The anti-snoring device is intended to alleviate orcorrect snoring	SAME	SAME
Respironics"Custom 1",(K033822)	The Respironics Custom I Oral Appliance isintended for use by a dentist on adult patients as anaid for the reduction or elimination of snoring andobstructive sleep apnea.	SAME	SAME
SnoreFree(K955336)	Intended to treat mild to moderate obstructive sleepapnea (OSA) and snoring in adults 18 years of ageor older only.	SAME	SAME
OSAP,(K960673)	Intended to treat mild to moderate sleep apnea,OSA and snoring in adults 18 years of age or older.	SAME	SAME

As shown, the Apnea Sciences Corporation ApneaRx has the following similarities to the predicate devices:

Same intended use .
Same design characteristics .
. Same operating principal
Same mechanism of action .
Same technological characteristics .

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Apnea Sciences Corporation ApneaRx is determined by Apnea Sciences Corporation, to be substantially equivalent to existing legally marketed devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

Public Health Service

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

Apnea Science Corporation C/O Mr. Gary Mocnik Regulatory Consultants Gary Mocnik and Associates 49 Coastal Oak Aliso Viejo, California 92656

Re: K113569

Trade/Device Name: ApneaRx Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea

Regulatory Class: II Product Code: LRK Dated: November 30, 2011 Received: December 2, 2011

Dear Mr. Mocnik:

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 Eederal Register.

MAR - 1 2012

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Page 2 - Mr. Mocnik

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

$\ln$

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

Anthony D. Watson, B.S., M.S., M.B.A.

Enclosure

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Indications for Use Statement 5.

INDICATIONS FOR USE STATEMENT

KIJ3569 510(k) Number (if known):

Device Name: ApneaRx

Indications for Use:

The Apnea Sciences Corporation "ApneaRx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

Page of

Susan Luna

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K113569

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.”