The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SnoreRx device, which is an intraoral device for the reduction of snoring. The document primarily focuses on establishing substantial equivalence to a predicate device (SnoreRx NS 9.0) rather than presenting a detailed clinical study with pre-defined acceptance criteria and reported device performance against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The document emphasizes nonclinical testing for biocompatibility and physical properties to demonstrate that minor material differences do not raise new safety or effectiveness concerns.

Here's a breakdown of the information that can be extracted or explicitly stated as not available based on the provided text:

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

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device based on technological aspects and nonclinical testing, not on clinical performance against specific acceptance criteria.

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

This information is not provided. The document describes nonclinical testing of materials, but not patient-based testing with a "test set" in the context of clinical performance.

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)

This information is not applicable/not provided. There is no mention of a "test set" requiring expert ground truth in the context of clinical performance. The evaluation is based on nonclinical material properties and a comparison to a predicate device.

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

This information is not applicable/not provided. There is no mention of a "test set" requiring an adjudication method.

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

This information is not applicable and not provided. The device is an anti-snoring intraoral device, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable and not provided. The device is an anti-snoring intraoral device, not an algorithm.

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

This information is not applicable/not provided in the context of clinical performance or a test set. The "ground truth" implicitly used for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device and the nonclinical testing of the new device's materials and design.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as the device is not algorithm-based.

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

This information is not applicable/not provided.

Summary of available information regarding compliance/testing:

The document focuses on nonclinical testing to support substantial equivalence.

Nonclinical Testing Performed:
- Biocompatibility Testing: The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993 and were determined to be biocompatible.
- Physical Properties Testing:
  - Tray material: Tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62).
  - Liner material: Tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183).
- Results: "All materials met device specifications." (Specific specifications are not detailed in this summary).

The core argument for acceptance is that the device is "substantially equivalent" to the predicate device (SnoreRx NS 9.0) because:

They are "nearly identical in design and functionality."
They both are mandibular repositioning devices, use a "boil and bite" method for molding, and allow jaw adjustment.
Minor differences in material (polycarbonate resin with higher tensile strength, copolymer with slightly different durometer) and manufacturing (streamlined process, larger frontal airway opening) "do not raise any new questions of safety or effectiveness."

In essence, the "acceptance criteria" here are met by demonstrating that the new device's materials are biocompatible and meet physical property specifications, and that the overall design and intended use are sufficiently similar to a legally marketed predicate device such that no new safety or effectiveness concerns are raised. No specific clinical performance metrics (e.g., reduction in AHI, reduction in snoring incidence by a certain percentage) are presented for the new device.

Summary

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

August 9, 2016

Apnea Sciences Corporation c/o James Smith, Ph.D. 29442 Pointe Royale Laguna Niguel. California 92677

Re: K153200

Trade/Device Name: SnoreRx® 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: July 27, 2016 Received: July 28, 2016

Dear Dr. James Smith:

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 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

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forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. 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 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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) K153200

Device Name SnoreRx

Indications for Use (Describe)

The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

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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Image /page/3/Picture/0 description: The image is a logo for Apnea Sciences. The logo is a blue rectangle with the words "APNEA" and "SCIENCES" in white letters. There is a white crescent moon shape between the two words. Below the rectangle, the words "SLEEP BETTER... LIVE BETTER" are written in a smaller font.

510(k) SUMMARY

Submitted by:
Owner's Name:	Apnea Sciences Corporation
Address:	27121 Aliso Creek Road, Ste. 140
	Aliso Viejo, CA 92656
Contact:	James Fallon, President/CEO
Telephone:	(949) 680-2770
Fax:	(928) 569-5974
E-mail:	jfallon@apneasciences.com
Contact Person:
Name	James Smith, Ph.D.
Address	29442 Pointe Royale
	Laguna Niguel, CA 92677
Telephone	949-340-7261
Fax:	949-340-7141
E-mail:	jrsmith00@cox.net

Date Prepared:	October 30, 2015
Trade Name:	SnoreRx
Common Name:	Mandibular repositioning device
Classification Name:	Anti-Snoring Device
Device Class:	Class II
Product Code:	LRK
Regulation No.	21 CFR 872.5570

Predicate Device:	SnoreRx NS 9.0 (Consumer Health Products, Inc.)
Predicate 510(k) #:	K112205
Device Description:	The SnoreRx is an intraoral device that repositions the jawanteriorly in order to increase the patient's pharyngeal space,which improves the ability to exchange air and decreases airturbulence, a causative factor in snoring. The device consistsof two custom fabricated trays that fit separately over theupper and lower dental arches and engage each other in theanterior area of the mouth.

Intended Use:	The SnoreRx is intended for use on adult patients 18 years ofage or older as an aid for the reduction of snoring.

Technology Comparison:The devices are nearly identical in design and functionality.
	Both the SnoreRx and its predicate consist of intraoral mouthpieces that are molded to the patient's teeth using a 'boil and

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Image /page/4/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" in white letters on a blue background. There is a white crescent moon shape between the two words. Below the logo is the tagline "SLEEP BETTER... LIVE BETTER" in a smaller font.

bite' method, and allows adjustment of the anterior positioning of the jaw to the patient's comfort. The SnoreRx is provided non-sterile and uses the same packaging system as the predicate device. The table below compares the technological aspects of the new and predicate devices.

Subject Area	New Device	Predicate	Differences
Product Code	- LRK	- LRK
ProductClassification	- Class II	- Class II
ClassificationName	- Anti-Snoring Device	- Anti-Snoring Device
ProprietaryName	SnoreRx	SnoreRx NS 9.0
Technological	Mandibularrepositioning devicethat advances thelower jaw to increasepharyngeal space.	Mandibularrepositioning devicethat advances thelower jaw to increasepharyngeal space.
Intended Use	Minimize airturbulence that causessnoring. Device isintended forprescription use.	Minimize airturbulence that causessnoring. Device isintended forprescription use.
Materials	- Polycarbonate resin- Ethylene vinyl acetatecopolymer	- Polycarbonate resin- Ethylene vinyl acetatecopolymer	The new device utilizesa polycarbonate resinwith a higher tensilestrength, and acopolymer with aslightly differentdurometer.
DesirableCharacteristics	- Home use, heatsensitive / moldable,adjustable jawadvancement position	- Home use, heatsensitive / moldable,adjustable jawadvancement position
Specifications:- Physical:- Mechanical:- Single use:	- Custom-fittedintraoral device- Repositions mandibleanteriorly up to 6 mm- Reusable	- Custom-fittedintraoral device- Repositions mandibleanteriorly up to 6 mm- Reusable	The new device utilizesa streamlinedmanufacturing processand has a frontal airwayopening that is largerthan the predicatedevice.
Sterility	Non-sterile	Non-sterile

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Image /page/5/Picture/0 description: The image is a logo for Apnea Sciences. The logo consists of the word "APNEA" on the left, a crescent moon shape in the middle, and the word "SCIENCES" on the right. The words and the crescent moon are all in blue and are contained within a blue rectangle with rounded edges. Below the rectangle, in a smaller font, are the words "SLEEP BETTER... LIVE BETTER".

Nonclinical Testing: The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization and were determined to be biocompatible in accordance with ISO 10993. Biocompatibility test reports have been submitted as part of this filing.

Device materials were tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). The liner material was tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183). All materials met device specifications.

Conclusion of Comparison: SnoreRx and its predicate are technologically identical. The minor differences in design and materials do not raise any new questions of safety or effectiveness. Therefore, the new device (SnoreRx) is determined to be substantially equivalent 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.”