The PureSleep® device for Over-the-Counter (OTC) use is an intraoral mandibular repositioning device that increases the pharyngeal space to improve the user's ability to exchange air and to decrease air turbulence, a causative factor in snoring. The device consists of two dental trays designed to conform to the shape of the upper and lower jaws.

AI/ML Overview

The provided text details a 510(k) summary for the PureSleep® (OTC use) device and its FDA clearance. However, it does not contain the specific acceptance criteria, detailed study design, or performance metrics that would typically be found in a comprehensive study report.

The submission focuses on demonstrating substantial equivalence to a predicate device (PureSleep® Rx) and a reference device (SnoreRx®) primarily based on technological characteristics and intended use. The supporting evidence mentioned is limited to non-clinical testing.

Here's an analysis of the requested information based only on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study Details (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria or quantitative device performance metrics are provided in the text. The submission focuses on demonstrating equivalence rather than meeting predefined performance thresholds.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
(No quantitative performance criteria or results are detailed in the provided text.)	(No quantitative performance results are detailed in the provided text.)

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

Test Set Sample Size: Not specified.
Data Provenance: The text mentions "real-world data gleaned from actual use of the PureSleep® Rx predicate device" and a "Human Factors and Usability Engineering (HFE/UE) study."
- The origin of the "real-world data" (e.g., country, retrospective/prospective) is not specified.
- The HFE/UE study's detailed provenance is not specified beyond its purpose for OTC environment use.

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

Not specified. The text does not describe a process for establishing ground truth for a test set in the context of clinical performance. The HFE/UE study would likely involve participants, but they are users, not typically "experts" establishing ground truth for clinical endpoints.

4. Adjudication Method for the Test Set

Not specified. No clinical trial or test set with explicit adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done. This device is an anti-snoring device, not an AI-powered diagnostic imaging tool that would typically involve human readers or AI assistance in interpretation. The provided text does not mention any AI component or human-in-the-loop interaction in its functionality.

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

No standalone algorithm performance study was done (or none is mentioned). This is not an algorithmic device. Its performance is related to its mechanical function as a mandibular repositioning device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically defined for diagnostic or AI performance studies (e.g., pathology, outcomes data) is not applicable or addressed for this device in the provided text. The "real-world data" mentioned would likely pertain to user experience, effectiveness in reducing snoring, or safety outcomes, but the specific "ground truth" methodology is not detailed.

8. The Sample Size for the Training Set

Not applicable. This device is a physical intraoral device, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this is not an algorithmic device requiring a training set or associated ground truth.

Summary of Device Acceptance and Evidence:

The provided 510(k) summary indicates that the PureSleep® (OTC use) device was accepted by the FDA based on the following:

Substantial Equivalence: The primary argument for acceptance is the device's substantial equivalence to the predicate device (PureSleep® Rx, K113022) and a reference device (SnoreRx®, K170825). The devices are "identical in all their technological characteristics (design, materials, functionality, principles of operations, etc.)."
Non-Clinical Testing:
- Biocompatibility: Materials meet ISO 10993-1 requirements for surface devices contacting mucosal membranes for prolonged durations.
- Human Factors and Usability Engineering (HFE/UE) Study: Performed to support safe and effective use in an OTC environment without professional assistance. This study likely assessed ease of use, understanding of instructions, and ability for users to properly fit and use the device. The text does not provide specific outcomes or criteria for this study.
- Risk Analysis: Conducted per ISO 14971:2007, addressing issues from FDA guidance. Risks were mitigated through design, verification/validation, or labeling.
Clinical Performance Testing: The text states "Real-world data is included in support of this submission." This data was "gleaned from actual use of the PureSleep® Rx predicate device." No specific study design, sample size, or quantitative results from this real-world data are presented in the summary. The purpose of this data was to support the clinical safety of the device for OTC use.

In conclusion, the document's focus is on demonstrating similar characteristics and safety to previously cleared devices, rather than presenting a detailed clinical study with specific acceptance criteria related to a novel performance claim. The "study that proves the device meets the acceptance criteria" largely refers to the demonstration of substantial equivalence through non-clinical testing and leveraging existing real-world data from the predicate device, rather than a new, independent clinical trial with predefined performance endpoints for the OTC version.

Summary

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510(k) Summary

Submitted by:

Owner's Name:	Sleep Science Partners, Inc.
Address:	900 Larkspur Landing Circle, Suite 207 Larkspur CA 94939 USA
Contact:	Noel P. Lindsay
Title:	Chairman & CEO
Tel:	+1 (415) 484-1452
Fax:	+1 (415) 925-1575
Email:	noel@sspi.com

Contact Person:

Name:	Valerie Followell
Title:	Senior RA & QA Consultant at Lean RAQA, LLC
Tel:	+1 (847) 400-6187
Email:	followell@leanraqa.com

Date Prepared:	January 10, 2019
Trade Name:	PureSleep®
Common Name:	Antisnoring device
Classification Name:	Intraoral devices for snoring and obstructive sleep apnea
Classification:	Class II
Product Code:	LRK
Regulation Number:	872.5570
Predicate Device:	PureSleep® (Rx use), Sleep Science Partners, Inc. (K113022)
Reference Device:	SnoreRx®, Apnea Sciences, Inc. (K170825)

DEVICE DESCRIPTION:

INTENDED USE:

PureSleep® (OTC) is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep

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COMPARISSION OF TECHNOLOGICAL CHARACTERISTICS:

The proposed OTC device and the PureSleep® (Rx) predicate device are identical in all their technological characteristics (design, materials, functionality, principles of operations, etc.). Both the PureSleep® for OTC use and its predicate device consist of intraoral mouth pieces that are molded to the user's teeth using a standard 'boil and bite' method and allows slight adjustment of the jaw to the user's comfort. The PureSleep® for OTC use is provided non-sterile and uses the same packaging system as the Rx predicate device, except for adapted product documentation (Instructions for Use and package labeling) for the retail consumers. The table below compares the indications for use and technological aspects of the proposed device against the predicate as well as a reference device that FDA had cleared that has a similar technology with OTC indications.

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		Proposed device	Predicate device	Reference device
Device Proprietary Name		PureSleep®	PureSleep®	SnoreRx®
Manufacturer		Sleep Science Partners, Inc.	Same	Apnea Sciences, Inc.
510(k)		K190058	K113022	K170825
Classification	RegulationProductCode	LABELING21 CFR 872.5570
	LRK	Same	Same
	Class.Name	Intraoral Device for Snoring andObstructive Sleep Apnea	Same	Same
		An intraoral mandibular repositioningdevice used on adults as an aid during	An intraoral mandibular repositioningdevice used during sleep to reduce	Intended for use on adultpatients 18 years of ageor older as an aid for the
Intended use		sleep to reduce snoring.	snoring and treat mild to moderateobstructive sleep apnea in adults.	reduction of snoring.
Indication foruse	Rx or OTCPatientpopulation	OTCAdults	RxSame	OTCSame
Labeling		Language, visuals and structure havebeen adapted for OTC use based on	Instructions divided into 1)instructions for use for the dentist to
		FDA guidance documents, HFE/UEstudy and RWD gained with K113022.	prepare and fit the device and 2)patient information on use and care.	Similar contraindicationsand warnings
		TECHNOLOGY

Mode of action		Mandibular repositioning device(MRD) that advances the lower jaw toincrease pharyngeal space andalleviate snoring	Same	Same
Environment		During sleep, at home	Same	Same
Placement of device		In the mouth, on the lower and upperjaws	Same	Same
Preparation / Set-up		Connect upper and lower parts perbite type.	Same	Squeeze mouthpiece in a'C' position and adjust.
Molding / Fitment		Custom impression to eachindividual's mouth using a "boil andbite" approach and thermal setting(heat sensitive) resins. Molded to theentire upper and lower arch of teeth.	Same	Same
Design		Consists of an upper and lower tray.Outer shell provides with structuralsupport and inner shell is lined withsofter material that is heat sensitiveand thus allows for custom fitting.	Same	Same
Adjustments		• Adjustable jaw advancementposition.• Adjustably positions the mandibleforward in three positions, 4mmapart anteriorly, while maintaining a9mm inferior placement for usercomfort	Same	Similar• Adjustable jaw advancementposition.• Ability to reset the adjustment.• The upper and lower trays areadjustable in 1mm incrementsup to 6mm.
Single Use / Reusable		Single user, multi-use	Same	Same
Cleaning instructions		Clean/rinse daily with toothbrush andtoothpaste or with effervescent oraldevice cleaning tablets. Deep cleanonce per week.	Same but recommended frequency isless prescriptive (i.e. periodiccleaning)	Clean/rinse daily. Deepclean every two weeks.
Sterile		No	Same	Same
Materials		Polypropylene homopolymer andethylene vinyl acetate copolymer	Same	The specific materials areunknown.
Biocompatibility		Meets ISO 10993-1 for a surfacedevice contacting mucosal membranefor a prolonged contact duration (>24h to 30 days): cytotoxicity,sensitization and irritation	Same	Same

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NON-CLINICAL TESTING

The materials and methods of manufacture of the product are biocompatible and meet the applicable requirements of ISO 10993.

A Human Factors and Usability Engineering (HFE/UE) study was performed for the use of PureSleep® in the OTC environment that support the safe and effective use of the product without assistance from a dental professional.

Documentation provided by Sleep Science Partners, Inc. presents real-world data gleaned from actual use of the PureSleep® Rx predicate device, along with the HFE/UE study which support the conclusion that the proposed device is clinically safe for OTC use.

Finally, Sleep Science Partners, Inc. conducted a risk analysis on the proposed device in accordance with ISO 14971:2007 and by considering the issues raised in the FDA quidance document "Class // Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea" (November 12, 2002). All identified risks have been addressed through device design, verification/validation or through documentation (labeling and Instructions for Use) provided to the consumer.

CLINICAL PERFORMANCE TESTING

Real-world data is included in support of this submission.

CONCLUSION

Based upon the similarities in technology and in intended use, as well as indications for use similar to the reference predicate, together with performance testing, we believe that PureSleep® for OTC use is substantially equivalent to the predicate devices.

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April11, 2019

Sleep Science Partners, Inc % Valerie Followell Senior RA & QA Consultant Lean RAQA, LLC 12602 North Summerwind Drive Marana, Arizona 85658

Re: K190058

Trade/Device Name: PureSleep (OTC use) 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: January 10, 2019 Received: January 11, 2019

Dear Valerie Followell:

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 and Part 809; 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Tina Kiang, Ph.D. for 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) K190058

Device Name PureSleep® (OTC use)

Indications for Use (Describe)

PureSleep® (OTC) is indicated for use for adults 18 years and in the reduction of snoring during hours of sleep

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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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.”