The Somnera System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and during an incipient apnea. The system includes a dedicated flow generator and a patient interface; and is intended for use in the home environment. The system is to be used by adult patients weighing more than 66 lbs. (30 kg.).

Device Description

The Somnera System is a positive airway pressure system comprised of an airflow generator and a patient interface. The patient interface has a SmartValve™ seated in either a nasal mask or nasal pillow mask. A hose connects the valve to the generator. The mask is held in place with adjustable headgear straps. The patient interface is supplied non-sterile and intended for single patient reuse in the home environment. The Somnera System is a prescription device.

AI/ML Overview

The Somnera System is intended to treat Obstructive Sleep Apnea (OSA) by delivering therapeutic breathing pressure to a patient. The provided text details the performance data, including a clinical study, to support the substantial equivalence of the Somnera System to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds for clinical performance. Instead, it describes a "primary effectiveness endpoint" and the results of a non-inferiority study designed to demonstrate that the subject device (Somnera System) is not worse than the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Effectiveness (Non-inferiority to Predicate Device for AHI Reduction)	The difference in mean Apnea-Hypopnea Index (AHI) between the predicate and subject device was 1.7/h. A 95% confidence interval of (-0.2 - 3.6) was reported. The non-inferiority p-value was 0.002, which demonstrates that the subject device is non-inferior to the predicate device in the treatment of OSA. (The non-inferiority margin is not explicitly stated in the provided text, but the p-value indicates the criterion was met.)
Safety	The study reported 8 subjects with a total of 20 adverse events during one or both randomization nights. One adverse event was reported as related to the predicate device, one to the subject device, and the remaining device-related events were associated with the patient interface. All events resolved by the end of the sleep night. Adverse event types were similar on both sleep nights and included primarily skin and nose irritation and difficulty breathing.
Biocompatibility	Evaluation conducted in accordance with FDA Guidance ISO 10993-1 and ISO 18562-1. Tests included Cytotoxicity, Irritation, Sensitization, Volatile Organic Compound (VOC) Analysis of Gas Pathway, Emitted Particulate Gas Analysis, Ozone Gas Analysis, Carbon Monoxide (CO) and Carbon Dioxide (CO2) Gas Analysis, and Extractables. (Presumably met acceptance criteria since the device was cleared).
Electrical Safety and EMC	Testing conducted according to IEC 60601-1, IEC 60601-1-2, and IEC60601-1-11. (Presumably met acceptance criteria since the device was cleared).
Software Verification and Validation	Conducted and documented as recommended by FDA guidance for software in medical devices. Designated as "moderate" level of concern. (Presumably met acceptance criteria since the device was cleared).
Performance Testing (Non-clinical)	Included sound power level, CO2 rebreathing, component cycling, pressure regulation, waveform testing, maximal output temperature testing, and device integrity testing. (Presumably met acceptance criteria since the device was cleared).

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

Sample Size for Test Set (Clinical Study): The study enrolled 52 subjects. Of these, 42 were available for primary endpoint analysis.
Data Provenance: The study was a multi-center study conducted at six U.S. sites. It was a prospective, open-label, randomized crossover assignment study.

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

Number of Experts: Not explicitly stated how many individual experts; however, the sleep nights were scored by "an independent, central scorer." The text implies a single entity or group providing the central scoring, rather than a panel of multiple individual experts.
Qualifications of Experts: Not explicitly stated beyond "independent, central scorer blinded to the sequence assignment." Typical qualifications for such a role would be a Registered Polysomnographic Technologist (RPSGT) or a board-certified sleep physician, but this is not detailed in the provided text.

4. Adjudication Method for the Test Set

The ground truth for the AHI endpoint was established by an "independent, central scorer blinded to the sequence assignment." There is no mention of an adjudication method (e.g., 2+1, 3+1) involving multiple human readers for conflicting interpretations, as the scoring was performed by a single central entity.

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

No, an MRMC comparative effectiveness study was not done. This study was a clinical trial comparing the performance of two different Positive Airway Pressure (PAP) devices (Somnera System vs. Predicate Device) on human subjects to treat OSA, specifically measuring AHI. It was not an AI-assisted diagnostic device study involving human readers and a comparison of their performance with and without AI assistance. The Somnera System is a PAP delivery system, not an AI diagnostic algorithm.

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

N/A. The Somnera System is a medical device, a positive airway pressure delivery system, and not a standalone AI algorithm for diagnosis or interpretation. The clinical study assessed the device's therapeutic effect (reduction in AHI) in patients.

7. The Type of Ground Truth Used

The primary ground truth for the effectiveness endpoint was the Apnea-Hypopnea Index (AHI) measurements derived from in-lab sleep studies, which were scored by an independent, central scorer. This can be categorized as expert consensus/measurement-based ground truth (as opposed to pathology or long-term outcomes data, though AHI is an objective measure of a physiological outcome). Safety ground truth was based on reported adverse events.

8. The Sample Size for the Training Set

Not applicable for this document. The document describes a clinical study to evaluate the performance of a medical device (Somnera System) for treatment. It does not describe the development or training of an AI algorithm, so there is no "training set" in that context. The device's internal algorithms (e.g., for auto-adjusting pressure) would have been developed and validated internally, but the document does not provide details on data used for that process.

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

Not applicable. As explained in point 8, this document does not describe the training of an AI algorithm or the establishment of ground truth for such a training set.

Summary

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June 29, 2020

Somnera Inc. Mary Lou Mooney Vice President of RA/OA/CA 1291 Puerta Del Sol Suite #200 San Clemente, California 92673

Re: K200698

Trade/Device Name: Somnera™ System Regulation Number: 21 CFR 868.5273 Regulation Name: Positive Airway Pressure Delivery System Regulatory Class: Class II Product Code: QBY Dated: Mav 26, 2020 Received: May 28, 2020

Dear Mary Mooney:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Somnera System

Indications for Use (Describe)

The Somnera System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and during an incipient apnea. The system includes a dedicated flow generator and a patient interded for use in the home environment. The system is to be used by adult patients weighing more than 66 lbs. (30 kg.).

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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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6. 510(k) Summary

510(k) Summary (as required by 21 CFR 807.92)

I. SUBMITTER

Somnera Inc. 1291 Puerta Del Sol, Suite 200 San Clemente, CA 92673 Phone: 949-542-3535 Fax: 949-542-8312

Contact Person:	Mary Lou Mooney, Vice President of RA/QA/CA
Date Prepared:	March 16, 2020

II. DEVICE

Name of Device:	Somnera™ System
Common or Usual Name:	Positive Airway Pressure System
Classification Name:	Positive Airway Pressure System (21 CFR 868.5273)
Regulatory Class:	II
Product Code:	QBY

III. PREDICATE DEVICE

Predicate Device:	FRESCA Medical CURVET™ Positive Airway PressureSystem (DEN170089)
Reference Device:	Respironics, Inc. Dream Station Go Auto CPAP (K131982)

IV. DEVICE DESCRIPTION

The Somnera System is a prescription device.

V. INDICATIONS FOR USE

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The Indications for Use for the Somnera System is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Use of positive airway pressure (PAP) to deliver therapeutic breathing pressure to the patient is the technological principle for both the subject and predicate devices. Both devices incorporate a valve (SmartValve™) that is seated in the patient mask. The valve controls airflow to provide PAP during inspiration and expiration, by utilizing the patient's own breathing effort along with airflow from the generator.

The subject and predicate device are based on the following same technological elements:

□ Use of a dedicated flow generator and patient interface
ロ Use of airflow controlled by a SmartValve™
□ Use of the same range of therapeutic pressure settings

The following technological differences exist between the subject device and the predicate device:

ロ Use of event detection for input to an auto-adjusting pressure algorithm
ロ Use (optional) of an auto-adjusting pressure mode ("APAP")

ロ Use (optional) of several patient comfort settings to ramp pressure at the start of therapy and/or reduce pressure during exhalation

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Characteristic	SubjectDeviceSomneraSystem	PredicateDeviceCurve PositiveAirwayPressureSystem(DEN170089)	ReferenceDeviceDreamStation GoAuto CPAP(K131982)	Comparison
PatientPopulation	Adultpatientsweighingmore than 66lbs (30 kg).	Adult patientsweighing morethan 66 lbs (30kg).	Patientsweighingmore than 66lbs (30 kg).	Identical topredicatedevice.
Intended UseEnvironment	Home use.	Home use.	Home orhospital use.	Identical topredicatedevice.
Systemcomponents	-Blower.-Mask, hose,valve,headgear.	-Blower.-Mask, hose,valve, headgear.	-Blower andhose(Mask andheadgear soldseparately.)	Blower.technology isidentical topredicatedevice.Nasal pillowmask, hosevalve andheadgear designare identical topredicatedevice.
Accessoryhumidifier	No	No	No	Identical topredicatedevice.
Characteristic	SubjectDeviceSomneraSystem	PredicateDeviceCurve PositiveAirwayPressureSystem(DEN170089)	ReferenceDeviceDreamStation GoAuto CPAP(K131982)	Comparison
Therapy Mode	PAPAPAP	PAP	CPAPAPAP	PAP mode isidentical topredicatedevice.APAP mode isa similar featureto the referencedevice.
TherapeuticPressure range	4-20 cmH2O(physicianselectableonly).	4-20 cmH2O(physicianselectable only).	4-20 cmH2O(physicianselectableonly).	Identical topredicatedevice.
PatientComfortFeatures:Go To Sleep	User-selectable as"Off" up to 45minutes.	NA	NA	Similar comfortfeature to rampin predicatedevice.
Pressure RampDuration	User-selectable as"Off" up to 45minutes.	User-selectableas “Off” up 45minutes.	User-selectable as"Off" up to 45minutes.	Identical topredicate device.
Characteristic	Subject Device	Predicate Device	Reference Device	Comparison
	Somnera System	Curve PositiveAirwayPressureSystem(DEN170089)	DreamStation GoAuto CPAP(K131982)
ExpiratoryPressureComfortSetting	Selectable asOff, 1, 2 or 3.	NA	Selectable asOff, 1, 2 or 3.	Similar feature toreference device.
Data Storage	Micro SDCard.	Standard-sizedSD Card.	Micro SDCard.	SD card isidentical featureto predicatedevice.
Graphical UserInterface	Touchscreendisplay.	LCD display.	Touchscreendisplay.	Touchscreendisplay similarfeature toreferencedevice.
Power Supply	Poweradaptor.	Power adaptor.	Power cordor batterypack.	Identical topredicatedevice.
Patient contactmaterials	Comply withISO 10993-1.	Comply withISO 10993-1.	Comply withISO 10993-1.	Testing and riskassessmentconfirm thebiocompatibilityof the newsystem.Changes do notimpact safety oreffectiveness.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation of the subject device was conducted in accordance with FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Tests were selected based on ISO 10993-1, ISO 18562 – 1 and use of well-characterized patient contact materials known to be widely used in medical devices. The skin contact components are categorized as skin surface devices with permanent (> 30 days) duration. The gas pathway components are categorized as external communicating devices, tissue/bone/dentin with permanent (> 30 days) duration. The battery of testing included the following tests:

Cytotoxicity
. Irritation
Sensitization ●
Volatile Organic Compound (VOC) Analysis of Gas Pathway
. Emitted Particulate Gas Analysis
Ozone Gas Analysis
Carbon Monoxide (CO) and Carbon Dioxide CO2) Gas Analysis ●
. Extractables

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the flow generator and power adaptor in accordance with the following standards:

IEC 60601-1:2005 + A1:2012 +C1:2009 +A2:2010/(R)2012: Medical electrical equipment - Partl : General requirements for safety of Medical electrical equipment -General requirements for basic safety and essential performance

IEC 60601-1-2:2014 and EN 60601-2:2015: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC60601-1-11:2015: Medical electrical equipment – Part1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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Software Verification and Validation Testing

Software verification and validation testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device was designated as a "moderate" level of concern, since a failure or latent flaw in the software could result in minor harm to the patient.

Performance Testing

Testing included sound power level, CO2 rebreathing, component cycling, pressure regulation, waveform testing, maximal output temperature testing and device integrity testing.

Clinical Testing

The clinical study was a non-inferiority, prospective, open-label, randomized crossover assignment, multi-center study at six U.S. sites. The study enrolled 52 subjects, of which 42 were available for primary endpoint analysis. Subjects completed two in-lab sleep nights, in a randomized sequence, with the predicate device programmed to PAP mode and the subject device programmed to APAP mode and an Exhale Pressure Comfort setting of 3. The in-lab sleep nights were scored by an independent, central scorer blinded to the sequence assignment.

Primary effectiveness endpoint:

The difference in mean Apnea-Hypopnea Index (AHI) between the predicate and subject device were tested after treatment intervention.

Primary safety endpoint:

Device and procedure-related adverse events were summarized after treatment intervention.

Effectiveness

The difference in mean AHI between treatment groups in this cross-over design was 1.7/h., with a 95% confidence interval of (-0.2-3.6) and non-inferiority p = 0.002. This demonstrates that the subject device is non-inferior to the predicate device in the treatment of OSA

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Safety

The study reported 8 subjects with a total of 20 adverse events occurring during one or both randomization nights. One adverse event was reported as related to the predicate device, one adverse event was reported as related to the subject device and the remaining device-related events were associated with the patient interface. All events resolved by the end of the sleep night. Adverse event types were similar on both sleep nights and included primarily skin and nose irritation and difficulty breathing.

Summary

Based on the results from this clinical study, the subject device was found to have a safety and effectiveness profile that is equivalent to the predicate device.

VIII. CONCLUSIONS

Based on the results of non-clinical and clinical studies, the subject device is shown to be substantially equivalent to the predicate device (DEN170089).

Regulation Number and Section

§ 868.5273 Positive airway pressure delivery system.

(a)
Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes.
(ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device.
(iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use.
(iv) Carbon dioxide rebreathing testing must be performed.
(v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed.
(vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures.
(vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed.
(viii) Maximum output temperature testing of delivered gas, if humidified, must be performed.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Therapy pressure range;
(ii) Use life and replacement schedule for all components;
(iii) Cleaning instructions; and
(iv) Instructions for assembly and connection of device components.