Somnera System

K200698 · Fresca Medical, Inc. · QBY · Jun 29, 2020 · Anesthesiology

Device Facts

• Record ID: K200698
• Device Name: Somnera System
• Applicant: Fresca Medical, Inc.
• Product Code: QBY · Anesthesiology
• Decision Date: Jun 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5273
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

The Somnera System is a home-use positive airway pressure (PAP) device for treating Obstructive Sleep Apnea. It consists of a flow generator, hose, and a patient interface (nasal or nasal pillow mask) containing a SmartValve™. The system utilizes the patient's own breathing effort combined with generator airflow to deliver therapeutic pressure during inspiration and expiration. It features an optional auto-adjusting pressure (APAP) mode, pressure ramp, and expiratory pressure comfort settings. The device is operated by the patient in a home environment. Data is stored on a micro SD card and viewed via a touchscreen display. The system provides therapeutic pressure to maintain airway patency, potentially improving patient sleep quality and reducing apnea events.

Clinical Evidence

A prospective, open-label, randomized crossover non-inferiority study was conducted at six U.S. sites with 52 enrolled subjects (42 analyzed). Subjects used the predicate device (PAP mode) and subject device (APAP mode) during in-lab sleep nights. The primary endpoint was the difference in mean Apnea-Hypopnea Index (AHI). Results showed a mean AHI difference of 1.7/h (95% CI: -0.2-3.6), with non-inferiority p=0.002. Safety data showed 20 adverse events across 8 subjects, primarily skin/nose irritation, with no significant safety concerns compared to the predicate.

Technological Characteristics

System includes flow generator, hose, and mask with SmartValve. Materials comply with ISO 10993-1. Pressure range: 4-20 cmH2O. Connectivity: Micro SD card for data storage. User interface: Touchscreen. Power: External adaptor. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 18562-1.

Indications for Use

Indicated for adult patients weighing >66 lbs (30 kg) with Obstructive Sleep Apnea requiring positive airway pressure therapy.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the positive airway pressure delivery system is subject to the following special controls:

*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.

Predicate Devices

• FRESCA Medical CURVET™ Positive Airway Pressure System (DEN170089)

Reference Devices

• Respironics, Inc. Dream Station Go Auto CPAP (K131982)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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: [phone] Fax: [phone]

| 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 Pressure<br>System (DEN170089) |
|-------------------|-----------------------------------------------------------------------|
| Reference Device: | Respironics, Inc. Dream Station Go Auto CPAP (K131982) |

# IV. 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.

- V. INDICATIONS FOR USE

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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.).

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 | Subject<br>Device<br>Somnera<br>System | Predicate<br>Device<br>Curve Positive<br>Airway<br>Pressure<br>System<br>(DEN170089) | Reference<br>Device<br>Dream<br>Station Go<br>Auto CPAP<br>(K131982) | Comparison |
|------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient<br>Population | Adult<br>patients<br>weighing<br>more than 66<br>lbs (30 kg). | Adult patients<br>weighing more<br>than 66 lbs (30<br>kg). | Patients<br>weighing<br>more than 66<br>lbs (30 kg). | Identical to<br>predicate<br>device. |
| Intended Use<br>Environment | Home use. | Home use. | Home or<br>hospital use. | Identical to<br>predicate<br>device. |
| System<br>components | -Blower.<br>-Mask, hose,<br>valve,<br>headgear. | -Blower.<br>-Mask, hose,<br>valve, headgear. | -Blower and<br>hose<br>(Mask and<br>headgear sold<br>separately.) | Blower.<br>technology is<br>identical to<br>predicate<br>device.<br>Nasal pillow<br>mask, hose<br>valve and<br>headgear design<br>are identical to<br>predicate<br>device. |
| Accessory<br>humidifier | No | No | No | Identical to<br>predicate<br>device. |
| Characteristic | Subject<br>Device<br>Somnera<br>System | Predicate<br>Device<br>Curve Positive<br>Airway<br>Pressure<br>System<br>(DEN170089) | Reference<br>Device<br>Dream<br>Station Go<br>Auto CPAP<br>(K131982) | Comparison |
| Therapy Mode | PAP<br>APAP | PAP | CPAP<br>APAP | PAP mode is<br>identical to<br>predicate<br>device.<br>APAP mode is<br>a similar feature<br>to the reference<br>device. |
| Therapeutic<br>Pressure range | 4-20 cmH2O<br>(physician<br>selectable<br>only). | 4-20 cmH2O<br>(physician<br>selectable only). | 4-20 cmH2O<br>(physician<br>selectable<br>only). | Identical to<br>predicate<br>device. |
| Patient<br>Comfort<br>Features:<br>Go To Sleep | User-<br>selectable as<br>"Off" up to 45<br>minutes. | NA | NA | Similar comfort<br>feature to ramp<br>in predicate<br>device. |
| Pressure Ramp<br>Duration | User-<br>selectable as<br>"Off" up to 45<br>minutes. | User-selectable<br>as “Off” up 45<br>minutes. | User-<br>selectable as<br>"Off" up to 45<br>minutes. | Identical to<br>predicate device. |
| Characteristic | Subject Device | Predicate Device | Reference Device | Comparison |
| | Somnera System | Curve Positive<br>Airway<br>Pressure<br>System<br>(DEN170089) | Dream<br>Station Go<br>Auto CPAP<br>(K131982) | |
| Expiratory<br>Pressure<br>Comfort<br>Setting | Selectable as<br>Off, 1, 2 or 3. | NA | Selectable as<br>Off, 1, 2 or 3. | Similar feature to<br>reference device. |
| Data Storage | Micro SD<br>Card. | Standard-sized<br>SD Card. | Micro SD<br>Card. | SD card is<br>identical feature<br>to predicate<br>device. |
| Graphical User<br>Interface | Touchscreen<br>display. | LCD display. | Touchscreen<br>display. | Touchscreen<br>display similar<br>feature to<br>reference<br>device. |
| Power Supply | Power<br>adaptor. | Power adaptor. | Power cord<br>or battery<br>pack. | Identical to<br>predicate<br>device. |
| Patient contact<br>materials | Comply with<br>ISO 10993-1. | Comply with<br>ISO 10993-1. | Comply with<br>ISO 10993-1. | Testing and risk<br>assessment<br>confirm the<br>biocompatibility<br>of the new<br>system.<br>Changes do not<br>impact safety or<br>effectiveness. |

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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).