TRANSCEND AUTO

K132127 · Somnetics International, Inc. · BZD · Oct 17, 2013 · Anesthesiology

Device Facts

• Record ID: K132127
• Device Name: TRANSCEND AUTO
• Applicant: Somnetics International, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

Device Story

Transcend Auto is a microprocessor-controlled, blower-based non-continuous ventilator. It uses a differential pressure sensor and internal pneumotach to monitor patient breathing and airflow. The device delivers positive airway pressure (4-20 cmH2O) to a patient's oral/nasal airway via a mask. It features auto-adjusting pressure and expiratory pressure relief to support OSA treatment. Used in home or hospital settings, the device is operated by the patient or clinician. Data is stored and can be downloaded via PC connection for clinical review. The system adjusts pressure based on real-time flow and pressure sensing to maintain airway patency, potentially improving patient sleep quality and reducing OSA symptoms.

Clinical Evidence

A 2x2 crossover clinical evaluation of 41 adult OSA patients assessed non-inferiority of Transcend Auto vs. REMstar Auto. Primary endpoint: AHI during treatment. Results showed non-inferiority (p<0.0001). One minor adverse event (headache) reported, possibly related to device. No unanticipated adverse effects. Bench testing included electrical safety, EMC, biocompatibility, and performance testing (pressure regulation, flow, altitude, battery life).

Technological Characteristics

Microprocessor-controlled blower system. Pressure range: 4-20 cmH2O. Sensing: differential pressure sensor with internal pneumotach. Connectivity: PC data download. Power: 100-240 VAC. Class II, Type BF equipment. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ISO 10993-1, ISO 14971, and BS EN 17510-1.

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 lbs (30 kg). Intended for home and hospital/institutional use.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Somnetics International, Inc., Model 300157 CPAP System (K100121)
• Respironics REMstar Auto CPAP with C-Flex (K041010)

Submission Summary (Full Text)

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#### 5 510(k) Summary

OCT 1 7 2013

[As required by 21 CFR 807.92]

510(k) Number: K132127

Date Prepared: October 17, 2013

| Submitter/Manufacturer | Somnetics International, Inc.<br>33 5th Ave NW, Suite 500<br>New Brighton, MN 55112 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration # 3008770104 |
| Contact Person | Melinda Swanson<br>Regulatory Consultant<br>Telephone: [phone]<br>Email: [e-mail] |
| Trade Name | Transcend Auto |
| Common/Usual Name | Non-continuous ventilator |
| Classification | Ventilator, Non-continuous (Respirator)<br>21 CFR 868.5905, Class II |
| Product Code | BZD |
| Predicate Devices | Somnetics International, Inc., Model 300157 CPAP System<br>(K100121)<br>Respironics REMstar Auto CPAP with C-Flex (K041010) |

# Device Description

The Transcend Auto is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.

# Indications for Use

The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

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# Substantial Equivalence and Summary of Studies

The Transcend Auto complies with the following standards:

| Document<br>Number | Title |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | Medical Electrical Equipment, Part 1: General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment – Collateral Standard: Electromagnetic<br>compatibility – Requirements and tests |
| IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: General requirements for basic<br>safety and essential performance - Collateral Standard: Usability |
| IEC 60601-11 | Medical Electrical Equipment – Collateral Standard: Requirements for home<br>health care environment |
| ISO 10993-1 | Biological evaluation of medical devices |
| ISO 14971 | Medical devices -- Application of risk management to medical devices |
| BS EN 17510-1 | Sleep apnoea breathing therapy, Part 1: Sleep apnoea breathing therapy<br>equipment |

The Transcend Auto is substantial equivalent to the predicate devices based on comparison of indications for use and technological characteristics.

| | | Model 300157,<br>(Transcend) CPAP<br>System | REMstar Auto<br>CPAP System with<br>C-Flex | Comparison: |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Transcend Auto | | | |
| 510(k) Number | Under review | K100121 | K041010 | NA |
| Product Code | BZD | BZD | BZD | Identical |
| Regulation Number | 868.5905 | 868.5905 | 868.5905 | Identical |
| Regulation Name | Ventilator, non-<br>continuous<br>(respirator) | Ventilator, non-<br>continuous<br>(respirator) | Ventilator, non-<br>continuous<br>(respirator) | Identical |
| Indications for Use | The Transcend Auto<br>provides positive<br>airway pressure for<br>treatment of<br>obstructive sleep<br>apnea (OSA) in adults<br>weighing over 66<br>pounds (30 kg). The | The Model 300157<br>CPAP System is a<br>single patient reusable<br>device. The Model<br>300157 CPAP System<br>provides continuous<br>positive airway<br>pressure (CPAP) to | The REMstar Auto<br>with C-Flex CPAP<br>System is a CPAP<br>(Continuous<br>Positive Airway<br>Pressure) device<br>designed for the<br>treatment of adult | Identical |
| Substantial Equivalence Comparison | | | . . | , ' |
| | I Transcend Auto | · Model 300157 | REMstar Auto | Comparison |
| | | (Transcend) CPAP | CPAP System with | |
| - - -<br>:" | | System | C-Flex | |
| | device is intended for | support treatment of | Obstructive Sleep | |
| | home and | adults (over 30 kg) | Apnea (OSA) only. | |
| | hospital/institutional | with Obstructive Sleep | The device is for | |
| | use. | Apnea. | use in the home or | |
| | | | hospital/institution | |
| | | | al environment. | |
| Intended | Adult | Adult | Adult | Identical |
| Population of Use | | | | |
| Accessories | For use with | For use with | For use with | ldentical |
| | Transcend CPAP | Transcend CPAP | REMstar | |
| | accessories | accessories | accessories | |
| Therapy Pressure | 4-20 cm H2O | 4-20 cm H2O | 4-20 cm H2O | ldentical |
| Pressure Regulation | ±1 cm H2O or 10%, | ±1 cm H2O or 10%, | <10.0 cm H2O (±0.5 | Identical to |
| | whichever is greater | whichever is greater | cm H2O) | Transcend |
| | | | | СРАР, |
| | | | ≥10.0 to 20.0 cm | equivalent |
| | | | H2O (±1.0 cm H2O) | to REMstar |
| Ramp Feature | Yes | Yes | Yes | identical |
| Ramp Time | 0 – 45 min (5 min | 0-45 min (5 min | 0 - 45 min (5 min | Identical |
| | increments) | increments) | increments) | |
| | | | | |
| Auto Adjust | Yes | No | જ્વર | Equivalent |
| | | | | to REMstar |
| Expiratory Pressure | Yes | No | પ્રદર | Identical to |
| Relief | | | | REMstar |
| Operating Altitude | 0 to 8,000 ft | 0 to 8,000 ft | 0 - 7500 ft | ldentical to |
| | | | | Transcend |
| | | | | СРАР |
| Operating | 5° C (41° F) to 35° C | 5° C (41° F) to 35° C | 5° C (41° F) to 35° C | ldentical |
| Temperature | (95° F) | (95°F) | (95° F)<br>- | |
| Operating Humidity | 10 - 80% relative | 10 - 80% relative | 15 - 95% relative | ldentical to |
| | humidity, non- | humidity, non- | humidity, non- | Transcend |
| | Transcend Auto | Model 300157<br>(Transcend) CPAP<br>System | REMstar Auto<br>CPAP System with<br>C-Flex | Comparison |
| | condensing | condensing | condensing | CPAP |
| Shipping/Storage<br>Temperature | -20° C (-4° F) to 60° C<br>(140° F) | -20° C (-4° F) to 60° C<br>(140° F) | -20° C (-4° F) to 60° C<br>(140° F) | Identical |
| Shipping/Storage<br>Humidity | 10 - 90% relative<br>humidity, non-<br>condensing` | 10 - 90% relative<br>humidity, non-<br>condensing` | 15 - 95% relative<br>humidity, non-<br>condensing` | Identical to<br>Transcend<br>CPAP |
| Shipping/Storage<br>Humidity | 10 - 90% relative<br>humidity, non-<br>condensing` | 10 - 90% relative<br>humidity, non-<br>condensing` | 15 - 95% relative<br>humidity, non-<br>condensing` | Identical to<br>Transcend<br>CPAP |
| Data Storage<br>Download | PC connection | PC connection | Data card; PC<br>connection | Identical |
| Power Supply | 100-240 VAC,<br>50/60 Hz | 100-240 VAC,<br>50/60 Hz | 100-240 VAC,<br>50/60 Hz | Identical |
| IEC 60601<br>Classification | Class II, Type BF | Class II, Type BF | Class II, Type BF | Identical |
| Warranty | 2 years | 2 years | 2 years | Identical |

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The device design was qualified through the following tests and assessments:

- . Electrical Safety
- Electromagnetic Compatibility o
- Biocompatibility Assessment ●
- Cleaning Validation .
- . Software Validation
- Packaging and Shipping
- Performance: shock and vibration, cycling, pressure regulation including pressure . adjustment, sound, flow, altitude, battery life, particulate generation, volatile organic compounds, and clinical validation

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In addition, a 2 x 2 crossover clinical evaluation was conducted that enrolled 41 adult patients with obstructive sleep apnea to assess the non-inferiority of the Transcend Auto to the REMstar Auto in the treatment of obstructive sleep apnea, as measured by apnea hypopnea index (AHI) during treatment. No unanticipated adverse device effects were reported during the study. One adverse event was reported by a patient who had a low-level headache following treatment with the Transcend Auto. The adverse event resolved without intervention and the investigator reported that the it was possibly related to the device. The study met its primary efficacy endpoint of non-inferiority in AHI (p<0.0001) and demonstrated comparable safety data.

Results of non-clinical and clinical tests and assessments did not raise new safety or efficacy questions. Therefore, the conclusion is that the Transcend Auto is as safe and effective as the REMstar.

### Conclusion

The Transcend Auto is substantially equivalent to the Transcend CPAP (K100121) and the Respironics REMstar Auto CPAP with C-Flex (K041010). The subject and predicate devices are used for the treatment of obstructive sleep apnea. They are equivalent in terms of technology and intended use. Risk assessments, biocompatibility evaluation, software, electromagnetic compatibility and electrical safety, bench testing, clinical validation, and compliance with recognized standards demonstrate that any differences do not raise new questions of safety or effectiveness. The Transcend Auto is, therefore, substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font. The words are stacked on top of each other, with "Public" and "Health" on the top line and "Service" on the bottom line.

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

#### October 17, 2013

Somnetics International, Incorporated Ms. Melinda Swanson Regulatory Consultant 33 5" Avenue, NW Suite 500 NEW BRIGHTON MN 22112

Re: K132127

Trade/Device Name: Transcend Auto Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 20, 2013 Received: September 23, 2013

#### Dear Ms. Swanson:

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 mislcading.

If your device is classified (sec 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.

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Page 2 - Ms. Swanson

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 (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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 [phone] or [phone] or at its Internet address http://www.fdagov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mary SRUNner -S

Kwame Ulmer M.S. Acting Division 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): K132127

Device Name: Transcend Auto

Indications for Use:

The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

Prescription Use _ X _ (Part 21 CFR 801 Subpart D)

-------------------------

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Image /page/7/Picture/11 description: The image shows the concurrence of CDRH, Office of Device Evaluation (ODE). The image also shows the signature of Anya C. Harry -S. The signature includes the date 2013.10.17 12:10:20-04:00 and the number 0.9.2342.19200300.100.1.1-0011315590.

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