Transcend 365 miniCPAP System

K180388 · Somnetics International, Inc. · BZD · Nov 30, 2018 · Anesthesiology

Device Facts

• Record ID: K180388
• Device Name: Transcend 365 miniCPAP System
• Applicant: Somnetics International, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

Device Story

Microprocessor-controlled, blower-based CPAP system; generates positive airway pressure (4-20 cmH2O) to treat OSA. Inputs: differential pressure sensor/internal pneumotach signal to monitor breathing/flow. Outputs: regulated airway pressure; therapy data stored on device. Used in home/hospital by patients/clinicians. Features integrated Capillary Force Vaporization™ humidifier (wick/ceramic heater); no heater plate. Adjusts pressure based on respiratory event detection algorithm (identical to predicate Transcend Auto). Healthcare providers use desktop software to download/review therapy data. Benefits: portable OSA treatment with integrated humidification; auto-adjusting pressure improves patient compliance/comfort.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993, ISO 18562), electrical safety/EMC (IEC 60601 series), software validation, and mechanical/acoustic performance (pressure regulation, auto-adjust functionality, humidifier output, component cycling).

Technological Characteristics

Microprocessor-controlled blower; 4-20 cmH2O pressure range. Integrated Capillary Force Vaporization™ humidifier (wick/ceramic heater). 22-mm connection port. IP22 water ingress protection. Powered by 100-240 VAC or 18.0 VDC battery. Biocompatible materials per ISO 10993/18562. Software: moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-74, ISO 8185.

Indications for Use

Indicated for adults >66 lbs (30 kg) with Obstructive Sleep Apnea (OSA) requiring positive airway pressure therapy. 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

• Transcend Auto (K132127)
• Transcend Heated Humidifier (K131388)

Reference Devices

• PARI Hydrate V (K072982)

Submission Summary (Full Text)

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November 30, 2018

Somnetics International, Inc. % Melinda Swanson Regulatory Consultant Bluebird Consulting, LLC 100 NE 2nd St. #340 Minneapolis, Minnesota 55413

Re: K180388

Trade/Device Name: Transcend 365 miniCPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD Dated: October 26, 2018 Received: October 30, 2018

Dear Melinda 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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# James J. Lee -S

for Tina Kiang, Ph.D. 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) K180388

Device Name Transcend 365 miniCPAP Auto System

#### Indications for Use (Describe)

The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

### 510(k) Number: K180388

Date Prepared: November 13, 2018

| Submitter/Manufacturer | Somnetics International, Inc.<br>33 5th Ave NW, Suite 500<br>New Brighton, MN 55112<br>Establishment Registration # 3008770104 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission<br>Correspondent | Melinda Swanson<br>Regulatory Consultant<br>Telephone: [phone]<br>Email: [e-mail] |
| Trade Name | Transcend 365 miniCPAP Auto System |
| 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.:<br>Transcend Auto (K132127) Transcend Heated Humidifier (K131388) Neither predicate device has been subject to a recall |
| Reference Device | PARI Innovative Manufacturers, Inc.<br>PARI Hydrate V (K072982) |

### Device Description

The Transcend 365 miniCPAP Auto System (Transcend 365) is a new member of Somnetics' family of devices used to treat obstructive sleep apnea which includes the Transcend Auto and Transcend Heated Humidifier devices and accessories cleared via K132127 and K131388. The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The Transcend 365 includes the following main modifications:

- Integrated CPAP and humidification system .
- . Modifications from predicate Transcend Auto device
- Graphic LCD interface vs LED in predicate o
- Housing design O

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- Updated air inlet filter o
- Use of a standard 22-mm connection port for air hose attachment O
- Integrated heated humidifier with water reservoir attached with magnets o
- Integrated humidifier uses Capillary Force Vaporization™ (Vapore) technology ●
- o Wick to a ceramic heater vaporizes water (instead of continuous heating with a heater plate)
- Similar to PARI Hydrate V (K072982); same supplier (Vapore) o
- Allows for a smaller water reservoir and footprint o

The Transcend 365 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. When interfaced with a mask though use of a 22 mm breathing hose, this flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. The system provides fixed or auto-adjust pressure from 4 to 20 cmH20 above the ambient atmospheric pressure to a patient's oral/nasal airway.

The humidifier uses Capillary Force Vaporization technology similar to that used in the PARI Hydrate V (Humidifier, Respiratory Gas (Direct Patient Interface); 868.5450, Product Code BTT) cleared under K072982. Water is drawn from a reservoir by a wick to a ceramic heater, which vaporizes the water resulting in comparable humidification output to the predicate devices. There is no heater plate and the water reservoir is not heated. Several humidification levels are available, with higher settings increasing the amount of water vapor. The humidifier is attached to the lower portion of the PAP through the use of magnets.

It includes the following components and accessories, which are all single patient reusable:

- . Filter Media
- P10 Battery ●
- Transcend 365 miniCPAP Unit .
- USB cable* ●
- Heater Cartridge .
- Wick
- Reservoir .
- Power supply PSA3 ●
- US 2-prong power cord

### Indications for Use

The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The

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device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

Both the subject and the predicate devices have the same intended use for the treatment of OSA. The Indications for Use statement for the Transcend 365 is not identical to the predicates; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness relative to the predicate.

## Comparison of Technological Characteristics with the Predicate Device

At a high level, the Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The subject and predicate device share the same intended use, same operating principal, and are manufactured and packaged with similar processes. The substantial equivalence comparison is provided below.

| Substantial Equivalence Comparison | | | | | |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Transcend 365<br>miniCPAP Auto | Primary<br>Predicate:<br>Transcend Auto | Predicate:<br>Transcend<br>Heated<br>Humidifier | Reference<br>PARI Hydrate<br>V | Comparison |
| Regulatory Classification | | | | | |
| 510(k) Number | NA | K132127 | K131388 | K072982 | NA |
| Product Code | BZD | BZD | BTT | BTT | Identical to Primary<br>Predicate |
| Regulation<br>Number | 868.5905 | 868.5905 | 868.5450 | 868.540 | Identical to Primary<br>Predicate |
| Regulation Name | Ventilator, non-<br>continuous<br>(respirator) | Ventilator, non-<br>continuous<br>(respirator) | Respiratory gas<br>humidifier | Respiratory<br>gas humidifier | Identical to Primary<br>Predicate |
| Intended Use and Indications for Use | | | | | |
| Indications for<br>Use | The 'Transcend<br>365 miniCPAP<br>Auto System'<br>provides<br>positive airway<br>pressure to | The Transcend<br>Auto provides<br>positive airway<br>pressure for<br>treatment of<br>obstructive sleep | The Transcend<br>Heated<br>Humidifier is<br>indicated for<br>the<br>humidification | The Hydrate V<br>is a<br>Respiratory<br>Gas Humidifier<br>which provides<br>heated | Identical Intended<br>Use: Intended to treat<br>patients with OSA<br>with an option for |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365<br>miniCPAP Auto | Primary<br>Predicate:<br>Transcend Auto | Predicate:<br>Transcend Heated<br>Humidifier | Reference<br>PARI Hydrate V | Comparison |
| | support<br>treatment of<br>adults over 66<br>pounds (30 kg)<br>with Obstructive<br>Sleep Apnea<br>(OSA). The<br>device is<br>intended for<br>home and<br>hospital/<br>institutional use.<br>The integrated<br>humidifier<br>provides<br>humidification of<br>air delivered<br>from the<br>Transcend 365<br>devices. The use<br>of the humidifier<br>is optional. | apnea (OSA) in<br>adults weighing<br>over 66 pounds<br>(30 kg). The<br>device is<br>intended for<br>home and<br>hospital/<br>institutional use. | of the air<br>delivered from<br>a compatible<br>Transcend<br>positive airway<br>pressure<br>therapy device.<br>The Humidifier<br>is intended for<br>single patient<br>re-use in the<br>home<br>environment<br>and in a<br>hospital/institu<br>tional<br>environment.<br>The Humidifier<br>is for use only<br>as<br>recommended<br>by a physician. | evaporated<br>water content<br>to dry<br>breathing<br>gases using<br>Capillary Force<br>Vaporization<br>technology. A<br>breathing<br>circuit is used<br>to deliver the<br>heated and<br>humidified gas<br>to the patient. | providing<br>humidification.<br><br>Indication for Use:<br>Similar to predicate<br>devices. Slight<br>modification to<br>incorporate the<br>intended use of the<br>integrated humidifier. |
| Pressure Delivery | Fixed | Yes | Yes | NA | Identical feature to<br>primary predicate |
| | Auto-adjust | Yes | Yes | NA | Identical feature to<br>primary predicate |
| Algorithm | Auto-adjust | Yes | Yes | NA | Algorithm is identical<br>to primary predicate |
| | AHI<br>Measurement | Yes | Yes | NA | Algorithm is identical<br>to primary predicate |
| | Ramp | Yes | Yes | NA | Algorithm is identical<br>to primary predicate |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365<br>miniCPAP Auto | Primary<br>Predicate:<br>Transcend Auto | Predicate:<br>Transcend<br>Heated<br>Humidifier | Reference<br>PARI Hydrate<br>V | Comparison |
| Expiratory<br>Pressure Relief | Yes | Yes | NA | NA | Algorithm is identical<br>to primary predicate |
| Drying Mode | Yes | Yes | NA | NA | identical feature to<br>primary predicate |
| Humidifier | | | | | |
| Integrated | Yes | No | No | NA | Similar. Both subject<br>and predicate devices<br>have a method to<br>attach a humification<br>system. |
| Humidification<br>Method | Capillary Force<br>VaporizationTM<br>Technology | NA | Pass over<br>humidification<br>through use of a<br>heater plate | Capillary Force<br>VaporizationTM<br>Technology | Similar to predicate;<br>Devices have a<br>method for providing<br>heated humidified air<br>in accordance with<br>industry standard<br>(ISO 8185). Capillary<br>Force Vaporization<br>Technology is found in<br>the reference device<br>PARI Hydrate V<br>(K072982) |
| Humidifier/PAP<br>Connection | Humidifier is<br>connected to<br>PAP via magnets | PAP is slide fit<br>into slots in top<br>of humidifier | PAP is slide fit<br>into slots in top<br>of humidifier | NA | Similar. Devices have<br>a mechanism for<br>securing the PAP and<br>humidifier<br>components together<br>as verified by<br>component cycling<br>testing. Change does<br>not impact safety or<br>effectiveness. |
| Humidifier<br>Settings | 0-10 | NA | 0-5 | Designed to<br>automatically<br>match the gas<br>flow rate to | Similar. Both devices<br>deliver a range of<br>humidity based on<br>setting level and are |
| | Transcend 365<br>miniCPAP Auto | Primary<br>Predicate:<br>Transcend Auto | Predicate:<br>Transcend<br>Heated<br>Humidifier | Reference<br>PARI Hydrate<br>V | Comparison |
| | | | | provide 100%<br>RH. Can be<br>physician<br>adjusted to<br>deliver lower<br>RH. | adjusted by the<br>patient for comfort.<br>Change does not<br>impact safety or<br>effectiveness. |
| Warm-up Time | NA | NA | Up to 1 hour<br>depending on<br>heat setting | NA | The subject and<br>predicate device heat<br>water using different<br>methods. The subject<br>device does not have a<br>warm up time, so this<br>does not affect safety<br>or effectiveness. The<br>reference device does<br>not have a warm up<br>time and uses the<br>same method to heat<br>water |
| Maximum<br>Heater Plate<br>Temperature | NA, device does<br>not include a<br>heater plate | NA, device does<br>not include a<br>heater plate | 55C | NA, device<br>does not<br>include a<br>heater plate | The subject and<br>predicate device heat<br>water using different<br>methods. The subject<br>device does not have a<br>heater plate, so this<br>does not affect safety<br>or effectiveness. |
| Water Reservoir<br>Volume | 195 ml to fill line | NA | 325 ml to fill<br>line | Up to 2 L | Similar to predicate.<br>Humidifier contains<br>water for 8 hours |
| Physical Characteristics | | | | | |
| Dimensions | 7.8 in X 3.8 in X<br>4.5 in | 6.1 in X 3.5 in X<br>2.8 in | 9 in X 5.5 in X<br>4.7 in | 12.5 in X 6.0 in<br>X 8.0 in | Dimensions are<br>smaller than predicate<br>humidifier which<br>forms the footprint of<br>the combined |
| Substantial Equivalence Comparison | | | | | |
| | Transcend 365<br>miniCPAP Auto | Primary<br>Predicate:<br>Transcend Auto | Predicate:<br>Transcend Heated<br>Humidifier | Reference<br>PARI Hydrate V | Comparison |
| Weight | 1.7 lbs | Less than 1 lb | 2.2 lb empty;<br>3.1 lbs with<br>water to max fill<br>line | 6.8 lbs | Weight is less than<br>combined weight of<br>combined predicate<br>devices when used<br>together. No impact<br>on safety and<br>effectiveness. |
| Redesigned<br>Enclosure | Yes | No | No | NA | Similar. Made of same<br>flame-retardant<br>materials (VO rating).<br>Enclosure design does<br>not impact safety or<br>effectiveness as<br>demonstrated by<br>performance testing. |
| Air Filter | Reusable/<br>replaceable inlet<br>filter updated to<br>include ease of<br>replacement. | Reusable/<br>replaceable inlet<br>filter | NA | Unknown | Similar. Air filter<br>update does not<br>impact safety or<br>effectiveness as<br>demonstrated by<br>cycling testing and<br>other performance<br>testing. The device<br>uses identical filter<br>media. |
| Connection Port | Compatible with<br>commercially<br>available 22 mm<br>breathing hoses | Universal hose<br>adaptor required<br>for compatibility<br>with<br>commercially<br>available 22 mm<br>breathing hoses | NA | Delivery tubes<br>and nasal<br>cannula | Similar. Devices are<br>compatible with<br>commercially<br>available 22 mm<br>breathing hoses<br>(compliant with ISO<br>5356-1). Does not<br>impact safety or<br>effectiveness |
| Substantial Equivalence Comparison | Transcend 365<br>miniCPAP Auto | Primary<br>Predicate:<br>Transcend Auto | Predicate:<br>Transcend Heated<br>Humidifier | Reference<br>PARI Hydrate V | Comparison |
| User Interface | Color LCD menu driven user interface | Power button 2 LEDs Push button to activate blower and ramp | Power button 3 LEDs Setting adjustment knob | Keypad control | Similar. Changes are not significant and do not impact safety or effectiveness as confirmed by usability testing (60601-1-6) |
| Accessories<br>Provided with<br>Device | None | Provided with standard 6 ft hose and universal hose adaptor. | Supplied with an industry standard 6 ft hose.<br>Compatible with commercially available 22 mm hoses and masks | Provided with a patient cable and power cord | Similar. All devices are compatible with a 22 mm air hose |
| Biocompatible | New heater materials. Yes; assessed and tested for biocompatibility according to ISO 10993 and 18562 | Yes; assessed for biocompatibility according to ISO 10993 | Yes; assessed for biocompatibility according to ISO 10993 | 510k summary does not indicate biocompat-ibility status | Testing and risk assessment confirm the biocompatibility of the new materials and device. Changes do not impact safety or effectiveness |
| Reuse/Cleaning/Sterility | | | | | |
| Multi-patient<br>Use | No | Yes, following instructions for cleaning and replacing parts | No | Yes, following instructions for cleaning of the unit and patient cable.<br>The humidification unit, water lines, and nasal cannula are for | Subject device and predicate humidifier are for single patient use only. Does not affect safety or effectiveness. |
| Substantial Equivalence Comparison |…