RESPIRONICS SLEEPEASY CPAP SYSTEM

K091112 · Respironics, Inc. · BZD · May 15, 2009 · Anesthesiology

Device Facts

• Record ID: K091112
• Device Name: RESPIRONICS SLEEPEASY CPAP SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: May 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

Device Story

Microprocessor-controlled blower-based positive airway pressure system; includes integrated heated humidifier. Operates by delivering continuous positive airway pressure to patient via patient circuit (tubing, exhalation device, mask). Features 'flex therapy' to ease transition from inspiration to exhalation for patient comfort. Used in home or hospital/institutional settings; operated by patient or clinician. Output is therapeutic positive pressure; assists in maintaining airway patency for OSA patients. Device design is smaller and lighter than predicates.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Microprocessor-controlled blower; integrated heated humidifier; positive pressure delivery. Connectivity via patient circuit (22mm tubing). Software-controlled therapy features (flex therapy). Complies with FDA guidance for software in medical devices (May 2005).

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.

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

• Respironics REMstar Plus CPAP System (K010263)
• Respironics REMstar Pro with C-Flex CPAP System (K021861)

Submission Summary (Full Text)

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Respironics SleepEasy CPAP System

K091112

Premarket Notification – Special 510(k)

MAY 15 2009

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Official Contact

Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

724-387-4120 724-387-7490 (fax) Email: Zita. [e-mail]

#### Classification Reference

Product Code

Common/Usual Name

Proprietary Name

Predicate Device(s)

Reason for submission

21 CFR 868.5905

BZD - Non-Continuous ventilator

CPAP System

Respironics SleepEasy CPAP System

Respironics REMstar Plus CPAP System (K010263)

Respironics REMstar Pro with C-Flex CPAP System (K021861)

Modified design.

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### Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

- Same intended use. 0
- Same operating principle. aj
- O Same technology.
- Same manufacturing process.

Design verification tests were performed on the Respironics SleepEasy CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

The modified device complies with the applicable standards referenced in the Guidance for FDA. Reviewers and Industry "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 2005.

# Intended Use

The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

## Device Description

The Respironics SleepEasy CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The SleepEasy CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its device predicates, the SleepEasy CPAP System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K091112

Trade/Device Name: Respironics SleepEasy CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 16, 2009 Received: April 17, 2009

Dear Ms. Yurko:

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.

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 requirements, including, but not limited to: registration

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Page 2- Ms. Yurko

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Susan Kunne

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1 of 1

510(k) Number (if known):

Device Name: Respironics SleepEasy CPAP System

#### Intended UseAndications for Use

The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

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

### Concurrence of CDRH, Office of Device Evaluation (ODE).

Prescription Use _ XX (Per 21 CFR 801.109)

OB

Over-The-Counter Use (Optional Format 1-2-96)

Susan Quinn

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion) Dentel Devices Division of Ancolnest - 37
Infection Control, Dental Devices

510(k) Number: Ka1112