REMSTAR PRO WITH C-FLEX CPAP SYSTEM

K021861 · Respironics, Inc. · BZD · Jun 19, 2002 · Anesthesiology

Device Facts

• Record ID: K021861
• Device Name: REMSTAR PRO WITH C-FLEX CPAP SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REMstar Pro with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Pro may be used in the home or hospital/institutional environment.

Device Story

Microprocessor-controlled blower-based CPAP system; provides continuous positive airway pressure to treat adult OSA. Features 'C-Flex' therapy mode providing pressure relief during exhalation. Device connects to patient via standard 22mm tubing and patient interface (mask). Used in home or hospital/institutional environments; operated by patients or clinicians. Output consists of regulated airflow pressure; helps maintain airway patency during sleep. Healthcare providers use device to manage OSA therapy; pressure relief feature intended to improve patient comfort and compliance.

Clinical Evidence

Bench testing only. Design verification tests performed based on risk analysis and product requirements; all tests met acceptance criteria.

Technological Characteristics

Microprocessor-controlled blower; 22mm tubing patient circuit; C-Flex pressure relief algorithm; software-controlled pressure delivery; intended for home/hospital use.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) requiring Continuous Positive Airway Pressure (CPAP) therapy. For use in home or hospital/institutional settings.

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 Auto CPAP System (K012554)
• Respironics BiPAP Pro Bi-level System (K011714)

Submission Summary (Full Text)

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# TAB 3 510(K) SUMMARY OF SAFETY & EFFECTIVE Official Contact Zita A. Yurko Manager, Regulatory Affairs/Product Assurance Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 724-387-4120 724-387-4216 (fax) email: [e-mail] Classification Reference 21 CFR 868.5905 BZD - Non-Continuous ventilator Product Code Common/Usual Name CPAP System Respironics REMstar Pro with C-Flex CPAP System Proprietary Name

Respironics REMstar Auto CPAP System (K012554) Predicate Device(s)

Respironics BiPAP Pro Bi-level System (K011714)

Reason for submission Modified design, enhanced mode.

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## Substantial Equivalence

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

- □ Same intended use.
- D Same operating principle.
- Q Same technology.
- O Same manufacturing process.

Design verification tests were performed on the Respironics REMstar Pro with C-Flex 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 device.

The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices", May 1998.

### Intended Use

The REMstar Pro with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Pro may be used in the home or hospital/institutional environment.

# Device Description

The Respironics REMstar Pro with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Pro with C-Flex 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, a method of venting exhaled gases, and a patient interface device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 9 2002

Respironics, Inc. c/o Ms. Zita A. Yurko 1001 Murry Ridge Lane Murrysville, PA 15668-8550

Re: K021861

Respironics REMstar Pro with C-Flex CPAP System Regulation Number: 868.5905 Regulation Name: Ventilator, Non-continuous Regulatory Class: II (two) Product Code: 73 BZD Dated: June 4, 2002 Received: June 6, 2002

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 such 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. Zita A. Yurko

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Della Tech

Donna-Bea Tillman. Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Respironics REMstar Pro with C-Flex CPAP System

#### Intended Use/Indications for Use

The REMstar Pro with C-Flex CPAP System is a CPAP (Continuous Positive Airway Presure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only.

#### Environment of Use/Patient Population

For use in the home or hospital/institutional environment on adult patients.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-------------------------------------------------------------------|---------|--------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
| <div><span style="text-align: center;">✓</span></div> | | |
| Division of Cardiovascular & Respiratory Devices<br>510(k) Number | K021861 | |