MODIFICATION TO REMSTAR AUTO CPAP SYSTEM

K031460 · Respironics, Inc. · BZD · Jun 24, 2003 · Anesthesiology

Device Facts

• Record ID: K031460
• Device Name: MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This device is intended for use in the home or hospital/institutional environment on adult patients.

Device Story

Microprocessor-controlled, blower-based CPAP system; generates positive airway pressures (4-20 cmH2O). Connects to patient via circuit and mask. Used in home or hospital/institutional settings by adult patients. Modifications include Split-Night with Auto-CPAP mode for simplified sleep studies and Non-Responsive Apnea Hypopnea (NRAH) flag for clinical monitoring. Clinicians use output (NRAH flag) to assess therapy effectiveness and adjust treatment. Benefits include automated pressure titration and improved diagnostic workflow for sleep apnea.

Clinical Evidence

Bench testing only. Design verification tests performed in accordance with risk analysis and product requirements; all tests met acceptance criteria.

Technological Characteristics

Microprocessor-controlled blower system; positive airway pressure 4-20 cmH2O. Includes Split-Night with Auto-CPAP mode and NRAH flag. Complies with FDA software guidance (May 1998).

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea requiring positive airway pressure therapy. No specific contraindications listed.

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 Virtuoso LX Smart CPAP System (K993433)

Submission Summary (Full Text)

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TAB 3

510(K) SUMMARY OF SAFETY & EFFECTIVENESS

| Official Contact | Zita A. Yurko<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 | K031460 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|---------|
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | BZD - Non-Continuous ventilator | |
| Common/Usual Name | CPAP System | |
| Proprietary Name | Respironics REMstar Auto CPAP System | |
| Predicate Device(s) | Respironics REMstar Auto CPAP System (K012554) | |
| | Respironics Virtuoso LX Smart CPAP System (K993433) | |
| Reason for submission | Modified design, additional accessories. | |

# Substantial Equivalence

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

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

Design verification tests were performed on the REMstar Auto CPAP System in accordance with 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.

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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 1998.

## Intended Use

The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This device is intended for use in the home or hospital/institutional environment on adult patients.

### Device Description

The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The previously cleared REMstar Auto has been modified to include a Split-Night with Auto-CPAP mode to simplify spilt night studies and to add a Non Responsive Apnea Hypopnea (NRAH) flag for clinical use. The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

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

Re: K031460

Trade/Device Name: REMstar Auto CPAP System Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: June 5, 2003 Received: June 6, 2003

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 vour 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.

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Page 2 -- Ms. Zita A. Yurko

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 (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.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely vours.

Susan Rann

Susan Runner, DDS, MA Interim 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Respironics® REMstar Auto CPAP System

#### Intended Use/Indications for Use

The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.

#### 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) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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| (Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | |
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| 510(k) Number: | K031460 |
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