REMSTAR AUTO CPAP SYSTEM

K012554 · Respironics, Inc. · BZD · Jan 29, 2002 · Anesthesiology

Device Facts

• Record ID: K012554
• Device Name: REMSTAR AUTO CPAP SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 29, 2002
• 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). Used in home or hospital settings by adult patients. Device connects to patient via circuit and mask. Modified from predicate to include hypopnea detection and integrated humidifier control interface. Output provides therapeutic airway pressure to treat Obstructive Sleep Apnea; helps maintain airway patency during sleep. Healthcare providers use device settings to manage therapy; patient uses device during sleep to alleviate apnea symptoms.

Clinical Evidence

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

Technological Characteristics

Microprocessor-controlled blower system; 4-20 cmH2O pressure range. Includes hypopnea detection and humidifier interface. Complies with FDA software guidance (May 1998).

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea requiring positive airway pressure 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

• Model 7410 Voyager (K974879)
• Respironics Remstar Plus CPAP System/Remstar Heated Humidifier (K010263)
• Respironics Virtuoso LX CPAP System (K993433)

Submission Summary (Full Text)

{0}------------------------------------------------

17

| Official Contact<br>JAN 2 9 2002 | David J. Vanella<br>Manager, Regulatory Affairs/Product Assurance<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>K012554 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) | Model 7410 Voyager (K974879) |
| | Respironics Remstar Plus CPAP System/Remstar Heated Humidifier<br>(K010263) |
| | Respironics Virtuoso LX CPAP System (K993433) |
| Reason for submission | Modified design, additional accessories. |

# Substantial Equivalence

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

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

Design verification tests were performed on the REMstar Auto CPAP System because 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.

{1}------------------------------------------------

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 Respironics Model 7410 Voyager has been modified to detect hypopneas and to add an interface to adjust the settings of the Remstar Heated Humidifier. The design implementation of the humidifier and the humidifier interface is the same as the Remstar Plus CPAP System (K010263). The basic functional and performance characteristic of the REMstar Auto CPAP System is unchanged from the predicate device (Model 7410 Voyager K974879).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2002

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

Re: K012554

Respironics® REMstar Auto CPAP System Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: Class II (two) Product Code: BZD Dated: January 2, 2002 Received: January 3, 2002

Dear Mr. Vanella:

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.

{3}------------------------------------------------

Page 2 - Mr. David J. Vanella

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must or any I catal statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607); accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by some (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) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premails in the modicate 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 additionally 21 011 594-4646. Additionally, for questions on the promotion and advertising of Compination at (301) 591-461 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 Oiner general 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,

Qo. V. Tille

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

K012554

510(k) Number (if known): KOLZ554

Device Name: Respironics® REMstar Auto CPAP System

### Intended UseAndications 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.

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

| Prescription Use | <div> <table style="display:inline-table;"><tr><td></td></tr></table> <table style="display:inline-table;"><tr><td><div> <table style="display:inline-table;"><tr><td></td></tr></table> </div></td></tr></table> </div> | | <div> <table style="display:inline-table;"><tr><td></td></tr></table> </div> | |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------|--|
| | | | | |
| <div> <table style="display:inline-table;"><tr><td></td></tr></table> </div> | | | | |
| | | | | |
| (Per 21 CFR 801.109) | | | | |

OR

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K012559