REMSTAR AFLEX CPAP SYSTEM

K063830 · Respironics Inc., Sleep & Home Respiratory Group · BZD · Mar 9, 2007 · Anesthesiology

Device Facts

• Record ID: K063830
• Device Name: REMSTAR AFLEX CPAP SYSTEM
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics REMstar Auto M-Series with AFLEX 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 CPAP system; provides positive airway pressure therapy. Features 'Auto' mode and 'AFLEX' comfort technology; eases pressure transition from inspiration to exhalation. Used in home or hospital settings; operated by patients or clinicians. Connects to patient via standard 22mm tubing, exhalation device, and mask. Device monitors breathing; adjusts pressure delivery to treat obstructive sleep apnea. Benefits patients by improving comfort and therapy compliance through automated pressure adjustments.

Clinical Evidence

Bench testing only. No clinical data provided. Design verification tests performed to confirm safety and effectiveness of modified design.

Technological Characteristics

Microprocessor-controlled blower system; integrated heated humidifier. 22mm smooth lumen tubing. Connectivity via patient circuit. Complies with FDA software guidance (May 2006).

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 Auto C-Flex CPAP System (K040101)
• Respironics REMstar M Series CPAP System (K052110)
• Respironics BiPAP Auto Bi-level System (K050759)
• Resmed S8 Pioneer (K041209)

Submission Summary (Full Text)

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

Respironics REMstar Auto M-Series with AFLEX CPAP System

Premarket Notification – Special 510(k)

TAB 3

K063830

# 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

MAR 0 3 2007

| Official Contact | Zita A. Yurko<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>724-387-4120<br>724-387-4206 (fax)<br>Email: [e-mail] | MAK |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | BZD - Non-Continuous ventilator | |
| Common/Usual Name | CPAP System | |
| Proprietary Name | Respironics REMstar Auto M-Series with AFLEX CPAP System | |
| Predicate Device(s) | Respironics REMstar Auto C-Flex CPAP System (K040101) | |
| | Respironics REMstar M Series CPAP System (K052110) | |
| | Respironics BiPAP Auto Bi-level System (K050759) | |
| | Resmed S8 Pioneer (K041209) | |
| Reason for submission | Modified design | |

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

### Substantial Equivalence

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

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

Design verification tests were performed on the Respironics REMstar Auto M-Series with AFLEX 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 Pre-market Submissions for Software Contained in Medical Devices," May 2006.

### Intended Use

The Respironics REMstar Auto M-Series with AFLEX 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 REMstar Auto M-Series with AFLEX CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Auto M-Series with AFLEX CPAP System also includes the auto mode and the flex therapy feature cleared in K040101 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the REMstar Auto M-Series with AFLEX device includes a Auto CPAP with AFLEX mode which provides added comfort for the user. Like its predicates, the REMstar Auto M-Series with AFLEX 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.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three overlapping wing shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane -Murrysville, Pennsylvania 15668

MAR 0 3 2007

Re: K063830

Trade/Device Name: Respironics REMstar Auto M-Series with AFLEX Series CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 6, 2007 Received: February 7, 2007

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.

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

Page 2 - Ms. 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 (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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

510(k) Number (if known): _

Device Name: Respironics REMstar Auto M-Series with AFLEX Series CPAP System

#### Intended Use/Indications for Use

The Respironics REMstar Auto M-Series with AFLEX Series CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.

#### Environment of Use/Patient Population

For use in the home or hospital/institutional environment.

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

이 대한민국 대학교 대학교

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------|
| Prescription UseXXXXXX | OR |
| (Per 21 CFR 801.109) | Over-The-Counter Use<br>(Optional Format 1-2-96) |

Nht Thul

Mary Imogene Bassett Hospital
Research Center, Clinical Devices
KOL 3830