REMSTAR AUTO A-FLEX

K091319 · Respironics Inc., Sleep & Home Respiratory Group · BZD · Aug 3, 2009 · Anesthesiology

Device Facts

• Record ID: K091319
• Device Name: REMSTAR AUTO A-FLEX
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics Q Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

Device Story

Microprocessor-controlled, blower-based positive airway pressure system with integrated heated humidifier. Used in home or hospital settings by patients for Obstructive Sleep Apnea therapy. Connects to patient via circuit (19mm tubing, exhalation device, mask). Features 'Auto' mode and 'AFLEX' therapy, which eases pressure transition from inspiration to exhalation to improve comfort. Device monitors breathing and adjusts pressure delivery. Healthcare providers use the system to provide therapeutic airway support, potentially improving patient compliance and comfort through pressure relief features.

Clinical Evidence

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

Technological Characteristics

Microprocessor-controlled blower system; integrated heated humidifier; 19mm smooth lumen tubing; positive pressure delivery; AFLEX comfort feature; software-controlled pressure regulation.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs).

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 M Series Auto with AFLEX CPAP System (K063830)

Submission Summary (Full Text)

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1091319

# TAB 3

AUG 03 2009

# 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<br>724-387-4120<br>724-387-4206 (fax)<br>Email: Zita. [e-mail] |
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| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - ventilator, non-continuous (respirator) |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar Q Series Auto with AFLEX CPAP System |
| Predicate Device(s) | Respironics REMstar M Series Auto with AFLEX CPAP System<br>(K063830) |
| Reason for submission | Modified design. |

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# Substantial Equivalence

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

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

Design verification tests were performed on the Respironics REMstar Q-Series Auto 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 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 2006.

### Intended Use

The Respironics Q Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

## Device Description

The Respironics REMstar Q Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Q Series Auto with AFLEX CPAP System includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition, the device includes the AFLEX therapy feature which provides added comfort for the user (also cleared in K063830). Like its predicate, the REMstar Q Series Auto 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 19mm tubing, an exhalation device, and a patient interface device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing service and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

# AUG 0 3 2009

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

Re: K091319

Trade/Device Name: Respironics O Series Auto with AFLEX CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 4, 2009 Received: May 5, 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.

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#### Page 2- Ms. Kurko

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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

For

Susan Runner, D.D.S., M.A. 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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510(k) Number (if known):

Device Name: Respironics Q Series Auto with AFLEX CPAP System

#### Intended UseAndications for Use

The Respironics Q Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

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| | | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription UseXXXXXX<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k091319