M-SERIES PRO CPAP SYTEM

K052110 · Respironics, Inc. · BZD · Oct 20, 2005 · Anesthesiology

Device Facts

• Record ID: K052110
• Device Name: M-SERIES PRO CPAP SYTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics REMstar Pro M Series 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; delivers positive airway pressure therapy. Includes integrated heated humidifier and 'flex therapy' feature to ease transition from inspiration to exhalation. Used in home or hospital/institutional settings; operated by patients or clinicians. Connects to patient via circuit (22mm tubing, exhalation device, mask). Provides comfort-focused pressure support to treat Obstructive Sleep Apnea.

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 system; integrated heated humidifier; flex therapy feature. Dimensions: smaller/lighter than predicate. Connectivity: patient circuit with 22mm tubing. Software complies with May 2005 FDA guidance for software in medical devices.

Indications for Use

Indicated for spontaneously breathing patients weighing over 30kg with Obstructive Sleep Apnea.

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 Pro with C-Flex CPAP System (K021861)

Submission Summary (Full Text)

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OCT 2005

100 million in the state

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# 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 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120<br>724-387-4206 (fax)<br>Email: [e-mail] |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar Pro M Series CPAP System |
| Predicate Device(s) | Respironics REMstar Pro with C-Flex CPAP System (K021861) |
| Reason for submission | Modified design. |

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## Substantial Equivalence

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

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

Design verification tests were performed on the Respironics REMstar Pro M Series 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 2005.

#### Intended Use

The Respironics REMstar Pro M Series CPAP System delivers positive ainway 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 Pro M Series CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M Series CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicate, the REMstar Pro M Series 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.

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Public Health Service

OCT 2 0 2005

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 Lanc Murrysville, Pennsylvania 15668

Re: K052110

Trade/Device Name: M-SERIRES PRO CPAP SYSTEM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 20, 2005 Received: September 21, 2005

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 referenced above antend 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 approvisions 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 cither class II (Special Controls) or class III if your device to such additional controls. Existing major regulations affecting (1 Nr.), it har or be subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.

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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 mean that 1 Dr. I has made statutes and regulations administered by other Federal agencies. or the Hot of all , I outh all the Act's requirements, including, but not limited to: registration 1 od intelse comply Trail and (21 CFR Part 801); good manufacturing practice and fisting (21 OF R Party of ), eguality systems (QS) regulation (21 CFR Part 820); and if requirements as bet forms in adiation control provisions (Sections 531-542 of the Act); appreadio, the elections of the will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA linding of substantial equivalence m 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), rr you desire specific at 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 may obtain 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,

Smite Y. Michael D.M.D.

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

Enclosure

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Page 1

510(k) Number (if known): ___

Device Name: Respironics REMstar Pro M Series CPAP System

#### Intended Use/Indications for Use

The Respironics REMstar Pro M 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseXXXXX_________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

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

on of Anesthesiolor General Hospital. Infection Control. Der 510(k) Number