BIPAP PRO 2 BI-LEVEL SYSTEM

K032834 · Respironics, Inc. · BZD · Mar 4, 2004 · Anesthesiology

Device Facts

• Record ID: K032834
• Device Name: BIPAP PRO 2 BI-LEVEL SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. For use in the home or hospital/institutional environment on adult patients.

Device Story

Microprocessor-controlled blower-based bi-level positive pressure system; delivers two distinct pressure levels (IPAP/EPAP) to provide pressure support therapy. Includes 'flex therapy' feature to ease transition from inspiration to exhalation for patient comfort. Used in home or hospital environments by adult patients. Device connects to patient via a circuit consisting of 22mm tubing, exhalation device, and mask interface. Healthcare providers use the system to treat Obstructive Sleep Apnea; therapy aims to improve patient comfort and compliance through bi-level pressure support.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Microprocessor-controlled blower system; bi-level positive pressure (IPAP/EPAP). Includes flex therapy feature. 22mm smooth lumen tubing. Software-controlled. Complies with FDA guidance for software in medical devices.

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

• Respironics BiPAP Pro Bi-level System (K011714)
• Respironics REMstar Auto CPAP System (K012554 & K031460)
• Respironics BiPAP Harmony Ventilatory Support System (K031656)
• Resmed VPAP II ST Nasal VPAP System (K961783)

Submission Summary (Full Text)

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A Respironics BiPAP Pro 2 Bi-level System

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# 510(K) SUMMARY OF SAFETY & EFFECTIVENESS # #

| Official Contact | Zita A. Yurko<br>Manager, Regulatory Affairs/Product Assurance<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 BiPAP Pro 2 Bi-level System |
| Predicate Device(s) | Respironics BiPAP Pro Bi-level System (K011714)<br>Respironics REMstar Auto CPAP System (K012554 & K031460)<br>Respironics BiPAP Harmony Ventilatory Support System (K031656<br>Resmed VPAP II ST Nasal VPAP System (K961783) |

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#### Substantial Equivalence

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

- D Same intended use.
- D Same operating principle.
- വ Same technology.
- Same manufacturing process. 口

Design verification tests were performed on the Respironics BiPAP Pro 2 Bi-level 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 1998.

#### Intended Use

The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. For use in the home or hospital/institutional environment on adult patients.

#### Device Description

The Respironics BiPAP Pro 2 Bi-level System is a microprocessor controlled blower based bi-level positive pressure system that delivers two different positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. The BiPAP Pro 2 Bi-level System also includes the flex therapy feature cleared in K011714 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicates, the BiPAP Pro 2 Bi-level 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Public Health Service

MAR - 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K032834

Trade Name: BiPAP Pro 2 Bi-level System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 2, 2004 Received: March 3, 2004

Dear Ms. Yurko:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encreations of the enactment date of the Medical Device Amendments, or to commerce prior to may 20, sire) in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Herefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelove, manevelle a Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is onashined (socials. Existing major regulations affecting your device can thay be subject to saen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast be advised that 1197 or levice complies with other requirements of the Act that I DT has Interes and regulations administered by other Federal agencies. You must or any I coleral statutes and reguirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Zita Yurko

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as scheen CFR Part 807), labeling (21 CFR Part 807), good xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on device as described in your Section 510(k) I his ietter will anow you to oegin manceang your and equivalence of your device to a legally premarket notification. THC 1971 midnig of basisting of 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 If you desire specific advice for Jour as 1) 594-4646. Also, please note the regulation entitled, Comact the Office of Complians an (21 trist Part 807.97). You may obtain " Misoranding by Telefone to premation inibilities under the Act from the Division of Small other general information on your respense at its toll-free number [phone] or Mandracturers, micrnational and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

Enclosure

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Page _1_of_1

510(k) Number (if known): K032834

Device Name: Respironics BiPAP Pro 2 Bi-level System

#### Intended Use/Indications for Use

The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.

### 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)

| Prescription Use (Per 21 CFR 801.109) | XXX |
|---------------------------------------|-----------------------------------------------|
| | OR |
| | Over-The-Counter Use (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dermal Devices

| 510(k) Number: | K032834 |
|----------------|---------|
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