BIPAP PRO BI-LEVEL SYSTEM

K011714 · Respironics, Inc. · BZD · Jun 28, 2001 · Anesthesiology

Device Facts

• Record ID: K011714
• Device Name: BIPAP PRO BI-LEVEL SYSTEM
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 28, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics BiPAP® Pro 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. Used in home or hospital/institutional settings by adult patients. Device connects to patient via circuit (22mm tubing, exhalation device, mask). Software includes feature to ease transition from inspiration to exhalation, improving patient comfort. Healthcare providers use device to treat Obstructive Sleep Apnea; output is therapeutic pressure delivery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Microprocessor-controlled blower system; bi-level positive pressure (IPAP/EPAP). 22mm smooth lumen tubing. 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

• Respironics BiPAP® Duet® LX Bi-level System (K000994)

Submission Summary (Full Text)

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、ある、最新は、この意義をする。

的意思,在一切的影音

K011714

Premarket Notification - Special 510(k)

上海电子 -

# ATTACHMENT 3 CHART 3 CHARREN CHARMER COMMENT COMMENT COMMENT COLORAL

# 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

| Official Contact | David J. Vanella<br>Manager, Regulatory Affairs/Product Assurance<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics BiPAP® Pro Bi-level System |
| Predicate Device(s) | Respironics BiPAP® Duet® LX Bi-level System (K000994) |
| Reason for submission | Modified design, enhanced mode |

©2001 Respironics Inc.

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### Substantial Equivalence

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

- Same intended use.
- Same operating principle. 0
- Same technology. 0
- Same manufacturing process. o

Design verification tests were performed on the Respironics BiPAP® Pro 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 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 1998.

#### Intended Use

The Respironics BiPAP® Pro 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 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. Respironics is adding an additional therapy feature to the existing BiPAP Pro Bi-level System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP® Pro 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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JUN 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550

Re: K011714

> Respironics BiPAP® Pro Bi-level System Regulation Number: 868.5905 Regulatory Class: II (two) Product Code: BZD Dated: May 23, 2001 Received: June 4, 2001

Dear Mr. Vanella:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish

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Page 2 - Mr. David J. Vanella

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Donk Tell

James E. Dillard III Director Division of Cardiovascular and Respiratory 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): _Koll 711 | 11 |

Device Name: Respironics BiPAP® Pro Bi-level System

#### Intended Use/Indications for Use

The Respironics BiPAP® Pro 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<br>(Per 21 CFR 801.109) | <span style="text-decoration: underline;"></span> ✓ |
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| Over-The-Counter Use<br>(Optional Format 1-2-96) | <span style="text-decoration: underline;"></span> |
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Division of Cardiovascular & Respiratory Devices
510(k) Number K011747