← Product Code [MNS](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS) · K020777

# BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX (K020777)

_Respironics, Inc. · MNS · Mar 20, 2002 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K020777

## Device Facts

- **Applicant:** Respironics, Inc.
- **Product Code:** [MNS](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS.md)
- **Decision Date:** Mar 20, 2002
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 868.5895
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology
- **Attributes:** Therapeutic

## Indications for Use

The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital/institutional environment. The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

## Device Story

Microprocessor-controlled, blower-based bi-level positive pressure system; delivers two distinct pressure levels (IPAP/EPAP) to provide pressure support therapy. Includes 'Bi-Flex' feature in Spontaneous 'S' mode to ease transition from inspiration to exhalation, improving patient comfort. Device connects to patient via circuit (22mm tubing) and interface (nasal or full-face mask). Used in hospital/institutional environments; operated by clinicians. Output is regulated airflow; assists patient breathing by reducing work of breathing. Benefits include improved comfort and effective non-invasive ventilation for respiratory insufficiency or obstructive sleep apnea.

## 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-based system; bi-level positive pressure (IPAP/EPAP). Includes Bi-Flex software feature for pressure transition. Uses standard 22mm patient circuit tubing. Complies with FDA software guidance (May 1998).

## Regulatory Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

## Predicate Devices

- Respironics BiPAP Pro System ([K011714](/device/K011714.md))
- Respironics BiPAP Synchrony Ventilatory Support System ([K010263](/device/K010263.md))

## Submission Summary (Full Text)

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# Y OF SAFET Zita A. Yurko Official Contact

Manager, Regulatory Affairs/Product Assurance Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

724-387-4120 724-387-4206 (fax) email: Zita.Yurko@Respironics.com

Classification Reference

Product Code

MNS - Non-Continuous ventilator

Ventilator, continuous, non-life supporting Common/Usual Name

21 CFR 868.5895

Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex Proprietary Name

Predicate Device(s)

Respironics BiPAP Pro System (K011714)

Reason for submission

Modified design, enhanced mode; change in environment of use.

Respironics BiPAP Synchrony Ventilatory Support System (K010263)

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## Substantial Equivalence

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

- ロ Same intended use.
- Same operating principle. a
- Same technology. ា
- Same manufacturing process. ට

Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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 Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital/institutional environment.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

## Device Description

The Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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 Spontaneous "S" mode in the BiPAP Synchrony Ventilatory Support System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP Synchrony Ventilatory Support System with Bi-Flex is intended

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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, a method of venting exhaled gases, and a patient interface device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 0 2002

Ms. Zita A. Yurko Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550

Re: K020777

> BiPAP Synchrony Ventilatory Support System with Bi-Flex Regulation Number: 868.5895 Regulation Name: Ventilator, Continuous, Non-Life Supporting Regulatory Class: II (two) Product Code: 73 MNS Dated: March 7, 2002 Received: March 11, 2002

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.

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#### Page 2 - Ms. Zita A. 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 Crici at 00779 mostems (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Darth Telle

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): __ Ko Zo 177

Device Name: Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex

#### Intended Use/Indications for Use

The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

### Environment of Use/Patient Population

For use in the hospital/institutional environment on adult patients.

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|  | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801.109) |
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OR

| Over-The-Counter Use<br>(Optional Format 1-2-96) |
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Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K020777 |
|---------------|---------|
|---------------|---------|

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K020777](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNS/K020777)

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