BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM

K012323 · Respironics, Inc. · MNS · Dec 20, 2001 · Anesthesiology

Device Facts

• Record ID: K012323
• Device Name: BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
• Applicant: Respironics, Inc.
• Product Code: MNS · Anesthesiology
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics BiPAP Synchrony Ventilatory Support System 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.

Device Story

Microprocessor-controlled, blower-based Bi-level positive pressure system; delivers two distinct positive pressure levels (IPAP/EPAP) to provide pressure support therapy. Used in hospital or home environments by clinicians or patients. Device connects to patient via patient circuit (22mm tubing) and interface (nasal or full-face mask). Modifications include addition of 3 alarms, expansion of EPAP setting to 30 cmH2O, and inclusion of a remote control accessory for clinical settings. Output provides non-invasive ventilatory support to improve patient comfort and treat respiratory conditions.

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; Bi-level positive pressure (IPAP/EPAP). EPAP range expanded to 30 cmH2O. Includes 3 alarms and remote control accessory. Patient circuit uses 22mm smooth lumen tubing. Complies with FDA software guidance (May 1998).

Indications for Use

Indicated for adult patients (>30 kg) with respiratory insufficiency or obstructive sleep apnea requiring non-invasive ventilation in hospital or home settings.

Regulatory Classification

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 Synchrony HC (K992530)

Submission Summary (Full Text)

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DEC 2 0 2001

K012323

# 510(K) SUMMARY OF SAFETY & EFFECTIVENES

| 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 | MNS - Non-Continuous ventilator |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Proprietary Name | Respironics BiPAP Synchrony Ventilatory Support System |
| Predicate Device(s) | Respironics BiPAP Synchrony HC (K992530) |
| Reason for submission | Modified design |

## Substantial Equivalence

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

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

Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support 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.

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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 Synchrony Ventilatory Support System 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.

### Device Description

The Respironics BiPAP Synchrony Ventilatory Support 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 modifying the existing device with the addition of 3 alarms, expanding the EPAP setting to 30 cmH2O and adding a remote control accessory for use in a clinical setting. The BiPAP Synchrony Ventilatory Support 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, a method of venting exhaled gases, and a patient interface device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 2 0 2001

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

#### Re: K012323

Synchrony Ventilatory Support System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II (two) Product Code: MNS Dated: November 23, 2001 Received: December 3, 2001

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 Yurko

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a built of a station of the requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations and iding, but not limited to: registration and listing (21 comply with an the Act s requirements, merceans, and acturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) I his letter will anow you to begin mailering of substantial equivalence of your device to a legally premarket nothication. The PDA maing of backander squaree 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 IT you desire specific advice for your as its of the sites , please contact the Office of additionally 21 CFN Fall 607.10 for mirrate cranestions on the promotion and advertising of Compliance at (301) 594-676. Thenkelling of Compliance at [phone]. Also, please note the your device, produce comary aby reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misorananing of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Daletull

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): _KOL2323___

Device Name: Respironics BiPAP Synchrony Ventilatory Support System

### Intended Use/Indications for Use

The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) f rno Cynomic of respiratory insufficiency (a condition in which the patient can for the trounner.
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 home or hospital/institutional environment on adult patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X (Per 21 CFR 801.109) |
|------------------|------------------------|
|------------------|------------------------|

OR

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

| 510(k) Number | K012323 |
|---------------|---------|
|---------------|---------|