BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM

K071509 · Respironics Inc., Sleep & Home Respiratory Group · MNS · Aug 8, 2007 · Anesthesiology

Device Facts

• Record ID: K071509
• Device Name: BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: MNS · Anesthesiology
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

Device Story

BiPAP Synchrony 2 is a non-continuous, non-invasive ventilator providing respiratory support. Device delivers positive airway pressure to patients with respiratory insufficiency or obstructive sleep apnea. Used in hospital or home settings by patients under physician prescription. System includes a main ventilator unit and a patient interface (mask). This submission adds a pediatric mask option to the existing system. Mask consists of a silicon cushion and polycarbonate faceplate with an integrated exhalation feature. Device operation remains unchanged from predicate; system monitors pressure, waveforms, triggering, and cycling to provide ventilation. Healthcare providers use device output to manage patient respiratory status. Benefits include non-invasive respiratory support for pediatric and adult populations.

Clinical Evidence

Bench testing only. Compatibility testing performed to verify the new pediatric mask functions correctly with the BiPAP Synchrony 2 system. Testing included pressure performance, waveform performance, triggering, cycling, and alarm functionality. All tests met acceptance criteria.

Technological Characteristics

Non-continuous ventilator. Materials: silicon cushion, polycarbonate faceplate. Features integrated exhalation port. Connectivity: standalone. Power: electrical. Operation: non-invasive positive pressure ventilation. Sterilization: not specified.

Indications for Use

Indicated for pediatric patients 7 years or older (>40 lbs) and adult patients (>66 lbs) with respiratory insufficiency or obstructive sleep apnea. For prescription use 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 2 Ventilatory Support System (K063533)
• Respironics Reusable Contour Nasal Mask (K991648)

Reference Devices

• Resmed Kidsta (K063533)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: This image shows a document labeled "TAB 3" and "510(K) SUMMARY OF SAFETY & EFFECTIVENESS". There is also a handwritten note that says "K071509" and "Page 1 of 2". The document appears to be a summary of safety and effectiveness for a medical device.

| Original Date of Submission | 30 May 2007 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | BiPAP Synchrony 2 Ventilatory Support System |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Establishment Registration # | 2518422 |
| Address of Mfr. Facility | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[phone] FAX [phone] CELL [phone] |
| Classification | Class II device |
| Classification Panel | Anesthesiology Devices |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | MNS - Noncontinuous ventilator |
| Predicate Device(s) | Respironics BiPAP Synchrony 2 Ventilatory Support System<br>(K063533) |
| | Respironics Reusable Contour Nasal Mask (K991648) |
| Labeling | Draft Labeling can be found in Tab 5. |
| Intended Use | The Respironics BiPAP Synchrony 2 is intended to provide non-<br>invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or<br>adult patients (> 66 lbs) with respiratory insufficiency or obstructive<br>sleep apnea, in the hospital or home. |
| Reason for Submission | Include a Respironics pediatric mask to use with this device. Device is<br>unchanged as a result of the addition of this mask |
| | AUG - 8 2007 |

## Substantial Equivalence

The BiPAP Synchrony 2 system has the following similarities to the previously cleared predicate device:

- □ Same intended use.
- □ Same operating principle.

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- Q Same technology.
- O Same manufacturing process.

There is no change to the intended use, operating principle, technology or manufacturing process for the BiPAP Synchrony. Further, there is no modification required to the BiPAP Synchrony 2 as a result of adding a Respironics pediatric mask to the existing cleared device (K063533). To demonstrate compatibility of the Respironics mask with the BiPAP Synchrony 2, mask compatibility testing was performed. This testing is provided in Tab 8 of this submission. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.

Respironics has followed the FDA's Guidance for Industry and FDA Staff document "pre-market assessment of pediatric medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the BiPAP Synchrony 2 system. As a result we conclude that the existing indications for use can be safety and effectively applied to this device with the new Respironics mask.

## Intended Use

The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (>66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

## Device Description

The Respironics BiPAP Synchrony 2 device is unchanged from K063533. The only change is to include a Respironics pediatric mask as a second option for use by its pediatric users. This mask is the same mask design as is used by the cleared Respironics Reusable Contour Deluxe Nask (K991648). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Pediatric Mask matches that of the Resmed Kidsta previously cleared in K063533.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is depicted with a modern, abstract design.

AUG - 8 2007

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K071509

Trade/Device Name: BiPAP Synchrony 2 Ventilatory Support System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: July 6, 2007 Received: July 9, 2007

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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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 forth in the quality systems (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), please contact 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 Division 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 vours.

Clus

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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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ BiPAP Synchrony 2______________________________________________________________________________________________________________________________________________

The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

Over-The-Counter Use __ Use Prescription X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

l
(Division Sign-Off) actings B.C.
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K071509

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