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 K092043. The BiPAP Synchrony 2 is a microprocessor controlled blower based Bi-level positive pressure system that delivers two 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. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The only change to the Respironics BiPAP Synchrony 2 device is to include the small size Respironics AF531 EE Leak 1 Full Face Mask (no built-in exhalation) and the small size Respironics AF531 EE Leak 2 Full Face Mask (with built-in exhalation) as options for use by its pediatric users. These two masks consist of a silicon cushion, polycarbonate faceplate, and an integrated entrainment valve elbow made of polycarbonate with a silicone flapper. All of the materials used within these masks are predicate materials. The small size Respironics AF531 EE Leak 1 Full Face Mask has an entrainment elbow with no additional exhalation and will require a separate exhalation device. Whereas, the small size Respironics AF531 EE Leak 2 Full Face Mask has an entrainment elbow with built-in exhalation, negating the need for a separate exhalation device. Both masks are designed to be used with either the four point style headgear or the capstrap style headgear, allowing the patient an option.

Anthropometric analysis was performed on the small size of the Respironics AF531 EE Leak 1 Full Face Mask and the small size Respironics AF531 EE Leak 2 Full Face Mask. This analysis has determined that these two small masks will appropriately fit the pediatric population (> 7 years of age, > 40 lbs).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Respironics BiPAP Synchrony 2. The submission is to include two additional pediatric full face masks for use with the device. The core device (BiPAP Synchrony 2) itself is unchanged from a previously cleared device (K092043). Therefore, the study focuses on proving the compatibility and substantial equivalence of the new masks with the existing device.

Here's an breakdown of the acceptance criteria and the study as described:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance and Methodology
Mask Compatibility	- Pressure performance	Mask compatibility testing was performed with each mask. The testing included: Pressure performance, waveform, triggering, cycling, and alarm functionality testing. All tests were verified to meet the required acceptance criteria. Results concluded that the testing raised no new issues of safety or effectiveness.
	- Waveform
	- Triggering
	- Cycling
	- Alarm functionality
Pediatric Fit	- Appropriate fit for pediatric population (> 7 years of age, > 40 lbs) for the small size AF531 EE Leak 1 and AF531 EE Leak 2 Full Face Masks.	Anthropometric analysis was performed on the small size of both masks. This analysis determined that these two small masks will appropriately fit the pediatric population (> 7 years of age, > 40 lbs).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated in terms of the number of masks or individual tests performed. However, "mask compatibility testing was performed with each mask" refers to the two new pediatric masks (AF531 EE Leak 1 and AF531 EE Leak 2). The "anthropometric analysis" was also performed on "the small size of both" masks.
Data Provenance: Not specified (e.g., country of origin). The testing seems to be internal verification testing by the manufacturer, Respironics, Inc. It's an internal, prospective study to validate the new mask additions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is for compatibility of new accessories (masks) with an existing medical device. The "ground truth" for the performance criteria (pressure, waveform, etc.) would be established by engineering specifications and regulatory standards for ventilator performance, not by expert medical opinion in this context. The anthropometric analysis implicitly relies on expert knowledge of pediatric anthropometry, but no specific external experts are mentioned.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings (e.g., multiple readers interpreting images). The "verification testing" implies comparison against predefined acceptance criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-based device or a diagnostic imaging study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (ventilator and masks), not an algorithm.

7. The type of ground truth used

For Mask Compatibility: The ground truth would be established by predefined engineering specifications and regulatory standards for ventilator performance (e.g., specific pressure ranges, waveform characteristics, triggering sensitivity, alarm thresholds).

For Pediatric Fit: The ground truth is anthropometric data for the target pediatric population (> 7 years of age, > 40 lbs) coupled with design specifications for mask fit.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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TAB 3
510(K) SUMMARY OF SAFETY & EFFECTIVENESS

Original Date of Submission	April 21, 2010
Device Trade Name	BiPAP Synchrony 2 SEP 2 2010
Common/Usual Name	Ventilator, continuous, non-life supporting
Establishment Registration #	2518422
Official Contact / Address ofMfr. Facility	Zita A. YurkoRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668(724) 387-4120 FAX (724)-387-7490 CELL (724) 882-4120Zita.Yurko@Respironics.com
Classification	Class II device
Classification Panel	Anesthesiology Devices
Classification Reference	21 CFR 868.5895
Product Code	MNS - Continuous ventilator
Predicate Device(s)	Respironics BiPAP Synchrony 2 Ventilatory Support System (K092043)Respironics Performax Total Face Mask (K072592)Respironics Spectrum 2 Full Face Mask (K002465)
Labeling	Draft Labeling can be found in Tab 5.
Intended Use	The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) oradult patients (> 66 lbs) with respiratory insufficiency or obstructivesleep apnea, in the hospital or home.
Reason for Submission	Include two additional Respironics pediatric full face masks to be usedwith this device. Device is unchanged as a result of the addition ofeither of these masks.

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Substantial Equivalence

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

D Same intended use.
O Same operating principle.
O Same technology.
Same manufacturing process. ០

There is no change to the intended use, operating principle, technology or manufacturing process for the BiPAP Synchrony. Furthermore, there is no modification required to the electromechanical platform of the BiPAP Synchrony 2 as a result of adding additional Respironics pediatric masks to the existing cleared device (K092043). To demonstrate compatibility of the small size Respironics AF531 EE Leak 1 Full Face Mask (no built-in exhalation) and the small size Respironics AF531 EE Leak 2 Full Face Mask (with built-in exhalation) with the BiPAP Synchrony 2, mask compatibility testing was performed with each mask. This testing is provided in Tab 8 of this submission. This testing included pressure performance, waveform nee, 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 by adding the small size of either of these full face masks to the cleared BiPAP Synchrony 2.

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 safely and effectively applied to this device with the small size of either the Respironics AF531 EE Leak 1 Full Face Mask or the Respironics AF531 EE Leak 2 Full Face 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.

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Device Description

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings and body. The eagle faces to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Respironics, Incorporated C/O Ms. Zita A. Yurko Director, Regulatory Affairs Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

SEP 2 2010

Re: K101130

Trade/Device Name: BiPAP Synchrony 2 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: August 5, 2010 Received: August 10, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your (1 will ), it thay of color 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K101130

Page _ 1 of 1

Indications for Use

510(k) Number (if known): _ .

Device Name: _________________________________________________________________________________________________________________________________________________________________

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.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) a Olli (Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Antool, Dental Devices 1101130 510(k) Number: __

000037

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).