The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. 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 with AVAPS 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 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 AVAPS feature is professionally selected and rides on top of the existing modality provided by the BiPAP Synchrony. The BiPAP Synchrony with AVAPS pressure control that contains various controls which are used to configure positive pressure therapies.

The BiPAP Synchrony with AVAPS is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The BiPAP Synchrony with AVAPS 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 device (mask).

AI/ML Overview

This submission describes the Respironics BiPAP Synchrony with AVAPS Ventilatory Support System, a continuous ventilator intended for non-invasive ventilatory support in adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The submission states that the device builds upon an existing cleared device platform, the Respironics BiPAP Synchrony (K992530, K012323, K020777).

1. Acceptance Criteria and Reported Device Performance:

The document mentions that "All tests were verified to meet the required acceptance criteria," but does not explicitly list the specific acceptance criteria or provide quantitative performance metrics. It generally states:

Performance Metric Category	Acceptance Criteria	Reported Device Performance
Equivalence to Predicate	Equivalent to or better than existing therapy without AVAPS.	"Results from this study determined that AVAPS is as effective as that of therapy without AVAPS."
Bench Testing	Meet required acceptance criteria.	"Bench testing has confirmed that the BiPAP Synchrony with AVAPS performs equivalently to the device predicate BiPAP Synchrony (K992530/K012323/K020777)."
Alarms Data	(Not specified)*	(Not specified)*
Triggering Data	(Not specified)*	(Not specified)*
Waveform Performance Data	(Not specified)*	(Not specified)*
Overall Event Detection and Control Data	(Not specified)*	(Not specified)*

* The document states that bench testing included collecting this data for comparison and confirmed equivalence, implying these aspects met their respective (unspecified) acceptance criteria.

2. Sample Size and Data Provenance for Test Set:

Sample Size: Not specified for the clinical study. Bench testing details are also not quantified in terms of number of tests or samples.
Data Provenance: The document does not specify the country of origin of the data. The clinical study is described as having been performed by Respironics, suggesting internal data. The nature of the study (clinical study and bench testing) suggests it could be prospective, but this is not explicitly stated.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

Not applicable. The study primarily relies on comparing the AVAPS feature to existing therapy and comprehensive bench testing. There is no mention of experts establishing a "ground truth" in the diagnostic or interpretative sense for the test set. The clinical study aimed to establish therapeutic effectiveness.

4. Adjudication Method for Test Set:

Not applicable. There is no mention of an adjudication process as would be typical for studies involving human interpretation or subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes a clinical study to assure therapy provided with AVAPS was equivalent to or better than existing therapy provided without AVAPS. It does not describe an MRMC study comparing human readers with and without AI assistance. The device is a ventilatory support system, not an interpretive AI tool for imaging or diagnostics.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, in essence. The clinical study evaluated the effectiveness of the AVAPS feature as delivered by the device, independent of direct human intervention during the process of ventilation delivery itself. The bench testing also assessed the device's technical performance in a standalone manner. The device is controlled by a microprocessor and delivers therapy based on its internal algorithms.

7. Type of Ground Truth Used:

For the clinical study, the "ground truth" was likely clinical outcomes or measures of therapeutic effectiveness, as the study aimed to determine if AVAPS was "as effective as that of therapy without AVAPS." The specific metrics are not detailed, but would typically involve physiological parameters related to ventilation and patient well-being for OSA/Respiratory Insufficiency. For bench testing, the ground truth was derived from engineering specifications and performance expectations for waveform, triggering, and alarm data.

8. Sample Size for the Training Set:

Not applicable. The device is built on an existing platform and the AVAPS feature is an added functionality. There is no mention of a machine learning model that would require a distinct "training set" in the context of this submission. The device is stated to be microprocessor-controlled, but the development process doesn't explicitly refer to a machine learning training phase.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no explicitly defined "training set" in the context of this submission. The development of the AVAPS algorithm would have been based on physiological principles and engineering design, potentially informed by clinical expertise and data from previous device iterations or relevant medical literature.

Summary

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Traditional 510(k) Tab 5 – 510(k) summary

<070328

TAB 5

2007 MAY 8 -

510(K) SUMMARY

Date of Submission	31 January 2007
Official Contact	Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668Zita.yurko@respironics.com
	724-387-4120 t724-882-4120 c724-387-4216 f
Classification Reference	21 CFR 868.5895
Product Code	MNS - Continuous ventilator
Common/Usual Name	Ventilator, continuous, non-life supporting
Proprietary Name	Respironics BiPAP Synchrony with AVAPS Ventilatory Support System
Predicate Device(s)	Respironics BiPAP Synchrony HC (K992530)
	Respironics BiPAP Synchrony S/T (K012323/K020777)
Reason for submission	new device (built on an existing cleared device platform)

Substantial Equivalence

The BiPAP Synchrony with AVAPS has the following similarities to the previously cleared predicate device:

□ Same intended use.
Same operating principle. ០
Q Same technology.
D Same manufacturing process.

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The BiPAP Synchrony was cleared in K992530/K012323/K020777. To establish a basis for effectiveness of the Average Volume Assured Pressure Support ventilation therapy feature, Respironics performed clinical study to assure therapy provided with AVAPS was equivalent to or better than existing therapy provided without AVAPS. Results from this study determined that AVAPS is as effective as that of therapy without AVAPS. Further, a risk analysis to identify the consideration of using the existing BiPAP Synchrony electromechanical platform with the Average Volume Assured Pressure Support Ventilation therapy feature to treat adult patients with OSA and Respiratory Insufficiency. To determine equivalence between the Respironics BiPAP Synchrony with AVAPS and the Respironics BiPAP Synchrony, comprehensive bench testing was performed. This testing including collecting waveform performance data, triggering data, alarms data, and overall event diction and control data for comparison. Bench testing has confirmed that the BiPAP Synchrony with AVAPS performs equivalently to the device predicate BiPAP Synchrony (K992530/K012323/K020777). All tests were verified to meet the required acceptance criteria.

Intended Use

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.

Device Description

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The BiPAP Synchrony with AVAPS is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is facing to the right, and the text is arranged around the circle.

MAY 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070328

Trade/Device Name: BiPAP Synchrony with AVAPS Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: April 30, 2007 Received: May 1, 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 (sec 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. 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 forth in the quality systems (OS) 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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): K070328

Device Name: _________________________________________________________________________________________________________________________________________________________________

Intended Use/Indications for Use

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.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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070328

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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).