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.

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.

AI/ML Overview

This 510(k) submission (K012323) is for a modification to the Respironics BiPAP Synchrony Ventilatory Support System, specifically adding 3 alarms, expanding the EPAP setting to 30 cmH2O, and adding a remote control accessory. It is a modification to an existing device, not a new device requiring extensive clinical studies with human readers or AI.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "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."

However, the specific acceptance criteria and the detailed performance results (e.g., alarm thresholds, EPAP accuracy, remote control reliability) are NOT explicitly provided in the public summary. The 510(k) summary typically contains a high-level overview. Detailed test reports would be part of the full 510(k) submission, which is not publicly released in its entirety.

Table Placeholder (based on general understanding of device modifications):

Acceptance Criteria Category	Specific Criteria (Inferred/Generic)	Reported Device Performance
New Alarms	Alarms activate correctly for specified conditions (e.g., low pressure, high pressure, disconnect).	"Verified to meet the required acceptance criteria." (Specifics not provided)
	Alarm audibility and visibility meet relevant standards.	"Verified to meet the required acceptance criteria." (Specifics not provided)
Expanded EPAP Setting	EPAP delivery accuracy across the expanded range (up to 30 cmH2O).	"Verified to meet the required acceptance criteria." (Specifics not provided)
	EPAP stability under varying conditions.	"Verified to meet the required acceptance criteria." (Specifics not provided)
Remote Control	Remote control functionality (e.g., start/stop, pressure adjustments) works reliably.	"Verified to meet the required acceptance criteria." (Specifics not provided)
	Remote control range and interference resistance.	"Verified to meet the required acceptance criteria." (Specifics not provided)
Overall Safety	No new safety hazards introduced by modifications.	"Modifications have no impact on the safety and effectiveness of the device."
Overall Effectiveness	Device continues to provide non-invasive ventilation as intended.	"Modifications have no impact on the safety and effectiveness of the device."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the test set or the data provenance. Design verification tests generally involve testing multiple units of the modified device. Given this is a device modification (not a clinical study of diagnostic accuracy), the "test set" would refer to the units of the device being tested, not patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this 510(k) submission as it describes a modification to a medical device's hardware/software features, not a diagnostic or prognostic algorithm that requires expert consensus on ground truth from clinical data. The "ground truth" for this type of submission is defined by engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical data, where there might be disagreement among experts. For device design verification, a pass/fail criterion based on pre-defined specifications is typical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is about a device modification, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No, a standalone (algorithm only) performance study was not done. This concept is for AI algorithms separate from a human operator. The modifications here are integrated features of the BiPAP Synchrony device.

7. The Type of Ground Truth Used:

The ground truth used for these design verification tests would be engineering specifications and performance requirements for the alarms, EPAP delivery, and remote control functionality, as well as adherence to relevant regulatory standards (e.g., for safety, EMC). It is not clinical ground truth like pathology, expert consensus on images, or outcomes data, as this is not a diagnostic or treatment outcome study.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) describes a traditional medical device modification, not an AI/ML-driven device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

DEC 2 0 2001

K012323

510(K) SUMMARY OF SAFETY & EFFECTIVENES

Official Contact	David J. VanellaManager, Regulatory Affairs/Product AssuranceRespironics, Inc.1001 Murry Ridge LaneMurrysville, 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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{4}------------------------------------------------

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.

(Please do not write Below this line - Continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-The-Counter Use	(Optional Format 1-2-96)
----------------------	--------------------------

Division of Cardiovascular & Respiratory Devices

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

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).