The BiPAP AutoSV Advanced is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Device Description

The Respironics BiPAP AutoSV Advanced 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 BiPAP AutoSV Advanced pressure control contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the PSmin control. The device may automatically provide additional pressure support with inspiratory pressures between PSmin and PSmax to normalize patient ventilation during sleep disordered breathing events. Note: When PSmin = PSmax, this is equivalent to traditional bi-level therapy.

The BiPAP AutoSV Advanced 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 AutoSV Advanced 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 and a method of venting exhaled gases.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the BiPAP AutoSV Advanced, focusing on its substantial equivalence to predicate devices and general performance modifications.

However, based on the text, I can extract the following relevant information:

Key Takeaways from the Text:

Clinical Validation: The manufacturer performed "clinical validation to ensure the efficacy of the algorithm was not affected" due to modifications to the AutoSV algorithm.
Bench Data: Other device modifications were validated using "bench data" including waveform performance, triggering data, and overall event detection and control data.
Equivalence Claim: The testing "confirmed that the BiPAP AutoSV Advanced performs equivalently to the device predicate BiPAP AutoSV (K063540). All tests were verified to meet the required acceptance criteria."

Given the limited information, I cannot accurately fill out many of the requested fields. Here's a structured response based on what is available and what cannot be determined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests were verified to meet the required acceptance criteria" and that the device "performs equivalently to the device predicate BiPAP AutoSV (K063540)." However, it does not provide a specific table of these criteria or quantitative reported performance values for each criterion.

Acceptance Criteria (Example - Not explicitly stated in document)	Reported Device Performance (Example - Not explicitly stated in document)
Event detection accuracy (e.g., % sensitivity/specificity for apneas)	"Improved event detection" compared to predicate. Equivalent to predicate.
Pressure control stability/accuracy	"Use of EPAP Control for pressure control when central events are detected." Equivalent to predicate.
Response time of backup rate	"Improving the response time of the backup rate." Equivalent to predicate.
Waveform performance	Met required acceptance criteria; equivalent to predicate.
Triggering performance	Met required acceptance criteria; equivalent to predicate.
Overall event detection and control	Met required acceptance criteria; equivalent to predicate.

2. Sample Size and Data Provenance:

Sample Size for Test Set: Not specified. The document mentions "clinical validation" but does not give the number of patients or cases.
Data Provenance: Not specified. It's unclear if the validation data was prospective or retrospective, or its country of origin.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method:

Adjudication Method: Not specified.

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

MRMC Study Done?: No information provided. The document focuses on performance equivalence to a predicate device, not on human reader improvement with AI assistance.

6. Standalone Performance Study:

Standalone Study Done?: Likely yes, as implied by "bench data" and "clinical validation to ensure the efficacy of the algorithm was not affected." However, specific metrics for standalone performance (e.g., sensitivity, specificity for event detection) are not provided. The comparison is made against a predicate device.

7. Type of Ground Truth Used:

Type of Ground Truth: Not specified explicitly. For clinical validation of a ventilator algorithm, it would typically involve physiological measurements and potentially expert interpretation of physiological signals (e.g., polysomnography data for sleep disordered breathing events). For bench testing, it would be against known physical models or simulated conditions.

8. Sample Size for Training Set:

Sample Size: Not specified. The document mentions modifications to an existing algorithm ("AutoSV algorithm") but does not detail a training set for a de novo algorithm development.

9. How Ground Truth for Training Set was Established:

How Ground Truth Established: Not specified. As it's an update to an existing algorithm, it's possible that historical data and expert-defined criteria from the predicate device's development were used, but this is conjecture.

Summary

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OCT 3 0 2009

TAB 5

510(K) SUMMARY

K96033

Date of Submission

23 February 2009

Official Contact

Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Zita.yurko@respironics.com

724-387-4120 t 724-882-4120 c 724-387-4216 f

Classification Reference 21 CFR 868.5895

Product Code

Common/Usual Name Ventilator, continuous, non-life supporting

Proprietary Name

Predicate Device(s)

Respironics BiPAP Synchrony 2 (K063533)

MNS – Non-Continuous ventilator

Respironics BiPAP AutoSV Advanced

Respironics BiPAP AutoSV (K063540)

Reason for submission new device

Substantial Equivalence

The BiPAP AutoSV Advanced has the following similarities to the previously cleared predicate device:

Same intended use.
0 Same operating principle.
Same technology.
ರ Same manufacturing process.

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The BiPAP AutoSV was cleared in K063540. The BiPAP Synchrony 2 (new platform) was cleared in K063533. To update the device platform for the BiPAP AutoSV algorithm, the device platform cleared in K063533 was used. This platform updates the styling of the device and allows for an interface to an integrated heated humidifier. In addition to this update, some modifications to improve the performance of the device. These included improved event detection, use of EPAP Control for pressure control when central events are detected and improving the response time of the backup rate. Because these modifications affected the AutoSV algorithm, it was determined that these device modifications required clinical validation to ensure the efficacy of the algorithm was not affected. The remainders of the device modifications were validated using bench data. This testing including collecting waveform performance data, triggering data, and overall event detection and control data for comparison to the BiPAP AutoSV device (K063540). This testing has confirmed that the BiPAP AutoSV Advanced performs equivalently to the device predicate BiPAP AutoSV (K063540). All tests were verified to meet the required acceptance criteria.

Intended Use

The BIPAP AutoSV Advanced is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Device Description

The BiPAP AutoSV Advanced 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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

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

OCT 8 0 2009

Re: K090539

Trade/Device Name: BiPAP AutoSV Advanced Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: October 20, 2009 Received: October 21, 2009

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 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); 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting Division 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 AutoSV Advanced

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

12090539 510(k) Number:

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).