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

The BiPAP AutoSV 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 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..

AI/ML Overview

The provided 510(k) summary for the BiPAP AutoSV device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them. This document is a summary and primarily focuses on demonstrating substantial equivalence to predicate devices through
bench testing and general comparisons, rather than a detailed report of clinical study outcomes or specific acceptance criteria for performance metrics.

However, based on the provided text, here's what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states: "Bench testing has confirmed that the BiPAP AutoSV performs equivalently to the device predicate VPAP Adapt (K051364). All tests were verified to meet the required acceptance criteria."

This statement confirms that acceptance criteria exist and were met, but the document does not specify what those criteria are, nor does it provide a table of performance metrics. It only broadly mentions "waveform performance data, triggering data, alarms data, and overall event diction and control data."

Acceptance Criteria	Reported Device Performance
Not specified in the provided document.	Equivalently performed to predicate VPAP Adapt (K051364) in waveform performance, triggering, alarms, and overall event detection and control data.
Specific thresholds for performance related to waveform, triggering, alarms, and event detection.	Met all required acceptance criteria for these tests.

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

The document refers to "comprehensive bench testing."

Sample Size: The sample size for the test set is not specified. This typically refers to the number of devices or test conditions used in bench testing.
Data Provenance: The data provenance is bench testing, meaning it's laboratory-generated data from Device A versus Device B comparison, rather than human subject data. The "country of origin" for the data is implicitly where the testing was conducted, likely the manufacturer's facilities (Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668, USA). This testing is retrospective in the sense that it compares a new device against an already cleared predicate device's performance characteristics.

3. Number of Experts and Their Qualifications for Ground Truth

This device's submission relies on bench testing for proving equivalence, not clinical studies involving human patients where expert-established ground truth would be relevant for diagnostic or therapeutic accuracy. Therefore, information about the number or qualifications of experts used to establish ground truth is not applicable in this context as described in the summary.

4. Adjudication Method for the Test Set

Since the testing described is primarily bench testing comparing device performance parameters, an "adjudication method" in the sense of resolving discrepancies between expert interpretations (e.g., 2+1, 3+1 for clinical evaluations) is not applicable. The "adjudication" would be based on objective measurements against pre-defined engineering or performance specifications.

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

No, an MRMC comparative effectiveness study was not done according to this 510(k) summary. The document explicitly states the equivalence was demonstrated through "comprehensive bench testing." MRMC studies are typically used for diagnostic devices to assess the impact of AI on human reader performance, which doesn't fit the context of this ventilatory support system's submission as described.

6. Standalone (Algorithm Only) Performance

The summary describes the device as a "microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels." The "AutoSV algorithm" is mentioned as a component. While the algorithm is a key part of the device's functionality, the performance testing described is for the integrated device ("BiPAP AutoSV performs equivalently"). Therefore, a standalone algorithm-only performance study is not explicitly mentioned or implied. The performance is assessed at the device level.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be the established performance specifications and data from the predicate device (Resmed VPAP Adapt, K051364). The BiPAP AutoSV's performance data (waveform, triggering etc.) was compared against these established benchmarks to demonstrate "equivalence." It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense.

8. Sample Size for the Training Set

This 510(k) submission is for a medical device (ventilator) that incorporates an algorithm. It is not an AI/ML diagnostic or prognostic software submission where a "training set" of patient cases for algorithm development would typically be disclosed as a distinct component. The document does not provide information on a "training set" for the AutoSV algorithm. Algorithm development often involves internal testing and refinement, but details about specific training data are not part of this 510(k) summary.

9. How Ground Truth for the Training Set Was Established

As a "training set" for an explicit AI/ML algorithm is not described in this 510(k) summary, the method for establishing its ground truth is not applicable/not provided.

Summary

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Abbreviated 510(k) Tab 5 - 510(k) summary

K063540

Date of Submission 22 November 2006

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

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

Classification Reference 21 CFR 868.5895

Product Code

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

Proprietary Name Respironics BiPAP AutoSV Ventilatory Support System

MNS – Non-Continuous ventilator

Predicate Device(s) Respironics BiPAP Synchrony HC (K992530) Respironics BiPAP Synchrony S/T (K012323) Respironics BiPAP Harmony (K031656) Resmed VPAP III ST-A / Kidsta system (K060105)

Reason for submission new device

Substantial Equivalence

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

0 Same intended use.
Same operating principle. D
Same technology. 0

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Tab 5 – 510(k) summary

O Same manufacturing process.

The BiPAP Synchrony was cleared in K992530/K012323/K020777. The VPAP Adapt was cleared in K051364. Respironics has performed a risk analysis to identify the consideration of using the existing BiPAP Synchrony electromechanical platform with the AutoSV algorithm to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. To determine equivalence between the Respironics BiPAP AutoSV and the Resmed VPAP Adapt, 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 to the VPAP Adapt. Bench testing has confirmed that the BiPAP AutoSV performs equivalently to the device predicate VPAP Adapt (K051364). All tests were verified to meet the required acceptance criteria.

Intended Use

The BIPAP AutoSV 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 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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... .....

Tab 5 – 510(k) summary

(End of Tab.)

000021

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 2 2 2007

Re: K063540

Trade/Device Name: BiPAP AutoSV Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: November 22, 2006 Received: November 24, 2006

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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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 (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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

Ellis-Lain, 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): _

Device Name: ____BiPAP AutoSV

The BiPAP AutoSV 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.

Over-The-Counter Use _ Prescription Use __ × AND/OR (Part 21 CFR 801 Subpart D) (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)

Will Maler for M. Husband

Anesthestology Concral Hospital Control. Dental Devices

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).