The Respironics BiPAP AVAPS Ventilatory Support System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. BiPAP AVAPS Ventilatory Support System may be used in the hospital or home.

Device Description

The Respironics BiPAP AVAPS Ventilatory Support System is a microprocessor controlled blower based positive pressure ventilatory system with integrated heated humidifier. The device platform being used as the key topic for this submission was previously cleared in K091319. The same ventilation modalities and therapy features, previously cleared in K071509 is also included in the BiPAP AVAPS Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous/Timed, Timed, Timed, Pressure Control modes with Bi-Flex or AVAPS therapy features available if enabled by the health care professional.

A Graphical user interface displays device data and device settings.

The BiPAP AVAPS Ventilatory Support System 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.

Like its predicates, the BiPAP 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 tubing, an exhalation device, and a patient interface device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics BiPAP AVAPS Ventilatory System:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting required criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as intended and safely	Design verification tests performed and verified to meet required acceptance criteria. Modifications have no impact on safety and effectiveness.
Compliance with applicable standards	Complies with "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 2006.
Substantially equivalent to predicate devices	Determined to be substantially equivalent to predicate devices based on intended use, operating principle, technology, and manufacturing process.

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

Sample Size: The document does not specify a separate "test set" and thus does not provide a sample size for it. The verification tests performed are mentioned generally, implying internal testing without a specific patient or image-based test set from external data.
Data Provenance: Not applicable, as a distinct test set with external data is not described. The document discusses design verification tests, which are typically conducted internally.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. The document does not describe the establishment of a "ground truth" for a test set using external experts. The verification appears to be against internal specifications and safety/effectiveness standards.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The document does not describe a process involving multiple reviewers or an adjudication method for a test set.

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

MRMC Study: No. The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is a ventilatory support system, not an AI-assisted diagnostic tool.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Standalone Study: The document describes "Design verification tests" performed on the BiPAP AVAPS System. While this implies testing of the device's functionality, it's not a "standalone algorithm-only study" in the context of typical AI/software performance evaluations. The device's primary function is mechanical ventilation, and the "software" aspect is inherent to its control system. The stated compliance with software guidance does not equate to an AI algorithm performance study.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" for this device's performance appears to be based on:
- Internal design specifications and requirements: The device was designed to meet certain functional and safety standards.
- Industry standards and regulations: Compliance with applicable medical device standards and FDA guidance.
- Substantial equivalence to predicate devices: The functionality and safety are indirectly validated by demonstrating similarity to previously cleared devices.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This document describes a ventilatory support system, not a device that employs machine learning or AI algorithms with a "training set" of data in the typical sense. The software and control logic are likely based on engineering principles and pre-programmed algorithms, not data-driven machine learning models.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning. The "ground truth" in the context of this device's development would be the fundamental physiological principles of ventilation and the desired performance characteristics of the system, established through engineering design, medical knowledge, and regulatory requirements.

Summary

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

510(K) SUMMARY OF SAFETY & EFFECTIVENESS
------------------------------------------

Official Contact	Zita A. YurkoDirector, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668	K092818JAN 22 2010
	724-387-4120724-387-7490 (fax)Email: Zita. Yurko@Respironics.com
Establishment Registration #	2518422
Classification Reference	21 CFR 868.5895
Product Code	MNS - ventilator, continuous, non-life supporting
Common/Usual Name	Ventilatory Support System
Proprietary Name	Respironics BiPAP AVAPS Ventilatory Support System
Predicate Device(s)	Respironics BIPAP Synchrony 2 Ventilatory Support System(K071509)Respironics REMstar Q Series Auto with AFLEX CPAP System(K091319)
Reason for submission	Modified design.

・

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

Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

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

Design verification tests were performed on the Respironics BiPAP AVAPS 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 d scribed in this submission is substantially equivalent to the predicate devices.

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 2006.

Intended Use

Device Description

A Graphical user interface displays device data and device settings.

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

The BiPAP AVAPS Ventilatory Support System 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.

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

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

JAN 2 2 2010

Re: K092818

Trade/Device Name: Respironics BiPAP AVAPS Ventilatory System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilators Regulatory Class: II Product Code: MNS Dated: September 11, 2009 Received: October 26, 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.

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

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 vours.

h fac

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

{5}------------------------------------------------

Page 1 of_1

Indications for Use

510(k) Number (if known):

Device Name: ____Respironics BiPAP AVAPS Ventilatory System

The Respironics BiPAP AVAPS Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP AVAPS Ventilatory System may be used 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 GDRH, Office of Device Evaluation (ODE)

L. Lw/thers

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

510(k) Numbe

000064

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).