The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. For use in the home or hospital/institutional environment on adult patients.

Device Description

The Respironics BiPAP Pro 2 Bi-level 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. The BiPAP Pro 2 Bi-level System also includes the flex therapy feature cleared in K032834 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. This clearance is seeking to extend the Bi-Flex range from 20 to 25 cmH2O maximum, to provide remote control of the device in a clinical setting and to allow viewing of compliance data by a physician/clinician. Like its predicates, the BiPAP Pro 2 Bi-level 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, an exhalation device, and a patient interface device.

AI/ML Overview

This document is a 510(k) premarket notification for a modified medical device, the Respironics BiPAP Pro 2 Bi-level System with Bi-Flex. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or comprehensive performance studies.

Therefore, much of the requested information regarding detailed acceptance criteria, study sizes, expert qualifications, and the specifics of a comparative effectiveness study is not provided in this regulatory submission.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Design verification tests were performed on the Respironics BiPAP Pro 2 Bi-level System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, no specific acceptance criteria or the reported device performance for those criteria are detailed in the provided text. The submission focuses on the argument of substantial equivalence based on sameness with predicate devices and compliance with general standards.

2. Sample Size for the Test Set and Data Provenance

Not applicable/Not provided. The submission refers to "design verification tests" but does not describe the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for these tests. The focus is on verifying engineering requirements rather than a clinical trial-like test set.

3. Number of Experts and Qualifications for Ground Truth of the Test Set

Not applicable/Not provided. Clinical trials with expert-established ground truth for a test set are not described in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. The submission is a 510(k) for a modified device, focusing on substantial equivalence, not a comparative effectiveness study showing improvement with AI assistance. The device also does not appear to incorporate AI.

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

No. This device is a hardware-based positive airway pressure system; it does not have a standalone "algorithm-only" performance that would typically be evaluated in such a study for software-as-a-medical-device (SaMD). The "design verification tests" would assess the integrated system's performance.

7. The Type of Ground Truth Used

The "ground truth" in the context of this submission refers to the engineering and performance specifications that the device was designed to meet, as verified by "design verification tests." The document states: "All tests were verified to meet the required acceptance criteria."

For the "Intended Use" and "Features": The ground truth is established by the functional requirements of the device (e.g., delivering positive airway pressure, bi-level pressure, Bi-Flex feature up to 25 cmH2O, remote control, viewing compliance data). Compliance with these features is assessed through engineering tests.
For "Safety and Effectiveness": The ground truth is compliance with applicable standards (e.g., 21 CFR 868.5905, Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 1998) and demonstration of substantial equivalence to predicate devices, implying similar safety and effectiveness profiles.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is not described as using machine learning or AI that would require a "training set" in the conventional sense. The "design verification tests" are for validating the product's engineering and performance against requirements.

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

Not applicable/Not provided, as there is no mention of a training set for an AI/ML algorithm. The "ground truth" for the device's design and testing would be based on engineering specifications and regulatory standards.

Summary

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

Respironics BiPAP Pro 2 Bi-level System with Bi-Flex

Official Contact Zita A. Yurko Manager, Regulatory Affairs/Product Assurance Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 724-387-4120 724-387-4206 (fax) Email: Zita.Yurko@Respironics.com 21 CFR 868.5905 Classification Reference BZD – Non-Continuous ventilator Product Code CPAP System Common/Usual Name Respironics BiPAP Pro 2 Bi-level System with Bi-Flex Proprietary Name Respironics BiPAP Pro 2 Bi-level System (K032834) Predicate Device(s)

Respironics BiPAP Synchrony Ventilatory Support System (K012323)

Reason for submission Modified design.

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

Substantial Equivalence

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

Same intended use. ロ
Same operating principle. a
ට Same technology.
D Same manufacturing process.

Design verification tests were performed on the Respironics BiPAP Pro 2 Bi-level 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 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 1998.

Intended Use

Device Description

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

and and the same and the comments of

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. :

patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

and the comments of the state of the season of the seems of

Comments of the

.. ..

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three parallel lines curving upwards and ending in a wavy, ribbon-like form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2005

Ms. Zita A. Yurko Manager, Regulatory Affairs/Product Assurance Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K043607

K043007
Trade/Device Name: Respironics BiPAP Pro 2 Bi-level System with Bi-Flex Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 29, 2004 Received: December 30, 2004

Dear Ms. Yurko:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 mendments, 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 the Feachar F 60at, Drag, Drag, therefore, market the device, subject to the general approvin application (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 (111), it a 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 Frease that FDA has made a determination that your device complies with other requirements mean that I DA nas made a december and regulations administered by other Federal agencies. UI fire Act of ally I occlar statues and equirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 et revior the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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) This letter will anon yourse of substantial equivalence of your device to a premaired notified.com - 11 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), rt you dents 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 maj overn 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 vours,

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

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

Page 1 of 1

510(k) Number (if known): 4043607

Device Name: Respironics BiPAP Pro 2 Bi-level System with Bi-Flex

Intended Use/Indications for Use

The Respironics BiPAP Pro 2 Bi-level System with Bi-Flex delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.

Environment of Use/Patient Population

For use in the home or hospital/institutional environment on adult patients.

メ Prescription Use_ (Per 21 CFR 801.109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cluz

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

510(k) Number. K043607

2 :

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).