K Number
K043607
Device Name
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
Manufacturer
Date Cleared
2005-01-28

(29 days)

Product Code
Regulation Number
868.5905
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The description focuses on microprocessor control, pressure delivery, and comfort features, with no mention of AI or ML technologies.

Yes
The device delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea, indicating a therapeutic purpose.

No

The device is described as a system that "delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea." Its function is therapeutic, not diagnostic. It does not mention any capabilities for detecting, analyzing, or identifying medical conditions.

No

The device description clearly states it is a "microprocessor controlled blower based bi-level positive pressure system" and mentions hardware components like tubing and a mask, indicating it is a physical device with software control, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for delivering positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description focuses on the mechanical function of delivering air pressure and managing patient comfort. It does not mention any analysis of biological samples (blood, urine, tissue, etc.).
  • Lack of IVD Keywords: There are no mentions of terms typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," etc.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device directly treats a condition by providing mechanical support to the airway.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

BZD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Home or hospital/institutional environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K032834, K012323

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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

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

2

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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.

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Comments of the

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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

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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)

OR

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

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