(175 days)
The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.
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 K011714 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. 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.
The provided text describes a 510(k) premarket notification for the Respironics BiPAP Pro 2 Bi-level System. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices. It focuses on demonstrating equivalence rather than proving novel efficacy through extensive clinical studies.
Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not directly applicable or explicitly detailed in this type of regulatory document. The submission primarily relies on design verification tests demonstrating that the modified device meets its own product requirements and assumed equivalence to predicate devices, rather than a quantifiable study proving specific clinical performance against acceptance criteria in the way a new AI-powered diagnostic might.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the 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, the specific "acceptance criteria" (e.g., pressure accuracy within X mmHg, flow rate within Y L/min, noise levels below Z dB) and the reported numerical performance against those criteria are not provided in this summary. The statement indicates that these criteria were met, but does not detail them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "design verification tests" are typically engineering and functional tests on the device itself, not a clinical study on a patient population with a "test set" in the context of AI/diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or provided. Ground truth in this context (a BiPAP machine) would likely refer to engineering specifications and performance standards, not expert clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical trials or studies where there is subjective interpretation of data, which is not the primary focus of this device's regulatory submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable or provided. The device is a BiPAP machine, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided. The device is a therapeutic BiPAP machine, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be against its engineering specifications and functional requirements (e.g., delivering specific pressure levels, maintaining certain flow rates, safety standards). This is not explicitly detailed beyond the statement that "All tests were verified to meet the required acceptance criteria."
8. The sample size for the training set
This information is not applicable or provided. The device is a hardware-based medical device, not an AI model trained on a dataset.
9. How the ground truth for the training set was established
This information is not applicable or provided. See point 8.
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A Respironics BiPAP Pro 2 Bi-level System
0
510(K) SUMMARY OF SAFETY & EFFECTIVENESS #
| Official Contact | Zita A. YurkoManager, Regulatory Affairs/Product AssuranceRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668 |
|---|---|
| 724-387-4120724-387-4206 (fax)Email: Zita.Yurko@Respironics.com | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics BiPAP Pro 2 Bi-level System |
| Predicate Device(s) | Respironics BiPAP Pro Bi-level System (K011714)Respironics REMstar Auto CPAP System (K012554 & K031460)Respironics BiPAP Harmony Ventilatory Support System (K031656Resmed VPAP II ST Nasal VPAP System (K961783) |
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- D Same intended use.
- D Same operating principle.
- വ Same technology.
- Same manufacturing process. 口
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 K011714 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
MAR - 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita Yurko Regulatory Affairs Manager Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, PA 15668
Rc: K032834
Trade Name: BiPAP Pro 2 Bi-level System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 2, 2004 Received: March 3, 2004
Dear Ms. Yurko:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encreations of the enactment date of the Medical Device Amendments, or to commerce prior to may 20, sire) in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Herefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelove, manevelle a Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is onashined (socials. Existing major regulations affecting your device can thay be subject to saen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast be advised that 1197 or levice complies with other requirements of the Act that I DT has Interes and regulations administered by other Federal agencies. You must or any I coleral statutes and reguirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Zita Yurko
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as scheen CFR Part 807), labeling (21 CFR Part 807), good xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on device as described in your Section 510(k) I his ietter will anow you to oegin manceang your and equivalence of your device to a legally premarket notification. THC 1971 midnig of basisting of 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 If you desire specific advice for Jour as 1) 594-4646. Also, please note the regulation entitled, Comact the Office of Complians an (21 trist Part 807.97). You may obtain " Misoranding by Telefone to premation inibilities under the Act from the Division of Small other general information on your respense at its toll-free number (800) 638-2041 or Mandracturers, micrnational and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
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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510(k) Number (if known): K032834
Device Name: Respironics BiPAP Pro 2 Bi-level System
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.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment on adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | XXX |
|---|---|
| OR | |
| Over-The-Counter Use (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dermal Devices
| 510(k) Number: | K032834 |
|---|---|
| ---------------- | --------- |
§ 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).