(9 days)
The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital/institutional environment.
The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.
The Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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. Respironics is adding an additional therapy feature to the existing Spontaneous "S" mode in the BiPAP Synchrony Ventilatory Support System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP Synchrony Ventilatory Support System with Bi-Flex 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, and a patient interface device.
The provided document is a 510(k) premarket notification for a medical device (Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex). It focuses on demonstrating substantial equivalence to a predicate device and does not contain the kind of detailed performance study information typically required for characterizing acceptance criteria, sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.
Therefore, most of the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, and sample sizes for training/test sets cannot be extracted from this document.
Here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document states: "Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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., specific pressure ranges, flow rates, response times) and the reported device performance against these criteria are not detailed in this submission. This document summarizes that tests were conducted and criteria were met, but it doesn't provide the criteria or performance data itself.
2. Sample sized 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 submission pertains to design verification, which typically involves engineering tests, not clinical data sets in the way an AI/ML study would.
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/provided. The device is a ventilatory support system, not an interpretive device that requires expert-established ground truth in the context of diagnostic performance studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically relevant for establishing ground truth in diagnostic studies, which is not the primary focus of this 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/provided. This device is a ventilatory support system, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device's performance relates to its mechanical and software functions to deliver ventilation, not an "algorithm only" performance in the context of an AI/ML model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not explicitly stated in the document, as the "ground truth" concept in this context would likely refer to engineering specifications and physical measurements, rather than clinical outcomes or expert consensus on diagnoses. The document mentions "risk analysis and product requirements" as the basis for design verification.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/ML product developed using training sets in the typical sense.
9. How the ground truth for the training set was established
This information is not applicable/provided.
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Y OF SAFET Zita A. Yurko Official Contact
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
Classification Reference
Product Code
MNS - Non-Continuous ventilator
Ventilator, continuous, non-life supporting Common/Usual Name
21 CFR 868.5895
Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex Proprietary Name
Predicate Device(s)
Respironics BiPAP Pro System (K011714)
Reason for submission
Modified design, enhanced mode; change in environment of use.
Respironics BiPAP Synchrony Ventilatory Support System (K010263)
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- ロ Same intended use.
- Same operating principle. a
- Same technology. ា
- Same manufacturing process. ට
Design verification tests were performed on the Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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 device.
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 Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital/institutional environment.
The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Device Description
The Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex 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. Respironics is adding an additional therapy feature to the existing Spontaneous "S" mode in the BiPAP Synchrony Ventilatory Support System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP Synchrony Ventilatory Support System with Bi-Flex is intended
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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, and a patient interface device.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
Ms. Zita A. Yurko Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550
Re: K020777
BiPAP Synchrony Ventilatory Support System with Bi-Flex Regulation Number: 868.5895 Regulation Name: Ventilator, Continuous, Non-Life Supporting Regulatory Class: II (two) Product Code: 73 MNS Dated: March 7, 2002 Received: March 11, 2002
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. Zita A. 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 Crici at 00779 mostems (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
Darth Telle
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __ Ko Zo 177
Device Name: Respironics BiPAP Synchrony Ventilatory Support System with Bi-Flex
Intended Use/Indications for Use
The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony may be used in the hospital or home.
The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Environment of Use/Patient Population
For use in the hospital/institutional environment on adult patients.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use(Per 21 CFR 801.109) |
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OR
| Over-The-Counter Use(Optional Format 1-2-96) |
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Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K020777 |
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§ 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).