(9 days)
Not Found
No
The description mentions a "microprocessor controlled blower based bi-level positive pressure system" and a new "therapy feature" to ease transition between inspiration and exhalation. It does not mention any AI or ML algorithms, training data, or performance metrics typically associated with AI/ML devices. The focus is on pressure delivery and timing control, which are standard functions of ventilatory support systems.
Yes
The device is described as providing "pressure support therapy" for conditions like respiratory insufficiency and obstructive sleep apnea, indicating its role in treating these medical conditions.
No
The device is described as providing non-invasive ventilation for treatment of respiratory insufficiency or obstructive sleep apnea, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "microprocessor controlled blower based bi-level positive pressure system" and mentions hardware components like tubing and masks, indicating it is a physical medical 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 clearly states that the Synchrony is for providing non-invasive ventilation to patients for the treatment of respiratory insufficiency or obstructive sleep apnea. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The description details a ventilatory support system that delivers positive pressure to the patient. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Synchrony is a therapeutic medical device, not an IVD.
N/A
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/institutional environment.
The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Product codes (comma separated list FDA assigned to the subject device)
MNS
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients (>30 kg)
Intended User / Care Setting
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 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.
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.
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
§ 868.5895 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).
0
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)
1
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
2
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.
3
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.
4
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
5
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.
(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) |
|---|
| ------------------------------------------ |
OR
| Over-The-Counter Use
| (Optional Format 1-2-96) |
|---|
| -------------------------------------------------- |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K020777 |
|---|---|
| --------------- | --------- |