(90 days)
Not Found
No
The description mentions a "microprocessor controlled blower based Bi-level positive pressure system" and "redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller". This indicates standard microprocessor control based on sensor data, not AI/ML. There is no mention of AI, ML, deep learning, or any related terms.
Yes
The device is intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea, delivering positive pressure therapy to improve breathing. This directly addresses and treats a medical condition.
No
The device is described as a "Ventilatory Support System" intended to provide "non-invasive ventilation" and "positive pressure therapy" for respiratory insufficiency or obstructive sleep apnea. Its function is to deliver two positive pressure levels, not to diagnose a condition.
No
The device description clearly states it is a "microprocessor controlled blower based Bi-level positive pressure system" and includes physical components like a blower assembly, flow sensor, and pressure sensors, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Respironics BiPAP Synchrony 2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Respironics BiPAP Synchrony 2 is a ventilatory support system that provides non-invasive positive pressure ventilation directly to the patient's airway. It does not analyze any biological specimens.
- Intended Use: The intended use is to provide respiratory support for patients with respiratory insufficiency or obstructive sleep apnea, not to perform diagnostic tests on samples.
Therefore, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 Ibs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
Product codes (comma separated list FDA assigned to the subject device)
MNS
Device Description
The Respironics BiPAP Synchrony 2 Ventilatory Support System is a microprocessor controlled blower based Bi-level positive pressure system that delivers two 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. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
The BiPAP Synchrony 2 also has a CPAP mode in which a fixed pressure is delivered and four bilevel operating modes which determine how the changes between IPAP and EPAP pressures are made, Spontaneous, Spontaneous/Timed, Timed and Pressure Control.
The BiPAP Synchrony 2 is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The BiPAP Synchrony 2 Ventilatory Support 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, a method of venting exhaled gases, and the Mirage Kidsta mask (K060105).
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
pediatric patients 7 years or older (> 40 lbs), adult patients (> 66 Ibs)
Intended User / Care Setting
Not Found
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)
Bench testing has confirmed that the BiPAP Synchrony 2 performs equivalently to the device predicate VPAP III ST-A (K060105). Additionally bench testing was performed to demonstrate compatibility of the Kidsta mask (K060105) with the BiPAP Synchrony. This testing included, pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria.
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.
K992530, K012323, K031656, K060105
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
Abbreviated 510(k) Tab 5 – 510(k) summary
4063533
BiPAP Synchrony 2
TAB 5
510(K) SU
| Date of Submission | 20 November 2006 |
|---|---|
| Official Contact | Zita A. Yurko |
| Manager, Regulatory Affairs | |
| Respironics, Inc. | |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Zita.yurko@respironics.com | |
| 724-387-4120 t | |
| 724-882-4120 c | |
| 724-387-4216 f | |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | MNS - Non-Continuous ventilator |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Proprietary Name | Respironics BiPAP Synchrony 2 Ventilatory Support System |
| Predicate Device(s) | Respironics BiPAP Synchrony HC (K992530) |
| Respironics BiPAP Synchrony S/T (K012323) | |
| Respironics BiPAP Harmony (K031656) | |
| Resmed VPAP III ST-A / Kidsta system (K060105) | |
| Reason for submission | Include pediatric (7 years and older > 40 lbs) indication |
Substantial Equivalence
The BiPAP Synchrony 2/ Kidsta system has the following similarities to the previously cleared predicate device:
- ロ Same intended use.
- Same operating principle.
- Same technology.
1
Tab 5 – 510(k) summary
D Same manufacturing process.
The BiPAP Synchrony was cleared in K992530/K012323. The BIPAP Harmony was cleared in K031656 using the BiPAP Synchrony as the device predicate. The Mirage Kidsta was cleared in K060105. Respironics has performed a risk analysis to identify the additional considerations of using the BiPAP Synchrony 2 / Kidsta system on pediatric patients (> 7 years and > 40 lbs). Additional testing based on the BiPAP Synchrony 2 / Kidsta risk analysis was performed to ensure the safety and efficacy of the BiPAP Synchrony 2/ Kidsta system when used on the pediatric patient (> 7 years and > 40 lbs). Bench testing has confirmed that the BiPAP Synchrony 2 performs equivalently to the device predicate VPAP III ST-A (K060105). Additionally bench testing was performed to demonstrate compatibility of the Kidsta mask (K060105) with the BiPAP Synchrony. This testing included, pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria.
Respironics has followed the FDA's Guidance for Industry and FDA Staff document "pre-market assessment of pediatric medical devices" and applied the principle of FDA's Least Burdensome Approach to demonstrate the Substantial Equivalence of the BiPAP Synchrony 2/ Kidsta mask system to its predicate devices (Respironics BiPAP Synchrony, BiPAP Harmony and the VPAP ST-A/Kidsta mask system). We conclude that the existing and cleared adult indications for use can be safety and effectively applied to pediatric patients (> 7 years and > 40 lbs).
Intended Use
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
Device Description
The Respironics BiPAP Synchrony 2 Ventilatory Support System is a microprocessor controlled blower based Bi-level positive pressure system that delivers two 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. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.
2
The BiPAP Synchrony 2 also has a CPAP mode in which a fixed pressure is delivered and four bilevel operating modes which determine how the changes between IPAP and EPAP pressures are made, Spontaneous, Spontaneous/Timed, Timed and Pressure Control.
The BiPAP Synchrony 2 is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
The BiPAP Synchrony 2 Ventilatory Support 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, a method of venting exhaled gases, and the Mirage Kidsta mask (K060105).
(End of Tab.)
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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Incorporated Ms. Zita A. Yurko Manager, Regulatory Affairs Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
FEB 2 0 2007
Re: K063533
Trade/Device Name: BiPAP Synchrony 2 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: November 20, 2006 Received: November 22, 2006
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. 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 forth in the quality systems (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). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely vours.
Chris
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
Indications for Use
510(k) Number (if known): __ ______
Device Name: _________________________________________________________________________________________________________________________________________________________________
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 Ibs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
Prescription Use ____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mh. A. Anker
sthesiology, General Hos
S0001 Number K063533
040019