(30 days)
Not Found
No
The summary explicitly states that the device is unchanged from previous versions and the only modification is the addition of a new mask. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea, which are therapeutic interventions.
No
The device is described as providing non-invasive ventilation for treatment of respiratory insufficiency or obstructive sleep apnea, not for diagnosing these conditions.
No
The device description explicitly mentions hardware components like a silicon cushion, polycarbonate faceplate, and an elbow with an exhalation feature, which are part of a physical mask. The submission also describes compatibility testing of this mask with a ventilation system, indicating a hardware-based device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide non-invasive ventilation for patients with respiratory insufficiency or obstructive sleep apnea. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a BiPAP machine and a mask, which are used to assist breathing. This aligns with a therapeutic device, not a diagnostic one that analyzes samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
Therefore, the Respironics BiPAP Synchrony 2 is a therapeutic medical device, not 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) or adult patients (> 66 lbs) 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 device is unchanged from K063533/K071509. The only change is to include the Respironics Performax Youth EE mask as a 3rd option for use by its pediatric users. This mask is the same mask design as is used by the small size of the cleared Respironics Performax Total Face Mask (K072592). The mask consists of a silicon cushion, polycarbonate faceplate with an elbow that contains the exhalation feature. The anthropometric profile of the Respironics Performax Youth EE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.
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) or adult patients (> 66 lbs)
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)
To demonstrate compatibility of the Respironics Performax Youth EE mask with the BiPAP Synchrony 2, mask compatibility testing was performed. This testing is provided in Tab 8 of this submission. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.
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
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| TAB 3 | K092043 |
|---|---|
| 510(K) SUMMARY OF SAFETY & EFFECTIVENESS | |
| Original Date of Submission | AUG 05 2009 |
| 30 June 2009 | |
| Device Trade Name | BiPAP Synchrony 2 |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Establishment Registration # | 2518422 |
| Address of Mfr. Facility | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 387-4120 FAX (724)-387-4216 CELL (724) 882-4120 | |
| Classification | Class II device |
| Classification Panel | Anesthesiology Devices |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | MNS - Noncontinuous ventilator |
| Predicate Device(s) | Respironics BiPAP Synchrony 2 Ventilatory Support System |
| (K063533/K071509) | |
| Respironics Performax Total Face Mask (K072592) | |
| Labeling | Draft Labeling can be found in Tab 5. |
| Intended Use | The Respironics BiPAP Synchrony 2 is intended to provide non- |
| invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or | |
| adult patients (> 66 lbs) with respiratory insufficiency or obstructive | |
| sleep apnea, in the hospital or home. | |
| Reason for Submission | Include a 3rd Respironics pediatric total face mask to use with this |
| device. Device is unchanged as a result of the addition of this mask |
.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Substantial Equivalence
The BiPAP Synchrony 2 system has the following similarities to the previously cleared predicate device:
- O Same intended use.
- D Same operating principle.
- O Same technology.
- D Same manufacturing process.
There is no change to the intended use, operating principle, technology or manufacturing process for the BiPAP Synchrony. Further, there is no modification required to the electromechanical platform of the BiPAP Synchrony 2 as a result of adding a third Respironics pediatric mask to the existing cleared device (K063533/K071509). To demonstrate compatibility of the Respironics Performax Youth EE mask with the BiPAP Synchrony 2, mask compatibility testing was performed. This testing is provided in Tab 8 of this submission. This testing included pressure performance, waveform performance, triggering, cycling and alarm functionality testing. All tests were verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness.
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 system. As a result we conclude that the existing indications for use can be safely and effectively applied to this device with the new Respironics mask.
Intended Use
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) or adult patients (>66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
Device Description
The Respironics BIPAP Synchrony 2 device is unchanged from K063533/K071509. The only change is to include the Respironics Performax Youth EE mask as a 3rd option for use by its pediatric users. This mask is the same mask design as is used by the small size of the cleared Respironics Performax Total Face Mask (K072592). The mask consists of a silicon cushion, polycarbonate faceplate with an
2
elbow that contains the exhalation feature. The anthropometric profile of the Respironics Performax Youth EE mask was designed to meet the 90" percentile for pediatrics age 7 and older and > 40 lbs.
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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 abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
AUG 0 5 2009
Re: K092043
Trade/Device Name: BiPAP Synchrony 2 Regulation Number: 868.5895 Regulation Name: Continuous Ventilators Regulatory Class: II Product Code: MNS Dated: June 30, 2009 Received: July 6, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Th for
Susan Runner, D.D.S., M.A. Acting 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
Indications for Use
510(k) Number (if known): J
Device Name: BiPAP Synchrony 2
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 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter 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)
(Division Sign-Off)
Anesthesiology, General Hospital
(Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Anosthoon Control, Devices
510(k) Number: K-092043
000037