(236 days)
The BiPAP® Synchrony™ HC is a non-invasive, pressure support ventilator used to
- i) Augment the breathing of patients suffering from acute or chronic respiratory insufficiency
- ii) Maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea.
It is not intended to provide the total ventilatory requirements of the patient.
The BiPAP® Synchrony™ HC is intended for use with nasal masks and full-face masks as recommended by Respironics.
The BiPAP Synchrony is intended to provide non-invasive ventilation in adult patients (>30kg) 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 ventilator is intended for use with nasal masks and fullface masks as recommended by Respironics.
The BiPAP® Synchrony™ HC is a noninvasive pressure support ventilator and is classified under product code MNS (continuous ventilator, non-life supporting).
The BiPAP Synchrony HC provides therapy in the Continuous Positive Airway Pressure (CPAP) Spontaneous/Timed (S/T), Pressure Assist, and Timed modes.
The provided text describes a medical device, the BiPAP® Synchrony™ HC, and its substantial equivalence to a predicate device. It details the device's functions, intended use, and various tests performed to demonstrate its safety and effectiveness. However, the document does not contain the specific information required to answer your questions about acceptance criteria and a study that proves the device meets those criteria.
Here's why and what's missing:
- No Acceptance Criteria Table: The document states that "Testing was performed to demonstrate that the performance of the BiPAP® Synchrony™ HC in its intended environment is as safe and effective as that of the legally marketed predicate device." It also mentions compliance with "standards referenced in the 'Draft FDA Reviewer Guidance for Ventilators,' July 1995 as well as with the 'Draft Reviewer Guidance for Premarket Notifications, 'November 1993." However, it does not provide a table outlining specific acceptance criteria (e.g., minimum accuracy percentages, maximum deviation values) for its performance and then reporting the device's measured performance against those criteria.
- No Study Details: While the document confirms that "performance-related testing in addition to electrical safety, electromagnetic compatibility, mechanical and environmental testing" was conducted, it does not provide any details about a specific study (e.g., clinical trial, validation study) that would assess the device's performance against predefined acceptance criteria. Therefore, information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies is absent.
In summary, based on the provided text, I cannot answer your request as the necessary study details and acceptance criteria are not present. The document focuses on regulatory approval (510(k) submission) by demonstrating substantial equivalence, which is a different scope than detailing specific performance studies with acceptance criteria.
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MAR 2 0 2000
SECTION 1
SUMMARY
Image /page/0/Picture/5 description: The image shows the logo for RESPIRONICS INC. The logo consists of a triangle with a stylized figure inside, and the text "RESPIRONICS INC." is written below the triangle. The address "1001 Murry Ridge Drive, Murrysville, PA 15" is written below the company name.
1001 Murry Ridge Drive, Mt
| Official Contact | David J. VanellaManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668 |
|---|---|
| Classification Reference | 21 CFR 868.5895 |
| Common/Usual Name | MNS (continuous ventilator, non-life-supporting) |
| Proprietary Name | BiPAP® Synchrony™ HC |
| Internal Project Name | Vireo |
| Predicate Device | Respironics Quantum™ PSV (K962517) |
| Reason for submission | New Device |
Substantial Equivalence
This premarket notification section 510(k) submission demonstrates that the BiPAP® Synchrony™ HC is substantially equivalent to, and has the same intended use as, the Respironics Quantum PSV.
Testing was performed to demonstrate that the performance of the BiPAP® Synchrony™ HC in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of BiPAP® Synchrony™ HC were verified through performance-related testing in addition to electrical safety, electromagnetic compatibility, mechanical and environmental testing. The BiPAP® Synchrony™ HC was tested and found compliant (as applicable for Code MNS)
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with the standards referenced in the "Draft FDA Reviewer Guidance for Ventilators," July 1995 as well as with the "Draft Reviewer Guidance for Premarket Notifications, "November 1993.
Intended Use/Indications for Use
The BiPAP® Synchrony™ HC is a non-invasive, pressure support ventilator used to
- i) Augment the breathing of patients suffering from acute or chronic respiratory insufficiency
- ii) Maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea.
It is not intended to provide the total ventilatory requirements of the patient.
The BiPAP® Synchrony™ HC is intended for use with nasal masks and full-face masks as recommended by Respironics.
Environment of Use/Patient Population
The BiP Synchrony™ HC is intended for use in the home, but may also be used in the hospital or other institutional settings.
The BiPAP® Synchrony™ HC is intended for adult patients (>30kg).
Brief Device Description
The BiPAP® Synchrony™ HC is a noninvasive pressure support ventilator and is classified under product code MNS (continuous ventilator, non-life supporting).
The BiPAP Synchrony HC provides therapy in the Continuous Positive Airway Pressure (CPAP) Spontaneous/Timed (S/T), Pressure Assist, and Timed modes.
CPAP Mode
In this mode, a clinician can set CPAP.
- The device delivers CPAP to the patient at the CPAP setting. t
Spontaneous/Timed (S/T) Mode
The clinician sets IPAP, EPAP, Rate, and Inspiratory Time.
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- The device delivers patient-triggered, pressure-limited, patient-cycled breaths if the patient's . breathing rate is above the Rate setting.
- The device delivers machine-triggered, pressure-limited, time-cycled breaths if the patient's . breathing rate falls below the Rate setting. The Inspiratory Time setting controls the triggering of the inspiratory phase. The Inspiratory Time setting does not affect the cycling of a spontaneous breath.
Pressure Assist Mode
The clinician sets IPAP, EPAP, Rate, and Inspiratory Time.
- The device delivers machine or patient-triggered, pressure-limited, machine-cycled breaths. .
- This mode is equivalent to the S/T mode with one exception: all breaths are machine-cycled and . therefore have a fixed Inspiratory Time. The patient may initiate a breath but all breaths will be pressure-limited (IPAP) and time-cycled. The cycle time is determined by the Inspiratory Time control setting.
- The patient-controllable Rise Time may enhance patient-ventilator synchrony and patient . comfort.
Timed Mode
The clinician sets IPAP, EPAP, Rate, and Inspiratory Time.
- The device delivers machine-triggered, machine-cycled breaths. The triggering is determined by ● the Rate control, and the cycle time is determined by the Inspiratory Time control.
Features
PERFORMANCE
- I Provides non-invasive application of CPAP and bi-level pressure support ventilation.
- Provides spontaneous triggering based on the Respironics Auto-Trak™ Sensitivity system. ■
- Compensates for most leaks in the patient circuit and patient interface. E
- Compensates the unit outlet pressure for flow based pressure drops in the patient circuit. ■
SAFETY
- Provides built-in alarms for high pressure and low pressure. 월
- 트 Provides internal circuit monitoring for safety.
- I Provides an optional oxygen valve that closes when the blower is off, preventing oxygen flow.
- 비 Provides a patient disconnect alarm with a time delay that is set by the clinician.
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Figure 1 shows the BiPAP® Synchrony™ HC system, which includes:
- BiPAP® Synchrony™ HC unit l
- Circuit tubing ■
- Patient interface 1
- 할 Exhalation port
Image /page/3/Figure/7 description: This image shows a BiPAP Synchrony HC device with various labeled components. The device features a keypad/LED display and an optional oxygen valve. Connected to the device via circuit tubing is a bacteria filter, also labeled as optional, and an exhalation port leading to a patient interface, which is marked as typical.
Figure 1. BiPAP® Synchrony™ HC System.
BiPAP® Synchrony™ HC Accessories
The BiPAP® Synchrony™ HC can be used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and headgear assemblies), humidifier, and circuit tubing.
(End of Section.)
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Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
MAR 2 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550
Re: K992530 BiPAP® Synchrony™ HC Regulatory Class: II (two) 73 MNS Product Code: December 30, 1999 Dated: January 3, 2000 Received:
Dear Mr. Vanella:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this. response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. David J. Vanella
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Jean H Westerman feg
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of_1
02
510(k) Number (if known): K992530
Device Name: Respironics® BiPAP Synchrony™ HC
Intended UseIIndications for Use
The BiPAP Synchrony is intended to provide non-invasive ventilation in adult patients (>30kg) 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 ventilator is intended for use with nasal masks and fullface masks as recommended by Respironics.
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 | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, and Neurological Devices | ||
| §10(k) Number | ||
| 02/15/00 TUE 14:49 [TX/RX NO 5963] 00 |
§ 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).