(130 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as "microprocessor controlled" with "pre-set (fixed)" and "user adjustable" alarms, which are typical features of traditional medical devices and do not indicate AI/ML.
Yes
The device is intended to provide non-invasive ventilatory support to treat patients with medical conditions like obstructive Sleep Apnea and Respiratory Insufficiency, indicating a therapeutic purpose.
No
Explanation: The device description states it is a "ventilatory support system" intended to "provide non-invasive ventilatory support." Its function is to deliver positive pressure ventilation, not to diagnose medical conditions.
No
The device description explicitly states it is a "microprocessor controlled blower based positive pressure ventilatory system with integrated heated humidifier," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide non-invasive ventilatory support to treat patients with sleep apnea and respiratory insufficiency. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as a ventilatory support system that provides positive pressure. It manages airflow and pressure to assist breathing.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, or tissue) or performing any tests to diagnose a condition. Its purpose is to treat a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Respironics BiPAP AVAPS Ventilatory Support System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. BiPAP AVAPS Ventilatory Support System may be used in the hospital or home.
The Respironics BiPAP AVAPS Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP AVAPS Ventilatory System may be used in the hospital or home.
Product codes (comma separated list FDA assigned to the subject device)
MNS
Device Description
The Respironics BiPAP AVAPS Ventilatory Support System is a microprocessor controlled blower based positive pressure ventilatory system with integrated heated humidifier. The device platform being used as the key topic for this submission was previously cleared in K091319. The same ventilation modalities and therapy features, previously cleared in K071509 is also included in the BiPAP AVAPS Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous/Timed, Timed, Timed, Pressure Control modes with Bi-Flex or AVAPS therapy features available if enabled by the health care professional.
A Graphical user interface displays device data and device settings.
The BiPAP AVAPS Ventilatory Support System 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.
Like its predicates, the BiPAP AVAPS 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 tubing, an exhalation device, 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 and pediatric (> 7 years of age; > 40 lbs)
Intended User / Care Setting
hospital or home
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 AVAPS System 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 d scribed in this submission is substantially equivalent to the predicate devices.
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
| 510(K) SUMMARY OF SAFETY & EFFECTIVENESS |
|---|
| ------------------------------------------ |
| Official Contact | Zita A. Yurko
Director, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 | K092818
JAN 22 2010 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | 724-387-4120
724-387-7490 (fax)
Email: Zita. Yurko@Respironics.com | |
| Establishment Registration # | 2518422 | |
| Classification Reference | 21 CFR 868.5895 | |
| Product Code | MNS - ventilator, continuous, non-life supporting | |
| Common/Usual Name | Ventilatory Support System | |
| Proprietary Name | Respironics BiPAP AVAPS Ventilatory Support System | |
| Predicate Device(s) | Respironics BIPAP Synchrony 2 Ventilatory Support System
(K071509)
Respironics REMstar Q Series Auto with AFLEX CPAP System
(K091319) | |
| Reason for submission | Modified design. | |
・
·
1
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- ට Same intended use.
- 0 Same operating principle.
- Same technology.
- Same manufacturing process. ට
Design verification tests were performed on the Respironics BiPAP AVAPS System 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 d scribed in this submission is substantially equivalent to the predicate devices.
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 2006.
Intended Use
The Respironics BiPAP AVAPS Ventilatory Support System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. BiPAP AVAPS Ventilatory Support System may be used in the hospital or home.
Device Description
The Respironics BiPAP AVAPS Ventilatory Support System is a microprocessor controlled blower based positive pressure ventilatory system with integrated heated humidifier. The device platform being used as the key topic for this submission was previously cleared in K091319. The same ventilation modalities and therapy features, previously cleared in K071509 is also included in the BiPAP AVAPS Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous/Timed, Timed, Timed, Pressure Control modes with Bi-Flex or AVAPS therapy features available if enabled by the health care professional.
A Graphical user interface displays device data and device settings.
2
The BiPAP AVAPS Ventilatory Support System 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.
Like its predicates, the BiPAP AVAPS 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 tubing, an exhalation device, and a patient interface device.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
JAN 2 2 2010
Re: K092818
Trade/Device Name: Respironics BiPAP AVAPS Ventilatory System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilators Regulatory Class: II Product Code: MNS Dated: September 11, 2009 Received: October 26, 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
h fac
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control, and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
Page 1 of_1
Indications for Use
510(k) Number (if known):
Device Name: ____Respironics BiPAP AVAPS Ventilatory System
The Respironics BiPAP AVAPS Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 lbs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP AVAPS Ventilatory System may be used in the hospital or home.
Prescription Use 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 GDRH, Office of Device Evaluation (ODE)
L. Lw/thers
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Numbe
000064