(246 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is not provided.
Yes
The device is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea, which are medical conditions, and is used in healthcare settings.
No
Explanation: The device is described as a "Ventilatory Support System" intended to "assist the ventilation" of patients, which indicates it is a therapeutic device, not a diagnostic one. It helps with breathing rather than identifying a condition.
No
The device is described as a "Ventilatory Support System," which inherently implies the presence of hardware components (like a ventilator) to provide ventilatory support. The summary does not mention it being software-only.
Based on the provided information, the SULLIVAN® VPAP™ II ST Ventilatory Support System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Ventilatory Support System intended to assist the ventilation of adult patients". This describes a device that directly interacts with the patient's respiratory system to provide physical support for breathing.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The provided description does not mention any analysis of biological samples, diagnostic testing, or any function related to analyzing substances from the body.
Therefore, the SULLIVAN® VPAP™ II ST Ventilatory Support System falls under the category of a medical device used for therapeutic support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SULLIVAN® VPAP™ II ST Ventilatory Support System is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.
Product codes
73 MNt
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Scott Dudevoir Resmed Ltd. C/O Resmed Corp. 5744 Pacific Centre Blvd. San Diego, CA 92131
Re: K974539 Sullivan® VPAP II ST Ventilatory Support System Requlatory Class: II (two) Product Code: 73 MNt Dated: August 3, 1998 Received: August 4, 1998
Dear Mr. Dudevoir:
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 requlations 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 regulatory 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.
1
Page 2 - Mr. Scott Dudevoir
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,
Thomas J. Callahan
Thomas J. CallaMan, Ph.D 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
510(k) Number (if known): K974539
Device Name: SULLIVAN® VPAP™ II ST Ventilatory Support System
- The SULLIVAN® VPAP™ II ST Ventilatory Support System is Indications For Use: intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark Uane
/ For PRESCRIPTION USE
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .