(212 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea, which directly addresses a health condition.
No
The device is described as assisting ventilation for spontaneously breathing patients, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The description refers to a "System" and "ventilation," which strongly implies hardware components like a ventilator and mask, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting the ventilation of spontaneously breathing adult patients. This is a therapeutic and life-support function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to obtain diagnostic information. IVDs are specifically designed for this purpose.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information about image processing, AI/ML, imaging modality, and performance studies related to diagnostic accuracy further supports that this is not an IVD.
In summary, the SULLIVAN VPAP II ST-A System is a respiratory support device, not a diagnostic device.
N/A
Intended Use / Indications for Use
The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.
Product codes
73 MNS
Device Description
Not Found
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 patients
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)
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/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle symbol. The eagle is depicted with three abstract, curved lines forming its body and wings, conveying a sense of motion and progress.
JUN 2 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Dudevoir Director Technology Development ResMed Corporation 10121 Carroll Canyon Road San Diego, CA 92131-1109
K974417 Re: SULLIVAN® VPAP II ST-A Nasal VPAP System Requlatory Class: II (two) Product Code: 73 MNS Dated: March 24, 1998 Received: March 26, 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 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 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. David D'Cruz
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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use 3.3.
510(k) Number (if known):
SULLIVAN® VPAP II ST-A Nasal VPAP System Device Name:
- The SULLIVAN VPAP II ST-A System is intended to assist Indications For Use: the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974417
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)