(13 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or complex predictive algorithms).
Yes
The device is a ventilator, which is used to assist or control breathing in patients. This directly addresses medical conditions by supporting a vital bodily function, classifying it as a therapeutic device.
No
A ventilator assists breathing and is not described as diagnosing medical conditions.
No
The summary describes a ventilator, which is a hardware device used for mechanical ventilation. There is no mention of software being the primary or sole component.
Based on the provided information, the Venturi® ventilator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "mechanically control or assist the breathing of adult and pediatric patients." This describes a device that interacts directly with the patient's respiratory system.
- IVD Definition: In vitro diagnostics are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to detect diseases, conditions, or infections. The Venturi® ventilator does not perform this function.
Therefore, the Venturi® ventilator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Venturi® ventilator is intended to mechanically control or assist the breathing of adult and pediatric patients. The Venturi® is designed for use in hospital intensive care units (ICU).
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
Venturi® Ventilator
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 and pediatric patients
Intended User / Care Setting
hospital intensive care units (ICU)
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.
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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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Mr. John LaViola Cardiopulmonary Corp. 200 Cascade Boulevard Milford, CT 06460
Re: K990429 Venturi® Ventilator Requlatory Class: II (two) Product Code: 73 CBK February 9, 1999 Dated: Received: February 11, 1999
Dear Mr. LaViola:
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 A substantially equivalent determination assumes compliance to 895. 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.
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Page 2 - Mr. John LaViola
This letter will allow you to begin marketing your device as described inis recei will arrow you co iceation. The FDA finding of substantial In your 510(x) premained noto a legally marketed predicate device equivalence or 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 regulacion (21 orrelate ase contact the Office of Compliance at Graghobers actroomally, for questions on the promotion and (301) 354 4040. haarenene please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 33 4009. Tiroo, passo premarket notification" (21 CFR 807.97). Hrobranding by Formation on your responsibilities under the Act may other general Information of Small Manufacturers Assistance at its be obtained trom eno bra8-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, 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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APPENDIX E
Indications for Use Statement
| 510(k)
| Number | K990429 |
|---|---|
| Device Name | Venturi® Ventilator |
| Indications for | |
| Use | The Venturi® ventilator is intended to mechanically control or assist the |
| breathing of adult and pediatric patients. The Venturi® is designed for use in | |
| hospital intensive care units (ICU). |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
z kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 990429 510(k) Number