(30 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) suggest a simpler verification mechanism.
No.
The device is designed to assist verification of placement of an endotracheal tube, acting as an adjunct to assess tracheal intubation. It is a diagnostic aid, not a device that provides therapeutic treatment itself.
Yes
The device is designed to "assist verification of placement of the endotracheal tube in the trachea," which is a diagnostic function to determine the correct location of a medical device within the body.
Unknown
The provided summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the Ventlab Verify II includes hardware components in addition to any potential software.
Based on the provided information, the Ventlab Verify II is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in verifying the placement of an endotracheal tube in the trachea. This is a procedure performed directly on a patient's airway, not on a sample of biological material taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on analysis of biological samples
The Ventlab Verify II appears to be a device used during a medical procedure to assess the location of a medical device (the endotracheal tube) within the body. This falls under the category of a medical device used for diagnosis or monitoring during a procedure, but not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ventlab Verify II is designed to assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation and does not eliminate clinical judgment.
Product codes
BTR
Device Description
Ventlab Verify II
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(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 features an abstract design of an eagle or bird-like figure with three stylized heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 1999
Mr. E. J. Smith Ventlab Corporation c/o Smith Associates P.O. Box 4341 Crofton, MD 21114-4341
K990098 Re: Ventlab Verify II Regulatory Class: II (two) Product Code: BTR January 7, 1999 Dated: Received: January 12, 1999
Dear Mr. Smith:
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, Druq, 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.
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Page 2 - Mr. E. J. Smith
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 requlation (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. Vallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name; Ventlab Verify II
Classification Panel: Class II, 876.5730, BTR
Indications for Use: The Ventlab Verify II is designed to assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation and does not eliminate clinical judgment.
Federal (USA) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over the Counter Use_
Christy Louman forms
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K990098