(289 days)
This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use.
This device includes the capability for monitoring the following patient parameters:
- ECG .
Heart Rate .
Pulse Oximetry .
Non-Invasive Blood Pressure ●
. Invasive Blood Pressure
End-Tidal Carbon Dioxide / Nitrous Oxide .
Respiration effort .
. Rra
Not Found
This document is a 510(k) clearance letter from the FDA for a patient monitor and does not contain the detailed study information typically requested for AI/ML device evaluations, such as acceptance criteria, performance metrics, sample sizes, or ground truth establishment.
A 510(k) clearance evaluates a new device for substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety like a PMA (Premarket Approval). Therefore, the document focuses on regulatory approval rather than a detailed performance study report.
Based on the provided text, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI/ML device, so such a study would not apply.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not applicable for this type of device.
- How the ground truth for the training set was established: Not applicable for this type of device.
The document primarily states:
- Device: Omni-Trak™ 3150 Series Patient Monitor
- Intended Use: Patient vital signs monitor during magnetic resonance imaging (MRI) scans. To be used by or on the order of a physician or similarly qualified healthcare professional in hospital environments (MRI, Radiology Clinic, or similar settings). Not intended for home use.
- Monitored Parameters: ECG, Heart Rate, Pulse Oximetry, Non-Invasive Blood Pressure, Invasive Blood Pressure, End-Tidal Carbon Dioxide / Nitrous Oxide, Respiration effort.
- Regulatory Class: II (two)
- Product Code: 74 MHX
- Determination: Substantially equivalent to devices marketed prior to May 28, 1976.
To obtain the kind of study data requested, one would typically need access to the full 510(k) submission, which would include detailed testing protocols and results demonstrating the device meets its own specifications and is substantially equivalent to a predicate device in terms of safety and effectiveness, but not necessarily advanced AI/ML performance metrics as posed in the question.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1998
Mr. Francis X. Casey Invivo Research, Inc. 12601 Research Parkway Orlando, FL 32826
K971840 Re: Omni-Trak™ 3150 Series Patient Monitor Regulatory Class: II (two) Product Code: 74 MHX Dated: February 16, 1998 February 17, 1998 Received:
Dear Mr. Casey
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 Existing major regulations affecting your device additional controls. 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. Francis X. Casey
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
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ATTACHMENT 1
INDICATIONS FOR USE
This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use.
This device includes the capability for monitoring the following patient parameters:
- ECG .
Heart Rate .
Pulse Oximetry .
Non-Invasive Blood Pressure ●
. Invasive Blood Pressure
End-Tidal Carbon Dioxide / Nitrous Oxide .
Respiration effort .
. Rra
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971840
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.