(84 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms or concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is indicated for continuous intracranial pressure monitoring, which is a diagnostic or monitoring function, not a therapeutic one. Therapeutic devices are used for treatment.
No
Explanation: The device is described as a "Parenchymal Bolt Pressure Monitoring Kit" that is used for "continuous intracranial pressure monitoring". Monitoring is a form of measurement, not diagnosis. While the data collected might be used in a diagnostic process, the device itself performs monitoring, not diagnosis.
No
The device description explicitly states "Parenchymal Bolt Pressure Monitoring Kit," implying a hardware component (the bolt) is part of the system, 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 is for "continuous intracranial pressure monitoring" on patients. This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is a "Parenchymal Bolt Pressure Monitoring Kit." This description aligns with a device used for direct physiological measurement.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device directly measures a physiological pressure within the body.
N/A
Intended Use / Indications for Use
The Parenchymal Bolt Pressure Monitoring Kit is indicated for use on patients that require continuous intracranial pressure monitoring.
Product codes
GWM
Device Description
Parenchymal Bolt Pressure Monitoring Kit
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
intracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or qualified personnel under the direction of a 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
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(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 caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Ms. Jody J. Fleming Regulatory Affairs Specialist Camino Neurocare, Inc. 5955 Pacific Center Blvd. San Diego, California 92121
Re: K981846 Trade Name: Parenchymal Bolt Pressure Monitoring Kit Regulatory Class: II Product Code: GWM Dated: May 22, 1998 Received: May 26, 1998
Dear Ms. Fleming:
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 requirement, 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 - Ms. Jody J. Fleming
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 vour 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) 594-4595. 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 vours.
Sincerely yours,
Marti N Mulkerson
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 8 - STATEMENT OF INDICATIONS FOR USE
K 981846 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Parenchymal Bolt Pressure Monitoring Kit
Indications for Use:
The Parenchymal Bolt Pressure Monitoring Kit is indicated for use on patients that require continuous intracranial pressure monitoring.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's Directions for Use.
Prescription Use Only (Per 21 CFR 801.109)
Mark N. Millman
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K981846