(38 days)
This ICP catheter is indicated for use on patients that require continuous intracranial pressure monitoring.
Ventrix™ Subdural Tunneling Pressure Monitoring Kit
This is a 510(k) clearance letter from 1998, which primarily establishes substantial equivalence to a predicate device. It predates the widespread use of AI in medical devices and the standardized reporting metrics for AI device performance that are now common. Therefore, the detailed information about acceptance criteria, specific studies proving AI performance, ground truth establishment for training data, and AI-specific study designs such as MRMC or standalone performance is not present in this document.
The document indicates that the device is a "Ventrix™ Subdural Tunneling Pressure Monitoring Kit" and its indications for use are "for patients that require continuous intracranial pressure monitoring."
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in the format usually requested for AI/software-driven devices (e.g., sensitivity, specificity, AUC).
The basis for clearance is "substantial equivalence (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This means the device was found to be as safe and effective as a legally marketed predicate device. The performance data would have been focused on demonstrating this equivalence, likely through traditional engineering and clinical validation rather than AI-specific metrics.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present in the clearance letter. For a 510(k) of this era and type of device (a physical monitoring kit, not an AI algorithm), the "test set" would refer to the clinical studies or engineering tests performed to demonstrate safety and effectiveness for substantial equivalence. Details on these are not included in the clearance letter itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not present. For a device like this, ground truth would typically be established through comparison to established clinical methods or other validated devices, rather than expert interpretation of images or other data for an AI algorithm.
4. Adjudication Method for the Test Set:
This information is not present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This information is not present. MRMC studies are specific to evaluating human reader performance, especially with and without AI assistance, and are not relevant to a physical intracranial pressure monitoring device from 1998.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not present. This device is a "kit" for monitoring pressure, implying a physical device used by clinicians, not a standalone algorithm.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. However, for an intracranial pressure monitoring device, the ground truth would typically involve:
- Direct measurement: Comparing the device's readings to other established methods of intracranial pressure measurement (e.g., direct ventricular catheterization, if applicable and considered the gold standard at the time).
- Clinical outcomes: Demonstrating that the information provided by the device aids in patient management resulting in comparable or improved clinical outcomes.
- Bench testing: Verifying the accuracy and reliability of the pressure readings against known pressure sources.
8. The Sample Size for the Training Set:
This information is not present. The concept of a "training set" is specific to machine learning and AI, which is not what this 1998 device falls under.
9. How the Ground Truth for the Training Set Was Established:
This information is not present for the reasons mentioned above.
In summary, this document is a 510(k) clearance for a physical medical device from 1998. It does not contain the type of detailed performance data or study design information typically associated with AI/software-driven devices or recent regulatory submissions that require such specificity. The clearance is based on substantial equivalence, implying that the device's technology and intended use were comparable to existing devices, and that relevant safety and performance data (which are not detailed here) supported this claim.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
Ms. Jody J. Fleming Senior Regulatory Affairs Specialist Camino Neurocare, Inc. 5955 Pacific Center Blvd. San Diego, California 92121
Re: K982702
Trade Name: Ventrix™ Subdural Tunneling Pressure Monitoring Kit Regulatory Class: II Product Code: GWM Dated: July 23, 1998 Received: August 3, 1998
Dear Ms. Flemming:
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 (OS) 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 - Ms. Jody J. Flemming
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) 594-4595. 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 yours,
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
{2}------------------------------------------------
Page 1 ___of of ___________________________________________________________________________________________________________________________________________________________________ 1
510(k) Number (if known):
Ventrix Subdural Tunneling Pressure Monitoring Device Name: Kit
Indications For Use:
This ICP catheter is indicated for use on patients that require continuous intracranial pressure monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices/682707
510(k) Number .
§ 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).