(70 days)
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No
The summary describes a traditional pressure transducer that converts fluid pressure into electrical signals for display. There is no mention of AI, ML, or any computational processing beyond signal conversion.
No
The device is used for monitoring, not for treating a disease or condition. It converts fluid pressure waveforms into electrical signals for display, which is a diagnostic function.
Yes
The device is described as a "TranStar Intracranial Pressure Transducer" intended for "external monitoring of Intracranial pressures (ICP)". Monitoring ICP is a diagnostic activity, as it provides information about a patient's physiological state to help diagnose conditions or guide treatment. It converts physical pressure into electrical signals for display, which is a key function of a diagnostic tool.
No
The device description explicitly states it is a "Transducer" which converts fluid pressure waveforms into electrical signals. This indicates a physical hardware component is involved, not just software.
Based on the provided information, the TranStar Intracranial Pressure Transducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "external monitoring of Intracranial pressures (ICP)". This involves measuring a physiological parameter within the patient's body (intracranial pressure).
- Mechanism: The device works by converting fluid pressure waveforms from the patient into electrical signals. This is a direct measurement of a physical parameter within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The TranStar device does not analyze samples taken from the body.
Therefore, the TranStar Intracranial Pressure Transducer falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.
Product codes
GWM
Device Description
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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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Law Regulatory Affairs Manager Medex, Inc. · 6250 Shier Rings Road Dublin, Ohio 43016-1295
Re: K020780
Trade/Device Name: TranStar Intracranial Pressure Transducer Regulation Number: 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: March 8, 2002 Received: March 11, 2002
Dear Ms. Law:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a rowe and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are based or 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Barbara Law
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Miriam C. Provost
Col Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
K.020780.
TranStar Intracranial Pressure Transducer Device Name:
Indications for Use:
The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020780
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use