(280 days)
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No
The description focuses on the device being an amplifier and electrical interface for pressure transducers, with no mention of AI or ML capabilities.
No
The device is described as an amplifier and electrical interface intended for "monitoring diagnostic pressures," not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section states that the device "is intended for use in monitoring diagnostic pressures."
No
The device description explicitly states it is a "Pressure Control Unit" and a "two-channel electrically isolated amplifier," which are hardware components. It provides an "electrical interface" between a transducer and a data acquisition module, further indicating a physical device.
Based on the provided text, the PCU-2000 Pressure Control Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring physiological pressures within the body (blood pressure, intracranial pressure, etc.). This involves direct interaction with the patient's body via a pressure catheter.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The PCU-2000 is a device that interfaces with a transducer (catheter) placed inside the body to measure physiological parameters. This falls under the category of a medical device used for in vivo measurements, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel
Product codes
DRO
Device Description
The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor.
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
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Indicated Patient Age Range
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Intended User / Care Setting
It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2002
Millar Instruments, Inc. c/o Ms. Monica R. Montanez Manager, Regulatory Affairs/Quality Assurance 6001-A Gulf Freeway Houston, TX 77023
Re: K013205
Trade Name: Pressure Control Unit PCU-2000 Regulation Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier and Conditioner Regulatory Class: Class II (two) Product Code: DRO Dated: April 8, 2002 Received: April 9, 2002
Dear Ms. Montanez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 aboye) 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.
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Page 2 - Ms. Monica R. Montanez - -
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.
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) 594-4646. 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.
Dala Mell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | K013205 |
|---|---|
| Device Name | Millar PCU-2000 |
| Indications for Use | The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDConcurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801. 109)
Dalateh
(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices
510(k) Number K013205
Over-The-Counter Use