(280 days)
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
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.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Pressure Control Unit PCU-2000" and an "Indications for Use Statement" attachment.
This document describes a medical device (transducer signal amplifier and conditioner) and its intended use, rather than an AI/algorithm-driven device that would undergo significant performance evaluation with acceptance criteria, ground truth, and studies like MRMC or standalone performance.
Therefore, the requested information about acceptance criteria and studies (including sample sizes, ground truth establishment, expert involvement, adjudication methods, and AI-specific studies) cannot be extracted from this document because:
- The device is a hardware component: The PCU-2000 is described as a "two-channel electrically isolated amplifier" intended to provide an "electrical interface" between a pressure transducer and a data acquisition module or medical monitor. It conditions analog signals, not processes complex image or sensor data with AI.
- The 510(k) clearance process for this type of device focuses on substantial equivalence: The letter confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This is different from the extensive performance validation required for AI/ML devices.
- No mention of AI, algorithms, or complex data analysis: The entire document refers to basic signal amplification and conditioning for physiological pressure measurements. There is no indication of any AI component, predictive modeling, or diagnostic algorithms that would necessitate the type of detailed performance studies you're asking about.
In summary, the provided text does not contain the information requested because the device described is not an AI/algorithm-driven device that would typically undergo such studies and evaluations.
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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
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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
§ 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).