The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to:

Color monitors for local and remote display of information
Chart recorders or printers for hardcopy records
Media for storage
Other devices to share information
Examples of areas where the MDP2000 is used include ICU, CCU, PACU, Emergency, Telemetry, Stepdown and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values such as heart rate and systolic, mean, and diastolic pressure.

Device Description

Color monitors for display of information
Chart recorders or printers for hardcopy records
Media for storage
Other devices to share information

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VIDCO MDP2000, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance to UL2601 (domestic standard of IEC 601-1)	Tested to and conforms with UL2601 (as a Class I Type B device). ETL listed indicating conformance.
Conformance to EN60601-1-2 (IEC 601-1-2) for Electromagnetic Compatibility (EMC)	Tested to and conforms to the requirements of EN60601-1-2. EMC performance exceeds the predicate devices.
Bench testing of specifications as called out in the Engineering Instrument Specification (integral part of the Device Master Record)	All tests were completed successfully. MDP2000 meets its specified performance.
Conformance to ANSI/AAMI EC13 (1992) Heart Rate Meters & Alarms	Performance includes those related to ANSI/AAMI EC13 (1992) Heart Rate Meters & Alarms.
Performance equivalent to or better than predicate devices	MDP2000 performance results are equivalent to or better than the predicate devices.
Safety and Effectiveness compared to predicate devices	No new questions of safety or effectiveness as it is performing essentially the same functions as the predicate devices. No new hazards arise.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" with a specific sample size in the context of clinical data. The primary validation method described is "bench testing of specifications." There is no mention of clinical data, human subjects, or specific data provenance like country of origin or retrospective/prospective study design, as the device is not patient-connected and its approval is based on substantial equivalence and technical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The validation method described is "bench testing of specifications" and regulatory standard conformance, not expert-adjudicated clinical data.

4. Adjudication method for the test set

Not applicable. The validation method described is "bench testing of specifications" to predefined engineering and regulatory standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The MDP2000 is a "Medical Data Processor" and not an AI-powered diagnostic tool that assists human readers. Its function is to process and display physiological information from existing patient monitoring equipment.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" system in its function. Its performance is evaluated based on its ability to process and output data according to established technical specifications and regulatory standards without human intervention being part of its core performance evaluation in the described tests. However, it's crucial to understand that it is intended for use in conjunction with patient monitoring equipment and for displaying information to human users. Therefore, its ultimate purpose is human-in-the-loop, but the device's individual performance (as described in the validation) is standalone from human judgment.

7. The type of ground truth used

The ground truth for the device's performance is based on:

Engineering Instrument Specifications: These define the expected technical performance characteristics.
Regulatory Standards: UL2601 (IEC 601-1), EN60601-1-2 (IEC 601-1-2), and ANSI/AAMI EC13 (1992). Compliance with these standards serves as the ground truth for safety, electrical performance, EMC, and specific physiological parameter processing (like heart rate).
Predicate Device Performance: The device's performance is also compared against and expected to be equivalent to or better than existing predicate devices, implying their established performance serves as a benchmark and a form of ground truth for substantial equivalence.

8. The sample size for the training set

Not applicable. As a medical data processor, the device's validation is based on engineering specifications and regulatory compliance, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the word "VIDCO" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The letters are evenly spaced and aligned horizontally.

OCT 22 1997
K972880

Information Display & Recording Systems

July 31, 1997

VIDCO MDP2000

510k SUMMARY

510k number:

Submitter: VIDCO, Inc. 6175 SW 112th Avenue Beaverton, OR 97008

Bradley A. Cohen Contact: Phone: (503) 641-1804 FAX (503) 641-1806

Device Name/Common Name: MDP2000 Medical Data Processor/Remote Display & Central Display

Color monitors for display of information
Chart recorders or printers for hardcopy records
Media for storage
Other devices to share information

The MDP2000 is substantially equivalent to current and previously marketed VIDCO products:

VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298)

The MDP2000 has no new questions of safety or effectiveness as it is performing essentially the same functions as the predicate devices. For the same rationale, no new hazards arise when comparing the MDP2000 to the predicate devices.

Technical characteristics of the MDP2000 are similar to the predicate devices. Primary differences include: Reduced physical size, improved display resolution capabilities (aesthetics), and improved user interface to simplify operation.

The MDP2000 has been tested to and conforms with UL2601, the domestic standard of IEC 601-1, as a Class I Type B device. Testing has been conducted by Intertek Testing Services (formerly Inchcape, Inc.), an NRTL (nationally recognized test laboratory), and Notified Body in the European Union. The MDP2000 is ETL listed indicating conformance to UL2601. The predicate devices, except 516YT and 520, were Underwriters Laboratory Listed under the now obsolete UL544.

The MDP2000 has been tested to and conforms to the requirements of EN60601-1-2 (IEC 601-1-2), Collateral Standard for Electromagnetic Compatibility. The testing was conducted by Northwest EMC which is an FCC, NIST, and NVLAP recognized testing facility in the United States and accepted and accredited internationally by agencies such as TÜV and NEMKO. The EMC performance of the MDP2000 exceeds the predicate devices.

Validation performed consists of bench testing of specifications as called out in the Engineering Instrument Specification that is an integral part of the Device Master Record. All tests were completed successfully and the MDP2000 meets it's specified performance including those related to ANSI/AAMI EC13 (1992) Heart Rate Meters & Alarms. The MDP2000 performance results are equivalent to or better than the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/3 description: The image shows the date October 22, 1997. The month is abbreviated to OCT. The day is 22 and the year is 1997. The text is in a simple, sans-serif font.

Mr. Bradley A. Cohen VIDCO, Inc. 6175 SW 112th Avenue 97008 Beaverton, Oregon

Re: K972880 MDP2000 Medical Data Processor Regulatory Class: II (two) 74 MSX Product Code: Dated: July 31, 1997 Received: August 5, 1997

Dear Mr. Cohen:

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 aqainst 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 Requlations, Title 21, Parts 800 to. 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, 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 requlations.

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Paqe 2 - Mr. Bradley A. Cohen

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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VIDCO MDP2000 510k

INTENDED USE STATEMENT

510k number: K972880

Device Name: MDP2000 Medical Data Processor

Color monitors for local and remote display of information
Chart recorders or printers for hardcopy records
· Media for storage
Other devices to share information

Examples of areas where the MDP2000 is used include ICU, CCU, PACU, Emergency, Telemetry, Stepdown and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values such as heart rate and systolic, mean, and diastolic pressure. This ملكة الكم over (1) to sixteen (16) pedside moritir Block Diagram

Image /page/3/Figure/10 description: The image shows a block diagram of a system labeled "MDP2000". The diagram has three inputs on the left side labeled "ANALOG", "DIGITAL", and "CONTROL". On the right side, there are four outputs labeled "VIDEO", "HARDCOPY", "DATA", and "SOUND". The arrows indicate the direction of signal flow from the inputs to the outputs through the MDP2000 system.

Arth. A. Liarlowski

(Division Sign-Off) Division of Cardiovascular, and Neurological Device 510(k) Number

Prescription Use $\frac{x}{(Per 21 CFR 801.109)}$

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).