HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B by HEWLETT-PACKARD GMBH

The Hewlett-Packard Viridia M3/M4 Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters' of adults, pediatrics, and neonates in the hospital and medical transport environments.

List of supported measurements ECG (a) Respiration (b) Invasive blood pressure (c) Non-invasive blood pressue ( વ ) SpO2 and Pleth (e) Temperature ( ) ) CO2 ( વે )

Device Description

The modification is the addition of a firmware and software based change that involves the addition of the M3016A Module to the portable Viridia M3/M4 Patient Monitor System to allow CO-Pressure, and Temperature measurements with the unit.

AI/ML Overview

The provided text describes a 510(k) summary for the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3016A, which is primarily a patient monitoring system. The information focuses on the substantial equivalence of the new device (with the M3016A module) to previously cleared HP devices.

However, the provided text does not contain the detailed information required to fill out all the sections of your request regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of an AI/algorithm-driven device. The document is for a patient monitor and its new module, not an AI diagnostic tool as implied by many of your questions (e.g., ground truth, MRMC study, standalone algorithm performance).

Based on the available text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document broadly states: "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence." This is a very high-level statement and does not provide specific numerical acceptance criteria or performance metrics for parameters like sensitivity, specificity, accuracy, or other typical AI performance measures.

Acceptance Criteria (General)	Reported Device Performance
Based on standards, where applicable.	Test results showed substantial equivalence to predicate devices.
Based on specifications cleared for predicate devices.	Test results showed substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text states: "Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems."
This indicates that a real-world patient test set was not used. No sample size for a test set is mentioned, nor is data provenance or whether it was retrospective/prospective, as it was based on simulated systems.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth from experts would be relevant for diagnostic devices interpreting findings, not for a patient monitor measuring physiological parameters with simulated systems.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is relevant for expert-adjudicated ground truth in diagnostic studies, which was not performed here.

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. This device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance.

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

The device is a patient monitor. Its "performance" refers to its ability to accurately measure physiological parameters. The text suggests testing was done on the system and its components. While it functions without human "interpretation" of its measurements in the diagnostic sense, it's not an algorithm in the sense of a standalone diagnostic AI. Its tests were against established specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the verification and validation, the "ground truth" or reference was likely derived from the specifications and standards used for the simulated systems, ensuring the device accurately measures the intended physiological parameters within acceptable tolerances. This is based on technical specifications rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is a patient monitor, not an AI model that requires a training set in the machine learning sense. The "simulated systems" were used for testing, not training.

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

Not applicable, as there was no training set in the AI/machine learning context.

Summary

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8.0 510 (k) Summary

JAN 2 8 2000

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is: Egon Pfeil Regulatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 D-71034 Germany 011 49 (7031) 14-2243 Tel: Fax: 011 49 (7031) 14-4297 Email:egon pfeil@hp.com
  This summary was prepared on June 10, 1999

The name of this device is the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3016A (Viridia M3/M4, Rel. B.). The common name is patient monitor. Classification names are as follows:

RegulationNumber	Classification Name
870.2850	Extravascular Blood Pressure Transducer
870.1435	Computer, Diagnostic, Pre-Programmed, Single-Function
870.1025	Detector and Alarm, Arrythmia
870.2900	Cable, Transducer and Electrode, Patient (includingconnector)
868.1499	Carbon Dioxide Gas Analyzer
880.2910	Clinical Electronic Thermometer

1. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K971910, K981576, and K990125.
1. The modification is the addition of a firmware and software based change that involves the addition of the M3016A Module to the portable Viridia M3/M4 Patient Monitor System to allow CO-Pressure, and Temperature measurements with the unit.
1. The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment or mobile environment for patient transport monitoring, the device is intended for measuring and displaying, recording, and alarrie multiple physiological parameters and waves in adult, pediatmin, and neonatal patients.
1. The new combination device has the same technological characteristics as the legally marketed predicate devices.

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1. Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems. Testing included system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is facing left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2000

Mr. Egon Pfeil Hewlett-Packard GmbH Herrenberger Strasse 110-140 Boeblingen GERMANY 71034

Re: K992273 M3016A Measurement Server Extension Regulatory Class: III (three) Product Code: MHX Dated: October 27, 1999 Received: November 1, 1999

Dear Mr. Pfeil:

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 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). 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 IT (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periedic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may rey busin 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.

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Page 2 - Mr. Egon Pfeil

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) 594-4648. Additionally, for questions on the promotion at 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" (2) 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/dsma/dsmamain.html".

Sincerely yours,

Jeanne A. Wuterdauken fu,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ODE Indications Statement 3.1

Indications for Use Statement 510 (k) Number (if known) The Hewlett-Packard Company (HP) Viridia M3/M4 Device Name Patient Monitoring System, Rel.B, with M3016A Measurement Server Extension. The Hewlett-Packard Viridia M3/M4 Patient Indications for Monitoring System, Rel.B is intended for Use monitoring, recording, and alarming of multiple physiological parameters' of adults, pediatrics, and neonates in the hospital and medical transport environments. 1. List of supported measurements ECG (a) Respiration (b) Invasive blood pressure (c) Non-invasive blood pressue ( વ ) SpO2 and Pleth (e) Temperature ( ) ) CO2 ( વે ) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Christy foreman

(Division Sign-Off)
	Cardiovascular, Respiratory, Devices
510(k) Number

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.