HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B by HEWLETT-PACKARD GMBH

The Hewlett-Packard Viridia M3/M4 (M3000A/M3046A) 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.

Device Description

The Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3015A (Viridia M3/M4, Rel. B.). The modification is the addition of a firmware and software based change that involves the addition of the M3015A Module to the portable Viridia M3/M4 Patient Monitor System to allow sidestream CO2, and a second invasive blood pressure and temperature measurements with the unit.

AI/ML Overview

The provided text is a 510(k) summary for the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3015A. It describes a modification to an existing device, which involves adding the M3015A Module to allow sidestream CO2, and a second invasive blood pressure and temperature measurements.

However, the summary does not contain the detailed information required to fill out your request, which typically applies to AI/ML or diagnostic devices with specific performance metrics. This document describes a hardware and firmware modification to a patient monitor, and its testing focuses on compliance with standards and equivalence to predicate devices rather than specific performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.

Therefore, many of the requested fields cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: The text states, "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices." However, it does not detail these specific criteria (e.g., specific accuracy ranges for CO2, blood pressure, or temperature).
Reported Device Performance: The text generally states, "The test results showed substantial equivalence." It does not provide quantitative performance metrics for the added functionalities (CO2, second invasive BP, temperature).

Acceptance Criteria	Reported Device Performance
Based on standards and specifications of predicate devices (details not provided)	Test results showed substantial equivalence. (Specific quantitative results not provided)

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

Sample Size for Test Set: Not specified. The document mentions "simulated systems" but gives no numbers.
Data Provenance: Not specified. It only mentions "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/Not specified. This type of device (patient monitor) does not typically involve expert review for ground truth in the same way a diagnostic imaging AI would. Testing would involve calibrated reference instruments.

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

Not applicable/Not specified. Adjudication methods are typically relevant for human-interpretable results, which is not the primary focus of this device's validation.

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:

No. This is not an AI/ML diagnostic device and such studies would not be relevant.

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

Not applicable. This is a hardware/firmware modification to a patient monitor, not an AI algorithm. Its performance is inherent in its measurement capabilities.

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

Likely calibrated reference instruments and physical standards. The text mentions "simulated systems," which implies controlled inputs with known, precise values against which the device's measurements would be compared.

8. The sample size for the training set:

Not applicable/Not specified. This device does not use machine learning in a way that would typically involve a "training set" for an algorithm. Its operation is based on established physiological measurement principles and programmed logic.

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

Not applicable. No training set as described for an AI/ML model.

Summary

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8.0 510(k) Summary

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

Tel: 011 49 (7031) 14-2243 Fax: 011 49 (7031) 14-4297

This summary was prepared on August 20, 1999.

1. The name of this device is the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3015A (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
870.1400	Carbon Dioxide Gas Analyzer
870.1025	Detector and Alarm, Arrythmia
870.2900	Cable, Transducer and Electrode,Patient (including connector)
868.1499	Carbon Dioxide Gas Analyzer
880.2910	Clinical Electronic Thermometer

1. The new combination device is substantially equivalent to previously cleared Nellcor Puritan Bennett™ NPB-75 and HP devices marketed pursuant to K964239, K981576 and K971910, respectively.

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4 . The modification is the addition of a firmware and software based change that involves the addition of the M3015A Module to the portable Viridia M3/M4 Patient Monitor System to allow sidestream CO2, and a second invasive blood 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 alarming multiple physiological parameters and waves in adult, pediatric and neonatal patients.
1. The new combination device has the same technological characteristics as the legally marketed predicate devices.
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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

.........

3 2000 FEB

Mr. Egon Pfeil Regulatory Affairs Medical Products Group - Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 Boeblingen, Germany 71034

Re: K993383 HP Viridia Model M3015A Measurement Server Module Regulatory Class: III (three) Product Code: 74 DSI Dated: January 10, 2000 Received: January 13, 2000

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 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. 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" (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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Quisite A. Goode for

Celia M. Witten, Ph.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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3.1 ODE Indications Statement

Indications for Use Statement

510 (k) Number (if known)

Device Name The Hewlett-Packard Company (HP) Viridia M3/M4 (M3000A/M3046A) Patient Monitoring System, Rel.B, with M3015A & M3016A Measurement Server Extensions.

Indications for The Hewlett-Packard Viridia M3/M4 Use (M3000A/M3046A) 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.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stace N. Ricord, MD for Tillman

Division Sign-Off
Division of Cardiovascular, Fle
and Neurological Devices
510(k) Number K993383

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

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.