K Number
K993171
Device Name
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
Date Cleared
1999-10-21

(30 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications: For central monitoring of multiple adult, pediatric, and neonatal patients. For monitoring cardiac arrhythmia of adult patients to gain information for addition of treatment, or to exclude causes of symptoms. For monitoring ST Segment of adult patients to gain information for addition of treatment, or to exclude causes of symptoms.
Device Description
The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.
More Information

Not Found

No
The summary describes software and hardware updates for central monitoring, focusing on remote access and networking capabilities. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.

No.
The device is used for monitoring and diagnosis, specifically for cardiac arrhythmia and ST segment, to gain information for treatment or to exclude causes of symptoms, but it does not directly provide therapy.

Yes

The device is indicated for "monitoring cardiac arrhythmia of adult patients to gain information for addition of treatment, or to exclude causes of symptoms" and "ST Segment of adult patients to gain information for addition of treatment, or to exclude causes of symptoms." This involves acquiring information relevant to a patient's medical condition for guiding treatment decisions, which aligns with the definition of a diagnostic device.

No

The device description explicitly states "improvements were made to upgrade the hardware and operating system environments," indicating it is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes monitoring physiological parameters (cardiac arrhythmia, ST Segment) of patients. This is a clinical monitoring function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
  • Device Description: The description focuses on software and hardware improvements for monitoring and networking capabilities. It doesn't mention any components or processes related to analyzing biological samples.
  • Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.

Therefore, this device falls under the category of a patient monitoring device, not an IVD.

N/A

Intended Use / Indications for Use

For central monitoring of multiple adult, pediatric, and neonatal patients. The new device has the same intended use as the legally marketed predicate device. It is used in the hospital environment for central monitoring, and to obtain information for treatment, monitoring the adequacy of treatment, or to exclude causes of symptoms when monitoring cardiac arrhythmia of patients, and ST segment analysis of adult patients.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, MLD

Device Description

The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult, pediatric, and neonatal patients

Intended User / Care Setting

hospital environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. Additionally, a Network Test Plan was performed in connection with Remote Access Services functionality under a variety of conditions and configurations. The results show that RAS functionality met all performance and reliability requirements and the testing passed.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K964832

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.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

OCT 21 1999

K993171

10.0 510(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: Dave Osborn Regulatory Affairs Engineer Hewlett-Packard Company Patient Monitoring Division 3000 Minuteman Road Andover, MA 01810-1085 978 659 3178 Tel:
      978 685 5624 Fax: Email:dosborn@hp.com

This summary was prepared on September 13, 1999

    1. The name of this device is the Hewlett-Packard Viridia Information Software, Release B.01. Classification names are as follows:

| Regulation

NumberClassification Name
870.1025Arrhythmia detector and alarm
870.1025Monitor, ST alarm
NonePhysiological Monitor, Patient Monitor
    1. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832.
    1. The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.
    1. The new device has the same intended use as the legally marketed predicate device. It is used in the hospital environment for central monitoring, and to obtain information for treatment, monitoring the adequacy of treatment, or to exclude causes of symptoms when monitoring cardiac arrhythmia of patients, and ST segment analysis of adult patients.
    1. The new device has the same technological characteristics as the legally marketed predicate device.
    1. Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. Additionally, a Network Test Plan was performed in connection with Remote Access Services functionality under a variety of conditions and configurations. The

1

results show that RAS functionality met all performance and reliability requirements and the testing passed.

:

2

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three wavy lines representing the body. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Dave Osborn Regulatory Affairs Engineer Hewlett-Packard Company Healthcare Solution Group Medical Products Group 3000 Minuteman Road Andover, Massachusetts 01810

Re: K993171 Trade Name: Hewlett-Packard Company CentralVue Software (for models M3150A, M3151A, M3153A, M3154A) Regulatory Class: III Product Codes: MHX, DSI, MLD Dated: September 20, 1999 September 21, 1999 Received:

Dear Mr. Osborn:

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 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 requlations 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 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

3

Page 2 - Mr. Dave Osborn

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.

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) 594-4646. 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 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,

Wely Sepnika MP

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

Enclosure

4

Page of

510(k) Number (if known): K993171

Device Name:

Hewlett Packard Viridia Information Center, newices Pack, Model M3150A/ M3151A/ M3153A/ M3154A

Indications for Use:

Indications: For central monitoring of multiple adult, pediatric, Indications: For Central montone of John Clinician decides to monitor and neonatal patrenss, and neonataly, and neonatal patients Cardial arrifychmia of adult patients to gain information for and/01 JF Segment of addition of treatment, or to exclude causes of symptoms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

N. Ruth Tulli

Cardiovascular