HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A by HEWLETT-PACKARD CO.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary and not a detailed clinical study report:

I. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Hewlett-Packard Viridia Information Software, Release B.01, does not detail specific, quantitative acceptance criteria common in clinical studies (e.g., sensitivity, specificity, accuracy thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device (HP CentralVue Software, K964832) through verification, validation, and testing activities.

The acceptance criteria can be inferred as:

The device performing according to the specifications established for the predicate device.
Meeting performance, functionality, and reliability requirements.

Acceptance Criteria (Inferred from documentation)	Reported Device Performance
Performance, functionality, and reliability consistent with predicate device.	"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."
Remote Access Services (RAS) functionality meets performance and reliability requirements.	"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."
Expansion of Remote Services Access for on-line troubleshooting while monitoring.	This capability was successfully implemented and its functionality met requirements per the Network Test Plan.
Enhanced standalone and networking capabilities.	These enhancements were verified and validated through a range of testing activities, demonstrating substantial equivalence to the predicate device.
Upgraded hardware and operating system environments.	The upgraded environments were incorporated, and the device's functionality and performance were confirmed through testing to remain equivalent to the predicate.

II. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., patient cases with diagnoses). The testing described is primarily software and system-level functional testing.

Sample Size: Not applicable in the traditional sense of patient samples. The testing involved "system level tests, integration tests, environmental tests, and safety testing." The "Network Test Plan" for Remote Access Services was performed "under a variety of conditions and configurations," but specific numbers are not given.
Data Provenance: Not applicable, as this was not a clinical study involving patient data. This was technical system testing.

III. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The "ground truth" for this type of software/system testing would be the predefined functional specifications and expected outputs of the software and hardware system.
Qualifications of Experts: If any "experts" were involved, they would likely be software engineers, quality assurance testers, and regulatory affairs personnel responsible for verifying compliance with specifications. Their specific qualifications are not listed.

IV. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing primarily involved verifying system functionality against predefined technical specifications, rather than adjudicating clinical interpretations. "Pass/Fail criteria were based on the specifications cleared for the predicate device."

V. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes technical verification and validation against a predicate device's specifications, not a study comparing human reader performance with and without AI assistance for tasks like arrhythmia detection or ST segment analysis.

VI. If a Standalone (algorithm only without human-in-the-loop performance) was done

Standalone Performance: The core function of the "Viridia Information Software" is to provide information for monitoring. While the software has "standalone" capabilities (as described in point 4 of the 510(k) summary), the document does not present quantitative performance metrics (e.g., sensitivity, specificity for arrhythmia detection) as a "standalone algorithm" in isolation from a human observer. The validation focuses on the software's functionality within the existing monitoring system.

VII. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's validation was primarily predefined technical specifications (functionality, performance, reliability requirements) derived from the predicate device and internal engineering standards. For the Remote Access Services, the successful operation "under a variety of conditions and configurations" against its specific requirements served as its ground truth.

VIII. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes a software update for an existing monitoring system, not the development of a novel machine learning algorithm that would require a "training set" of data.

IX. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as no training set for a machine learning algorithm is mentioned or implied.

Summary

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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:

RegulationNumber	Classification Name
870.1025	Arrhythmia detector and alarm
870.1025	Monitor, ST alarm
None	Physiological 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

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

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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

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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

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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

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

N. Ruth Tulli

Cardiovascular

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.