HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH by HEWLETT-PACKARD GMBH

The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI™ ST segment Monitoring is indicated for: Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the

Device Description

The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI™ electrode system. The EASI™ capability is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.

AI/ML Overview

The provided text is a 510(k) summary for the Hewlett-Packard Viridia Component Monitoring System with EASI™ ST Segment measurement. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a novel device. As such, much of the requested information regarding detailed study design, ground truth establishment, expert involvement, and sample sizes for training/test sets is not explicitly present in the provided document.

However, I can extract what is available and indicate where information is missing based on the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study comparing the new device against such criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device, implying that its performance is comparable.

Acceptance Criteria (Not Explicitly Stated for this 510(k))	Reported Device Performance (Implied from Substantial Equivalence)
(Specific quantitative thresholds for ST segment measurement accuracy, sensitivity, specificity, etc., are not provided in the document)	The device's measurement technology and transmission of ECG signals are "similar" and "essentially the same" as legally marketed predicate devices. This implies that the performance is considered equivalent to those predicate devices.

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

This information is not provided in the document. The 510(k) focuses on the technological equivalence and intended use rather than a detailed clinical validation study with a specified test set.

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

This information is not provided in the document. Since a detailed test set and ground truth establishment methodology are not described, the involvement of experts for this purpose is also absent from the summary.

4. Adjudication Method for the Test Set

This information is not provided in the document. Without a described test set and ground truth establishment, an adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not provided in the document. The submission is about a software enhancement to a monitoring system, not a diagnostic aid that would typically involve human readers. Therefore, an MRMC study is not relevant to this type of device and is not mentioned.

6. If a Standalone (Algorithm Only) Performance Study Was Done

The document describes a "software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI™ electrode system." It also states that "monitoring technology identical to that used in the predicates." This implies that the core ST segment measurement algorithm is either the same as or very similar to the predicate and that the focus is on the EASI™ electrode system's ability to provide signals for this existing algorithm. However, a standalone performance study with specific metrics for the algorithm itself (isolated from the entire monitoring system) is not explicitly detailed in this summary. The "study" here is more about demonstrating that the EASI™ technology can provide equivalent input for the existing ST segment measurement.

7. The Type of Ground Truth Used

Given the nature of the device (ST segment monitoring via ECG), the ground truth for such a device, if a study were conducted, would typically be a clinically accepted standard for ECG interpretation (e.g., expert cardiologists' readings of standard 12-lead ECGs obtained simultaneously, or sometimes correlational studies with other diagnostic tests). However, the document does not explicitly state the type of ground truth used for any performance evaluation, as it relies on substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided in the document. As the device is an enhancement to an existing system, and the technology is described as "identical to that used in the predicates," it's possible that no "training set" in the context of a new machine learning algorithm was used. If a training set was used for the original development of the ST segment algorithm, that information is not part of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, for the reasons outlined in point 8.

Summary

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DEC - 8 1999

9925-95

9.0 510(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.

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 011 49 (7031) 14-4297 Fax: Email:egon_pfeil@hp.com

This summary was prepared on April 17, 1999

1. The name of this device is Hewlett-Packard Viridia Component Monitoring System, M1175A/76A/77A/ Viridia 24/26 M1205A with The common name is HP Virdia EASI™ ST Seqment measurement. Classification names are as follows: CMS, Rev.K.

RequlationNumber	Classification Name
870.2300	Monitor, Cardiac (including Cardiotachometer & RateAlarm)
870.2350	Adapter, Lead Switching, Electrocardiograph
870.1025	Detector and Alarm, Arrythmia and ST Segment Monitor

The new device with EASI™ ST Segment measurement is substantially equivalent to the HP predicate CMS Viridia Component Monitoring System M1175A/76A/77A and Viridia 24/26 M1205A devices with standard lead ST Segment measurement functionality enabled with EASI™ technology for ECG monitoring (K990476, June 22, 1999). The EASI™ ST Segment measurement will operate with the HP M1001A/B and M1002A/B ECG plug-in modules previously cleared under K973437 (December 12, 1997). The accessories and materials are optional and are the same accessories originally cleared for use with HP M1175A/76A CMS K882609 (January 19, 1989).

1. The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI™ electrode system. The EASI™ capability

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is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.

1. The HP CMS Rev.K with the EASI™ ST Segment measurement has the same intended use as the legally marketed predicate devices. When used in the hospital environment, the HP EASI™ ST Seqment measurement monitor is intended for use where 12-Lead ECG monitoring is indicated in adult patients.
1. The CMS Rev.K with the EASI™ ST Segment measurement function operates using a monitoring technology identical to that used in the predicates. The measurement technology and the transmission of ECG signals are similar and therefore the technological characteristics are essentially the same as those of the legally marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 1999

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

Re: K992595 Hewlett-Packard Viridia Component Monitoring System (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev. K with EASI™ ST-Segment Monitoring Requlatory Class: III (three) Product Code: 74 MHX, MLD Dated: November 4, 1999 Received: November 8, 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 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 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 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,

feanno A. Weckeshauser fer,

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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Indications for Use Statement

510(k) Number(if known)	K992595
Device Name	The Hewlett-Packard Viridia Component MonitoringSystem (M1175A/76A/77A), and Viridia 24/26(M1205A) Rev. K with EASI™ ST segment Monitoring
Indications forUse	The Hewlett-Packard Viridia Component MonitoringSystem, (M1175A/76A/77A), and Viridia 24/26(M1205A) Rev.K with EASI™ ST segmentMonitoring is indicated for:Assessment of real time ST segment analysis inadult patients. Assessment is indicated for the

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices/

k! Number K992595
Over-The-Counter Use

Prescription Use
(Per 21 CFR 801.109)

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.