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

K992595 · Hewlett-Packard GmbH · MHX · Dec 8, 1999 · Cardiovascular

Device Facts

• Record ID: K992595
• Device Name: HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
• Applicant: Hewlett-Packard GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 8, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

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 Story

Software enhancement for Hewlett-Packard Viridia Component Monitoring System (CMS) enabling EASI™ ST segment measurement; utilizes 5-lead EASI™ electrode placement pattern to derive 12-lead ECG signals; compatible with existing M1001A/B or M1002A/B ECG frontend modules; used in hospital environments by clinicians for real-time ST segment monitoring; provides continuous ECG analysis to assist in cardiac assessment; benefits patients through non-invasive, continuous cardiac monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and monitoring technology identical to the predicate devices.

Technological Characteristics

Software-based enhancement for existing CMS hardware; utilizes 5-lead EASI™ electrode configuration to derive 12-lead ECG; compatible with M1001A/B and M1002A/B ECG frontend modules; operates within existing Viridia CMS platform.

Indications for Use

Indicated for real-time ST segment analysis in adult patients in a hospital environment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HP CMS Viridia Component Monitoring System M1175A/76A/77A and Viridia 24/26 M1205A (K990476)

Reference Devices

• HP M1001A/B ECG plug-in module (K973437)
• HP M1002A/B ECG plug-in module (K973437)
• HP M1175A CMS (K882609)

Submission Summary (Full Text)

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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.

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 011 49 (7031) 14-4297 Fax: Email:[e-mail]

This summary was prepared on April 17, 1999

- 2. 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.

| Requlation<br>Number | Classification Name |
|----------------------|---------------------------------------------------------------|
| 870.2300 | Monitor, Cardiac (including Cardiotachometer & Rate<br>Alarm) |
| 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).

- 4. 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.

- 5. 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.
- 6. 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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<br>(if known) | K992595 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | The Hewlett-Packard Viridia Component Monitoring<br>System (M1175A/76A/77A), and Viridia 24/26<br>(M1205A) Rev. K with EASI™ ST segment Monitoring |
| Indications for<br>Use | The Hewlett-Packard Viridia Component Monitoring<br>System, (M1175A/76A/77A), and Viridia 24/26<br>(M1205A) Rev.K with EASI™ ST segment<br>Monitoring is indicated for:<br><br>Assessment of real time ST segment analysis in<br>adult patients. Assessment is indicated for the |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

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

k! Number K992595
Over-The-Counter Use

Prescription Use
(Per 21 CFR 801.109)

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