HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K

K990125 · Hewlett-Packard GmbH · DSI · Jan 29, 1999 · Cardiovascular

Device Facts

• Record ID: K990125
• Device Name: HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
• Applicant: Hewlett-Packard GmbH
• Product Code: DSI · Cardiovascular
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Hewlett-Packard Viridia Component Monitoring System is intended for use in monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.

Device Story

The HP Viridia Component Monitoring System is a multi-parameter patient monitor used in hospital environments. It integrates software from the HP Clinical Monitoring System (M1175A, M1176A, M1177A, M100B/M1002B) and the HP Component Transport System Viridia (M1205A). The device collects physiological data—including ECG, respiration, oxygen saturation, blood pressure, and temperature—via connected sensors and transducers. It processes these signals to provide real-time monitoring, recording, and alarming. Healthcare professionals use the system to observe patient status and make clinical decisions based on the displayed physiological parameters. The system is designed to facilitate shared functionality across HP monitoring platforms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and software integration of previously cleared predicate devices.

Technological Characteristics

Multi-parameter patient monitoring system; software-based integration of existing HP monitoring platforms. Supports ECG, respiration, SpO2, blood pressure, and temperature monitoring. Includes display, alarm, and recording capabilities. Connectivity via patient cables, transducers, and electrodes.

Indications for Use

Indicated for monitoring, recording, and alarming of physiological parameters in adult, neonatal, and pediatric patients in healthcare facilities by healthcare professionals.

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

• K941811
• K973437
• K981376

Submission Summary (Full Text)

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K990125

ir

JAN 2 9 1999

## 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 Email:egon [e-mail]

This summary was prepared on December 30, 1998

- 2. The name of this device is Hewlett-Packard Viridia Component Monitoring System. The common name is Patient Monitor. Classification names are as follows:

| egulation<br>umber | Classification Name |
|--------------------|-------------------------------------------------------------------|
| 68.2375 | Monitor, Breathing (Ventilatory) Frequency |
| 68.1720 | Analyzer, Gas, Oxygen, Gaseous Phase |
| 70.2340 | Electrocardiograph |
| 70.2700 | Oximeter |
| 70.2300 | Monitor, Cardiac (including Cardiotachometer & Rate Alarm) |
| 70.2350 | Adapter, Lead Switching, Electrocardiograph |
| 70.2810 | Recorder Paper Chart 510(k) exempt |
| 70.1100 | Alarm, Blood Pressure |
| 70.1110 | Computer, Blood Pressure |
| 70.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 70.2450 | Display, Cathode-Ray Tube, Medical |
| 70.1025 | Detector and Alarm, Arrythmia |
| 70.2900 | Cable, Transducer and Electrode, Patient (including<br>connector) |
| 70.1120 | Cuff, Blood-Pressure |
| 70.1130 | System, Measurement, Blood Pressure, Non-invasive |
| 80.2910 | Clinical Electronic Thermometer |

3. The new combination device is substantially equivalent to previously cleared HP devices marketed pursuant to K941811, K973437 and K981376

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- 4. The modification is a software based change that combines software in the HP Clinical Monitoring System product line (M1175A, M1176A and M1177A, M100B/M1002B ECG/RESP) with the software in the HP Component Transport System Viridia, (M1205A), the devices are to be known collectively as the HP Viridia Component Monitoring System. The combination system will allow for shared future functionality capabilities in HP patient monitoring systems.
- 5. The new combination device has the same intended use as the legally marketed predicate devices. When used in the hospital environment, the HP Viridia Component Monitoring System is intended for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric and neonatal patients.
- 6. The new combination device has the same technological characteristics as the legally marketed predicate devices.

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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 image of an eagle or bird with three heads in profile, facing to the right. The bird is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

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

Re: · · K990125 HP Viridia Component Monitoring System, Model Rev K Regulatory Class: III (three) Product Code: DSI Dated: December 30, 1998 Received: January 13, 1998

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 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 Failure to comply with the GMP regulation may result in assumptions.

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requlatory 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.

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 [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, 2 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. 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)

The Hewlett-Packard Viridia Component Monitoring Device Name System

- Indications for The Hewlett-Packard Viridia Component Monitoring System is intended for use in monitoring, Use recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

V. Calvillo

で

Division of Cardiovascular, Respiratory, and Neurological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use