HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B

K993383 · Hewlett-Packard GmbH · DSI · Feb 3, 2000 · Cardiovascular

Device Facts

• Record ID: K993383
• Device Name: HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
• Applicant: Hewlett-Packard GmbH
• Product Code: DSI · Cardiovascular
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Hewlett-Packard Viridia M3/M4 (M3000A/M3046A) Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in the hospital and medical transport environments.

Device Story

The Viridia M3/M4 Patient Monitor (M3000A/M3046A) is a portable system for physiological monitoring. The M3015A Measurement Server Module adds capabilities for sidestream CO2, a second invasive blood pressure channel, and temperature measurement. The device processes physiological signals from connected sensors and transducers, displaying waveforms and numerical data to clinicians. It provides real-time monitoring and alarm functions for patients in hospital settings or during transport. Clinicians use the output to assess patient status and make clinical decisions. The system is designed for use by healthcare professionals.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, environmental tests, safety testing based on hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on applicable standards and specifications cleared for predicate devices.

Technological Characteristics

Portable patient monitor system with M3015A Measurement Server Module. Measures physiological parameters including sidestream CO2, invasive blood pressure, and temperature. Connectivity via transducer/electrode cables. Firmware/software-based operation. Testing conducted per system-level, environmental, and safety standards.

Indications for Use

Indicated for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients within hospital and medical transport environments.

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

• Nellcor Puritan Bennett NPB-75
• HP device (K964239)
• HP device (K981576)
• HP device (K971910)

Submission Summary (Full Text)

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## 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

This summary was prepared on August 20, 1999.

- 2. The name of this device is the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3015A (Viridia M3/M4, Rel. B.). The common name is patient monitor. Classification names are as follows:

| Regulation<br>Number | Classification Name |
|----------------------|-------------------------------------------------------------------|
| 870.2850 | Extravascular Blood Pressure Transducer |
| 870.1435 | Computer, Diagnostic, Pre-Programmed,<br>Single-Function |
| 870.1400 | Carbon Dioxide Gas Analyzer |
| 870.1025 | Detector and Alarm, Arrythmia |
| 870.2900 | Cable, Transducer and Electrode,<br>Patient (including connector) |
| 868.1499 | Carbon Dioxide Gas Analyzer |
| 880.2910 | Clinical Electronic Thermometer |

- 3. The new combination device is substantially equivalent to previously cleared Nellcor Puritan Bennett™ NPB-75 and HP devices marketed pursuant to K964239, K981576 and K971910, respectively.

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- 4 . The modification is the addition of a firmware and software based change that involves the addition of the M3015A Module to the portable Viridia M3/M4 Patient Monitor System to allow sidestream CO2, and a second invasive blood pressure and temperature measurements with the unit.
- 5. The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment or mobile environment for patient transport monitoring, the device is intended for measuring and displaying, recording and alarming multiple physiological parameters and waves in adult, pediatric and neonatal patients.
- 6. The new combination device has the same technological characteristics as the legally marketed predicate devices.
- 7. Verification, validation and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems. Testing included system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

.........

3 2000 FEB

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

Re: K993383 HP Viridia Model M3015A Measurement Server Module Regulatory Class: III (three) Product Code: 74 DSI Dated: January 10, 2000 Received: January 13, 2000

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 Regulations, 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 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 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, "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,

Quisite A. Goode for

Celia M. Witten, Ph.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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3.1 ODE Indications Statement

## Indications for Use Statement

510 (k) Number (if known)

Device Name The Hewlett-Packard Company (HP) Viridia M3/M4 (M3000A/M3046A) Patient Monitoring System, Rel.B, with M3015A & M3016A Measurement Server Extensions.

Indications for The Hewlett-Packard Viridia M3/M4 Use (M3000A/M3046A) Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in the hospital and medical transport environments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Stace N. Ricord, MD for Tillman

Division Sign-Off
Division of Cardiovascular, Fle
and Neurological Devices
510(k) Number K993383

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use