HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P

K991773 · Hewlett-Packard GmbH · DSI · Jun 7, 1999 · Cardiovascular

Device Facts

• Record ID: K991773
• Device Name: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
• Applicant: Hewlett-Packard GmbH
• Product Code: DSI · Cardiovascular
• Decision Date: Jun 7, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Hewlett-Packard family of patient monitor products is intended for 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

Viridia M3000A/M3046A patient monitors process physiological signals to provide real-time monitoring, recording, and alarming. Used in hospital and mobile transport environments by healthcare professionals. Device utilizes STAR software for arrhythmia and ST segment measurement. Output displayed on monitor for clinical decision-making; enables continuous patient surveillance and timely intervention for physiological abnormalities.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, safety testing from hazard analysis, and interference testing. Pass/Fail criteria based on predicate device specifications; results demonstrated substantial equivalence.

Technological Characteristics

Patient monitor with measurement computer processing unit. Features STAR software for arrhythmia and ST measurement. Connectivity for physiological parameter monitoring. Designed for hospital and mobile transport use.

Indications for Use

Indicated for monitoring, recording, and alarming of physiological parameters in adult, pediatric, and neonatal patients in health care facilities by health care 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

• K964122
• K971910
• K981576

Submission Summary (Full Text)

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## JUN 7 1999

K991773

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.

l. 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 [e-mail]

This summary was prepared on April 27, 1999

- 2. The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M3000A/M3046A (Viridia The common name is patient monitor. Classification names are M3/4) . . as follows:

| Regulation<br>Number | Classification Name |
|----------------------|-------------------------------------------------------------------|
| 870.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 870.1025 | Detector and Alarm, Arrhythmia |
| 870.2900 | Cable, Transducer and Electrode, Patient (including<br>connector) |

- 3. The modified device is substantially equivalent to previously cleared HP devices that contain the same STAR software and that are marketed pursuant to K964122, K971910, and K981576.
- 4. The modification consists of the addition of software that involves only the arrhythmia and ST measurement alqorithm of the measurement computer processing unit of each device.
- 5. The new device has the same intended use as the leqally 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.

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- 7. Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the STAR algorithm using bench studies. Testing involved system level tests, inteqration tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 7 1999

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

Re: K991773 Viridia HP M3000A/M3046A (M3/M4), Rel.B Portable Patient Monitor Requlatory Class: III (three) Product Code: 74 DSI Dated: May 10, 1999 Received: May 25, 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 reqistration, 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 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 requlation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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,

Thomas J. Collehan

Thomas J. Caflahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ODE Indications Statement 3.1

Indications for Use Statement

510(k) Number
(if known)

K991773

The Hewlett-Packard Company (HP) Viridia Device Name M3000A/M3046A Patient Monitor Rev.B with ST/AR Software. Viridia HP M3000A/M3046A Patient Monitor Rel.B

- Indications for The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, Use 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)

Ath. A. Ciachochi.

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The-Counter Use