HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A

K992674 · Hewlett-Packard GmbH · MHX · Nov 8, 1999 · Cardiovascular

Device Facts

• Record ID: K992674
• Device Name: HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
• Applicant: Hewlett-Packard GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 8, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Hewlett-Packard Viridia CMS Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.

Device Story

The Hewlett-Packard Viridia M1175A/76A/77A Component Monitoring System is a patient monitor modified with the M1027A EEG module. The device accepts electroencephalographic (EEG) signals via connected electrodes. It processes these signals to provide real-time measurement and display of EEG data. Used in operating rooms and intermediate/critical care environments, the system is operated by healthcare professionals. The output is displayed on the monitor for clinical review, assisting providers in patient assessment and monitoring. The device benefits patients by enabling continuous EEG monitoring in clinical settings.

Clinical Evidence

Clinical performance evaluations validated two-channel functionality in hospital environments. User feedback indicated >90% acceptance regarding applicability, usability, and efficiency. No adverse events reported, except one instance of minor skin irritation.

Technological Characteristics

Component monitoring system with M1027A EEG module. Measures EEG signals via electrodes. Designed for adult, pediatric, and neonatal use. Tested for safety, interference, and hardware reliability per established standards and predicate specifications.

Indications for Use

Indicated for measurement and display of EEG signals in adult, pediatric, and neonatal patients in operating rooms and intermediate/critical care 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

• HP devices (K990125)
• HP devices (K922974)
• Telefactor Neurotrac-II (K914571)
• SpaceLab EEG module 90481 (K932842)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary 9.0

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 Requlatory 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 July 28, 1999

2. The name of this device is the Hewlett-Packard Viridia M1175A/76A/77A Component Monitoring System with M1027A EEG module. The common name is patient monitor. Classification name is as follows:

| Regulation<br>Number | Classification Name |
|----------------------|-----------------------|
| 882.1400 | Electroencephalograph |

- 3. The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K990125, and K922974, and to the Telefactor Neurotrac-II K914571, and to the SpaceLab EEG module 90481, K932842.
- 4. The modification is the addition of new applications software and firmware that involves the addition of the M1027A EEG Module to the HP M1175A/76A/77A Component Monitoring System to allow the measurement of electroencephalographic signals.
- 5. The new device has the same intended use as the legally marketed predicate devices. When connected by appropriate electrodes, and used in the operating room and intermediate/critical care environments, the device is intended for measuring EEG signals in adult, pediatric, and neonatal patients.
- 6. The new device has the same technological characteristics as the legally marketed predicate devices.
- 7. Validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards,

{1}------------------------------------------------

where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence.

Clinical performance evaluations were conducted with the EEG module to validate two channel functionality under conditions existing in the indicated hospital environments. More than 90% of the users found the applicability, usability, and efficiency of EEG M1027A module monitoring acceptable or better. Apart from one instance of minor skin irritation, no adverse events were reported during the studies.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and features an abstract image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

8 1999 NOV

Re: K992674

> Trade Name: Hewlett-Packard Viridia Component Monitoring System Regulatory Class: III Product Code: GWQ, MHX Dated: August 5, 1999 Received: August 10, 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 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 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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.

{3}------------------------------------------------

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/dsmamain.html".

Sincerely yours,

James F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

ODE Indications Statement 3.1

## Indications for Use Statement

510 (k) Number (if known)

- The Hewlett-Packard Company (HP) Viridia CMS Device Name Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module.
- The Hewlett-Packard Viridia CMS Patient Indications for Monitoring System, Rel.K, with M1027A EEG Use Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K992674
510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

er Use