HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A

K993171 · Hewlett-Packard Co. · DSI · Oct 21, 1999 · Cardiovascular

Device Facts

• Record ID: K993171
• Device Name: HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
• Applicant: Hewlett-Packard Co.
• Product Code: DSI · Cardiovascular
• Decision Date: Oct 21, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

For central monitoring of multiple adult, pediatric, and neonatal patients. Clinician decides to monitor cardiac arrhythmia of adult patients to gain information for and/or ST Segment of addition of treatment, or to exclude causes of symptoms.

Device Story

Hewlett-Packard Viridia Information Center (Release B.01) functions as a central monitoring system for hospital environments. It receives physiological data from networked patient monitors; processes cardiac arrhythmia and ST segment signals for adult patients; and displays information for clinicians to assess treatment adequacy or investigate symptoms. The system supports standalone and networked configurations, including Remote Services Access for on-line troubleshooting during monitoring. Clinicians use the output to inform clinical decision-making regarding patient status and therapy. Benefits include centralized oversight of multiple patients and enhanced remote diagnostic capabilities.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, environmental tests, and safety testing based on hazard analysis. A specific Network Test Plan was executed to validate Remote Access Services functionality under various conditions and configurations. All testing met pre-defined pass/fail criteria based on predicate specifications.

Technological Characteristics

Software-based central monitoring system for patient data. Operates on updated hardware and operating system environments. Features include network connectivity for remote troubleshooting and standalone/networked monitoring capabilities. No specific materials or energy sources defined beyond standard computing hardware.

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients; specifically for cardiac arrhythmia monitoring and ST segment analysis in adult patients to assist in treatment decisions or symptom evaluation.

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 CentralVue Software (K964832)

Submission Summary (Full Text)

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## OCT 21 1999

K993171

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.

- 1. The submitter of this premarket notification is: Dave Osborn Regulatory Affairs Engineer Hewlett-Packard Company Patient Monitoring Division 3000 Minuteman Road Andover, MA 01810-1085 978 659 3178 Tel:
978 685 5624 Fax: Email:[e-mail]

This summary was prepared on September 13, 1999

- 2. The name of this device is the Hewlett-Packard Viridia Information Software, Release B.01. Classification names are as follows:

| Regulation<br>Number | Classification Name |
|----------------------|----------------------------------------|
| 870.1025 | Arrhythmia detector and alarm |
| 870.1025 | Monitor, ST alarm |
| None | Physiological Monitor, Patient Monitor |

- 3. The new device is substantially equivalent to the previously cleared HP CentralVue Software device marketed pursuant to K964832.
- 4. The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.
- 5. The new device has the same intended use as the legally marketed predicate device. It is used in the hospital environment for central monitoring, and to obtain information for treatment, monitoring the adequacy of treatment, or to exclude causes of symptoms when monitoring cardiac arrhythmia of patients, and ST segment analysis of adult patients.
- 6. The new device has the same technological characteristics as the legally marketed predicate device.
- 7. Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. Additionally, a Network Test Plan was performed in connection with Remote Access Services functionality under a variety of conditions and configurations. The

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results show that RAS functionality met all performance and reliability requirements and the testing passed.

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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 human figure with three wavy lines representing the body. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Dave Osborn Regulatory Affairs Engineer Hewlett-Packard Company Healthcare Solution Group Medical Products Group 3000 Minuteman Road Andover, Massachusetts 01810

Re: K993171 Trade Name: Hewlett-Packard Company CentralVue Software (for models M3150A, M3151A, M3153A, M3154A) Regulatory Class: III Product Codes: MHX, DSI, MLD Dated: September 20, 1999 September 21, 1999 Received:

Dear Mr. Osborn:

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 aqainst 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 requlations 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 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

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Page 2 - Mr. Dave Osborn

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 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" (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,

Wely Sepnika MP

Wolf Sapirstein, 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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Page of

510(k) Number (if known): K993171

Device Name:

Hewlett Packard Viridia Information Center, newices Pack, Model M3150A/ M3151A/ M3153A/ M3154A

Indications for Use:

Indications: For central monitoring of multiple adult, pediatric, Indications: For Central montone of John Clinician decides to monitor and neonatal patrenss, and neonataly, and neonatal patients Cardial arrifychmia of adult patients to gain information for and/01 JF Segment of addition of treatment, or to exclude causes of symptoms.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

N. Ruth Tulli

Cardiovascular