MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

K012171 · Visicu, Inc. · MSX · Jul 24, 2001 · Cardiovascular

Device Facts

• Record ID: K012171
• Device Name: MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
• Applicant: Visicu, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Jul 24, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The VISICU ARGUS System is intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The VISICU ARGUS System is intended to provide patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology and dedicated telephone lines. The VISICU ARGUS System is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

Device Story

The Argus System is a hospital-based clinical information management and surveillance network. It interfaces with independent bedside monitoring devices and ancillary systems to collect and store patient data. The system transmits this data via wide area networking and dedicated telephone lines to a remote supplementary care location. Clinicians at the remote site use the system to monitor patient status, enabling expert care oversight. The device facilitates centralized surveillance of patients across different hospital locations, aiming to improve clinical decision-making and patient outcomes through continuous remote access to bedside data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The system functions as a networked clinical information management platform. It utilizes wide area networking technology and dedicated telephone lines for data transmission between bedside devices and remote monitoring stations. It is designed exclusively for hospital environments.

Indications for Use

Indicated for use in hospital environments for data collection, storage, and clinical information management of patients monitored by bedside devices and ancillary systems, facilitating surveillance at both the point of care and remote supplementary locations.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 4 2001

Ms. Nannette Spurner Compliance Manager VISICU, Inc. 2400 Boston Street, Suite 302 Baltimore, MD 21224

Re: K012171

Trade Name: Argus System - Continuous Expert Care Network Regulation Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 MSX Dated: July 9, 2001 Received: July 12, 2001

Dear Ms. Spurner:

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 control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulters to a

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 affective 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 sod. Dreng Administration (FDA) will verify such assumptions. Failure to comply with t ood and 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 announcements tontification submission does not affect any obligation you might have under sections 531 through 522 of the

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### Page 2 - Ms. Nannette Spurner

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.

Q. K. Heth

mes E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VISICU ARGUS System Special 510{k}: Device Modification

# Indication for Use

510(k) Number:

Device Name:

Indications for Use:

012/7/

ARGUS System - Continuous Expert Care Network

The VISICU ARGUS System is intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks.

The VISICU ARGUS System is intended to provide patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology and dedicated telephone lines.

The VISICU ARGUS System is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number R012174

Jake Tilli

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

CONFIDENTIAL

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