(12 days)
Not Found
Not Found
No
The summary describes a data collection, storage, and information management system, with no mention of AI, ML, or related concepts.
No
The device is described as a system for data collection, storage, and clinical information management, along with patient information and surveillance. It does not perform any therapeutic intervention or treatment.
No
The device is described as a system for data collection, storage, and clinical information management, providing patient information and surveillance. It does not state that it performs diagnosis or provides diagnostic results.
No
The description focuses on data collection, storage, and clinical information management from independent bedside devices and ancillary systems, implying interaction with and reliance on hardware components beyond just software. The lack of a "Device Description" section prevents a definitive confirmation of software-only status.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes data collection, storage, and clinical information management from independent bedside devices and ancillary systems. It focuses on providing patient information and surveillance. This is characteristic of a clinical information system or patient monitoring system, not a device that performs tests on biological samples in vitro.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic results based on such analysis.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator for IVD classification.
- Other Sections: The absence of information about image processing, AI/ML, imaging modality, anatomical site, patient age range, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These sections are often relevant for devices that perform diagnostic analysis, especially those involving imaging or AI.
In summary, the VISICU ARGUS System's intended use clearly places it in the category of a clinical information and patient surveillance system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
74 MSX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.
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
1
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 (301) 594-4645. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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
18