(189 days)
Not Found
No
The summary describes a clinical information system for data collection, display, management, and storage. There is no mention of AI, ML, or related concepts in the intended use, device description, or specific sections for AI/ML mentions or training/test sets.
No
The device is described as a "Graphical Patient Information System" used for data collection, display, management, and storage. It does not directly provide therapy or treatment to a patient.
No
The device description indicates it is a clinical information system for data collection, display, management, and storage, not for diagnosing medical conditions. It assists healthcare providers by organizing patient data.
No
The device description explicitly states the system is resident on a server and one or more workstations, which are hardware components. While the core functionality is software, the system includes and relies on specific hardware for its operation and deployment.
Based on the provided information, the MetaVision Graphical Patient Information System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "data collection, display, management, and storage in the intensive care unit." It is used in conjunction with independent patient bedside devices and systems. This describes a clinical information system for managing patient data, not a device that performs tests on biological samples.
- Device Description: The description reinforces that it's a "clinical information system utilized for data collection, display, management, and storage in the ICU environment." It communicates with bedside devices and displays data on workstations. This aligns with a data management system, not an IVD.
- Lack of IVD Characteristics: There is no mention of the system performing tests on biological samples (blood, urine, tissue, etc.), analyzing biomarkers, or providing diagnostic information based on such tests. IVDs are specifically designed for these purposes.
The system's function is to collect, organize, and display data from other medical devices and systems, which is characteristic of a clinical information system, not an IVD.
N/A
Intended Use / Indications for Use
The MetaVision Graphical Patient Information System is indicated for use in data collection, display, management, and storage in the intensive care unit.
The system is used in conjunction with independent patient bedside devices and systems, connected via a network.
The way the system is used for generating patient records, computation of drug and fluid dosage The way are 15th is determined by the health care providers, in terms of their environment and requirements.
The MetaVision application is resident on a workstation that provides for data input and patient data display -- to health care professionals.
Typically, a MetaVision system comprises several workstations connected via a network system to one or more servers. Data is stored and managed by servers.
The MetaVision system network can communicate with a number of remotely located patient care units.
Product codes
MWI
Device Description
The MetaVision Graphical ICU Patient Information System is a clinical information system utilized for data collection, display, management, and storage in the ICU environment. The ICU may be a normal adult ICU, a neonatal ICU, or other type of ICU. The system can communicate with bedside devices that are attached to a local network. The system may display patient data on one or more work stations running under the Windows NT/2000 operating system.
The MetaVision system is resident on a server and one or more workstations and communicates via a network with other workstations and patient monitoring devices on the network. The MetaVision system can also communicate with a number of remotely located patient care units.
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
health care professionals / intensive care unit (ICU), normal adult ICU, neonatal ICU, or other type of ICU.
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
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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)
Reference Device(s)
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
JAN 2 9 2002
K012349
p. 1/2
510(k) Summary
MetaVision 5.0 Clinical Information System
Common/Classification Name: Medical Cathode Ray Tube Display, 21 CFR 870.2450
MDsoft, Ltd. Kiryat Atidum, Building 4 Dvora Hanevi's Street Tel Aviv 61581 ISRAEL
Contact: Yoav Palit Prepared: June 27, 2001
LEGALLY MARKETED PREDICATE DEVICES A.
MetaVision is substantially equivalent to the Hewlett-Packard Carevue 9000 Clinical Information System that was cleared for marketing as K992636 on August 31, 1999.
DEVICE DESCRIPTION B.
The MetaVision Graphical ICU Patient Information System is a clinical information system utilized for data collection, display, management, and storage in the ICU environment. The ICU may be a normal adult ICU, a neonatal ICU, or other type of ICU. The system can communicate with bedside devices that are attached to a local network. The system may display patient data on one or more work stations running under the Windows NT/2000 operating system.
The MetaVision system is resident on a server and one or more workstations and communicates via a network with other workstations and patient monitoring devices on the network. The MetaVision system can also communicate with a number of remotely located patient care units.
C. INTENDED USE
The MetaVision Graphical Patient Information System is indicated for use in data collection, display, management, and storage in the intensive care unit.
1
The system is used in conjunction with independent patient bedside devices and systems, connected via a network.
The way the system is used for generating patient records, computation of drug and fluid dosage and research tasks is determined by the health care providers, in terms of their environment and requirements.
The MetaVision application is resident on a workstation that provides for data input and patient data display -- to health care professionals.
Typically, a MetaVision system comprises several workstations connected via a network system to one or more servers. Data is stored and managed by servers.
The MetaVision system network can communicate with a number of remotely located patient care units.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The MetaVision is a medical device, and it has very similar indications for use as the legally marketed predicate device, and it has the same intended use--the display of patient medical information. The MetaVision has the same technological characteristics as the predicate device--both are software products operating in a network This premarket notification will describe the environment. characteristics of the MetaVision in sufficient detail to assure substantial equivalence.
E. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are identical to those of the predicate device. Both employ software and computers to communicate with patient monitoring devices and other workstations to enter and display patient data.
F. TESTING
Software is tested according to well-controlled procedures at MDsoft.
G. CONCLUSIONS
The 510(k) has demonstrated Substantial Equivalence with the predicate device. The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in this 510(k) is limited to the way they are defined in, and used by FDA in accordance with, Sections 513(f)(1) and 513(l)(1) of the Federal Food, Drug, and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2002
Mr. T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852
Re: K012349
Trade Name: MetaVision Graphical Patient Information System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: November 13, 2001 Received: November 15, 2001
Dear Dr. Athey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. T. Whit Athey, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read or nove a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Daula Tuth
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MetaVision Graphical Patient Information System
Indications For Use:
The MetaVision Graphical Patient Information System is indicated for use in data collection, display, management, and storage in the intensive care unit.
The system is used in conjunction with independent patient bedside devices and systems, connected via a network.
The way the system is used for generating patient records, computation of drug and fluid dosage The way are 15th is determined by the health care providers, in terms of their environment and requirements.
The MetaVision application is resident on a workstation that provides for data input and patient data display -- to health care professionals.
Typically, a MetaVision system comprises several workstations connected via a network system to one or more servers. Data is stored and managed by servers.
The MetaVision system network can communicate with a number of remotely located patient care units.
(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 K012349
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use - - -