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 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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the MetaVision 5.0 Clinical Information System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical performance data or acceptance criteria in the way one might find for novel or higher-risk devices.

Based on the provided text, the document does not contain the detailed information required to fill out the requested table and answer many of the questions. This is common for 510(k) submissions, especially for clinical information systems, where the substantial equivalence determination relies more on technological characteristics and intended use alignment with existing devices rather than new clinical effectiveness studies with specific performance metrics.

Here's an analysis of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable / Not provided. The document states that "Software is tested according to well-controlled procedures at MDsoft" and that "The 510(k) has demonstrated Substantial Equivalence with the predicate device." It does not provide specific performance metrics, acceptance criteria, or results from any clinical performance study. The focus is on demonstrating equivalence to the predicate device (Hewlett-Packard Carevue 9000 Clinical Information System, K992636) in terms of intended use and technological characteristics.

2. Sample size used for the test set and the data provenance

Not provided. No information about a test set, sample size, or data provenance (country of origin, retrospective/prospective) is included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided. No information about a test set or ground truth establishment by experts is included.

4. Adjudication method for the test set

Not provided. No information about a test set or adjudication method is included.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not performed / Not provided. The document describes a "Clinical Information System" for data collection, display, management, and storage. It is not an AI-assisted diagnostic or decision support tool that would typically undergo MRMC studies to evaluate human reader improvement. There is no mention of AI or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable / Not provided. This device is a "Clinical Information System" intended for use by healthcare professionals as a tool, not a standalone diagnostic algorithm. No standalone performance data is presented.

7. The type of ground truth used

Not applicable / Not provided. Given the nature of the device as a clinical information system, the concept of "ground truth" for a diagnostic algorithm is not directly relevant in the context presented. There are no diagnostic claims requiring a defined ground truth.

8. The sample size for the training set

Not provided. No information about a training set is included, as this is not an AI/machine learning model submission.

9. How the ground truth for the training set was established

Not applicable / Not provided. As there is no training set of an AI/machine learning model, this question is not relevant.

Summary from the provided document:

The MetaVision 5.0 Clinical Information System (K012349) is a "Medical Cathode Ray Tube Display, 21 CFR 870.2450", classified as a Cardiac Monitor (21 CFR 870.2300, Class II, Product Code MWI). It received 510(k) clearance by demonstrating substantial equivalence to the Hewlett-Packard Carevue 9000 Clinical Information System (K992636).

Intended Use: Data collection, display, management, and storage in the intensive care unit.
Technological Characteristics: Both MetaVision and the predicate device "employ software and computers to communicate with patient monitoring devices and other workstations to enter and display patient data."
Testing: "Software is tested according to well-controlled procedures at MDsoft." No specific performance metrics or clinical study results are detailed in this summary.

This 510(k) summary focuses on regulatory compliance through substantial equivalence, which typically does not necessitate the kind of detailed performance studies and ground truth establishment required for AI/ML-based diagnostic devices.

Summary

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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 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.

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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)

Over-The-Counter Use - - -

Regulation Number and Section

§ 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).