Indication for use for Web Viewer displays information received from other networked devices. It is comprised of a Mobile Care Server and Web Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Web Viewer clients. The Web Viewer client runs on a generic computer that is connected to the hospital local area network (LAN). The Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for Pocket Viewer. The Pocket Viewer displays information received from other networked devices. It is comprised of a Mobile Care Server and Pocket Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Pocket Viewer dients. The Pocket Viewer client runs on a generic handheld computer (PDA) that is connected to the hospital local area network (LAN). The Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for Cellular Viewer displays information received from other networked devices, It is comprised of a Mobile Care Server and Cellular Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Cellular Viewer clients. The Cellular Viewer dient runs on a generic cellular phone that is connected to the hospital local area network (LAN). The Celtular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Cellular Viewer is not a primary alarm source. The device is for use by qualified personnel only.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided 510(k) document regarding acceptance criteria and supporting studies.

Based on the provided K061994 FDA 510(k) document, there is no detailed information regarding specific acceptance criteria for device performance, nor a study design with reported performance metrics that would typically be associated with AI/algorithm-based diagnostic devices.

The device described, "Web Viewer, Pocket Viewer, and Cellular Viewer with L-WEB05 software," is a set of remote monitoring devices designed to display information from other networked medical devices (bedside monitors, etc.) for consultation and remote monitoring in a hospital setting. The 510(k) submission focuses on its function as a communication and display system, not as a diagnostic algorithm or AI.

Therefore, many of the requested points in your prompt are not applicable to this specific submission. However, I can address the applicable points and explain why others cannot be answered from the provided text.

Acceptance Criteria and Study Information for K061994

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Specified for algorithmic performance. The submission primarily focuses on functional equivalence to predicate devices for remote display of physiological data.	The document does not contain specific metrics or performance data (e.g., sensitivity, specificity, accuracy, latency, resolution fidelity) for the software's display capabilities or data transmission performance. It establishes substantial equivalence to predicate devices as a remote monitoring system.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable / Not Provided. As this is not an AI/algorithm for diagnostic interpretation, there is no mention of a "test set" in the context of clinical data for model evaluation. The 510(k) relies on establishing substantial equivalence to predicate devices for its intended use as a data display and communication platform.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable / Not Provided. Since there's no clinical "test set" for diagnostic performance evaluation, there's no ground truth establishment by experts in the context of AI evaluation.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided. (See point 3).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe an MRMC study. This type of study is typically conducted for diagnostic devices where human readers interpret medical images or data, and the device (with or without AI assistance) impacts their performance. The Web Viewer, Pocket Viewer, and Cellular Viewer are described as display and communication tools, not devices intended to provide diagnostic interpretations or enhance human reader performance in that way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. The device is a system for displaying existing patient data to qualified medical personnel. It is inherently human-in-the-loop, as the purpose is to provide information for human consultation and monitoring. There is no standalone algorithm making diagnostic decisions being evaluated.

7. Type of Ground Truth Used:

Not Applicable / Not Provided. (See point 3).

8. Sample Size for the Training Set:

Not Applicable / Not Provided. This document does not pertain to an AI or machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Provided. (See point 8).

Summary of Device Functionality (from the document):

The Web Viewer, Pocket Viewer, and Cellular Viewer (with L-WEB05 software) are designed to:

Display information received from other networked medical devices (e.g., bedside monitors) from Datex-Ohmeda Network or Unity Network.
Function as clients (running on generic computers, PDAs, or cellular phones) connected to the hospital LAN.
Be used for consultation and remote monitoring of patients in the hospital.
Not be a primary alarm source.
Be used by qualified medical personnel only.

The 510(k) appears to be primarily focused on demonstrating the safety and effectiveness of this system as a means to remotely access and display existing physiological data, asserting substantial equivalence to other legally marketed remote monitoring devices. It does not present as a submission for a novel diagnostic algorithm or AI.

Summary

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K061994

AUG 1 1 2006

Premarket Notification 510(k) Summary As required by section 807.92

Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB05 software

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

July 11, 2006

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB05 software

COMMON NAME:

Remote monitoring device

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

Classification Name CFR Section Product Code System, network and communication, physiological monitors 870.2300 MSX

Page 1 of 1

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Public Health Service

Image /page/1/Picture/2 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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

GE Healthcare c/o Joel Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K061994

Trade/Device Name: Cellular Viewer, Pocket Viewer, and Cellular Viewer Regulation Number: 21 CFR 870.2300 Regulation Name: Network and Communicaiton Physiological System Regulatory Class: Class II Product Code: MSX Dated: July 11, 2006 Received: July 14, 2006

Dear Mr. Kent:

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. Joel Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 Of it Fart 807), its estems (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) rms let notification. The FDA finding of substantial equivalence of your device to a legally p arketed 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), please n you t the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Zimmerman fo

B. Zimmerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB05 software.

Indications for use:

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

(Division sign-On
Division of Cardiovascular Devices
510(k) Number Ko1994

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).