(28 days)
Not Found
Not Found
No
The description focuses solely on the device's function as a viewer and network connector for displaying information from other devices, with no mention of AI or ML capabilities.
No
The device is described as displaying and processing information from other networked devices for consultation and remote monitoring, not for treating any condition.
No
The device is described as displaying and processing information from other networked devices for consultation and remote monitoring, explicitly stating it is not a primary alarm source and does not provide diagnostic capabilities itself.
Yes
The device is described as software components (Mobile Care Server, Web Viewer client, Pocket Viewer client, Cellular Viewer client) running on generic computing platforms (generic computer, generic handheld computer (PDA), generic cellular phone) and connecting to existing hospital networks and other networked devices. There is no mention of proprietary hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended use described for the Web Viewer, Pocket Viewer, and Cellular Viewer is to display information received from other networked devices, specifically bedside monitors and other networked devices. This information is likely physiological data or other patient parameters, not results from testing biological samples.
- The description focuses on network connectivity, data display, and remote monitoring, which are characteristic of patient monitoring systems, not IVD devices.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
Therefore, based on the provided text, this device falls under the category of a patient monitoring or information display system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
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.
The 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.
Product codes
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
qualified medical personnel, hospital
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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.
2
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
3
Indications for Use
510(k) Number (if known):
Device Name: Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB05 software.
Indications for use:
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.
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