WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE

K061994 · GE Healthcare · MSX · Aug 11, 2006 · Cardiovascular

Device Facts

• Record ID: K061994
• Device Name: WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
• Applicant: GE Healthcare
• Product Code: MSX · Cardiovascular
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

System consists of Mobile Care Server and client software (Web, Pocket, Cellular). Inputs: physiological data from networked bedside monitors (Datex-Ohmeda or Unity Network). Transformation: server coordinates network connections; client software renders data on generic hardware (PC, PDA, cellular phone). Output: visual display of patient information for consultation/remote monitoring. Context: hospital LAN; operated by qualified medical personnel. Benefit: enables remote access to patient data for clinical decision-making. Not a primary alarm source.

Clinical Evidence

No clinical data provided; device is a remote monitoring display system.

Technological Characteristics

Software-based remote monitoring system. Operates on generic hardware (PC, PDA, cellular phone) connected via hospital LAN. Integrates with Datex-Ohmeda or Unity Network. L-WEB05 software manages data transmission and display.

Indications for Use

Indicated for hospital patients requiring remote monitoring or consultation. For use by qualified medical personnel only. Not intended as a primary alarm source.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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

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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 [phone]. 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 [phone] or [phone] 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:

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)

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