K Number
K071982
Device Name
MODIFICATION TO: UNITY NETWORK ID
Date Cleared
2007-09-21

(64 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.
Device Description
The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors. The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.
More Information

Not Found

No
The description focuses on data communication and conversion, with no mention of AI/ML terms or functionalities.

No
The device is described as being for data collection and clinical information management, not for treating or diagnosing medical conditions. It acquires, converts, and transmits data but does not perform therapeutic actions or control clinical devices.

No
Explanation: The device is described as a data collection and management system that communicates patient data from various sources to clinical information systems and patient monitors. It explicitly states it is "not intended for monitoring purposes" and "not intended to control any of the clinical devices," which are functions typically associated with diagnostic devices. Its purpose is data transmission and conversion for networking, rather than direct medical diagnosis.

No

The device description explicitly states that the Unity Network ID acquires digital data from eight serial ports and converts it, indicating the presence of hardware components (serial ports and conversion circuitry) beyond just software.

Based on the provided information, the Unity Network ID is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for "data collection and clinical information management through networks with independent bedside devices." It explicitly states it is "not intended for monitoring purposes." IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. This device does not perform such examinations.
  • Device Description: The description focuses on acquiring digital data from other devices, converting it, and transmitting it. It does not describe any process involving the analysis of biological samples.
  • Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
    • Analysis of biological specimens (blood, urine, tissue, etc.)
    • Reagents or assays
    • Diagnostic purposes based on sample analysis

The Unity Network ID is a data management and communication device for clinical settings, not a diagnostic tool that analyzes biological samples.

N/A

Intended Use / Indications for Use

The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.

Product codes (comma separated list FDA assigned to the subject device)

MWI

Device Description

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors.
The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

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

Not Found

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)

The subject of this 510(k) is a design modification for the Unity Network ID. The Unity Network ID complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:

  • Risk Analysis.
  • Requirements Reviews ◆
  • Design Reviews.
  • Subsystem Verification.
  • Integration testing (System verification).
  • Final acceptance testing (Validation) ♥
  • Performance testing ◆
  • Safety testing.
  • Environmental testing.
    The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051518 Unity Network ID

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

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K071982

SEP 2 1 2007

510(k) Summary of Safety and Effectiveness
--------------------------------------------
Date:July 18, 2007
Submitter:GE Medical Systems Information Technologies
8200 West Tower Avenue
Milwaukee, WI 53223 USA
Contact Person:Lisa M. Baumhardt
Regulatory Affairs Program Manager
GE Medical Systems Information Technologies
Phone: (414) 362-3242
Fax: (414) 362-2585
E-mail: Lisa.Baumhardt@med.ge.com
Secondary Contact
Person:John Pendergast
Regulatory Affairs Specialist
GE Medical Systems Information Technologies
Phone: (414) 362-2506
Fax: (414) 362-2585
E-mail: john.pendergast@med.ge.com
Device Trade Name:Unity Network ID
Common /Usual Name:Physiological Patient Monitor
Classification Names:21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms)
Predicate Devices:K051518 Unity Network ID
Device Description:The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies patient monitors.
The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.
Intended Use:The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinica! devices (independent bedside devices/ information systems) it is connected to.
Technology:The Unity Network ID employs the same functional technology as the predicate device.

.

: :

4

1

Test Summary:

The subject of this 510(k) is a design modification for the Unity Network ID. The Unity Network ID complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:

  • Risk Analysis .
  • Requirements Reviews ◆
  • Design Reviews .
  • Subsystem Verification .
  • Integration testing (System verification) .
  • Final acceptance testing (Validation) ♥
  • Performance testing ◆
  • Safety testing .
  • Environmental testing .

Conclusion:

The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate device.

2

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

SEP 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Lisa Baumhardt Regulatory Affairs Program Manager 8200 West Tower Ave Milwaukee, WI 53223

Re: K071982

Unity Network ID Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: August 23, 2007 Received: August 24, 2007

Dear Ms. Baumhardt:

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.

3

Page 2 - Ms. Lisa Baumhardt

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 forth in the quality systems (OS) 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), please contact 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.Bommemafor

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

Enclosure

4

Indications for Use K071982

510(k) Number (if known):

Unity Network ID

Indications for Use:

Device Name:

The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices {independent bedside devices/ information systems) it is connected to.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number K071982

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