(99 days)
No
The description focuses on data communication and conversion, with no mention of AI/ML terms or functionalities like learning, prediction, or complex data analysis beyond simple protocol conversion. The performance studies also focus on standard software and hardware testing, not AI/ML model validation.
No.
The document clearly states that the device is for "data collection and clinical information management" and is "not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices". It acts as a communication hub for patient data, not a direct therapeutic intervention device.
No
The device is described as collecting and transmitting patient data from independent bedside devices to clinical information systems or patient monitors. It does not perform any analysis or interpretation of the data to arrive at a diagnosis. Its function is data management and communication, not diagnostic evaluation.
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 In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "data collection and clinical information management through networks with independent bedside devices." This describes a system for managing and transmitting patient data, not for performing tests on biological samples to diagnose or monitor a disease or condition.
- Device Description: The description focuses on acquiring digital data from serial ports, converting it to a specific protocol, and transmitting it. This is a data communication and management function, not an in vitro test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Using reagents or assays
- Providing diagnostic or monitoring information based on the analysis of biological samples
The Unity Network ID appears to be a data networking and integration device used within a clinical setting to facilitate the flow of information from various bedside devices to other systems. This falls outside the scope of an IVD.
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
MWI
Device Description
The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. 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
The Unity Network ID V7 and its applications were tested to, and comply with, applicable voluntary standards. The Unity Network ID V7 was tested to assure that the device meets its design specifications. Testing included all new or modified features.
The following quality assurance measures were applied to the development and testing of the of the system:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, Unity Network ID V7, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Unity Network ID V6 K103432
Reference Device(s)
Drager Evita infinity V500 (K093633), Radiometer TCM4 (K043003), Radiometer TCM40 (K043003), Radiometer TCM CombiM (K093154), Radiometer TCM Tosca (K093154), Pulsion PiCCO plus (K060898), Pulsion PiCCO2 (K072735), GE Datex-Ohmeda Aisys (K061609), GE Datex-Ohmeda Avance (K040743), GE Datex-Ohmeda Engstrom (K062710)
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
Public Health Service
Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2015
GE Healthcare Robert Casarsa Regulatory Affairs Leader 8200 West Tower Ave. Milwaukee, Wisconsin 53223
Re: K142840
Trade/Device Name: Unity Network ID V7 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: December 5, 2014 Received: December 8, 2014
Dear Robert Casarsa.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): n/a Device Name: Unity Network ID V7 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.
Prescription Use X (Part 21 CFR 801 Sub part D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 26, 2014 |
|---|---|
| Submitter: | GE Healthcare |
| 8200 W. Tower Ave. | |
| Milwaukee, WI 53223 | |
| Primary Contact Person: | Robert Casarsa |
| Regulatory Affairs Leader | |
| GE Medical Systems Information Technologies, Inc. | |
| Email: robert.casarsa@ge.com | |
| Ph: (414) 362-3063 | |
| Fax: (414) 262-2585 | |
| Secondary Contact | |
| Person: | Douglas Kentz |
| Regulatory Affairs Director | |
| GE Medical Systems Information Technologies, Inc. | |
| Ph: (414) 362-2038 | |
| Device Trade Name: | Unity Network ID |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names: | |
| Product Code: | 21 CFR 870.2300 Monitor, Physiological, Patient (without |
| arrhythmia detection or alarms) | |
| MWI | |
| Predicate Device(s): | Unity Network ID V6 K103432 |
| Device Description: | The Unity Network ID system communicates patient data from |
| sources other than GE Medical Systems Information | |
| Technologies, Inc. equipment to a clinical information system, | |
| central station, and/or GE Medical Systems Information | |
| Technologies Inc. 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 clinical devices (independent
bedside devices/ information systems) it is connected to. |
| Technology: | The device converts the output from independent bedside
device's RS-232 protocol into the Unity Network protocol |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The Unity Network ID V7 and its applications were tested to, and
comply with, applicable voluntary standards. The Unity Network
ID V7 was tested to assure that the device meets its design
specifications. Testing included all new or modified features. |
| | The following quality assurance measures were applied to the
development and testing of the of the system: |
| | • Risk Analysis |
| | • Requirements Reviews |
| | • Design Reviews |
| | • Testing on unit level (Module verification) |
| | • Integration testing (System verification) |
| | • Performance testing (Verification) |
| | • Safety testing (Verification) |
| | • Simulated use testing (Validation) |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, Unity Network ID V7,
did not require clinical studies to support substantial
equivalence. |
| Comparison: | Hardware: |
| | 1) No change to the Unity Network ID hardware |
| | 2) Create interface cables for the newly supported devices |
| | Software: |
| | 1) Add interface support for the following third party
devices: |
| | (a) Drager Evita infinity V500 (K093633) |
| | (b) Radiometer TCM4 (K043003) |
| | (c) Radiometer TCM40 (K043003) |
| | (d) Radiometer TCM CombiM (K093154) |
| (e) Radiometer TCM Tosca (K093154) | |
| 2) Add interface support for the following GE
Healthcare devices:
(a) Carescape R860 (not sold in USA)
(b) Carestation 600 (not sold in USA) | |
| 3) Support of additional parameteres from currently
supported devices:
Pulsion PiCCO plus (K060898): Cardiac Index (CI),
Continuous Cardiac Index (CCI) and System Vascular
Resistance Index (SVRI)
Pulsion PiCCO2 (K072735): Cardiac Index (CI), Continuous
Cardiac Index (CCI) and System Vascular Resistance
Index (SVRI)
GE Datex-Ohmeda Aisys (K061609): volume waveform
GE Datex-Ohmeda Avance (K040743): volume waveform
GE Datex-Ohmeda Engstrom (K062710): volume
waveform | |
| Conclusion: GE Healthcare considers the Unity Network ID V7 to be as safe,
as effective, and its performance is substantially equivalent to
the predicate device(s). | |
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Image /page/4/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a decorative border that resembles water droplets or stylized leaves.
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Image /page/5/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle is surrounded by stylized, curved lines that resemble water droplets or waves, giving the logo a dynamic and fluid appearance.