Unity Network ID

K142840 · GE Healthcare · MWI · Jan 7, 2015 · Cardiovascular

Device Facts

• Record ID: K142840
• Device Name: Unity Network ID
• Applicant: GE Healthcare
• Product Code: MWI · Cardiovascular
• Decision Date: Jan 7, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

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.

Device Story

Unity Network ID V7 acts as a data gateway/interface; acquires digital physiological data from independent bedside devices via eight serial ports; converts RS-232 protocol data into Unity Network protocols; transmits data over monitoring network to central stations, patient monitors, or clinical information systems. Used in clinical environments; operated by healthcare staff. Device does not perform patient monitoring; does not control connected bedside equipment. Benefits include centralized data management and integration of third-party device information into GE monitoring infrastructure. Healthcare providers view transmitted data on connected displays to support clinical information management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including module verification, system integration, performance, safety, and simulated use testing.

Technological Characteristics

Data gateway device; converts RS-232 serial protocol to Unity Network protocol. Hardware remains unchanged from predicate. Connectivity via eight serial ports to bedside devices and network interface to GE monitoring systems. Software-based protocol conversion.

Indications for Use

Indicated for data collection and clinical information management in clinical settings using independent bedside devices. No specific patient population, age, or gender restrictions defined.

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.

Predicate Devices

• Unity Network ID V6 (K103432)

Reference Devices

• 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)

Submission Summary (Full Text)

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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<br>8200 W. Tower Ave.<br>Milwaukee, WI 53223 |
| Primary Contact Person: | Robert Casarsa<br>Regulatory Affairs Leader<br>GE Medical Systems Information Technologies, Inc.<br>Email: [e-mail]<br>Ph: [phone]<br>Fax: [phone] |
| Secondary Contact<br>Person: | Douglas Kentz<br>Regulatory Affairs Director<br>GE Medical Systems Information Technologies, Inc.<br>Ph: [phone] |
| Device Trade Name: | Unity Network ID |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names:<br>Product Code: | 21 CFR 870.2300 Monitor, Physiological, Patient (without<br>arrhythmia detection or alarms)<br>MWI |
| Predicate Device(s): | Unity Network ID V6 K103432 |
| Device Description: | The Unity Network ID system communicates patient data from<br>sources other than GE Medical Systems Information<br>Technologies, Inc. equipment to a clinical information system,<br>central station, and/or GE Medical Systems Information<br>Technologies Inc. patient monitors.<br><br>The Unity Network ID acquires digital data from eight serial<br>ports, converts the data to Unity Network protocols, and<br>transmits the data over the monitoring network to a Unity<br>Network device such as a patient monitor, clinical information<br>system or central station. |
| Intended Use: | The Unity Network ID is indicated for use in data collection and<br>clinical information management through networks with |
| | independent bedside devices. The Unity Network ID is not<br>intended for monitoring purposes, nor is the Unity Network ID<br>intended to control any of the clinical devices (independent<br>bedside devices/ information systems) it is connected to. |
| Technology: | The device converts the output from independent bedside<br>device's RS-232 protocol into the Unity Network protocol |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The Unity Network ID V7 and its applications were tested to, and<br>comply with, applicable voluntary standards. The Unity Network<br>ID V7 was tested to assure that the device meets its design<br>specifications. Testing included all new or modified features. |
| | The following quality assurance measures were applied to the<br>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,<br>did not require clinical studies to support substantial<br>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<br>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<br>Healthcare devices:<br>(a) Carescape R860 (not sold in USA)<br>(b) Carestation 600 (not sold in USA) | |
| 3) Support of additional parameteres from currently<br>supported devices:<br>Pulsion PiCCO plus (K060898): Cardiac Index (CI),<br>Continuous Cardiac Index (CCI) and System Vascular<br>Resistance Index (SVRI)<br>Pulsion PiCCO2 (K072735): Cardiac Index (CI), Continuous<br>Cardiac Index (CCI) and System Vascular Resistance<br>Index (SVRI)<br>GE Datex-Ohmeda Aisys (K061609): volume waveform<br>GE Datex-Ohmeda Avance (K040743): volume waveform<br>GE Datex-Ohmeda Engstrom (K062710): volume<br>waveform | |
| Conclusion: GE Healthcare considers the Unity Network ID V7 to be as safe,<br>as effective, and its performance is substantially equivalent to<br>the predicate device(s). | |

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