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, 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.

Accessories include device specific interface cables and mounting hardware.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the Unity Network ID v8, does not contain any information about acceptance criteria or a study proving that an AI/device meets specific performance metrics.

The device, Unity Network ID v8, is described as a data collection and clinical information management system that communicates patient data from various medical devices to a clinical information system. It is explicitly stated that this device is not intended for monitoring purposes, nor is it intended to control any clinical devices.

The document focuses on demonstrating substantial equivalence to a predicate device (Unity Network ID v7). This involves showing that the new version has similar technological characteristics and performance. The changes in v8 primarily involve software updates to support new third-party medical devices.

Therefore, many of the requested elements for describing acceptance criteria and a performance study (especially in the context of AI or advanced device performance) are not applicable to this submission.

Here's a breakdown of why this document doesn't provide the requested information, and what it does provide:

No AI/Algorithm Component: This device is a data integration and communication system, not an artificial intelligence or an algorithm with diagnostic or prognostic capabilities that would require performance metrics like sensitivity, specificity, or reader studies.
Focus on Substantial Equivalence: The entire submission is built around demonstrating that Unity Network ID v8 is substantially equivalent to its predecessor. This means focusing on hardware and software changes, and ensuring basic safety and functionality.

However, to address the prompt's structure based on the absence of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are stated because the device's function is data collection and management, not diagnostic interpretation. The acceptance criteria would likely revolve around successful data transfer, protocol compatibility, and absence of data loss or corruption.
Reported Device Performance: No quantitative performance metrics are reported. The "performance data" section in the document refers to compliance with electrical safety, EMC, and software verification/validation standards.

Table:

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated for Performance)	Reported Device Performance (Compliance/Verification)
Data Communication	Ability to successfully receive, convert, and transmit data	Stated as performing these functions, verified via software testing.
Protocol Compatibility	Correct interpretation and conversion of various device protocols	Software updates add support for new devices, implying successful protocol integration.
Data Integrity	No loss or corruption of data during transfer	Verified through software testing (Unit, Integration, Regression).
Safety	Compliance with relevant electrical safety and EMC standards	Complies with IEC 60601-1, -1-2, -1-6, and IEC 62336.
Usability	Compliance with usability engineering standards	Complies with IEC 60601-1-6 and IEC 62336.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device does not use a "test set" of patient data in the sense of a machine learning model. Testing consists of software verification and validation (V&V) through bench tests, ensuring the software correctly performs its intended functions (receiving, converting, and transmitting data) and complies with design inputs. These are functional and non-functional tests of the software itself and its interfaces, not performance on a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" in the clinical sense for this device. Its function is data transfer, not interpretation. Software verification does not involve expert clinical review of "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is necessary as there's no clinical "ground truth" to establish or interpret.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretive device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm that produces a clinical output or diagnosis. Its "standalone" function is data integration and transfer, which is addressed through software and hardware verification.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no "ground truth" as it pertains to clinical outcomes or diagnoses. The "truth" in testing relates to the correct functioning of the software and hardware according to specifications (e.g., "does data get transferred correctly?", "does the system comply with electrical safety standards?").

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this is not relevant.

In summary: The provided 510(k) submission for the Unity Network ID v8 describes a data communication and management device. It does not present performance data or studies typical for AI/ML-driven medical devices that output diagnostic or prognostic information. The "study" mentioned in the document refers to software verification and validation testing, and compliance with general medical device safety and quality standards, rather than clinical performance studies against a "ground truth."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 12, 2017

GE Healthcare Robert Casarsa Regulatory Affairs Leader 8200 West Tower Ave. Milwaukee, Wisconsin 53223

Re: K170199

Trade/Device Name: Unity Network ID v8 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: April 13, 2017 Received: April 14, 2017

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.

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.

M.A. Hillemann

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

510(k) Number (if known)

K170199

Device Name

Unity Network ID v8

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary

l. SUBMITTER

GE Healthcare GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, Wisconsin 53223

Contact Person: Robert Casarsa Phone: 414-362-3062 Date Prepared: April 7, 2017

II. DEVICE

Name of Device: Unity Network ID v8 Common or Usual Name: Physiological Patient Monitor Classification Name: 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms Regulatory Class: II Product Code: MWI

III. PREDICATE DEVICE

Unity Network ID v7 K142840 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

Accessories include device specific interface cables and mounting hardware.

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V. INDICATONS FOR USE

The indication for use is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Technological Characteristics of the Unity Network ID are exactly the same as all previous versions of the Unity Network ID.

The device collects data from equipment connected to any of eight RS-232 serial communications ports. The data is converted from the independent bedside manufacturer's RS-232 protocol into the GEMS IT Unity Network protocol. Data collected consists of real-time waveforms, parameter numeric data, device confiquration data and parameter alarm data.

The communication between the Unity Network ID and an interfaced device is bidirectional. However, communication to an interfaced device is limited to information requests or to transfer of patient demographic data. No commands are sent which could affect how the interfaced device operates.

The device operates in either a stand-alone mode or a peripheral mode of operation.

Hardware:

No change to the Unity Network ID hardware 1)
Create interface cables for the newly supported devices 2)
1. Create new interface cable for existing device:
- a) Draeger Fabius GS (K011404)

Software:

This version of Unity Network ID adds support for the following devices:

Capnostream 20p Monitor (K123690) (a)
(b) SenTec Digital Monitor (K151329)
(c) Hamilton G5 Ventilator (K131774)
Vista BIS (K072286) (d)
Edwards EV1000 (K160552) (e)
(f) Draeger Perseus A500 (K133886)

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Draeger Babylog VN500 (K093632) (g)
(h) Draeger Savina 300 (K121886)
(i) Draeger Evita V300 (Not for sale in US)
(j) Draeger Oxylog 3000 Plus (K103625)
(k) Puritan Bennett 980 Ventilator (K131252)

The following categories of devices are supported by the Unity Network ID:

Anesthesia Machines ●
. Continuous Cardiac Output Monitors
Gas Analyzers
Infusion Pumps ●
. Patient Monitors
. Pulse Oximeters
Transcutaneous Monitors
Urometers
. Ventilators
Blood Analyzer
. Bispectral Index Monitor

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

No biocompatibility testing was performed as the Unity Network ID has no patient contact.

Electrical safety and electromagnetic compatibility (EMC)

The Unity Network ID was designed and tested for compliance with the following standards:

1. IEC 60601-1:2005. +Corr 1:2006. +Corr 2:2007 +A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
1. IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests
1. IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
1. IEC 62336: 2007 + A1:2014 Medical devices -- Part 1: Application of usability engineering to medical devices

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Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, where a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information of through the action of a care provider.

The following bench tests were performed:

Unit Testing: Code reviews and/or static code analysis are the methods are . adopted for the software unit verification to ensure the unit acceptance criteria, as defined in the SDLC procedure, are met.
Integration Testing: Functional procedures were executed to test the interface requirements.
Regression Testing: Regression testing was performed to ensure additional confidence of the build or to test the regression of the software build.

Mechanical and acoustic testing

No mechanical or acoustic testing was performed on the Unity Network ID as the only changes were software based.

Animal Study

No animal studies have been performed on the Unity Network ID.

Clinical Studies

No clinical studies have been performed on the Unity Network ID.

VIII. CONCLUSIONS

This version of the Unity Network ID (v8) is substantially equivalent to the prior versions (v1-v8). The submitted device uses the same technology for the interface, has no device hardware changes, and adds new interface cables for the newly interfaced devices. Verification testing has assured that the design outputs meets the requirements of the design inputs. Testing to internationally recognized standards demonstrate the safety of the device.

Regulation Number and Section

§ 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).