The Nihon Kohden Vital Sign Telemeters GZ-120P and GZ-130P are intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. Both GZ-120P and GZ-130P transmit electrocardiogram (ECG) and respiration data, and GZ-130P transmits blood oxygen saturation (SpO₂) in addition. The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the devices can be configured for use as a temporary simple monitor to display the patient's vital signs on the device screens and generate alarms without transmitting the data to other Nihon Kohden monitor.

The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

Device Description

The Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P is mainly used as a telemetry system within a medical facility. The device transmits patient's vital signs (ECG, SpO2*, respiration, pulse waveform) and alarm information via wireless LAN connection to the central monitoring station. The device can be configured to display the patient's vital signs on the screen and generate alarms for use as a temporary simple monitor. *SpO2 is for GZ-130P only.

AI/ML Overview

The provided text describes the Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P and details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel algorithm's performance. The document focuses on regulatory approval based on safety, essential performance, and equivalence to existing devices.

Therefore, many of the requested categories regarding algorithm-specific performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it describes a hardware device with monitoring capabilities, not an AI/algorithm-driven diagnostic/decision-support tool.

However, I can extract information related to the device's general performance and the types of tests conducted for its regulatory approval.

Here's the information based on your request, with an emphasis on what is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the context of an algorithm's diagnostic accuracy. Instead, it refers to compliance with safety and performance standards.

Implicit "Acceptance Criteria" (Compliance with Standards) and "Reported Performance" (Validation of Compliance):

Acceptance Criteria Category	Implicit Acceptance Criteria / Standard Compliance	Reported Device Performance / Validation
Electrical and Electromagnetic Safety	Compliance with relevant electrical and electromagnetic safety standards.	Testing to compliance standards for electrical and electromagnetic safety was performed. Standards include: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2007, IEC 60601-1-2:2014.
Wireless Coexistence	Compliance with IEC 60601-1-2 (Edition 4, 2014) regarding immunity to proximity fields from radio frequency wireless communications equipment.	Wireless coexistence testing and evaluation was performed following IEC 60601-1-2 (Edition 4, 2014), and the device's immunity was validated.
Alarm Systems	Compliance with standards for alarm systems in medical electrical equipment.	Compliance with IEC 60601-1-8: 2006 + Am1: 2012 (General requirements, tests and guidance for alarm systems). The device may generate an audible and/or visible alarm when an arrhythmia exists, measured physiological rate falls outside preset limits, or a technical error is detected.
Electrocardiographic Monitoring Performance	Compliance with particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment.	Compliance with IEC 60601-2-27: 2011 (Particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment). The device transmits ECG data and its specifications of parameter measurements, ECG analysis and alarming function are "equivalent to the predicate device, BSM-6000."
Software Functionality	Software is verified and validated.	Includes software verification and validation test, software unit test, integration test, and system test. Traceability documented between all system specifications to validation test results.
Overall Safety and Effectiveness	Substantial equivalence to predicate devices and no new questions of safety or effectiveness.	Performance is "substantially equivalent" to predicate devices (Nihon Kohden BSM-6000 Series Bedside Monitor and Nihon Kohden ZS-940PA Transmitter), and "raises no safety or effectiveness issues." Differences were minor and did not raise questions regarding safety or efficacy. The device's "specifications of parameter measurements, ECG analysis and alarming function are equivalent to the predicate device."
Water Resistance	Meets applicable water resistance standards.	Water resistance specification is "better than that of the predicates, and the improved function is evaluated by safety standard."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "sample size" in terms of number of patients or physiological recordings for evaluating performance of an algorithm. The testing described is primarily related to engineering and regulatory compliance of the device itself (hardware, software, communication protocols). Therefore, data provenance is not discussed in terms of country of origin or retrospective/prospective collection as there isn't patient data being evaluated for a diagnostic algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This document describes the regulatory clearance for a vital sign telemeter, which transmits physiological data (ECG, respiration, SpO2) and generates alarms. It does not involve a diagnostic algorithm that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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. The device is a monitor and telemeter, not an AI-assisted diagnostic tool that would involve human readers and their improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document does not describe a standalone algorithm performance study. The device itself performs functions like arrhythmia detection and alarm generation, but these are inherent to the monitor's functionality, not a separate "algorithm" requiring a standalone performance study. Its performance for these functions is indicated as being "equivalent to the predicate device."

7. The Type of Ground Truth Used

Not applicable in the context of an algorithm's diagnostic accuracy. The "ground truth" here would relate to the accuracy of the physiological measurements themselves against calibrated standards, and the proper functioning of alarms as per specifications and standards. This is implied by the "Test Summary" and "Standards compliance testing" sections.

8. The Sample Size for the Training Set

Not applicable. This device is not described as having an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated above.

Summary

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September 2, 2016

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

Nihon Kohden Corporation % Tom Bento Sr. Vice President, Quality and Regulatory Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618

Re: K153707

Trade/Device Name: Nihon Kohden Vital Sign Telemeter, GZ-120P / GZ-130P0 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DRG Dated: August 12, 2016 Received: August 15, 2016

Dear Tom Bento:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

Muda Jellman
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153707

Device Name

Nihon Kohden Vital Sign Telemeter GZ-120P, GZ-130P

Indications for Use (Describe)

The Nihon Kohden Vital Sign Telemeters GZ-120P are intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. Both GZ-120P and GZ-130P transmit electrocardiogram (ECG) and respiration data, and GZ-130P transmits blood oxygen saturation (SpO2) in addition. The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the devices can be configured for use as a temporary simple monitor to display the patient's vital signs on the device screens and generate alarms without transmitting the data to other Nihon Kohden monitor.

The devices are intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P

Submitter:Address:	Nihon Kohden Corporation1-31-4 Nishiochiai, 1-Chome, Shinjuku-KuTokyo, Japan 161-8560
Phone number:	81-2-59968020
Contact person:Phone number:Fax number:	Tom Bento(949) 680-9048(913) 273-0732
Date prepared:	September 01, 2016
Device name:Common name:Device classification:	Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130PPatient monitorMonitor, physiological, patient (with arrhythmia detection or alarms).Transmitters and Receivers, Physiological Signal, RadioFrequency
Primary Product code:Regulation:	MHX21 CFR 870.1025
Secondary Product Code:Regulation:	DRG21 CFR 870.2910
Substantial equivalentclaimed to:	Nihon Kohden BSM-6000 Series Bedside Monitor (K080342)andNihon Kohden ZS-940PA Transmitter (K043517)

Description:

Indications for Use:

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transmit electrocardiogram (ECG) and respiration data, and GZ-130P transmits blood oxygen saturation (SpO₂) in addition. The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the devices can be configured for use as a temporary simple monitor to display the patient's vital signs on the device screens and generate alarms without transmitting the data to other Nihon Kohden monitor.

Technological Characteristics - Substantial Equivalence Discussion:

The Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P is substantially equivalent to the predicate devices, Nihon Kohden BSM-6000 Series Bedside Monitor (K080342) and Nihon Kohden ZS-940PA Transmitter (K043517). Differences between the devices are minor and do not raise questions regarding safety or efficacy.

These differences include:

. The GZ-120P/GZ-130P provides less number of physiological parameters and less maximum traces than its predicates. It is because the device is smaller in size with a smaller screen when compared to the predicates. Its specifications of parameter measurements, ECG analysis and alarming function are equivalent to the predicate device. BSM-6000. one of Nihon Kohden's high-end patient monitoring device.
. The GZ-120P/GZ-130P has limited memory when compared to the predicate. BSM-6000 Bedside Monitor. This is because GZ-120P/GZ-130P is intended to transmit acquired data which are then saved at the central monitor. The other predicate, ZS-940PA is a telemeter and does not have any memory storage.
. The GZ-120P/GZ-130P uses radiofrequency wireless technology for its communication with central patient monitoring network to help portability of the device. The communication method is in compliance with the FCC rule and the associated risks are properly managed for successful validation of functional performance of the device.
. The water resistance specification of GZ-120P/GZ-130P is better than that of the predicates, and the improved function is evaluated by safety standard.

Test Summary:

Performance testing for the Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P includes software verification and validation test, software unit test, integration test, system test, and testing to compliance standards for electrical and electromagnetic safety. Wireless coexistence testing and evaluation was performed following IEC 60601-1-2

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(Edition 4, 2014), and the device's immunity to proximity fields from radio frequency wireless communications equipment was validated.

Traceability has been documented between all system specifications to validation test results.

Standards compliance testing includes:

1. ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
1. IEC 60601-1-2:2007: Electromagnetic compatibility
1. IEC 60601-1-2:2014: Electromagnetic compatibility, enclosure port immunity to radiated RF EM fields and proximity fields from RF wireless communications equipment only.
1. IEC 60601-1-8: 2006 + Am1: 2012: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
1. IEC 60601-2-27: 2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Verification and validation testing includes:

1. Software Verification and Validation Test
1. Software Unit Test
1. Integration Test
1. System Test

Conclusion:

The performance of the Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P is substantially equivalent to the predicate devices, the Nihon Kohden BSM-6000 Series Bedside Monitor and the Nihon Kohden ZS-940PA Transmitter, and raises no safety or effectiveness issues.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.