Next Generation NetKonnect is interface the Nihon Kohden monitoring network with networked client PCs to annunciate and display patient monitoring information to healthcare providers. The device is intended for use in near real-time monitoring of routing patient status and alarm events. Next Generation NetKonnect supplements the primary patient monitoring system by providing a forwarding for annunciating and displaying patient alarm events and event related information including vital signs values and waveforms. The system is intended for use on any patients as determined by qualified medical personnel within a hospital or clinical environment.

Device Description

NGNK is a software product that runs on Microsoft Windows architecture. NGNK will communicate with Nihon Kohden devices by a network connection and through the Gateway. The NGNK is intended to interface the Nihon Kohden monitoring network to annunciate and display patient monitoring information to healthcare providers. The device is intended for use in near real-time monitoring of patient status and alarm events. NGNK supplements the primary patient monitoring system by providing remote monitoring capability, including vital signs, alarms and waveforms.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Next Generation NetKonnect device. This device is a software product designed to interface with the Nihon Kohden monitoring network to annunciate and display patient monitoring information to healthcare providers. It is an update to a previously cleared device, NetKonnect Remote Network Extension (K112637).

The document focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel device. The primary changes are updates to the User Interface and support for current 64-bit Windows architectures.

Here's an breakdown of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for physiological measurements or alarm detection. This is because the device primarily functions as a display and annunciation system for data already processed by the primary patient monitoring system, which itself has established performance.

Instead, the "acceptance criteria" appear to be implicit in demonstrating that the modified device performs its intended functions (displaying vital signs, waveforms, and alarm events) reliably and safely, consistent with its predicate. The "reported device performance" is summarized in a qualitative manner through the non-clinical testing.

Feature/Requirement	Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence	The device must perform the same core functions as the predicate: interface with the monitoring network, annunciate/display patient monitoring info (vital signs, waveforms, alarm events), and act as a supplementary system.	The "Description of Communication requirements" and "Performance Specification" sections indicate that the subject device (NGNK) "SAME" as the predicate for receiving and forwarding waveform/numerical data using Nihon Kohden's proprietary “NET9” protocol. The primary function of displaying patient history information (Trend Data, Hemodynamics lists, Arrhythmia recall, ST recall, Full disclosure, ECG 12 lead analysis) is also stated as "SAME".
Safety and Effectiveness	The modifications (UI update, OS support) must not introduce new questions of safety or effectiveness. The device must be as safe and effective as the predicate.	"The required testing of the Next Generation NetKonnect was performed in accordance with the requirements of the design control guidelines and established quality assurance processes to demonstrate substantial equivalence... The software testing demonstrated that the software version meets it design requirements." Conclusion: "Based on the design and results of testing, it can be concluded that the subject device - Next Generation NetKonnect - is as safe, as effective, and performs as well as or better than the predicate."
Alarm Notification	Alarm notification functionality should be clear and not replace the primary alarm system. (Note: NGNK differs slightly but is deemed substantially equivalent).	Predicate: "Alarm notification is a secondary notification system and does not replace the primary alarm notification at the bedside monitor." Subject device: "SAME." However, the subject device "NGNK does not forward alarm notification. This difference does not affect the device from performing in a manner in which it is intended to operate from the predicate device “NetKonnect”". This implies that while the mechanism might be different, it still serves the intended supplementary purpose without compromising the primary system.
Operating System Support	The device should run on a compatible and current operating system.	Predicate: "Micorsoft windows that support Win32 service processes." Subject device: "Substantially equivalent: NGNK now supports current standard 64 bit Windows archetures." This is an improvement to support modern IT environments.
User Interface (UI) Design	The UI should be updated to be consistent with current technology and user experience while maintaining clarity and functionality similar to connected FDA cleared devices.	Predicate: "User interface is similar to the connected FDA cleared devices Nihon Kohden bedside monitoring and primary central monitoring systems." Subject device: "Substantially equivalent: Updates in the user interface to be consistent with current user interfaces on connected FDA cleared devices Nihon Kohden bedside monitoring and primary central monitoring systems." The primary objective of NGNK was stated as "to update the User Interface due to advancements in technologies and match current on-market products for a consistent experience."

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

The document states: "No clinical testing was required or performed since substantial equivalence of the device was supported by the non-clinical testing."

Therefore, there is no clinical test set, sample size, or specific data provenance (country, retrospective/prospective) to report for the performance of the device on patient data. The evaluation was primarily internal engineering and software testing.

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)

Given that no clinical testing was performed and the evaluation relied on non-clinical (software) testing, there were no external experts or "ground truth" derived from patient data for an independent performance evaluation. The "ground truth" for software testing usually refers to specified design requirements and expected outputs, which are internally verified by the manufacturer's engineering team.

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

There was no adjudication method used for a clinical test set, as no clinical testing was performed.

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

No MRMC study was performed. The device is not an AI-assisted diagnostic tool that would typically involve human readers and their performance improvement. It is a display and annunciation system.

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

The device itself is software that operates "standalone" in the sense that it processes and displays data from patient monitors. However, its purpose is to complement human monitoring in a clinical environment. The software testing mentioned is effectively a standalone performance evaluation against its design requirements and functional specifications. The specific results of this software testing (e.g., bug reports, pass/fail rates for specific test cases) are not detailed in this summary.

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

For the non-clinical (software) testing, the "ground truth" would be the design specifications and functional requirements of the software. This involves verifying that the software correctly receives, processes, and displays the data as intended, and that the user interface functions as designed, without introducing errors or safety concerns. This type of ground truth is established by the manufacturer during the design and development process.

8. The sample size for the training set

The document does not mention any training set. This is not an AI/machine learning device that typically requires training data. It is a communication and display software.

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

As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2022

Nihon Kohden Digital Health Solutions, Inc. Maria Pronina Regulatory Affairs Manager 14 Bunsen Irvine, California 92618

Re: K220989

Trade/Device Name: Next Generation NetKonnect 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 Dated: March 31, 2022 Received: April 4, 2022

Dear Maria Pronina:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Next Generation NetKonnect

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/3/Picture/0 description: The image shows the logo for Nihon Kohden Digital Health Solutions, Inc. The logo consists of a blue abstract shape on the left, followed by the text "NIHON KOHDEN" in blue. Below the text, there is a blue line, and below the line, the text "Digital Health Solutions, Inc." is written in blue.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K220989

Submitted by:	Nihon Kohden Digital Health Solutions, Inc.14 BunsenIrvine, CA 92618
Establishment RegistrationNumber:	2032233
Contact Person:	Maria ProninaRegulatory Affairs ManagerPhone: 949.591.9596E-mail: maria_pronina@nihonkohden.com
Date Summary Prepared:	March 31, 2022
Reason for PremarketNotification:	Device Modification
Trade Name:	Next Generation NetKonnect
Common Name:	Patient Physiological Monitor Network
Regulation Name:	Patient Physiological Monitor with Arrhythmia detector and alarm(including ST-segment measurement and alarm)
Regulation Number:	21 CFR 870.1025
Product Code:	MHX
Regulatory Class:	II
Panel:	Cardiovascular

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Image /page/4/Picture/0 description: The image contains the logo of Nihon Kohden, a Japanese medical equipment manufacturer. The logo consists of a blue square with a white abstract design on the left, and the company name "NIHON KOHDEN" in blue capital letters on the right. The design in the square resembles a stylized wave or a rising sun, conveying a sense of innovation and progress.

Special 510(k): Device Modification Next Generation NetKonnect K220989

Digital Health Solutions, Inc.

Predicate Device:

NetKonnect Remote Network Extension (K112637) Nihon Kohden America received clearance for the NetKonnect (K112637). Ownership of K112637 was transferred to Nihon Kohden Digital Health Solutions (formerly NKUS Lab).

Device Description:

Physical Description

Picture 1: All Beds screen

Image /page/4/Figure/9 description: The image shows a medical monitor displaying various vital signs and waveforms. The monitor displays heart rate, blood pressure, oxygen saturation, temperature, and other parameters. The heart rate is displayed as 80, 120, 130, and other values. The blood pressure is displayed as 118/76, and the oxygen saturation is displayed as 98.

Principles of Operation

The NGNK receives the data from the Gateway to provide remote monitoring of single or multiple patients. Remote monitoring function includes waveform, vital signs and alarms. When the system is started, it runs automatically and detects each of the Nihon Kohden devices on

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Image /page/5/Picture/0 description: The image contains the logo for NIHON KOHDEN. The logo consists of a blue square with a white design inside, followed by the text "NIHON KOHDEN" in blue. The design inside the square appears to be a stylized representation of a beam of light or a wave.

the patient monitoring network and establishes a vital signs and patient status communication with each one.

Modified Design Features

The primary objective of NGNK is to update the User Interface due to advancements in technologies and match current on-market products for a consistent experience. The modified feature included an update of User Interface consistent with current technology and common user experience.

Intended Use:

Next Generation NetKonnect is intended to interface the Nihon Kohden monitoring network with networked client PCs to annunciate and display patient monitoring information to healthcare providers. The device is intended for use in near real-time monitoring of routing patient status and alarm events. Next Generation NetKonnect supplements the primary patient monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and event related information including vital signs values and waveforms. The system is intended for use on any patients as determined by qualified medical personnel within a hospital or clinical environment.

Technological comparison to predicate device:

The Next Generation NetKonnect device is technologically equivalent to NetKonnect Remote Network Extension (K112637). Any differences are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness.

Summary of Substantial Equivalence:

Features	Predicate deviceNetKonnect (K112637)	Subject deviceNext Generation NetKonnect
Manufacturer	Nihon Kohden America, Inc.	Nihon Konden Digital HealthSolutions, Inc. (NKDHS)Ownership of K112637 wastransferred from NihonKohden America to NihonKohden Digital HealthSolutions (formerly NKUSLab)
Classification Name	Arrhythmia detector andalarm (including ST-segmentmeasurement and alarm)	SAME
Product code	MHX	SAME
Regulation Number	21 CFR 870.1025	SAME
Class	II	SAME
Indications for use	The NetKonnect RemoteNetwork Extension isintended to interface theNihon Kohden monitoringnetwork with networkedclient PCs to annunciate anddisplay patient monitoringinformation to healthcareproviders. The device isintended for use in real-timemonitoring of routine patientstatus and alarm events.NetKonnect Remote NetworkExtension supplements theprimary patient monitoringsystem by providing aforwarding mechanism forannunciating and displayingpatient alarm events andevent related informationincluding vital signs valuesand waveforms.The system is intended foruse by qualified medicalpersonnel within a hospitalor clinical environment. Thestimulator is available for useon any patient as determinedby the qualified medicalpersonnel.	SAME
Alarm Notification	Alarm notification is asecondary notificationsystem and does not replacethe primary alarmnotification at the bedsidemonitor	SAME
Description ofCommunicationrequirements	Receives and forwardswaveform data using NihonKohden's proprietary “NET9”protocol language.	SAME
	Receives and forwardsnumerical data using Nihon	SAME

Communication Design	Kohden's proprietary “NET9” protocol language.Receives and forwards alarm notification to other Nihon Kohden cleared devices such as Central Nurse station using proprietary “NET9” protocol language.When used with PC or Portable device, no alarm notification is available	Substantially equivalent:NGNK does not forward alarm notification. This difference does not affect the device from performing in a manner in which it is intended to operate from the predicate device “NetKonnect”
OS requirements	Real Time monitoringMicorsoft windows that support Win32 service processes	Substantially equivalent:NGNK now supports current standard 64 bit Windows archetures
Target Population	NetKonnect does not affect the target population of the cleared monitoring devices that the patients are connected to. The device is available for use by medical personnel on all patient populations.	SAME
User Interface	User interface is similar to the connected FDA cleared devices Nihon Kohden bedside monitoring and primary central monitoring systems.	Substantially equivalent:Updates in the user interface to be consistent with current user interfaces on connected FDA cleared devices Nihon Kohden bedside monitoring and primary central monitoring systems
Oerational Requirements	Software Product. No hardware installed with this product.Runs on any PC with Microsoft .NET Framework environment.	SAME
Performance Specification	NetKonnect can download and display the following patient history information	Substantially equivalent -NGNK has been updated to be a Windows application due to changes in the PC environment.
which is stored in StorageDevice such as the NihonKohden Central MonitoringDevices. The total number ofthese events depends on thestorage device.Trend Data (Graphical,Tabular, NIBP)Hemodynamics listsArrhythmia recallST recallFull disclosureECG 12 lead analysisNetKonnect does notperform arrhythmiadetection and makes nodetermination or generationof alarm conditions. Alldisplay elements aregenerated based on the datafrom the bedside monitors orcentral monitor.	SAME

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Image /page/6/Picture/0 description: The image features the logo of NIHON KOHDEN. The logo consists of a blue square with a white design inside, resembling a stylized sunrise or abstract shape. To the right of the square is the company name, "NIHON KOHDEN," written in a bold, blue sans-serif font.

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Nihon Kohden Digital Health Solutions, Inc

14 Bunsen Irvine, California 92618 Telephone (949) 474-9207 Fax (949) 474-8267

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Image /page/8/Picture/0 description: The image features the logo of Nihon Kohden, a medical equipment manufacturer. The logo consists of a blue square with a white abstract design on the left, followed by the company name "NIHON KOHDEN" in bold, blue capital letters. The overall design is clean and corporate, reflecting the company's focus on technology and healthcare.

Summary of Non-Clinical Testing:

The required testing of the Next Generation NetKonnect was performed in accordance with the requirements of the design control guidelines and established quality assurance processes to demonstrate substantial equivalence of the subject device to the predicate device. The software testing demonstrated that the software version meets it design requirements.

Summary of Clinical Testing:

No clinical testing was required or performed since substantial equivalence of the device was supported by the non-clinical testing.

Conclusion:

Based on the design and results of testing, it can be concluded that the subject device - Next Generation NetKonnect - is as safe, as effective, and performs as well as or better than the predicate. The Next Generation NetKonnect is substantially equivalent to the predicate device.

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.