Next Generation NetKonnect

K220989 · Nihon Kohden Digital Health Solutions, Inc. · MHX · Jul 29, 2022 · Cardiovascular

Device Facts

• Record ID: K220989
• Device Name: Next Generation NetKonnect
• Applicant: Nihon Kohden Digital Health Solutions, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Next Generation NetKonnect (NGNK) is a software-based interface connecting Nihon Kohden patient monitoring networks to networked client PCs. It receives physiological data—waveforms, vital signs, and alarm events—from bedside monitors or central monitoring systems via a network gateway. NGNK functions as a secondary, remote monitoring tool for healthcare providers, displaying patient status and alarm information to supplement primary bedside monitoring. It does not perform independent arrhythmia detection or generate alarm conditions; all displayed data is derived from primary monitoring devices. The system runs on 64-bit Windows architecture and is intended for use by qualified medical personnel in clinical settings. By providing remote access to patient data, it facilitates timely clinical awareness of patient status and alarm events, potentially improving patient care through enhanced monitoring visibility.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical software testing and design verification.

Technological Characteristics

Software-only product running on 64-bit Microsoft Windows architecture. Communicates via proprietary 'NET9' protocol with Nihon Kohden monitoring network and gateway. Displays waveforms, vital signs, and alarm events. No hardware components. No independent arrhythmia detection or alarm generation capabilities.

Indications for Use

Indicated for near real-time monitoring of patient status and alarm events in hospital or clinical environments. Intended for use on any patient population as determined by qualified medical personnel. Supplements primary patient monitoring systems by forwarding and displaying vital signs, waveforms, and alarm events.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NetKonnect Remote Network Extension (K112637)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.<br>14 Bunsen<br>Irvine, CA 92618 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 2032233 |
| Contact Person: | Maria Pronina<br>Regulatory Affairs Manager<br>Phone: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | March 31, 2022 |
| Reason for Premarket<br>Notification: | Device Modification |
| Trade Name: | Next Generation NetKonnect |
| Common Name: | Patient Physiological Monitor Network |
| Regulation Name: | Patient Physiological Monitor with Arrhythmia detector and alarm<br>(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

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.

### 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 device<br>NetKonnect (K112637) | Subject device<br>Next Generation NetKonnect |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Nihon Kohden America, Inc. | Nihon Konden Digital Health<br>Solutions, Inc. (NKDHS)<br>Ownership of K112637 was<br>transferred from Nihon<br>Kohden America to Nihon<br>Kohden Digital Health<br>Solutions (formerly NKUS<br>Lab) |
| Classification Name | Arrhythmia detector and<br>alarm (including ST-segment<br>measurement and alarm) | SAME |
| Product code | MHX | SAME |
| Regulation Number | 21 CFR 870.1025 | SAME |
| Class | II | SAME |
| Indications for use | The NetKonnect Remote<br>Network Extension is<br>intended to interface the<br>Nihon Kohden monitoring<br>network with networked<br>client PCs to annunciate and<br>display patient monitoring<br>information to healthcare<br>providers. The device is<br>intended for use in real-time<br>monitoring of routine patient<br>status and alarm events.<br>NetKonnect Remote Network<br>Extension supplements the<br>primary patient monitoring<br>system by providing a<br>forwarding mechanism for<br>annunciating and displaying<br>patient alarm events and<br>event related information<br>including vital signs values<br>and waveforms.<br>The system is intended for<br>use by qualified medical<br>personnel within a hospital<br>or clinical environment. The<br>stimulator is available for use<br>on any patient as determined<br>by the qualified medical<br>personnel. | SAME |
| Alarm Notification | Alarm notification is a<br>secondary notification<br>system and does not replace<br>the primary alarm<br>notification at the bedside<br>monitor | SAME |
| Description of<br>Communication<br>requirements | Receives and forwards<br>waveform data using Nihon<br>Kohden's proprietary “NET9”<br>protocol language. | SAME |
| | Receives and forwards<br>numerical data using Nihon | SAME |
| | | |
| Communication Design | Kohden's proprietary “NET9” protocol language.<br>Receives and forwards alarm notification to other Nihon Kohden cleared devices such as Central Nurse station using proprietary “NET9” protocol language.<br>When used with PC or Portable device, no alarm notification is available | Substantially equivalent:<br>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 monitoring<br>Micorsoft windows that support Win32 service processes | Substantially equivalent:<br>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:<br>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.<br>Runs on any PC with Microsoft .NET Framework environment. | SAME |
| Performance Specification | NetKonnect can download and display the following patient history information | Substantially equivalent -<br>NGNK has been updated to be a Windows application due to changes in the PC environment. |
| which is stored in Storage<br>Device such as the Nihon<br>Kohden Central Monitoring<br>Devices. The total number of<br>these events depends on the<br>storage device.<br>Trend Data (Graphical,<br>Tabular, NIBP)<br>Hemodynamics lists<br>Arrhythmia recall<br>ST recall<br>Full disclosure<br>ECG 12 lead analysis<br>NetKonnect does not<br>perform arrhythmia<br>detection and makes no<br>determination or generation<br>of alarm conditions. All<br>display elements are<br>generated based on the data<br>from the bedside monitors or<br>central 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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Image /page/7/Picture/0 description: The image contains the logo for NIHON KOHDEN. The logo consists of a blue square with a white design on the left and the text "NIHON KOHDEN" in blue on the right. The text is in a sans-serif font and is all capitalized.

Nihon Kohden Digital Health Solutions, Inc

14 Bunsen Irvine, California 92618 Telephone [phone] Fax [phone]

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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.