(116 days)
Not Found
No
The description focuses on network interfacing, data display, and alarm annunciation, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an interface for monitoring networks to display patient monitoring information and alarm events, supplementing primary monitoring systems. It does not provide any treatment or therapeutic intervention.
No
Explanation: The device is described as an interface to display and annunciate patient monitoring information, including vital signs and alarms, from a primary monitoring system. It supplements the primary system by providing remote monitoring capabilities. It does not perform analysis or interpretation of medical data to aid in diagnosis, but rather presents data already collected by other monitoring equipment.
Yes
The device description explicitly states that NGNK is a "software product that runs on Microsoft Windows architecture" and its function is to interface with existing hardware (Nihon Kohden devices) via a network connection to display and annunciate information. There is no mention of any hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device "interface the Nihon Kohden monitoring network with networked client PCs to annunciate and display patient monitoring information to healthcare providers." It focuses on displaying and forwarding real-time patient monitoring data (vital signs, alarms, waveforms) from existing monitoring systems.
- No Sample Analysis: There is no mention of the device analyzing any biological samples or performing any tests on samples taken from the patient. Its function is purely data display and communication.
Therefore, the Next Generation NetKonnect is a patient monitoring data display and communication system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX
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.
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 the patient monitoring network and establishes a vital signs and patient status communication with each one.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The system is intended for use on any patients as determined by qualified medical personnel within a hospital or clinical environment.
Intended User / Care Setting
Qualified medical personnel within a hospital or clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical testing was required or performed since substantial equivalence of the device was supported by the non-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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)
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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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 Bunsen
Irvine, CA 92618 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 2032233 |
| Contact Person: | Maria Pronina
Regulatory Affairs Manager
Phone: 949.591.9596
E-mail: maria_pronina@nihonkohden.com |
| Date Summary Prepared: | March 31, 2022 |
| Reason for Premarket
Notification: | 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
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
NetKonnect (K112637) | Subject device
Next Generation NetKonnect |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Nihon Kohden America, Inc. | Nihon Konden Digital Health
Solutions, Inc. (NKDHS)
Ownership of K112637 was
transferred from Nihon
Kohden America to Nihon
Kohden Digital Health
Solutions (formerly NKUS
Lab) |
| Classification Name | Arrhythmia detector and
alarm (including ST-segment
measurement and alarm) | SAME |
| Product code | MHX | SAME |
| Regulation Number | 21 CFR 870.1025 | SAME |
| Class | II | SAME |
| Indications for use | The NetKonnect Remote
Network Extension 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 real-time
monitoring of routine patient
status and alarm events.
NetKonnect Remote Network
Extension 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 by qualified medical
personnel within a hospital
or clinical environment. The
stimulator is available for use
on any patient as determined
by the qualified medical
personnel. | SAME |
| Alarm Notification | Alarm notification is a
secondary notification
system and does not replace
the primary alarm
notification at the bedside
monitor | SAME |
| Description of
Communication
requirements | Receives and forwards
waveform data using Nihon
Kohden's proprietary “NET9”
protocol language. | SAME |
| | Receives and forwards
numerical 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 monitoring
Micorsoft 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 Storage
Device such as the Nihon
Kohden Central Monitoring
Devices. The total number of
these events depends on the
storage device.
Trend Data (Graphical,
Tabular, NIBP)
Hemodynamics lists
Arrhythmia recall
ST recall
Full disclosure
ECG 12 lead analysis
NetKonnect does not
perform arrhythmia
detection and makes no
determination or generation
of alarm conditions. All
display elements are
generated based on the data
from the bedside monitors or
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 (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.