(91 days)
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 patients as determined by the qualified medical personnel.
NetKonnect is a software product that runs on Microsoft .NetKonnect will communicate with Nihon Kohden patient monitoring devices by the direct network connection (NetKonnect-LT) or through the gateway (NetKonnect will allow hospitals to provide full featured remote overview access capability to its clinicians inside the hospital and outside of hospital by using the dial-up connection or Internet connection at minimal cost.
This document is a 510(k) premarket notification for a software product called "NetKonnect Remote Network Extension" by Nihon Kohden America, Inc. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device (Nihon Kohden CGS-9001 GWY). As a software product designed for displaying patient monitoring information, rather than directly diagnosing or treating, the provided document does not contain traditional "acceptance criteria" and "study results" in the same manner as a diagnostic or therapeutic medical device.
Instead, the submission focuses on demonstrating how the new device's specifications and intended use are substantially equivalent to the predicate device, emphasizing that any differences do not increase the risk to patient safety or affect the device's intended operation. The primary "study" is a comparative analysis against the predicate device.
Here's an analysis based on the provided text, aligning it as much as possible with the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a software product for remote display and is undergoing a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would typically be found in a study for a diagnostic device.
Instead, the "acceptance criteria" can be inferred as the device's ability to maintain functional equivalence and safety compared to the predicate device. The reported device performance is presented in the "Comparative Information" table by comparing the new device (Nihon Kohden NetKonnect Extension CGS-9003) against the predicate (Nihon Kohden CGS-9001 GWY).
| Criteria (Inferred from Comparative Information) | Substantial Equivalence (Acceptance) |
|---|---|
| Description of communication requirements (Waveform data) | The new device "Receives and forwards waveform data using Nihon Kohden's proprietary 'NET9' protocol language." The predicate device is "Same, but data must be converted." |
| Description of communication requirements (Numerical data) | The new device "Receives and forwards Numerical data using Nihon Kohden's proprietary 'NET9' protocol language." The predicate device is "Same, but data must be converted." |
| Description of communication requirements (Alarm notification) | The new device "Receives and forwards Alarm notification to other Nihon Kohden approved devices such as Central Nurse station using Nihon Kohden's proprietary 'NET9' protocol language. When used with PC or portable device, no alarm notification is available." The predicate device is "Same, but data must be converted." |
| Alarm notification nature | The new device's alarm notification is a "secondary notification system and does not replace the primary alarm notification of the bedside monitor." The predicate device is "Same." |
| Communication with monitors/receivers | The new device "Communicates with bedside monitors and telemetry receivers via Ethernet." The predicate device is "Same." |
| Communication design | The new device supports "Real time monitoring." The predicate device is "Same." |
| OS requirements | The new device requires "Microsoft windows that support Win32 service processes." The predicate device is "Same." |
Comments on Performance: For the communication requirements (waveform, numerical, alarm data), the difference noted is that the predicate device converts data, while the new device uses the proprietary "NET9" protocol directly. The submission explicitly states: "We have determined that this difference does not increase the risk of patient safety or affect the device from performing in the manner in which it is intended to operate from the predicate device CGS-9001." This indicates its performance is deemed equivalent from a safety and functional perspective.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the traditional sense of patient data used for evaluation. This 510(k) submission is for a software interface that forwards and displays data, not a diagnostic algorithm.
- Sample Size for Test Set: Not applicable in the context of this type of submission. The evaluation is based on comparison of technical specifications and intended use.
- Data Provenance: Not applicable. There is no direct patient data being analyzed by this specific device for diagnostic purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As explained above, there is no "test set" of patient data requiring ground truth establishment by experts for this software interface.
4. Adjudication Method for the Test Set
Not applicable. There is no test set adjudication involving multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a software product for displaying information, not an AI or diagnostic tool designed to assist human readers in interpreting medical images or data. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an "algorithm" in the sense of making independent clinical judgments or interpretations. It is an interface for forwarding and displaying existing patient monitoring information, always intended for human review.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the clinical diagnostic sense required for this type of software. The "ground truth" for its function would be whether it accurately transmits and displays the data generated by the primary patient monitoring system, which is addressed through engineering verification and validation (though details of these tests are not provided in this specific excerpt, they would be part of the full 510(k) submission).
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is used.
Summary of the "Study" (inferred from the document):
The "study" presented is primarily a comparative analysis of technical specifications and intended use against a legally marketed predicate device (Nihon Kohden CGS-9001 GWY). The goal is to demonstrate "substantial equivalence" as required for a 510(k) submission. The document asserts that any differences between the new device and the predicate device do not raise new questions of safety or effectiveness. The core of this "study" is the table comparing specifications and the commentary affirming that differences (like data conversion methods) do not affect safety or intended operation.
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Nihon Kohden America, INC. 11/15/2011
Special 510(k) Notification NetKonnect Remote Network Extension
DEC - 9 2011
K112637 わける
510(k) Summary
1.1. Intended Use
The NetKonnect Remote Network Extension 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 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 and displaying patient alarm events and events and event related information including vital signs values and waveforms.
Device/Package Labels 1.2.
The proposed product labels for the device are located in Attachment 13 .
1.3. Proposed Packaging
Packaging is depicted in Attachment 13.
- 1.4. Instructions for Use The proposed instructions for use (user manuals) are provided with each packaged device and are presented in Attachment 13.
- Advertisement/Promotional Literature 1.5. To date no advertisement or promotional literature for the new has been created for distribution in the United States.
1.6. Contraindications, Precautions & Warnings Warnings and cautions are listed in the Operator's Manual as shown in Attachment 13.
1.7. Indications for Use Statement Indication for use statement is presented in Attachment 4.
DEVICE DESCRIPTION
Photographs/Engineering Drawings 2.1. The proposed drawings are provided in Attachment 13.
Physical Description 2.2.
NetKonnect is a software product that runs on Microsoft .NetKonnect will communicate with Nihon Kohden patient monitoring devices by the direct network connection (NetKonnect-LT) or through the gateway (NetKonnect will allow hospitals to provide full featured remote overview access capability to its clinicians inside the hospital and outside of hospital by using the dial-up connection or Internet connection at minimal cost.
2.3. Principles of Operation
Netkonnect has no user interface (except administrator functions) and performs all functions automatically without user intervention. When the network hosting NetKonnect is started, NetKonnect runs automatically and detects each of the Nihon Kohden devices on the patient monitoring network and establishes a vital signs and patient status communication connection with each one. Client PCs can communicate with NetKonnect to provide for remote monitoring of single or multiple patients. Remote monitoring function includes waveform and vital signs viewing, alarm notification and review of stored patient information.
2.4. Design Features
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17/3
2.5. Device Specifications
The device specifications are provided in Attachment 16.
2.6. Accessories
NetKonnect is a software only product, there are no accessories.
- 2.7. Significant Changes that could affect Safety or Effectiveness or Intend Use. There are no significant changes as compared to the predicate devices that would affect the safety or effectiveness of the device as intended for use.
| Nihon KohdenNetKonnect ExtensionCGS-9003 | Nihon KohdenCGS-9001 GWY510k # K083271 | Comments | |
|---|---|---|---|
| SPECIFICATION | |||
| Description ofcommunicationrequirements | Receives and forwardswaveform data usingNihon Kohden'sproprietary "NET9"protocol language. | Same, but data mustbe converted | Predicate device also converts(translates) the data into alanguage that is supported by the3rd party application. We havedetermined that this differencedoes not increase the risk ofpatient safety or affect the devicefrom performing in the manner inwhich it is intended to operatefrom the predicate device CGS-9001 |
| Receives and forwardsNumerical data usingNihon Kohden'sproprietary "NET9"protocol language. | Same, but data mustbe converted | Predicate device also converts(translates) the data into alanguage that is supported by the3rd party application. We havedetermined that this differencedoes not increase the risk ofpatient safety or affect the devicefrom performing in the manner inwhich it is intended to operatefrom the predicate device CGS-9001 | |
| Receives and forwardsAlarm notification to otherNihon Kohden approveddevices such as CentralNurse station using NihonKohden's proprietary"NET9" protocollanguage.When used with PC orportable device, no alarmnotification is available | Same, but data mustbe converted | Predicate device also converts(translates) the data into alanguage that is supported by the3rd party application. We havedetermined that this differencedoes not increase the risk ofpatient safety or affect the devicefrom performing in the manner inwhich it is intended to operatefrom the predicate device CGS-9001 | |
| Alarm notification is a | Same |
COMPARATIVE INFORMATION
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| secondary notificationsystem and does notreplace the primary alarmnotification of the besidemonitor | ||||
|---|---|---|---|---|
| Communicates withbedside monitors andtelemetry receivers viaEthernet | Same | |||
| Communication design | Real time monitoring | Same | ||
| OS requirements | Microsoft windows thatsupport Win32 serviceprocesses | Same |
3.1. Intended 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.
3.2 Physical Characteristics
The NetKonnect Remote Network Extension is a software only product available on CD Rom.
3.3 . Target Population
The NetKonnect Remote Network Extension will not change 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.
3.4. Product Labeling
I. Labeling
To date no advertisement or promotional literature has been created for distribution in the United States. Labeling for the currently marketed is located in Attachment 13.
II. Instructions for Use
Instructions for use are provided with each packaged device and are presented in Attachment 13.
III. Proposed Packaging
Packaging is presented in Attachment 13.
IV. Engineering Drawings/Photographs
Drawings of the device are provided in Attachment 13.
3.5. Substantial Equivalence
Substantial equivalence discussion can be found in attachment # 12
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles facing right, connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 9 2011
Nihon Kohden America, Inc. c/o Mr. Steve Geerdes Director or Quality Assurance and Regulatory Affairs 90 Icon Foothill Ranch, CA 92610
Re: K112637
Trade/Device Name: NetKonnect Remote Network Extension Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: November 22, 2011 Received: November 30, 2011
Dear Mr. Geerdes:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Mr. Steve Geerdes
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):
Device Name: ___ NetKonnect Remote Network Extension
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 patients as determined by the qualified medical personnel.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 12/12637 510(k)
Page 1 of
§ 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.