(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.
§ 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.