The CNS-6200 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit.

This product will be available for use by medical personnel on all patient populations within a medical facility.

Device Description

The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Nihon Kohden CNS-6200 Series Central Nurse Station. This device is an update to a previously cleared predicate device (CNS-9701A). The submission focuses on demonstrating substantial equivalence rather than a new performance claim, therefore, details on specific acceptance criteria for a new device's performance, a comprehensive study proving those criteria, or a standalone performance study are not explicitly included in the provided text as one might find for a novel AI/software medical device.

However, based on the information provided, we can infer some aspects related to acceptance criteria and validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Electrical Standards Compliance:	CNS-6200 Series Central Nurse Station complies with IEC 60601-1 subclause 56.3 (C), implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.
Proper Operation according to Design Specifications:	Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.
Electromagnetic, Environmental, and Safety Performance:	The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the proper operation of the device.
Functional Equivalence to Predicate Device:	The technical characteristics of the CNS-9701A predicate and the new CNS-6200 Series are the same with the exception that the new device has new hardware such as CPU and LCD monitor. (This implies that the new device performs the same functions, including cardiac and vital signs monitoring, display, recording, and alarm mimicking, as the predicate.)
Intended Use Compliance:	The device's operation aligns with its intended use: "cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry received transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit."

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study in the typical sense of a novel device requiring a test set of patient data for performance evaluation (e.g., sensitivity, specificity for arrhythmia detection algorithms). Instead, the validation is focused on engineering verification and validation (V&V) activities and demonstrating substantial equivalence to a predicate device.

Sample Size for Test Set: Not applicable or not specified in the context of clinical performance data. The "test set" would primarily refer to the device itself undergoing various engineering and functional tests.
Data Provenance: Not applicable, as this submission isn't based on retrospective or prospective patient data for an algorithm's performance. The validation is based on the device's adherence to design specifications and safety standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. For this type of device (a patient monitoring system that displays and relays information, rather than autonomously making a diagnosis or interpretation), "ground truth" established by clinical experts on a test set of patient cases is not a requirement for this 510(k) submission. The ground truth would reside in the functioning of the connected bedside monitors or telemetry units for arrhythmia detection.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of a human-reviewed test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or interpretative aids where human reader performance is a key metric. The CNS-6200 Series Central Nurse Station is a monitoring and display system, not a diagnostic interpretation tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Study: No, a standalone performance study (in the context of an algorithm's diagnostic or interpretive accuracy) was not described or performed. The device's function is to display and record physiological data and mimic alarms from other primary devices (bedside monitors and telemetry units). The core arrhythmia detection function, for example, resides in the connected telemetry receivers/transmitters or individual bedside monitors, not the central station itself. The central station's "performance" is in accurately receiving, displaying, recording, and relaying these statuses and alarms.

7. The Type of Ground Truth Used

Type of Ground Truth: The concept of "ground truth" as typically applied to algorithmic performance (e.g., pathology, outcomes data) is not directly relevant here. The ground truth for the CNS-6200 Series would be:
- Design Specifications: The device accurately performs according to its documented design.
- Predicate Device Functionality: The new device replicates the functions and technical characteristics of the legally marketed predicate device.
- Regulatory Standards: The device adheres to mandated safety and electrical performance standards (e.g., IEC 60601-1, 21 CFR 868).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data. Its development is based on engineering design principles for hardware and software, not on machine learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as no training set was used.

Summary

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510(K) SUMMARY

. Name and Address of Applicant
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, Ca 92610

. . . . . .

Telephone: (949) 580-1555 Ext. 3325 Fax: (949) 580-1550 Attn: Steve Geerdes, Director of Regulatory Affairs

・ = ・・・・・・・・・・・・・・・・・・・・・・・・・・ - - -

DEC - 7 2010

102376

Date: August 12, 2010

Name/Trade Name of the Device: CNS-6200 Series Central Nurse Station (i.e. CNS-6201) and . Accessories
. The common or usual Name: Monitor, physiological, patient (with arrhythmia detection or alarms) and Telemetry Monitoring Station.
. The Classification: The device has been classified as Class II by the Cardiovascular Device Classification Panel under 21 CFR Part 870.1025 "Monitor, Physiological, Patient (with arrhythmia detection or alarms)" per MHX
The legally marketed equivalence: The predicate device is the Nihon Kohden CNS-9701 and . Accessories per 510(k) K023475 cleared on October 16, 2002,
A description of the device: The device is intended for use by medical professionals to provide . cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor.

. Intended Use

This product will be available for use by medical personnel on all patient populations within a medical facility.

A summary of the technological characteristics of the device compared to the predicate . device:
- The technical characteristics of the CNS-9701A predicate and the new CNS-6200 Series o are the same with the exception that the new device has new hardware such as CPU and LCD monitor

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CNS-6200 Series Central Nurse Station complies with IEC 60601-1 subclause 56.3 (C) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.

To date, no other special controls or performance standards are known or established for this device.

The device is not sterile.

The device is not contacting patients. Therefore, no good laboratory practice studies were required per 21 CFR 58.

Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.

The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device. Design validation confirmedthe operation of the software and hardware of the device is in accordance to the design specifications.

Therefore based on the above, Nihon Kohden believes that the CNS-6200 Series Central Nurse Station is substantially equivalent to the predicate device, Nihon Kohden CNS-9701A Central Nurse Station.

102376

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Nihon Kohden Corporation c/o Mr. Steve Geerdes Director. OA/RA 90 Icon Street Foothill Ranch, CA 92610

DEC - 7 2010

Re: K102376

Trade/Device Name: Nihon Koden CNS-6200 Series Central Nurse Station, Model Number CNS-6201 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection and alarms) Regulatory Class: II (two) Product Code: MHX Dated: November 8, 2010 Received: November 9, 2010

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, listing 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 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.

Sincerely yours.

Dinah R-Vahmer

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): __ K | 0 2 3 7 6

Device Name: ___ CNS-6200 Series Central Nurse Station____

DEC - 7 2010

Indications for Use:

.. - - - - - ---- ----------

This product will be available for use by medical personnel on all patient populations within a medical facility.

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)

Anne R. V. Hines

Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K102376

Page 1 of

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.