The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. This will be available for use by medical personnel on all patient populations.

Device Description

The CGS-9001A Series Communication Gateway Server is an Optional Accessory to the BSM-2300A and BSM-6000 Bedside Monitors, it is a software product that allows the Nihon Kohden Patient Monitoring System to transfer alarm event information from the monitoring device to a third party system. The Communication Gateway Server collects alarm information from all networked patient monitors in a Nihon Kohden Patient Monitoring System and forwards it to a commercially available third party Secondary Alarm Notification System. The alarm notification generated by the third party alarm (not marketed by Nihon Kohden America, Inc.) is for Secondary Alarm Notification Only.

AI/ML Overview

The provided text describes a 510(k) summary for the Nihon Kohden BSM-2300A and BSM-6000 Bedside Monitors with the CGS-9001A Communication Gateway Server. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing specific performance acceptance criteria for a new clinical indication.

Therefore, many of the requested elements for describing specific acceptance criteria and a study that proves the device meets them cannot be fully extracted from this document, as the submission primarily pertains to the safety and performance verification of a device accessory that facilitates alarm information transfer, not a diagnostic or therapeutic AI algorithm.

However, I can extract the available information and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device complies with IEC 601-1 sub-clause 56.2(c) implemented by 21 CFR 868 Performance Standard for Electrode Lead Wires and Patient Cables.	The device complies with IEC 601-1 sub-clause 56.2(c) implemented by 21 CFR 868 Performance Standard for Electrode Lead Wires and Patient Cables.
Performance: The device performs within specifications.	The BSM-2300A and BSM-6000 Bedside Monitors with the CGS-9001A Series Communication Gateway Server Accessory was subjected to safety and performance testing procedures. These tests verified that the device performed within specifications. (Note: Specific performance specifications are not detailed in this document.)
Sterility: Not applicable.	The device is not sterile.
Patient Contact: Not applicable for direct contact.	The device does not directly contact patients.
Substantial Equivalence: Device is substantially equivalent to Nihon Kohden predicate device (K011918 and K080342).	Nihon Kohden US Lab believes that the device is substantially equivalent to the Nihon Kohden predicate device as stated. The FDA issued a substantial equivalence determination.

2. Sample size used for the test set and the data provenance

This information is not explicitly provided. The documentation refers to "safety and performance testing procedures" but does not detail the sample size (e.g., number of patients, number of alarm events tested) for these tests, nor the data provenance (country of origin, retrospective/prospective). Since the device is a communication gateway for alarm events, the testing would likely involve system integration and alarm transmission validation, rather than a clinical dataset in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Given the nature of the device (a communication gateway accessory), the "ground truth" would likely involve technical validation of alarm transmission and accuracy, rather than clinical consensus by medical experts in diagnosing conditions.

4. Adjudication method for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-powered algorithms where human interpretation of medical images or data is involved. The CGS-9001A is an accessory to facilitate alarm notification and does not involve AI or direct human interpretation of complex medical data for diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable in the context of an "algorithm only" as found in AI/ML devices. The device's primary function is to collect and forward alarm information. Performance testing would likely focus on the accuracy and reliability of this transmission, which is a standalone function of the accessory. The document states "These tests verified that the device performed within specifications," confirming a form of standalone performance evaluation for its intended function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of "ground truth" used. For a communication gateway device, the ground truth would likely refer to the accurate transmission of alarm data as generated by the bedside monitors to a third-party system, verified against the actual alarm events occurring on the monitors. This would involve comparing the transmitted data with the source data rather than an external clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable and not provided. The CGS-9001A is a software product for alarm communication, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no training set for this device.

Summary

{0}------------------------------------------------

NIHON KOHDEN AMERICA, INC.

BSM-2300A & BSM-6000 Bedside Monitors with CGS-9001A Accessory

KO83271

SECTION 2- 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc.

90 Icon Street Foothill Ranch, CA 92610

Contact: Jack Coggan Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550

Trade/Device Name: BSM-2300 Series and BSM-6000 Series with CGS-9001A Series Communication Gateway Server Optional Accessory.

Common or usual Name: Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor, Anesthesia Monitor

Legally Marketed Predicate: Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories per 510(k) K011918, commercial distribution certification dated September 12, 2001 and BSM-6000 Series Bedside Monitor per 510(k) K080342, commercial distribution certification date February 26, 2008.

Intended Use:

This device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor the electrocardiogram and generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. This will be available for use by medical personnel on all patient populations.

A summary of the technological characteristics of the device compared to the predicate device:

DEC 2 4 2008

{1}------------------------------------------------

Performance Testing

The device complies with IEC 601-1 sub-clause 56.2(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 does not directly contact patients. Therefore, good laboratory practice . studies were not required per 21 CFR Part 58.
The BSM-2300A and BSM-6000 Bedside Monitors with CGS-9001A Series . Communication Gateway Server Optional Accessory is a new device.
The BSM-2300A and BSM-6000 Bedside Monitors with the CGS-9001A Series . Communication Gateway Server Accessory was subjected to safety and performance testing procedures. These tests verified that the device performed within specifications.
Therefore. Nihon Kohden US Lab believes that the device is substantially . equivalent to the Nihon Kohden predicate device as stated.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2008

Nihon Kohden America, Inc. c/o Mr. Jack Coggan Director of Regulatory Affairs/Quality Assurance 90 Icon Street Foothill Ranch, California 92610-1601

Re: K083271

Trade Name: BSM-2300A and BSM-6000 Bedside Monitors with CGS-9001A Series Communication Gateway Server Optional Accessory Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II (two) Product Code: MHX Dated: December 10, 2008 Received: December 12, 2008

Dear Mr. Coggan:

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 such 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

{3}------------------------------------------------

Page 2- Mr. Jack Coggan

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{4}------------------------------------------------

G. Indications for Use Statement:

KOB3271 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: The BSM-2300A and BSM-6000 Bedside Monitors with the CGS-9001A Series Communication Gateway Server Optional Accessory

Indications for Use:

Prescription Use: X (Part 21 CFR 801 Subpart D)

and/or

Over the Counter Use: (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

eamall.

Division Sian-Off Division of Cardiovascular Devices K083271 510(k) Number

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.