K Number
K083271
Device Name
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
Date Cleared
2008-12-24

(48 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a communication gateway server that transmits alarm information from patient monitors to a third-party system. There is no mention of AI or ML being used for data analysis, interpretation, or decision-making within the device itself. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

No
The device is described as a monitor that records and displays physiological data and provides alarm notifications. It does not provide any treatment or therapy.

No.
The device's Intended Use describes monitoring, displaying, and recording physiological data, and generating alarms when measured rates fall outside preset limits or when an arrhythmia exists. This is indicative of a monitoring device, not a diagnostic device which typically interprets data to identify a disease or condition. The device description also states it is a Communication Gateway Server which transfers alarm event information from monitoring devices, further supporting its role as a monitoring accessory rather than a diagnostic tool.

Yes

The device description explicitly states that the CGS-9001A Series Communication Gateway Server is a "software product" and an "Optional Accessory" to existing hardware bedside monitors. Its function is to transfer data, not to perform monitoring or analysis 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 described device (CGS-9001A Series Communication Gateway Server as an accessory to bedside monitors) is designed to monitor, display, and record physiological data directly from the patient. It collects data like ECG, heart rate, blood pressure, SpO2, temperature, CO2, and respiratory rate. It also transmits alarm information.
  • No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient to gather real-time physiological measurements.

The device falls under the category of patient monitoring equipment, which is distinct from in vitro diagnostics.

N/A

Intended Use / Indications for 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.

Product codes

MHX

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.

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

all patient populations

Intended User / Care Setting

medical personnel within a medical facility

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K011918, K080342

Reference Device(s)

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.

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:

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.

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:

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.

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