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 visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations.

Device Description

The device is a multi-parameter monitor consisting of a color LCD touchscreen to display waveforms and numerics of monitored parameters, multi-parameter input unit (socket for input cables), and a removable battery pack. Options include a built-in thermal array recorder and network communication card. The device is software driven.

AI/ML Overview

The provided document describes a 510(k) notification for the Nihon Kohden BSM-2300A Series Bedside Monitor. The primary focus of the performance testing section is on compliance with electrical safety, electromagnetic compatibility, and general functional specifications, rather than detailed clinical performance metrics for arrhythmia detection or specific vital sign monitoring accuracy.

Therefore, many of the requested elements regarding acceptance criteria for specific clinical performance, sample sizes for test sets with ground truth, expert adjudication, or MRMC studies are not available in the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized electrical and safety standards and internal product specifications.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General)	Reported Device Performance
Compliance with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 (Lead Wires and Patient Cables)	Device complies.
Compliance with applicable performance standards	Device is designed to and the completed testing showed it met the following standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), IEC 60601-1-2 (1993-05), CISPR11 Group 1, Amendment 1 (1996-09), AAMI EC 12-27 (1994), IEC 60601-2-30 (1995-03), IEC 60601-2-34 (1994-12).
Biocompatibility of patient-contacting accessories	Disposable SpO2 probes use 3M Nonwoven Medical Tape (No. 1776), which was tested in accordance with ISO 10993. The manufacturer (3M) attests to the biocompatibility of adhesive materials within historically acceptable levels.
Environmental Testing (temperature/humidity stress, EMI/EMC)	Completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards.
Safety Standards Testing	Completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards.
Software Functionality	Product verification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications.
Overall Safety and Effectiveness	No significant changes in function, biocompatibility, performance, or manufacturability compared to the predicate device that would affect the safety and effectiveness. (This is a statement of substantial equivalence, not a direct performance metric).
Arrhythmia Detection & Alarms	The document states the device is intended to monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. No specific performance metrics (e.g., sensitivity, specificity, accuracy) for arrhythmia detection are provided in the text.
Other Vital Sign Monitoring (HR, PR, SpO2, NIBP, IBP, Temp, CO2, Resp)	The document states the device is intended to monitor these parameters and generate alarms when a measured rate falls outside preset limits. No specific performance metrics (e.g., accuracy against a gold standard) for these parameters are provided in the text.

Note: The provided text does not include specific numerical acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection, or accuracy ranges for vital signs) nor corresponding reported numerical device performance for such criteria. The performance testing described is focused on engineering and safety standards compliance and internal product specifications.

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

Sample Size for Test Set: Not specified for clinical performance. The document mentions "product verification and validation" for software and "completed testing" for environmental/safety, but no sample sizes for patients or data points are provided.
Data Provenance: Not specified. Given the nature of the testing described (compliance with standards, software validation, environmental), it likely involved in-house engineering testing rather than patient data collected from a specific country. If patient data was used for validation of arrhythmia or vital signs, it is not mentioned.
Retrospective or Prospective: Not specified.

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

Not applicable/Not specified. The document does not describe the establishment of ground truth for clinical performance using human experts. The testing described focuses on engineering and safety compliance.

4. Adjudication method for the test set

Not applicable/Not specified. There is no mention of clinical test sets requiring adjudication.

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 device is a bedside monitor with automated arrhythmia and vital sign detection/alarms, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance. The technology described predates widespread "AI" as we understand it in medical devices today.

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

Yes, implicitly. The device itself is designed to perform monitoring, detect arrhythmias, and generate alarms without continuous human intervention. The testing described (compliance with standards, software functionality) would inherently evaluate the device's standalone performance against its specifications and the requirements of the standards. However, specific standalone performance metrics (e.g., sensitivity/specificity for arrhythmia without human review) are not provided.

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

Not specified for clinical performance. For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the applicable standards (e.g., IEC 60601-1, AAMI EC 12-27). For software, the ground truth would be the expected functional behavior defined in the product specifications.

8. The sample size for the training set

Not applicable/Not specified. This document is for a conventional medical device (bedside monitor) from 2001 and does not describe machine learning or AI models requiring training sets as typically understood in current contexts.

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

Not applicable/Not specified, as no training set for a machine learning model is mentioned.

Summary

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Koll918 P

NIHON KOHDEN AMERICA, INC. June 19, 2001

510(k) NOTIFICATION BSM-2300A Series Bedside Monitor

SEP 1 2 2001

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant

Nihon Kohden America, Inc. Contact: Regulatory Affairs Manager 90 Icon Street Foothill Ranch, CA 92610

Phone: (949) 580-1555 Fax: (949) 580-1550

Device Name: BSM-2300A Series Bedside Monitor. Common names for the device include Bedside Device Name: Dow 2007 Coence Bouttor, Cardiac Monitor and Vital Signs Monitor. The classification Monitor, F Gallerinention Patient Monitor with Arrhytmia Detection and Alarms

Legally Marketed Predicate: Nihon Kohden BMS-4100A Series Bedside Monitor per 510(k)# K001693.

Description and Intended Use: The device is a multi-parameter monitor consisting of a color LCD touchscreen to display waveforms and numerics of monitored parameters, multi-parameter input unit (socket Screen to display waronomic and namovable battery pack. Options include a built-in thermal array pailer, visual alanm lindications card. The device is software driven. Both the device and the starside of recorder and hetwork communitor, direr it is display and record physiological data to provide cardiac predicale have the same intention association and the is intended to monitor the electrocaciliogram and vital 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 monitor mean rate, pulse fate, plood oxygon oataration (2) respiratory rate. The device may generate an blood pressure (fDT ); body tomporation of SS and SS (and St. This device may also condition addide and or visual alam who i modour calls Tato Talle Talle Taller will be available for use by medical personnel on all patient populations.

Performance Testing

formanos Tooting
The device complies with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 1 The donion of the read on " Sead Wires and Patient Cables. To date, no other special controls r enomance olandards are known or established for this device. The device is designed to comply or performance candards and the standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), IEC 60601-1-2 (1993-05), CISPR11 Group 1, Allianonent = (1000-00), 12-27 (1994), JEC 60601-2-30 (1995-03), IEC 60601-2-34 (1994-12)
The device is not sterile. 트
The device does not directly contact patients. Accessories that contact patients, such as probes and ■ The device are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories except as noted below. The disposable SpO2 probes include No.1776 3M Nonwoven Medical Tape which may contact the surface of intact skin. According to the manufacturer, 3M, the material was tested in accordance with ISO 10993 and Good Aooorang to the manafactively of adhesive materials within historically acceptable levels.
The device was subjected to environmental testing including temperature/humidity stress testing, . electromagnetic interference / electromagnetic compatibility testing and safety standards testing and performance testing procedures. Test criteria is established prior to testing based upon product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. product operification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications.

There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use. Therefore, Nihon Kohden believes that the new BSM-2300 Series, is substantially equivalent to the predicate BSM-4100A Series Bedside Monitor.

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K011918 p.2/2

NIHON KOHDEN AMERICA, INC. June 19, 2001

510(k) NOTIFICATION BSM-2300A Series Bedside Monitor

SECTION 3 - PROPOSED LABELING

Intended Use A.

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 vital signs monitoring withili a modical land/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 nonimasive blood probodio (NBC) and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

B. Device/Package Labels

The proposed product labels for the device are located in Attachment 2.

C. Proposed Packaging

Packaging for the device is depicted in Attachment 3.

D. Instructions for Use

The proposed instructions for use are provided with each packaged device and are presented in Attachment 9.

Advertisement/Promotional Literature E.

To date no advertisement or promotional literature for this device has been created for distribution in the United States.

Contraindications, Precautions & Warnings F.

Warnings and cautions are listed in the Operator's Manual as shown in Attachment 4.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2001

Ms. Bonnie Bishop Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610

Re: K011918

Trade Name: Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: MHX Dated: June 19, 2001 Received: June 20, 2001

Dear Ms. Bishop:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Ms. Bonnie Bishop

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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G. Indications for Use Statement

510(k) Number (if known):	K011918
---------------------------	---------

Device Name: BSM-2300A Series Bedside Monitors

Indications for Use:

Dale Tell

Division of Cardiovascular & Respiratory Devices
510(k) Number K011915

Prescription Use
(Per 21 CFR 801.109)

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.