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 produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen santuation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), Carbon dioxide Concentration (C02) and EtCO2 respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoofburane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO2 Monitors .The device may generate an audible and/or visual alsommore a measured rate falls outside preset limits.

Device Description

Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor and Anesthesia Monitor.

AI/ML Overview

The provided text does NOT contain information about acceptance criteria or specific studies proving the device meets acceptance criteria in the format requested.

The document is a 510(k) notification for a bedside monitor, primarily focusing on demonstrating substantial equivalence to a predicate device. It briefly mentions general performance testing and software validation.

Here's what can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available. The document states that "performance testing procedures" and "software validation" were performed and the "results confirmed that the device performed within specifications," but it does not detail these specifications (acceptance criteria) or the specific performance metrics achieved.

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

Not available. The document does not provide details on sample sizes for any test sets or the origin/nature of data used for testing (e.g., retrospective or prospective, country of origin).

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

Not available. There is no mention of expert-established ground truth or the involvement of experts in any testing described.

4. Adjudication method for the test set:

Not available. No adjudication method is mentioned.

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/Not available. This device is a physiological patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, an MRMC study and effect size for human reader improvement are not relevant or discussed.

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

Given that this is a bedside monitor with arrhythmia detection, it implies an algorithm operating in standalone mode. However, the document does not provide specific details or a dedicated "standalone study" report. It mentions "software validation tested the operation of the software function of the device," which indirectly supports standalone algorithm testing, but lacks specifics.

7. The type of ground truth used:

Not available. The document does not specify the type of ground truth used for any testing. For a device like this, ground truth would typically be established against known physiological signals or reference equipment, but this is not detailed.

8. The sample size for the training set:

Not available. The document does not mention any training sets, which is typical for a 510(k) for a device like this where the technology is largely established and the changes are minor, not involving new machine learning algorithm development from scratch.

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

Not applicable/Not available. As above, no training set is mentioned.

Summary of available information related to performance testing:

The document broadly states:

"The BSM-9100A Series Bedside Monitor device was subjected to tests for electromagnetic, environmental, safety and performance testing procedures."
"These tests verified the operation of the device."
"The software validation tested the operation of the software function of the device."
"The results confirmed that the device performed within specifications."

However, these are very general statements and do not provide the detailed information requested regarding specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement. This is common for 510(k) submissions focusing on substantial equivalence with minor changes, where detailed performance data might be referenced internally within the manufacturer's quality system but not explicitly detailed in the public 510(k) summary.

Summary

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

K082785 P1/3

NIHON KOHDEN AMERICA, INC.

SPECIAL 510(k) NOTIFICATION BSM-9100A Series Bedside Monitor

Name and Address of Applicant

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

Contact:

Jack Coggan NOV 2 6 2008 Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550

Trade/Device Name:

BSM-9100A Series Bedside Monitor

Common or Usual Name:

Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor and Anesthesia Monitor.

Classification Name:

The device has been classified as Class II by the Cardiovascular Device Classification Panel under 21 CFR Part 870.1025, Physiological patient Monitor with Arrabythmia Detection and Alarms as MHX and under 21 CFR 870.2340, ECG Analysis System as LOS. Functions of the device have also been classified as Class II by the Anesthesiology Device Classification Panel.

Legally Marketed Predicate Device:

Nihon Kohden BSM-6000 Series Bedside Monitor and Accessories per 510(k) K080342 commercial distribution certification dated February 26, 2008.

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 produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythminar rists. The device is also intended to monitor heart rate, pulse rate, blood oxygen santuation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), Carbon dioxide Concentration (C02) and EtCO2 respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoofburane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO2 Monitors .The device may generate an audible and/or visual alsommore a measured rate falls outside preset limits.

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

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

Similarities:

. The indications of use are identical.
The fundamental technology has not changed, in that the beside monitor . technology remains the same.
The alarm display, electrosurgery interference filter, heart rate counting method . and VPC counting range remains the same.
The arrhythmia graphic trend, arrhythmia alarm and arrhythmia recall remains the . same.
. The SpO2 display range and declared range remains the same.
The NIBP noninvasive blood pressure methods, display measuring range and . alarm limits remains the same.
. Invasive Pressure (IBP) measuring method, range accuracy, alarm limits, pulse sync tone, pulse rate count range and counting accuracy remains the same.
. Cardiac Output (CO) measuring method, range, accuracy and alarm limits remains the same.
. External communication, user interface, recorder, ECG acquisition and analysis and environmental conditions remain the same.
. Number of ECG electrodes remains the same.
. The heart rate counting, arrhythmia recall, respiration method and user interface all remains the same.

Minor Differences:

. Number of traces are increased to 16.
To the arrhythmia alarm parameters section we added the following arrhythmia . events: Extreme Brady, Extreme Tachy, V Brady, SV Tachy, Pause, VPC, V Rhythm. Trigeminy, Irregular RR, No Pacer Pulse and Pacer Non-Capture.
. To the Pulse Alarm Limits section we changed the Upper Limits to 31 to 250 bpm. Lower Limits to 30 to 249 bpm.
To the O2 Alarms Limits section we changed the Upper Limits to 11 to 100% and . the Lower Limits to 10 to 99%.
. To the Invasive Blood Pressure section we changed the number of channels to 8 on the new device.
To the Power Requirements section we changed to 210VA (Main Unit). .
The change of QRS detection which is divided into three and becomes selectable ◆ to be optimized for each patient (adult, child/neonate).

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

K082785 P3/3

SPECIAL 510(k) NOTIFICATION BSM-9100A Series Bedside Monitor

510(k) Summary:

. The device is not sterile.
The device does not directly contact patients. Accessories that contact patients, . such as probes and thermistors, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories. Therefore, good laboratory practice studies were not required per 21 CFR Part 58.
The device complies with the IEC 60601-1 standard and sub-clause 56.3 (c) . implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.
The BSM-9100A Series Bedside Monitor device was subjected to tests for . electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device. The results confirmed that the device performed within specifications.
Therefore, Nihon Kohden believes that the device is substantially equivalent to . the predicate device.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2008

Nihon Kohden America, Inc. c/o Mr. Jack Coggan Director, Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610

Re: K082785

Trade/Device Name: BSM-9100A Series Bedside Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II Product Codes: MHX Dated: October 29, 2008 Received: November 3, 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 markcted 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. Iisting 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

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

Page 2 - Mr. Jack Coggan

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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrl/industry/support/index.html.

Sincerely yours,

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

Enclosure

{5}------------------------------------------------

NIHON KOHDEN AMERICA, INC.

G. Indications for Use Statement:

510(k) Number (if known): KO8278 ک

Device Name: BSM-9100A Series Bedside Monitor

Indications of 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 produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), Carbon dioxide Concentration (C02) and EtCO2 respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoffurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO2 Monitors .The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

Prescription Use	X	AND/OR	Over The Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

	for B Zuckerman
(Division Sign-Off)	11/26/08
Division of Cardiovascular Devices

Page 10 of 28	510(k) Number	K082785
---------------	---------------	---------

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.