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 ECG. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) 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. Waveforms, numeric data, trendgraphs, and vital signs lists can be recorded manually or automatically on the optional recorder unit. Waveforms and parameter data from the monitor can be sent to a Cardiac Telemetry System, or to a Central Monitor via a Multiple Patient Receiver and transmitter. 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 screen to display waveforms and numerics of monitored parameters. Options include a builtin thermal array recorder. The device is software driven. Both the device and the predicate have the same intended use 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. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also condition and transmit physiological signals via radio frequency. This device will be available for use by medical personnel on all patient populations.

AI/ML Overview

The Nihon Kohden OPV Series Bedside Monitor is a multi-parameter monitor intended to display and record physiological data for cardiac and vital signs monitoring within a medical facility. The device monitors ECG, heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and respiratory rate. It can generate alarms and transmit physiological signals.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain a specific table detailing acceptance criteria for each physiological parameter (ECG, HR, SpO2, NIBP, Respiration Rate) and the device's reported performance against those criteria. Instead, it focuses on compliance with general medical device standards.

Therefore, a table cannot be constructed from the given text.
Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a sample size for a "test set" in the context of assessing individual physiological parameter accuracy with clinical data.

The performance testing mentioned refers to:
- Compliance with IEC 60601-1 subclause 56.3(c) implemented by 21 CFR Part 898: This pertains to Electrode Lead Wires and Patient Cables.
- Compliance with voluntary industrial standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-30. These are general electrical safety and performance standards for medical electrical equipment.
- Environmental testing: Temperature/humidity stress, electromagnetic interference/compatibility.
- Safety standards testing and performance testing procedures: These were based on "product specifications and applicable standards."
The text indicates that "The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards." However, it does not specify the type of data (retrospective/prospective, country of origin) used for these "performance testing procedures" in relation to clinical accuracy of the monitored parameters. It seems to refer more to technical and safety performance rather than clinical validation of parameters against a gold standard.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not describe the use of human experts to establish ground truth for a clinical test set for the physiological parameters. The performance testing seems to relate to technical standards and specifications rather than a multi-expert clinical review of monitoring accuracy.
Adjudication Method for the Test Set:

Since the document does not describe a process involving human expert review for establishing ground truth on a clinical test set, there is no mention of an adjudication method (e.g., 2+1, 3+1).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention is made of an MRMC comparative effectiveness study, or how human readers (medical personnel) improve with or without AI assistance. The device in question is a bedside patient monitor, not an AI-powered diagnostic tool requiring human interpretation improvement studies.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

The document describes the device's inherent function as a standalone monitor. The performance testing mentioned ("met its product specifications and verified conformance to safety, reliability, and applicable standards") implicitly refers to the device's standalone performance in fulfilling its monitoring role. However, it doesn't provide specific standalone performance metrics (e.g., accuracy, sensitivity, specificity) for each physiological parameter against a clinical gold standard. The device's primary function is data acquisition and display, rather than an "algorithm" with a specific diagnostic output separate from human interpretation.
Type of Ground Truth Used:

The "ground truth" implicitly referred to in the document's performance testing section appears to be product specifications and applicable standards (e.g., IEC standards for electrical safety and performance, FDA performance standards for electrode lead wires). There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for the accuracy of displayed physiological parameters.
Sample Size for the Training Set:

The document pertains to a hardware device (bedside monitor) with software control for parameter display. It does not describe a machine learning or artificial intelligence algorithm that would require a "training set" in the conventional sense. The development likely involved engineering design, calibration, and verification against known inputs and technical specifications, rather than data-driven machine learning training.
How Ground Truth for the Training Set Was Established:

As there is no mention of a traditional "training set" for a machine learning algorithm, the concept of establishing ground truth for such a set is not applicable here. The device's functionality is based on established physiological measurement principles and engineering design, with verification against technical standards.

Summary

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SEP 1 6 2003

NIHON KOHDEN AMERICA, INC.

510(k) NOTIFICATION OPV Series Bedside Monitor

SECTION 2 - 510(K) SUMMARY

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

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

Device Name: OPV Series Bedside Monitor. Common names for the device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor.

Legally Marketed Predicate: Nihon Kohden BMS-2300A Series Bedside Monitor per 510(k)# K011918.

Description and Intended Use: The device is a multi-parameter monitor consisting of a color LCD screen to display waveforms and numerics of monitored parameters. Options include a builtin thermal array recorder. The device is software driven. Both the device and the predicate have the same intended use 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. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also condition and transmit physiological signals via radio frequency. This device will be available for use by medical personnel on all patient populations.

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. The new device is a simplified version of BSM-2300 as well as BSM-4100 and does not include arrhythmia detection. Therefore, Nihon Kohden believes that the new OPV Series, is substantially equivalent to the predicate BSM-2300A Series Bedside Monitor.

Performance Testing

The device complies with IEC 60601-1 subclause 56.3(c) implemented by 21 CFR Part 898 . 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 designed to comply with the following voluntary industrial standards: IEC 60601-1 (1988), Amendment 1 (1991), Amendment 2 (1995), IEC 60601-1-1 Amendment 1 (1995), IEC 60601-1-2 (1993-05), IEC 60601-2-27 (1994), IEC 60601-2-30 (1995)
프 The device is not sterile.
트 The device does not directly contact patients. Accessories that contact patients, such as ECG leads, SpO2 probes and NIBP cuffs, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories.
The device was subjected to environmental testing including temperature/humidity stress す 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health and human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

SEP 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nihon Kohden America, Inc. c/o Ms. Serrah Namini Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610

Re: K032749

Trade Name: OPV Series Bedside Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class IL (two) Product Code: MWI Dated: August 31, 2003 Received: September 5, 2003

Dear Ms. Namimi:

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

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Page 2 - Ms. Serrah Namini

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 (OS) 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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NIHON KOHDEN AMERICA, INC.

510(k) NOTIFICATION OPV Series Bedside Monitor

G. Indications for Use Statement

510(k) Number (if known): K032749

Device Name: OPV Series Bedside Monitors

Indications for Use:

Helton

510(k) Number K:032749

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).