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 audible and/or visual alarms when an arrhythmia exists. The device is also intended to monitor patients' physiological data including heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP), body temperature respiratory rate and apnea. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device receives physiological signals via radio from the transmitters. The device has the capability of communicating with external devices, such as personal computers. Vital sign data can be sent to a central monitor through the network via network card.

Device Description

The system provides for monitoring ECG, ST levels, VPC rate, arrhythmia events, SpO2, NIBP, temperature, respiration and apnea. The device will be offered with up to 5 multi-connectors and SpO2. The system is comprised of a receiver (WEP-4200A), and a transmitter (ZS-910P). WEP is a multi-parameter monitor consisting of a color LCD touch-screen to display waveforms and numerics of monitored parameters, multi-parameter receiver unit, visual alarm indicator, external communications port, and a removable battery pack for transmitter. Options include a thermal array recorder and a laser printer interface card.

AI/ML Overview

The provided text is a 510(k) summary for the Nihon Kohden WEP-4200A series Central Telemetry System, seeking clearance as substantially equivalent to previously marketed predicate devices. It describes the device, its intended use, and a summary of non-clinical tests conducted. However, the document does not contain explicit acceptance criteria or detailed study results with specific performance metrics (like sensitivity, specificity, accuracy) to "prove the device meets acceptance criteria" in the way typically expected for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to existing devices, primarily by highlighting that the new device uses the same underlying technology, algorithms, and accessories for its physiological monitoring functions (ECG, arrhythmia detection, SpO2, NIBP, temperature, respiration) as the predicate devices. The main differences noted are an updated transmitting frequency band (WMTS) and increased storage memory.

Therefore, many of the requested items cannot be directly extracted from the provided text. I will address what can be inferred or explicitly stated.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of quantitative acceptance criteria (e.g., minimum sensitivity/specificity for arrhythmia detection) or corresponding reported device performance metrics for specific functions. Instead, it relies on demonstrating that the core monitoring functionalities are "the same" as or use "the same control software" or "same algorithm" as legally marketed predicate devices.

The closest to "acceptance criteria" are compliance with regulatory standards and verification of operation.

Acceptance Criteria (Inferred from text)	Reported Device Performance
Compliance with FDA Special Controls for arrhythmia detector and alarm system	"The device is in compliance with the FDA Special Controls for arrhythmia detector and alarm system."
Compliance with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 (Electrode Lead Wires and Patient Cables)	"The device complies with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables."
Compliance with applicable sections of IEC standard	"The device is also in compliance with applicable sections of IEC standard as listed in this application."
Operation verification through electromagnetic, environmental, safety, and performance testing	"The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device."
Software and hardware function validated through design validation	"Design validation confirmed the operation of the software functions as well as hardware of the device."
Physiological monitoring features (ECG, arrhythmia, SpO2, NIBP, Temp, Respiration) equivalent to predicate devices	"These features are currently available in the legally marketed Nihon Kohden predicate devices..." and "The device incorporates the same multi-template arrhythmia detection and analysis of the predicate device..." and "The device uses the same control software as the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of performance evaluation for detection algorithms. The "non-clinical tests" mentioned refer to compliance with standards and design validation, not a clinical performance study with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as the submission relies on equivalence to predicate devices and compliance with engineering/safety standards rather than a de novo clinical ground truth establishment for a novel algorithm.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a clinical test set requiring adjudication in the context of algorithm performance.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, an MRMC comparative effectiveness study was not done or mentioned in this document. The device is a "Central Telemetry System" for physiological monitoring and arrhythmia detection, which typically involves automated algorithms rather than human "readers" interpreting cases in the same way a diagnostic imaging AI might.

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

The document implies standalone algorithm performance was established by demonstrating that the arrhythmia detection and other physiological monitoring algorithms are the same as those in legally marketed predicate devices. It states: "The device incorporates the same multi-template arrhythmia detection and analysis of the predicate device..." and "The software algorithm that determines the respiration rate count is the same in both the new device and the predicate." However, specific standalone performance metrics (e.g., sensitivity, specificity) for these algorithms on a defined dataset are not provided.

7. The Type of Ground Truth Used

For the specific algorithms, the ground truth establishment is implicitly linked to the predicate devices. Since the algorithms are stated to be "the same," their original validation (which would have involved expert consensus or known physiological states for ground truth) for the predicate devices serves as the basis. The current document does not detail this original ground truth establishment.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This is likely because the device is not introducing a new, independently trained AI/ML algorithm but re-using or updating established (presumably rule-based or historically trained) algorithms from predicate devices.

9. How the Ground Truth for the Training Set was Established

This information is not provided, as the document focuses on substantial equivalence based on existing, proven technologies from predicate devices rather than the development and training of a new algorithm. The ground truth for the predicate devices' algorithms would have been established historically, but those details are not in this submission.

Summary

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SECTION 2 - 510(K) SUMMARY

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

Date: 05/19/2004

JUN = 1 2004

K040395
p. 1 of 3

Phone: (949) 580-1555 Dial 9 and then Ext. 4401 Fax: (949) 580-1550 Attn: Serrah Namini, Regulatory Affairs Assoc. Dir.

Name of the device: WEP-4200A series Central Telemetry System .
Trade or proprietary name: WEP-4200A series Central Telemetry System .
The common or usual name: Central Telemetry System .
. The classification name: Physiological Patient Monitor with Arrhytmia Detection and Alarms per 21 CFR Part 870.1025,
The legally marketed equivalence: The predicate device is Nihon Kohden's Central . Telemetry system, WEP-8430A, 510K: K945944, dated 11/27/95. All features available with the new WEP-4200 are also available on Nihon Kohden BSM-4104A, 510K: K001693
A description of the device: The system provides for monitoring ECG, ST levels, VPC rate, . arrhythmia events, SpO2, NIBP, temperature, respiration and apnea. The device will be offered with up to 5 multi-connectors and SpO2. The system is comprised of a receiver (WEP-4200A), and a transmitter (ZS-910P). WEP is a multi-parameter monitor consisting of a color LCD touch-screen to display waveforms and numerics of monitored parameters, multi-parameter receiver unit, visual alarm indicator, external communications port, and a removable battery pack for transmitter. Options include a thermal array recorder and a laser printer interface card.
A summary of the technological characteristics of the device compared to the . predicate device:

The telemetry system is intended to monitor, record and display physiological data including ECG, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), body temperature, respiration and apnea. These features are currently available in the legally marketed Nihon Kohden predicate devices, such as WEP-8430 and BSM-4100A series.

The device acquires ECG signals through electrodes placed on the patient. The ECG signals are then amplified, filtered and displayed on a color LCD. Heart rate value is determined from the ECG signal or the pulse waveform and the device may sound an alarm when the heart rate falls outside preset upper and lower limits. These features are currently available in the legally marketed Nihon Kohden predicate devices, such as WEP-8430 and BSM-4100A series.

The device monitors the ECG to detect arrhythmias. User selectable options are provided to control the alarm, storage and recording of arrhythmia events. The device is capable of generating an audible and visual alarm when an arrhythmia event is detected. The device incorporates the same multi-template arrhythmia detection and analysis of the predicate device WEP-8430 and BSM-4100A series.

The device includes a pulse oximeter, which measures the blood oxygen saturation using finger, foot, ear, and multi-site probes and displays a numeric value and a pulse plethysmograph waveform. When the SpO2 value falls outside preset upper and lower limits, the alarm is activated. The device uses the same control software as the predicate device.

The device includes a noninvasive blood pressure measurement system, which measures and displays the systolic, diastolic, and mean pressures through the use of pressure cuffs placed on the arm or leg. The NIBP measurement interval may be set to manual, continuous or selected time intervals. When NIBP measurements are set to time intervals, the user may also select an additional trigger method called PWTT as offered with the predicate device. An alarm may be generated when the systolic, diastolic or mean pressure values fall outside preset upper and lower limits.

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K040395
p 2 of 3

The device measures temperature through the use of the same commercially available temperature thermistors as the predicate device WEP-8430. Temperature thermistors measures temperature through the use of the same commercially available temperature thermistors as the predicate device. The control software for the temperature function is the same in both the new device and the predicate.

The device measures respiration rate through impedance (picked up through the ECG electrodes), through the sensor or through the use of a thermistor respiration pickup transducer. Respiratory waveform is displayed on the monitor and respiration rate is calculated and displayed on the monitor. The device may generate an audible and visual alarm when the measured respiration value falls outside preset upper and lower limits. The software algorithm that determines the respiration rate count is the same in both the new device and the predicate.

A thermal array recorder is available as an option to allow the printing of waveforms and alphanumeric data. Automatic alarm recording, manual recording, and timed recording are available.

All system functions are operable from AC or battery power. A battery charging circuit is incorporated into each device.

A summary of the technological differences between the device compared to the . predicate devices:

The new device is an updated version of the WEP-8430A, eight patient telemetry, based on the same technology platform as the BSM-4104A bedside monitor. It uses features and capabilities from the predicate devices.

The transmitting frequency of the new device is in the 608-614 MHz (WMTS) frequency band. The predicate device transmitted in the UHF frequency band. This change was made to meet FCC and FDA recommendations for WMTS.

The new device has more storage memory, which is used to expand the storage of arrhythmia recall files and full disclosure. The basic functions of the arrhythmia recall and full disclosure remain unchanged.

Indications for Use: .

The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring. The device is intended to present 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 saturation (SpO2), noninvasive blood pressure (NIBP), body temperature, respiration rate and apnea. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The system communicates in the new WMTS band as required by FCC. The device will be available for use by medical personnel on all patient populations within a medical facility, including ICU, CCU, recovery room and general ward.

Non-clinical tests:

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 is in compliance with the FDA Special Controls for arrhythmia detector and alarm system. The device complies with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. The device is also in compliance with applicable sections of IEC standard as listed in this application.

The device is not sterile.

The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Design validation confirmed the operation of the software functions as well as hardware of the device.

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p. 3 . F 3 Therefore, Nihon Kohden believes that the device is substantially equivalent to the Nihon Kohden
predicate devices as indicated.

1-040395

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Image /page/3/Picture/11 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2004 ___

Nihon Kohden America c/o Ms. Serrah Namini RA Assoc. Dir. 90 Icon Street Foothill Ranch, CA 92610

Re: K040395

K040579
Trade Name: WEP-4200A Series Central Telemetry System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: May 25, 2004 Received: May 25, 2004

Dear Ms. Namini:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manation province Amendments, or to commence prior to May 20, 1976, are exactions of the Federal Food, Drug, devices that have occh rechasined in assere approval of a premarket approval application (PMA). and Cosment ACT (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the devices, sologie requirements for annual registration, listing of general controls provisions of the fiel 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 If your device is classified (500 a0070) ins . Existing major regulations affecting your device can thay be subject to subli dualities, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.

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Page 2 - Ms. Serrah Namini

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I DTT Unstance or our deviee complies with other requirements of the Act mar I Dri has made a sond regulations administered by other Federal agencies. You must or any I catal statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the 110 - 21 CFR Part 801); good manufacturing practice requirements as set OI IT at 0077, idocime (21 OFF earlation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comi or to begin marketing your device as described in your Section 510(k) I ms letter will anow you'le cogni maining of substantial equivalence of your device to a legally premailed 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 If you desire specific acriously 3 at (301) 594-4648. Also, please note the regulation entitled, Connect the Office of Comments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrinational 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,

Neil R.P. Ogden

Bram D. Zuckerman, M.D. ナレ 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 Central Telemetry System

G. Indications for Use Statement

510(k) Number (if known): KOYO39S S

Device Name: WEP-4200A Series Telemetry system

Indications for Use:

The device is comprised of transmitters and a receiver communicated via WMTS radio frequency. The series of device are 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 audible and/or clookida organization produced by the novice is also intended to monitor patients' physiological data including heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP), body temperature respiratory rate and apnea. The device may generate an audible and/or visual alarm body temperature roopiratory no and limits. This device receives physiological signals via radio when a motor the transmitters. The device has the capability of communicating with external devices, such as personal computers. Vital sign data can be sent to a central monitor through the network via network card.

The device will be available for use by medical personnel on patients within a medical facility including adults, children and infants. n

for BDZ

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K040398

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

Page 1 of 1

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.