The device, ZS-940PA series, is intended to transmit physiological data, such as: electrocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring applications. The transmitter can change channels when connected to the QI-910PK channel writer. The front LCD displays SpO2%, NIBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The monitored physiological parameters communicated via radiofrequency can be displayed, stored and printed at a Nihon Kohden Central monitor, such as WEP-4000 or ORG-9700/CNS-9700.

The device will be available for sale only upon the order of a physician or licensed health care provider and it will be available for use by medical personnel on all patient populations within a medical facility, including ICU, CCU, recovery room and general ward.

The device is intended to monitor, display and transfer physiological data. Specifically, the device is intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO22), respiratory rate, and non- invasive blood pressure (NIBP). This device may be used to transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations within a medical facility.

The device is intended to transmit physiological data, such as: electrocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring. The transmitter can change channels when connected to the QI-910PK channel writer. The front LCD displays SpO2%, NIBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The device will be available for use within a medical facility, including ICU, CCU, recovery room and general ward by medical personnel on adults and children for NIBP and all other functions for all patient populations, including neonates.

Device Description

AI/ML Overview

The provided text describes a 510(k) notification for the Nihon Kohden ZS-940PA Transmitter. This document primarily focuses on regulatory submission and does not contain detailed information about specific acceptance criteria, performance studies, or the scientific evidence typically expected to prove a device meets acceptance criteria in the manner of a clinical or technical study report.

The document indicates that "Safety and efficacy was documented through Design validation of the software and hardware of the device," and that "The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the intended operation of the device." However, specific quantitative acceptance criteria or detailed results from these studies are not presented.

Therefore, I cannot fulfill all parts of your request based solely on the provided text. I will interpret "acceptance criteria" as the claimed functionalities and regulatory compliance mentioned in the document, and "reported device performance" as confirmation of meeting claimed functionalities and compliance.

Here's a response based on the available information:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) notification for the Nihon Kohden ZS-940PA Transmitter outlines its intended use and regulatory compliance. The "acceptance criteria" can be inferred from the stated functions and compliance requirements. The "study that proves the device meets the acceptance criteria" is broadly referred to as "Design validation of the software and hardware" and various "testing procedures" without specific details about their methodology, sample sizes, or results.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Document)	Reported Device Performance (Summary from Document)
Transmit physiological data:
- Electrocardiogram (ECG)	"These tests verified the intended operation of the device."
- Respiration	"These tests verified the intended operation of the device."
- Blood oxygen saturation (SpO2)	"These tests verified the intended operation of the device."
- Noninvasive blood pressure (NIBP)	"These tests verified the intended operation of the device."
- Pulse waveform	"These tests verified the intended operation of the device."
Display information on front LCD:
- SpO2%	"These tests verified the intended operation of the device."
- NIBP	"These tests verified the intended operation of the device."
- Pulse rate	"These tests verified the intended operation of the device."
- Pulse waveform amplitude	"These tests verified the intended operation of the device."
- Electrode condition mark	"These tests verified the intended operation of the device."
- Battery condition	"These tests verified the intended operation of the device."
- NIBP measuring mode and interval	"These tests verified the intended operation of the device."
Communication:
- WMTS band compliance (FCC)	"The system communicates in the new WMTS band as required by FCC."
- Interoperability with Nihon Kohden central monitors (WEP-4000, ORG-9700/CNS-9700)	"The monitored physiological parameters communicated via radiofrequency can be displayed, stored and printed at a Nihon Kohden Central monitor..."
Safety and Efficacy:
- Compliance with IEC 60601-1 sub-clause 56.3(c) (Electrode Lead Wires and Patient Cables)	"The device complies with IEC 60601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables."
- Compliance with applicable IEC standards	"The device is also in compliance with applicable sections of IEC standard as listed in this application."
- Electromagnetic, environmental, safety, and performance	"The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the intended operation of the device."
- Design validation of software and hardware	"Safety and efficacy was documented through Design validation of the software and hardware of the device."

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

The provided document does not specify the sample size used for any test sets related to performance evaluation (e.g., number of patients, number of devices tested). It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned ("electromagnetic, environmental, safety and performance testing procedures," and "Design validation of the software and hardware") appear to be internal engineering and validation tests, not clinical studies with patient data.

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

Given that the described "tests" are primarily device performance and regulatory compliance evaluations, the concept of "ground truth" established by external clinical experts (like radiologists) for a test set is not detailed in the provided text. It's likely that internal engineers and quality assurance personnel established the "ground truth" during design validation, meaning the device's output was compared against known reference standards or expected operational parameters, but no information on the number or qualifications of such experts is provided.

4. Adjudication Method for the Test Set

No information on an adjudication method is provided. This type of submission is for a physiological data transmitter, which typically involves technical validation of signal transmission and accuracy against reference systems, rather than clinical adjudication of diagnostic findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is described in the provided text. This device is purely a data transmission device, not an interpretative AI algorithm, so such a study would not be applicable in this context.

6. If a Standalone (Algorithm Only) Performance Was Done

The concept of "standalone performance" for an algorithm is not applicable here as the ZS-940PA is a physical device transmitting physiological data, not an algorithm that interprets data. The "performance testing procedures" and "Design validation of the software and hardware" would assess the device's ability to accurately acquire and transmit data.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance would primarily be established through technical specifications, reference instruments, and calibrated measurement standards. For example, ECG transmission would be validated against a known ECG signal generator, SpO2 against a calibrated SpO2 simulator, and so on. The document implicitly confirms that these engineering validations were conducted: "These tests verified the intended operation of the device."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable as this device is a hardware transmitter for physiological data, not a machine learning or AI algorithm that requires training data.

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

As there is no training set for this device, this question is not applicable.

Summary

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510(k) NOTIFICATION ZS-940PA Transmitter

14-3511

FEB - 3 2005

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant

Phone: (949) 580-1555 Nihon Kohden America, Inc. Dial 9 and then Ext. 4401 Fax: (949) 580-1550 90 Icon St. Attn: Serrah Namini, Foothill Ranch, Ca 92610 Regulatory Affairs Assoc. Dir.

Indications for Use:

The device complies with IEC 60601-1 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.

Sterilization is not required for the device.

The device does not directly contact patients; It is place in a pocket of a non-latex blood pressure cuff on a patient's arm. Accessories that contact patients, such as SpO2 probes, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the accessories of predicate devices. Therefore, good laboratory practice studies required per 21 CFR Part 58 are not applicable for this submission.

The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the intended operation of the device. Safety and efficacy was documented through Design validation of the software and hardware of the device.

Therefore, Nihon Kohden believes that the device is substantially equivalent to the Nihon Kohden predicate devices.

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K043517
p2/2

SECTION 3 - PROPOSED LABELING

A. Intended Use

Device/Package Labels B.

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

C. Proposed Packaging

Packaging drawings/ specifications for the device is depicted in Attachment # A.

D. Instructions for Use

The proposed instructions for use is provided with each packaged device and is presented in Attachment # H, Operator's Manual .

Advertisement/Promotional Literature E.

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

F. Contraindications, Precautions & Warnings

Warnings and Cautions listed in the Operator's Manual are depicted in Attachment # B.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Nihon Kohden America, Inc. c/o Ms. Serrah Namini RA Associate Director 90 Icon St. Foothill Ranch, CA 92610

Re: K043517

Trade Name: ZS-940PA Transmitter Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: DRT Dated: December 16, 2004 Received: December 20, 2004

Dear Ms. Namini:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(x) premainter as abstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to tegary manated president Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 26, 1976, the enaordance with the provisions of the Federal Food, Drug.
In a lead have been reclassified in accordance with the provisions of the United devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act . Je and Costheric Ac. (Act) that do not require approvince subject to the general controls provisions of the Act. The You may, merefore, mance the do rece, solo, e requirements for annual registration, listing of the general controls provisions of the flor 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
may be subject to such additional controls. Existing major may be subject to such additional bonatorior Linkstong Collections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouch oncerning 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 Please be advised that IDA's issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regalations and adding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, more and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons our device as described in your Section 510(k) This letter will anow you to ogin manseans your and equivalence of your device to a legally premarket notheation: "The PDF mining of easification 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 acvice for your as (240) 276-0120 Also, please note the regulation entitled, Comact the Office of Compularse an (21CFR Part 807.97). You may obtain Misbranding by reference to premantonitiiiiiiiis under the Act from the Division of Small other general information on your responses 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,

B. Zimmer for

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 ZS-940PA Transmitter

G. Indications for Use Statement

K043517 510(k) Number (if known): __

Device Name: ZS-940PA Series

Indications for Use:

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)

K043517 B/Ammer

i Cardiovascular Devices 510(k) Number

Page 1 of

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).