(45 days)
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.
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 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.
§ 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).