(91 days)
The SVM-7200 series Vital Signs Monitor is intended for monitoring of physiologic parameters, including non-invasive blood pressure (systolic, and mean arterial pressure), pulse rate, non-invasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and temperature, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
The SVM-7200 series Vital Signs Monitor is intended to be used by clinicians, doctors, nurses, and medically qualified personnel for measuring noninvasive blood pressure (NIBP), noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), body temperature (TEMP) of one patient at a time. The monitors can be used in the specialized health care environment such as hospitals, clinics, special medical facilities, independent surgery centers, multitherapy facilities and wards. Adults, children and neonates can be monitored using this device. The SVM-7200 series monitors have an eight-inch TFT color display and two modes: spot check and continuous mode. The monitor can operate with either a wired or wireless LAN connection.
The NIHON KOHDEN SVM-7200 series Vital Signs Monitor obtained FDA clearance (K190468) based on its substantial equivalence to predicate devices, leveraging previously validated clinical accuracy data for its sub-systems.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of quantitative acceptance criteria for device performance (e.g., specific accuracy ranges for SpO2, NIBP, Temperature). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various recognized standards and by leveraging clinical accuracy data from previously cleared sub-systems.
The reported device performance for the SVM-7200 series (referring to accuracy) is based on the validation of its constituent clinical sub-systems, not on new, standalone performance studies for the integrated SVM-7200 itself.
| Performance Characteristic | Standard Complied With (Acceptance Criteria) | Reported Device Performance (Leveraged from Predicates) |
|---|---|---|
| NIBP Measurement | IEC 80601-2-30:2009+A1:2013 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) | The NIBP monitoring capabilities (both inflation and deflation modes) are based on Nihon Kohden iNIBP and NIBP boards/algorithms, sensor cables, and cuffs that were previously validated and cleared in other 510(k) devices (e.g., K163459, K082785, K914092, K011918, K032749, K080342). These prior clearances imply that the performance met the relevant NIBP standards at the time of their original submission. The document states "New clinical accuracy validation testing was not necessary as these subsystems along with their accessories have been previously validated and cleared." |
| SpO2 Monitoring | ISO 80601-2-61:2011 (Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment) | The SpO2 sub-systems (Masimo, Nellcor, and Nihon Kohden options) including boards/algorithms, sensor cables, and probes were previously validated and cleared in earlier 510(k) devices (e.g., K053269, K080342, K060576, K151080, K052186, K012891, K082785, K163459, K043517, K120888). The device leverages the clinical accuracy data from these prior clearances, indicating compliance with SpO2 standards implicitly met during their original approvals. |
| Temperature Measurement | ISO 80601-2-56:2009 (Medical Electrical Equipment - Part 2-56: Particular Requirements for the Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement) | The temperature measurement sub-systems (Covidien and Exergen options) including boards/algorithms, thermometer probes, and accessories were previously validated and cleared in other 510(k) devices (e.g., K003313, K011291, K171751). The clinical accuracy data from these prior approvals is leveraged to demonstrate compliance with temperature measurement standards. |
| General Safety & Performance | IEC 60601-1:2005 + CORR.1:2006 + CORR.2:2007 + A1:2012; IEC 60601-1-2:2014 (EMC); IEC 60601-1-6:2010 + Amd 1:2013 (Usability); IEC 62366:2007 + Amd 1:2014 (Usability); IEC 60601-1-8:2006 & A1:2012 (Alarms); IEC 60601-2-49:2011 (Patient Monitoring) | The device has undergone software verification and validation, system level testing, summative usability validation, and testing to compliance standards for electrical and electromagnetic safety. These tests demonstrate the integrated system's general safety and performance meet the requirements of the standards listed, verifying the overall system functionality and safety. |
| Software | IEC 62304:2006 + Amd1:2015 (Medical Device Software - Software Life-cycle Processes) | Software verification and validation tests were performed, including unit testing, integration level testing, and system level testing, per the software requirements specification. Traceability between system specifications and validation test results was documented, indicating compliance with software lifecycle processes. |
| Wireless & Co-existence | AAMI TIR69: 2017; ANSI IEEE C63.27-2017; ANSI IEEE C63.4-2003 | Testing was performed to ensure proper wireless communication and coexistence, demonstrating compliance with these standards. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document states: "New clinical accuracy validation testing was not necessary as these subsystems along with their accessories have been previously validated and cleared. This 510(k) leverages the previous clinical accuracy data from the predicates..."
Therefore, there is no new sample size for a test set conducted specifically for the SVM-7200 series for clinical accuracy. The "test set" in this context refers to the data used in the original validation studies of the individual sub-systems (Masimo SpO2, Nellcor SpO2, Nihon Kohden SpO2, Covidien TEMP, Exergen TEMP, Nihon Kohden NIBP). The document does not provide details on the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) of these historical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Since no new clinical accuracy studies were conducted specifically for the SVM-7200 series, this information is not provided in the document. The ground truth for the leveraged clinical accuracy data from the sub-systems would have been established during their original validation studies, but details on experts and their qualifications are not included here.
4. Adjudication Method for the Test Set:
This information is not provided as no new clinical accuracy studies were performed for the SVM-7200 series in this submission.
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:
This device is a vital signs monitor, not an AI-assisted diagnostic tool that would involve "human readers" interpreting images or data. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device performance, particularly for its various measurement sub-systems (NIBP, SpO2, Temp), is essentially "standalone" in the sense that the algorithms embedded within these components calculate the physiological parameters. The document confirms that "New clinical accuracy validation testing was not necessary as these subsystems along with their accessories have been previously validated and cleared." This implies that the algorithms for calculating these vital signs had their standalone performance validated in previous 510(k) submissions. The SVM-7200 (the subject device) integrates these already validated standalone sub-systems.
7. The Type of Ground Truth Used:
The ground truth for the clinical accuracy of the individual sub-systems (NIBP, SpO2, Temperature) would have been established using reference methods or clinically accepted gold standards during their original validation studies. For example:
- SpO2: Co-oximetry for arterial blood gas analysis would typically be the ground truth.
- NIBP: Invasive arterial blood pressure measurement or auscultatory methods would be common ground truths.
- Temperature: Rectal temperature, or other highly accurate core body temperature measurements, are typically used.
The document does not detail the specific ground truth methods for the (already cleared) sub-systems, but it implicitly relies on their validation against such standards.
8. The Sample Size for the Training Set:
The SVM-7200 is not described as utilizing machine learning or AI models that require "training sets" in the conventional sense. Its sub-systems (NIBP, SpO2, Temp) are based on established algorithms and hardware. Therefore, information regarding a "training set sample size" is not applicable/provided.
9. How the ground truth for the training set was established:
As no training set is discussed or implied for this device in the context of machine learning, this information is not applicable/provided.
§ 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).