(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.
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May 28, 2019
Nihon Kohden Corporation % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K190468
Trade/Device Name: Nihon Kohden SVM-7200 series Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, FLL Dated: April 25, 2019 Received: April 26, 2019
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Matthew Hillebrenner
Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190468
Device Name
Nihon Kohden SVM-7200 series Vital Signs Monitor
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the logo for NIHON KOHDEN. The logo consists of a blue square with a white abstract design on the left, followed by the company name "NIHON KOHDEN" in blue, sans-serif font. The text is bold and slightly blurred, giving it a soft appearance.
510(k) Summary K190468
| Sponsor: | Nihon Kohden Corporation1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560 |
|---|---|
| Contact: | Natalie J. KennelNJK & Associates |
| Address | 13721 Via Tres VistaSan Diego, CA 92129 |
| Phone | (858) 705-0350 |
| Fax | (858) 764-9739 |
| nkennel@njkconsulting.com |
- May 22, 2019 Date Prepared:
DEVICE INFORMATION:
| Proprietary Name: | Nihon Kohden SVM-7200 series Vital Signs Monitor | |
|---|---|---|
| Common Name: | Vital Signs Monitor, Patient Monitor | |
| Classification: | Monitor, Physiological, Patient, (without arrhythmia detection or alarms) Class II | |
| Product Codes: | MWI, DXN, DQA, FLL | |
| Regulations: | 21 CFR 870.2300 | |
| Predicate: | Capsule Technologies SmartLinx Vitals Plus Patient Monitoring System (K171751) |
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Reference Device: Nihon Kohden Bedside Monitor, BSM-6000 series (K080342)
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PRODUCT DESCRIPTION:
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 models included are:
| Model Name | Screen Size(inch) | Parameters |
|---|---|---|
| SVM-7230 | 8 | Masimo SpO2, NIBP, Temperature |
| SVM-7250 | 8 | Nellcor SpO2, NIBP, Temperature |
| SVM-7260 | 8 | Nihon Kohden SpO2, NIBP, Temperature |
The thermometer options include the commercially available Covidien FILAC 3000 Thermometer or Exergen TAT-5000S Temporal Scanner.
INDICATIONS FOR USE:
The SVM-7200 series Vital Signs Monitor is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, non-invasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
TECHNOLOGICAL CHARACTERISTICS - SUBSTANTIAL EQUIVALENCE:
Table 1 is a detailed comparison of the Nihon Kohden SVM-7200 Series Vital Signs Monitor and its predicate, SmartLinx Vitals Plus. The Nihon Kohden SVM-7200 Vital Signs Monitor is substantially equivalent to the SmartLinx Vitals Plus Patient Monitoring System, other than the minor differences described below. These differences do not raise questions regarding safety or efficacy.
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| SmartLinx Vitals Plus | SVM-7200 Series Vital Signs Monitor | |
|---|---|---|
| Characteristic | Predicate Device (K171751) | Subject Device |
| Indications forUse | The SmartLinx Vitals Plus PatientMonitoring System is intended formonitoring and alarming of physiologicparameters, including non-invasive bloodpressure (systolic, diastolic, and meanarterial pressure), pulse rate, functionalarterial oxygen saturation (SpO2), andtemperature, on adult, pediatric, andneonatal patients in hospital environmentswhen used by clinical physicians orappropriate medical staff under thedirection of physicians. | The SVM-7200 series is intended for monitoringand alarming of physiologic parameters,including non-invasive blood pressure (systolic,diastolic, and mean arterial pressure), pulse rate,non-invasive functional oxygen saturation ofarteriolar hemoglobin (SpO2), and temperature,on adult, pediatric, and neonatal patients inhospital environments when used by clinicalphysicians or appropriate medical staff under thedirection of physicians. |
| NIBPMeasurement | Oscillometric design for Spot Check andIntervals Mode measurements. | Oscillometric design for Spot Check andIntervals Mode measurements. |
| SpO2 Monitoring | Masimo SpO2 for Spot Checkmeasurements and ContinuousMonitoring with the following features:1) Pulse tone pitch varying with oxygensaturation2) SpO2 alarm delay3) SpO2 sensor off alarm | Masimo SpO2, Nellcor SpO2, or Nihon KohdenSpO2 for Spot Check measurements andContinuous Monitoring with the followingfeatures:1) Pulse tone pitch varying with oxygensaturation2) SpO2 alarm delay3) SpO2 sensor off alarm |
| TemperatureMeasurement | Two different thermometry options:1) Covidien FILAC 3000 thermometer2) Exergen TAT- 5000S temporal scanner | Two different thermometry options:1) Covidien FILAC 3000 thermometer2) Exergen TAT- 5000S temporal scanner |
| Alarms | Configuration, annunciation, andacknowledgement of physiological andtechnical alarms for (Sys, Dia, MAP,Pulse Rate, SpO2, and Temp).Alarms are visibly annunciated andacknowledged on the screen.Alarms are audibly annunciated viaspeaker. | Configuration, annunciation, andacknowledgement of physiological and technicalalarms for (Sys, Dia, MAP, Pulse Rate, SpO2,and Temp).Alarms are visibly annunciated andacknowledged on the screen.Alarms are audibly annunciated via speaker. |
| Energy Source | Battery type: Lithium-IonPower Supply: 100-240V AC, 50-60 Hz | Battery type: Lithium-IonPower Supply: 100-240V AC, 50-60 Hz |
Table 1 Comparison of the Nihon Kohden SVM-7200 Series Vital Signs Monitor to its Predicate
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These differences between the subject device and predicate are describe below:
-
NIBP Measurement Ranges: The SVM-7200 has a higher end cut-off for systolic, diastolic and mean arterial pressure ranges for adults, pediatrics, and neonates as compared to the predicate. The subject device complies with the NIBP standard IEC 80601-2-30.
-
SpO2 Monitoring: The SVM-7200 offers additional SpO2 probe options as compared to the predicate which only offers the Masimo SpO2 probe. The SVM-7200 can be used with its own Nihon Kohden SpO2 and Nellcor SpO2 pulse oximeter probes. All three SpO2 probe options were tested with the subject device which complies with the SpO2 standard IEC 80601-2-61.
-
Operating Conditions: The SVM-7200 has a lower minimum operating temperature of 5°C as compared to 10°C of the predicate and reference devices. Also, the subject device has a lower maximum operating humidity of 85%, while the predicate and the reference device have a maximum humidity of 95%. This very minor difference should not affect the general functionality of the device and has no effect on safety or effectiveness. The subject device has been tested and complies to IEC 60601-1.
-
Storage Conditions: The SVM-7200 has a higher maximum storage temperature of 65°C, as compared to 50°C of the predicate. Also, the subject device has a higher maximum storage humidity of 95% while the predicate has a maximum humidity of 90%. This very minor difference should not affect the general functionality of the device. The subject device has been tested and complies to IEC 60601-1.
Since some of the features are not exactly the same between the subject device and the predicate, a reference device, the Nihon Kohden Bedside Monitor, BSM-6000 series (K080342) is utilized to provide technical information to help address the safety and effectiveness of the different characteristics. The methods used to test the SVM-7200 series Vital Signs Monitor are according to the same standards as the cleared reference device BSM-6000 and have been deemed acceptable. Also, the BSM-6000 series incorporates the NIBP module. SpO2 module and firmware of the same design as the SVM-7200 series which controls the operation of NIBP (including measurement ranges) and SpO2 monitoring. Additionally, the storage conditions of the BSM-6000 series bedside monitor are the same as for the SVM-7200 series Vital Signs Monitor and the method used to test the maximum storage temperature and humidity is the same.
PERFORMANCE TESTING
Performance testing for the Nihon Kohden SVM-7200 series Vital Signs Monitor includes software verification and validation test which encompassed software unit testing, integration level testing, and system level testing. A system test was also performed per the software requirements specification. A summative usability validation has been conducted with the subject device in a simulated environment. Testing to compliance standards for electrical and electromagnetic safety was also performed.
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Traceability has been documented between all system specifications to validation test results. Table 2 lists the performance testing to compliance standards for the VSM-7200 series Vital Signs Monitor.
| PerformanceCharacteristics | Standard Number | Standards Title |
|---|---|---|
| General | IEC 60601-1:2005 +CORR.1:2006 + CORR.2:2007 + A1:2012 (withCAN/CSA C22.2 No.60601-1:14) | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| EMC | IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: ElectromagneticCompatibility - Requirements and Tests |
| Usability | IEC 60601-1-6:2010 + Amd1:2013 | Medical Electrical Equipment - Part 1-6: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: Usability |
| IEC 62366:2007 +Amendment 1:2014 | Medical devices -- Application of usabilityengineering to medical devices | |
| Alarms | IEC 60601-1-8:2006 &A1:2012 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - collateral standard: Generalrequirements, tests and guidance for alarm systemsin medical electrical equipment and medicalelectrical systems |
| PatientMonitoring | IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particularrequirements for the basic safety and essentialperformance of multifunction patient monitoringequipment |
| NIBP | IEC 80601-2-30:2009+A1:2013 | Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essentialperformance of automated non-invasivesphygmomanometers |
| Temp | ISO 80601-2-56:2009 | Medical Electrical Equipment - Part 2-56: ParticularRequirements for the Basic Safety and EssentialPerformance of Clinical Thermometers for BodyTemperature Measurement |
| SpO2 | ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particularrequirements for the basic safety and essentialperformance of pulse oximeter equipment |
| Software | IEC 62304:2006 +Amd1:2015 | Medical Device Software - Software Life-cycleProcesses |
| Wireless and Co-Existence | AAMI TIR69: 2017 | Technical Information Report Risk management ofradio-frequency wireless coexistence for medicaldevices and systems. |
| PerformanceCharacteristics | Standard Number | Standards Title |
| Wireless and Co-Existence | ANSI IEEE C63.27-2017 | American National Standard for Evaluation ofWireless Coexistence |
| ANSI IEEE C63.4-2003 | American National Standard for Methods ofMeasurement of Radio-Noise Emissions from LowVoltage Electrical and Electronic Equipment in theRange of 9 kHz to 40 GHz. |
Table 2 Performance Testing to Standards
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CLINICAL ACCURACY VALIDATION
The Nihon Kohden SVM-7200 series Vital Signs Monitor incorporates clinical subsystems from Masimo, Nellcor and Nihon Kohden for SpO2 monitoring, from Covidien and Exergen for temperature measurement, and from Nihon Kohden for NIBP monitoring. 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, as shown in Table 3, for all of the clinical functionalities in the subject device.
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| PatientMonitoringSubsystem | Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | ||||
|---|---|---|---|---|---|---|---|
| Method | Component | 510(k) | Device NameManufacturer | SVM-7230 | SVM-7250 | SVM-7260 | |
| OxygenSaturation(SpO2)Masimo | Masimo | Board,Algorithm | K053269K080342 | Masimo Set Rad-8 Pulse OximeterMasimoBSM-6000Nihon Kohden | X | ||
| Sensor cable(connectioncord) | K080342K151080 | BSM-6000 (for JL-632P)Nihon KohdenCSM-1901(for JL-631P)Nihon Kohden | X | ||||
| Probes | K040214K060143K992340 | SpO2 probeMasimo | X | ||||
| OxygenSaturation(SpO2)Nellcor | Nellcor | Board,Algorithm | K060576K080342 | N-600XNellcorBSM-6000Nihon Kohden | X | ||
| Sensor cable(connectioncord) | K151080 | CSM-1901Nihon Kohden | X | ||||
| PatientMonitoringSubsystem | Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | ||||
| Method | Component | 510(k) | Device NameManufacturer | SVM-7230 | SVM-7250 | SVM-7260 | |
| OxygenSaturation(SpO2)Nihon KohdenNihon Kohden | Probes | K052186K012891 | SpO2 probeNellcor | X | |||
| NihonKohden | Board,Algorithm | K080342 | BSM-6000 Nihon Kohden | X | |||
| Sensor cables(connectioncord) | K082785 | BSM-9100Nihon Kohden | X | ||||
| K163459 | GZ-140PNihon Kohden | X | |||||
| Finger probes | K043517 | ZS-940PNihon Kohden | X | ||||
| Multisiteprobes | K043517 | ZS-940PNihon Kohden | X | ||||
| Disposableprobes | K120888 | PSG-1100Nihon Kohden | X | ||||
| K151080 | CSM-1901Nihon Kohden | X | |||||
| K163459 | GZ-140PNihon Kohden | X | |||||
| PatientMonitoringSubsystem | Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | ||||
| Method | Component | 510(k) | Device NameManufacturer | SVM-7230 | SVM-7250 | SVM-7260 | |
| Non-invasiveBlood Pressuremonitoring(NIBP)(inflationmode) | NihonKohdeniNIBP(inflation) | Board,Algorithm | K163459 | GZ-140PNihon Kohden | X | X | X |
| Sensor cables(air hoses) | K082785 | BSM-9100Nihon Kohden | X | X | X | ||
| Cuffs -Reusable anddisposable | K163459 | GZ-140PNihon Kohden | X | X | X | ||
| Non-invasiveBlood Pressuremonitoring(NIBP)(deflationmode) | NihonKohdenNIBP(deflation) | Board,Algorithm | K914092K011918K032749K080342 | BSM-2101BSM-2302OPV-1510BSM-6100Nihon Kohden | X | X | X |
| Sensor cables(air hoses) | K151080 | CSM-1901Nihon Kohden | X | X | X | ||
| K082785 | BSM-9100Nihon Kohden | X | X | X | |||
| Cuffs -Reusable anddisposable | K163459 | GZ-140PNihon Kohden | X | X | X | ||
| Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | |||||
| PatientMonitoringSubsystem | Method | Component | 510(k) | Device NameManufacturer | SVM-7230 | SVM-7250 | SVM-7260 |
| BodyTemperature(TEMP) | Covidien | Board.algorithm | K003313 | FILAC FAS TEMPCovidien | X | X | X |
| Thermometerprobe | K003313 | FILAC FAS TEMPCovidien | X | X | X | ||
| Accessories | K003313 | FILAC FAS TEMPCovidien | X | X | X | ||
| BodyTemperature(TEMP) | Exergen | Thermometer | K011291K171751 | Temporal ScannerExergenSmartLinx Vital Plus Patient MonitoringCapsule Technologies | X | X | X |
Table 3 SVM-7200 Series Clinical Subsystems in SVM-7200 Series with Corresponding Subsystems in Predicates
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CONCLUSION
Based on a review of indications for use, technological characteristics, safety and performance testing, the Nihon Kohden SVM-7200 series Vital Signs Monitor is as safe and effective as the SmartLinx Vitals Plus Patient Monitoring System for the intended use described above. Furthermore, the minor differences do not raise new concerns of safety and effectiveness. Therefore, the data provided shows that the subject device is substantially equivalent to the predicate.
§ 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).