(91 days)
No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities, image processing, or data training/testing sets typically associated with such technologies.
No
The device is described as a "Vital Signs Monitor" which is intended for "monitoring of physiologic parameters." It measures various vital signs but does not state any therapeutic function or intervention.
No
The device is a vital signs monitor that measures physiological parameters like blood pressure, pulse rate, SpO2, and temperature. While this information is used by clinicians, the device itself is for monitoring and does not provide a diagnosis.
No
The device description explicitly mentions an "eight-inch TFT color display" and the need for testing to compliance standards for "electrical and electromagnetic safety," indicating the presence of hardware components beyond just software.
Based on the provided information, the SVM-7200 series Vital Signs Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The SVM-7200 series Vital Signs Monitor measures physiological parameters directly from the patient's body (blood pressure, pulse rate, oxygen saturation, temperature) using non-invasive methods.
- The intended use and device description clearly state that it monitors physiological parameters of patients. There is no mention of analyzing biological specimens.
Therefore, the SVM-7200 series Vital Signs Monitor falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
MWI, DXN, DQA, FLL
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
clinical physicians or appropriate medical staff under the direction of physicians.
hospital environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Traceability has been documented between all system specifications to validation test results. Test results were not provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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 Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560 |
|----------|--------------------------------------------------------------------------------------|
| Contact: | Natalie J. Kennel
NJK & Associates |
| Address | 13721 Via Tres Vista
San Diego, CA 92129 |
| Phone | (858) 705-0350 |
| Fax | (858) 764-9739 |
| email | 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) |
4
Reference Device: Nihon Kohden Bedside Monitor, BSM-6000 series (K080342)
5
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.
6
| SmartLinx Vitals Plus | SVM-7200 Series Vital Signs Monitor | |
|---|---|---|
| Characteristic | Predicate Device (K171751) | Subject Device |
| Indications for | ||
| Use | The SmartLinx Vitals Plus Patient | |
| Monitoring System is intended for | ||
| monitoring and alarming of physiologic | ||
| parameters, including non-invasive blood | ||
| pressure (systolic, diastolic, and mean | ||
| arterial pressure), pulse rate, functional | ||
| arterial oxygen saturation (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. | The SVM-7200 series 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. | ||
| NIBP | ||
| Measurement | Oscillometric design for Spot Check and | |
| Intervals Mode measurements. | Oscillometric design for Spot Check and | |
| Intervals Mode measurements. | ||
| SpO2 Monitoring | Masimo SpO2 for Spot Check | |
| measurements and Continuous | ||
| Monitoring with the following features: |
- Pulse tone pitch varying with oxygen
saturation - SpO2 alarm delay
- SpO2 sensor off alarm | Masimo SpO2, Nellcor SpO2, or Nihon Kohden
SpO2 for Spot Check measurements and
Continuous Monitoring with the following
features: - Pulse tone pitch varying with oxygen
saturation - SpO2 alarm delay
- SpO2 sensor off alarm |
| Temperature
Measurement | Two different thermometry options: - Covidien FILAC 3000 thermometer
- Exergen TAT- 5000S temporal scanner | Two different thermometry options:
- Covidien FILAC 3000 thermometer
- Exergen TAT- 5000S temporal scanner |
| Alarms | Configuration, annunciation, and
acknowledgement of physiological and
technical alarms for (Sys, Dia, MAP,
Pulse Rate, SpO2, and Temp).
Alarms are visibly annunciated and
acknowledged on the screen.
Alarms are audibly annunciated via
speaker. | Configuration, annunciation, and
acknowledgement of physiological and technical
alarms for (Sys, Dia, MAP, Pulse Rate, SpO2,
and Temp).
Alarms are visibly annunciated and
acknowledged on the screen.
Alarms are audibly annunciated via speaker. |
| Energy Source | Battery type: Lithium-Ion
Power Supply: 100-240V AC, 50-60 Hz | Battery type: Lithium-Ion
Power Supply: 100-240V AC, 50-60 Hz |
Table 1 Comparison of the Nihon Kohden SVM-7200 Series Vital Signs Monitor to its Predicate
7
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.
8
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.
| Performance
| Characteristics | Standard Number | Standards Title |
|---|---|---|
| General | IEC 60601-1:2005 + | |
| CORR.1:2006 + CORR. | ||
| 2:2007 + A1:2012 (with | ||
| CAN/CSA C22.2 No.60601- | ||
| 1:14) | Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential | ||
| performance | ||
| EMC | IEC 60601-1-2:2014 | Medical Electrical Equipment - Part 1-2: General |
| Requirements for Basic Safety and Essential | ||
| Performance - Collateral Standard: Electromagnetic | ||
| Compatibility - Requirements and Tests | ||
| Usability | IEC 60601-1-6:2010 + Amd | |
| 1:2013 | Medical Electrical Equipment - Part 1-6: General | |
| Requirements for Basic Safety and Essential | ||
| Performance - Collateral Standard: Usability | ||
| IEC 62366:2007 + | ||
| Amendment 1:2014 | Medical devices -- Application of usability | |
| engineering to medical devices | ||
| Alarms | IEC 60601-1-8:2006 & | |
| A1:2012 | Medical electrical equipment - Part 1-8: General | |
| requirements for basic safety and essential | ||
| performance - collateral standard: General | ||
| requirements, tests and guidance for alarm systems | ||
| in medical electrical equipment and medical | ||
| electrical systems | ||
| Patient | ||
| Monitoring | IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular |
| requirements for the basic safety and essential | ||
| performance of multifunction patient monitoring | ||
| equipment | ||
| NIBP | 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 | ||
| Temp | 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 | ||
| SpO2 | ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular |
| requirements for the basic safety and essential | ||
| performance of pulse oximeter equipment | ||
| Software | IEC 62304:2006 + | |
| Amd1:2015 | Medical Device Software - Software Life-cycle | |
| Processes | ||
| Wireless and Co- | ||
| Existence | AAMI TIR69: 2017 | Technical Information Report Risk management of |
| radio-frequency wireless coexistence for medical | ||
| devices and systems. | ||
| Performance | ||
| Characteristics | Standard Number | Standards Title |
| Wireless and Co- | ||
| Existence | ANSI IEEE C63.27-2017 | American National Standard for Evaluation of |
| Wireless Coexistence | ||
| ANSI IEEE C63.4-2003 | American National Standard for Methods of | |
| Measurement of Radio-Noise Emissions from Low | ||
| Voltage Electrical and Electronic Equipment in the | ||
| Range of 9 kHz to 40 GHz. |
Table 2 Performance Testing to Standards
9
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.
10
| Patient
Monitoring
| Subsystem | Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | ||||
|---|---|---|---|---|---|---|---|
| Method | Component | 510(k) | Device Name | ||||
| Manufacturer | SVM- | ||||||
| 7230 | SVM- | ||||||
| 7250 | SVM- | ||||||
| 7260 | |||||||
| Oxygen | |||||||
| Saturation | |||||||
| (SpO2) | |||||||
| Masimo | Masimo | Board, | |||||
| Algorithm | K053269 | ||||||
| K080342 | Masimo Set Rad-8 Pulse Oximeter | ||||||
| Masimo | |||||||
| BSM-6000 | |||||||
| Nihon Kohden | X | ||||||
| Sensor cable | |||||||
| (connection | |||||||
| cord) | K080342 | ||||||
| K151080 | BSM-6000 (for JL-632P) | ||||||
| Nihon Kohden | |||||||
| CSM-1901(for JL-631P) | |||||||
| Nihon Kohden | X | ||||||
| Probes | K040214 | ||||||
| K060143 | |||||||
| K992340 | SpO2 probe | ||||||
| Masimo | X | ||||||
| Oxygen | |||||||
| Saturation | |||||||
| (SpO2) | |||||||
| Nellcor | Nellcor | Board, | |||||
| Algorithm | K060576 | ||||||
| K080342 | N-600X | ||||||
| Nellcor | |||||||
| BSM-6000 | |||||||
| Nihon Kohden | X | ||||||
| Sensor cable | |||||||
| (connection | |||||||
| cord) | K151080 | CSM-1901 | |||||
| Nihon Kohden | X | ||||||
| Patient | |||||||
| Monitoring | |||||||
| Subsystem | Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | ||||
| Method | Component | 510(k) | Device Name | ||||
| Manufacturer | SVM- | ||||||
| 7230 | SVM- | ||||||
| 7250 | SVM- | ||||||
| 7260 | |||||||
| Oxygen | |||||||
| Saturation | |||||||
| (SpO2) | |||||||
| Nihon Kohden | |||||||
| Nihon Kohden | Probes | K052186 | |||||
| K012891 | SpO2 probe | ||||||
| Nellcor | X | ||||||
| Nihon | |||||||
| Kohden | Board, | ||||||
| Algorithm | K080342 | BSM-6000 Nihon Kohden | X | ||||
| Sensor cables | |||||||
| (connection | |||||||
| cord) | K082785 | BSM-9100 | |||||
| Nihon Kohden | X | ||||||
| K163459 | GZ-140P | ||||||
| Nihon Kohden | X | ||||||
| Finger probes | K043517 | ZS-940P | |||||
| Nihon Kohden | X | ||||||
| Multisite | |||||||
| probes | K043517 | ZS-940P | |||||
| Nihon Kohden | X | ||||||
| Disposable | |||||||
| probes | K120888 | PSG-1100 | |||||
| Nihon Kohden | X | ||||||
| K151080 | CSM-1901 | ||||||
| Nihon Kohden | X | ||||||
| K163459 | GZ-140P | ||||||
| Nihon Kohden | X | ||||||
| Patient | |||||||
| Monitoring | |||||||
| Subsystem | Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | ||||
| Method | Component | 510(k) | Device Name | ||||
| Manufacturer | SVM- | ||||||
| 7230 | SVM- | ||||||
| 7250 | SVM- | ||||||
| 7260 | |||||||
| Non-invasive | |||||||
| Blood Pressure | |||||||
| monitoring | |||||||
| (NIBP) | |||||||
| (inflation | |||||||
| mode) | Nihon | ||||||
| Kohden | |||||||
| iNIBP | |||||||
| (inflation) | Board, | ||||||
| Algorithm | K163459 | GZ-140P | |||||
| Nihon Kohden | X | X | X | ||||
| Sensor cables | |||||||
| (air hoses) | K082785 | BSM-9100 | |||||
| Nihon Kohden | X | X | X | ||||
| Cuffs - | |||||||
| Reusable and | |||||||
| disposable | K163459 | GZ-140P | |||||
| Nihon Kohden | X | X | X | ||||
| Non-invasive | |||||||
| Blood Pressure | |||||||
| monitoring | |||||||
| (NIBP) | |||||||
| (deflation | |||||||
| mode) | Nihon | ||||||
| Kohden | |||||||
| NIBP | |||||||
| (deflation) | Board, | ||||||
| Algorithm | K914092 | ||||||
| K011918 | |||||||
| K032749 | |||||||
| K080342 | BSM-2101 | ||||||
| BSM-2302 | |||||||
| OPV-1510 | |||||||
| BSM-6100 | |||||||
| Nihon Kohden | X | X | X | ||||
| Sensor cables | |||||||
| (air hoses) | K151080 | CSM-1901 | |||||
| Nihon Kohden | X | X | X | ||||
| K082785 | BSM-9100 | ||||||
| Nihon Kohden | X | X | X | ||||
| Cuffs - | |||||||
| Reusable and | |||||||
| disposable | K163459 | GZ-140P | |||||
| Nihon Kohden | X | X | X | ||||
| Data Collection Method | Subsystem Cleared in 510(k) | SVM7200 Model | |||||
| Patient | |||||||
| Monitoring | |||||||
| Subsystem | Method | Component | 510(k) | Device Name | |||
| Manufacturer | SVM- | ||||||
| 7230 | SVM- | ||||||
| 7250 | SVM- | ||||||
| 7260 | |||||||
| Body | |||||||
| Temperature | |||||||
| (TEMP) | Covidien | Board. | |||||
| algorithm | K003313 | FILAC FAS TEMP | |||||
| Covidien | X | X | X | ||||
| Thermometer | |||||||
| probe | K003313 | FILAC FAS TEMP | |||||
| Covidien | X | X | X | ||||
| Accessories | K003313 | FILAC FAS TEMP | |||||
| Covidien | X | X | X | ||||
| Body | |||||||
| Temperature | |||||||
| (TEMP) | Exergen | Thermometer | K011291 | ||||
| K171751 | Temporal Scanner | ||||||
| Exergen | |||||||
| SmartLinx Vital Plus Patient Monitoring | |||||||
| Capsule Technologies | X | X | X |
Table 3 SVM-7200 Series Clinical Subsystems in SVM-7200 Series with Corresponding Subsystems in Predicates
11
12
13
14
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.