(174 days)
The Accutorr 7/VS-900/VS-900c Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
. The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
The Accutorr 7/VS-900/VS-900c Vital Signs Monitors are composed of the main unit and parameter modules. The main unit has the following functions:
- Provides operation interface, such as keys, touchscreen, and display screen.
- Communicates with the parameter modules.
- Delivers the setup commands of parameters to the parameter modules.
- Obtains the parameter measurements.
- Displays and stores the parameter numeric measurements and waveforms, and sends the data to Mindray's central monitoring system or Mindray's eGateway.
The parameter measurement modules include Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2). Their measurement principles are as follows:
Pulse Oxygen Saturation (SpO2) monitoring is a non-invasive technique used to determine the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detector side of the probe. When the pulse active part of the light signal is examined, the amount of light absorbed by the hemoglobin is measured and the pulse oxygen saturation can be calculated. The SpO2 module processes the electrical signal and displays a waveform and numeric values for SpO2 and pulse rate.
The monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations, which appear as tiny pulsations in cuff pressure. The Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.
CO2 monitoring is based on measuring the absorption of infrared (IR) light of specific wavelengths. CO2 has its own absorption characteristic and the amount of light passing to the gas probe depends on the concentration of the measured CO2. When a specific band of IR light passes through respiratory gas samples, some of the IR light will be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO2 is calculated.
The monitor supports two kinds of TEMP module: Mindray TEMP and Exergen TEMP. Different TEMP modules cannot be used at same time. The customers need to choose one kind of TEMP module before they buy the monitor.
- Mindray TEMP Module has two measuring modes, Monitor mode and Predictive mode.
- In the Monitor mode, the thermal resistance in the probe reflects the subject's temperature by sensing the temperature change of the subject according to the thermal equilibrium principle. In the Predictive mode, the subject's temperature is predicted by the temperature rise curve (which is obtained by collecting multiple temperature measurements) at the time of initial thermal conduction.
- The Exergen Temperature Module is an infrared thermometer designed for accurate and completely non-invasive temperature assessment by scanning the temporal artery (TA). Temperature is measured by gently swiping the Temporal Scanner across the forehead, and includes a momentary touch of the probe to the neck area behind the ear lobe to account for any cooling of the forehead as a result of diaphoresis. The patented arterial heat balance technology (AHB™) automatically measures the temperature of the skin surface over the artery and the ambient temperature. It samples these readings approximately 1000 times a second, ultimately recording the highest temperature measured (peak) during the course of the measurement. The Temporal Scanner emits nothing - it only senses the natural thermal radiation emitted from the skin.
Here's a breakdown of the acceptance criteria and study information for the Accutorr 7/VS-900/VS-900c Vital Signs Monitor, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K170712) for the existing features and compliance with relevant standards for modifications. Therefore, the "acceptance criteria" for the subject device are largely defined by matching or exceeding the performance and specifications of the predicate device and meeting consensus standards.
Here's a table focusing on the key physiological parameters mentioned in the device description and the "Device Comparison Table," identifying areas where performance is explicitly stated or where changes were made.
| Feature | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Integrated display and touchscreen | 8.4" 800x600 pixels | Same |
| Power supply | One rechargeable Lithium-ion battery or AC power supply | Same |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh | Same |
| Data Recorder | Thermal recorder used to print patient information, measurement numerics, and waveforms. | Same |
| Speaker | Alarm tones (45 to 85 dB), key tones; support PITCH TONE multi-level tone modulation. | Same |
| WiFi | 2.4G/5G dual band WiFi, compatible with IEEE 802.11 a/b/g/n. | Same |
| Mindray Temperature Module | Technique: Thermal resistanceMeasurement range (Monitor mode): 25 to 44 °C (77 to 111.2 °F)Measurement range (Predictive mode): 35 to 43 °C (95 to 109.4 °F)Accuracy (Monitor mode): - 25 to <32°C: ± 0.2 °C - 32 to 44°C: ± 0.1 °C (± 0.2 °F)Response Time (Monitor mode): <60 sResponse Time (Predictive mode): <20 s (typical < 12s) | Same |
| Exergen Temperature Module | Not supported (for predicate) & Performance expectations for K011291 (secondary predicate)Measurement range: 16.0°C to 43.0°C (61°F~110°F)Accuracy: ±0.2°C | Supported (Integrated an optional OEM temp module cleared in K011291)Measurement range: 16.0°C to 43.0°C (61°F~110°F)Accuracy: ±0.2°C |
| Mindray SpO2 Module | Measurement range: 0 to 100%Accuracy (70-100%): - ± 2% (without motion, adult/pediatric) - ± 3% (without motion, neonate) | Same |
| Masimo SpO2 Module | Measurement range: 1 to 100%Accuracy (70-100%): - ± 2% (without motion, adult/pediatric) - ± 3% (without motion, neonate) - ± 3% (with motion) | Same |
| Nellcor SpO2 Module | Measurement range: 0 to 100%Accuracy (70-100%): - ± 2% (adult/pediatric) - ± 3% (neonate) | Same |
| Pulse Rate (PR) from NIBP Module | Measurement range: 40 to 240 bpmAccuracy: ±3bpm or ±3%, whichever is greater | Measurement range expanded to: 30 to 300 bpmOther specifications: Same (implying accuracy remains ±3bpm or ±3%, whichever is greater for the overlapping range, and the device meets the expanded range). |
| Non-invasive Blood Pressure (NIBP) | Oscillometric methodMeasurement range (Adult): Systolic: 40-270, Diastolic: 10-210, Mean: 20-230 mmHgMeasurement range (Pediatric): Systolic: 40-200, Diastolic: 10-150, Mean: 20-165 mmHgMeasurement range (Neonate): Systolic: 40-135, Diastolic: 10-100, Mean: 20-110 mmHgAccuracy: - Maximum average error: ±5 mmHg - Maximum standard deviation: 8mmHgMaximum measurement time: 180 s (Adult/Pediatric), 90 s (Neonate)Static pressure measurement range: 0-300mmHgStatic pressure measurement accuracy: ±3 mmHg | Oscillometric methodExpanded (new) Measurement range (Adult): Systolic: 25-290, Diastolic: 10-250, Mean: 15-260 mmHgExpanded (new) Measurement range (Pediatric): Systolic: 25-240, Diastolic: 10-200, Mean: 15-215 mmHgExpanded (new) Measurement range (Neonate): Systolic: 25-140, Diastolic: 10-115, Mean: 15-125 mmHgAll other specifications are the same (Accuracy, measurement time, static pressure range/accuracy). This implies compliance with IEC 80601-2-30: 2013 for the expanded ranges. |
| Carbon Dioxide (CO2) | Measurement range: 0-20%Resolution: 1mmHgAccuracy (Full, after warm-up): - 0%≤CO2<1%: ±0.1% - 1%≤CO2<5%: ±0.2% - 5%≤CO2<7%: ±0.3% - 7%≤CO2<12%: ±0.4% - 12%≤CO2≤13%: ±0.5% - 13%<CO2≤20%: ±(0.43%+8%rel)Accuracy (During warm-up, ISO Accuracy): Add ±0.3%ABS to the FULL accuracyAccuracy drift: Meets requirement for measurement accuracy within 6 hours.Sampling flow rate: 50ml/min | Same |
| EMC & Electrical Safety | Meet AAMI ANSI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012, A2:2010/(R)2012; IEC 60601-1-2:2014 (Fourth Edition). | Testing conducted shows product continues to meet specifications and performance is equivalent to predicate device for modifications. |
| Functional & System Performance | Meet specifications of predicate device (K170712) and relevant consensus standards (IEC 80601-2-30: 2013-07, IEC 60601-2-49:2011). | Testing conducted shows product continues to meet specifications and performance is equivalent to predicate device for modifications, and meets relevant consensus standards. |
| Software V&V | Meet FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Verification and validation testing conducted to ensure product works as designed (verification) and to check design and performance (validation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "Non-clinical testing" which includes:
- EMC and Electrical Safety Testing: Performed on the "subject device" to confirm continued compliance with standards after modifications. This is bench testing, not involving human subjects.
- Performance Testing - Bench: Functional and system-level testing on the "subject devices." This is bench testing, not involving human subjects.
- Software Verification and Validation Testing: This is testing of the software itself, not involving human subjects and no specific sample size of patient data is mentioned for testing performance on diagnostic tasks.
For the physiological parameter measurements (SpO2, NIBP, TEMP, CO2), the submission relies on the substantial equivalence to the predicate devices and applicable consensus standards rather than new clinical trials with patient sample sizes.
- For NIBP, the expanded display range is stated to "comply with IEC 80601-2-30: 2013," indicating adherence to a standard that typically specifies requirements for accuracy testing (often involving a specified number of subjects across different age groups, but this specific study's details are not provided in this summary).
- The Exergen Temperature Module is a previously cleared OEM module (K011291), meaning its performance was established in its own 510(k) submission.
Data Provenance: Not explicitly stated as the testing described is primarily bench/software related. For the incorporated OEM Exergen module, its original clearance (K011291) would hold the provenance for temperature accuracy studies. For NIBP and SpO2 metrics, "compliance with consensus standards" implies those standards' requirements for testing (which might involve human subjects to validate accuracy against a reference method) were met, but details of such studies are not in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The described testing is primarily non-clinical (bench and software testing) and relies on meeting pre-defined technical specifications and consensus standards, not on expert adjudication of diagnostic outcomes. For physiological measurements, validation is typically against a reference instrument or method, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the document describes technical performance testing against specifications and standards, not a diagnostic study requiring expert adjudication or ground truth establishment in a clinical setting.
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
Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation device. The "Modified Early Warning Score (MEWS)" is a clinical assessment tool generated by combining measured vital signs, not an AI-driven interpretation that would require an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone vital signs monitor. Its performance for individual parameters (SpO2, NIBP, TEMP, CO2) is evaluated against technical specifications and standards (as shown in the table). Its function is to measure and display parameters, not to provide an AI-driven diagnosis or recommendation in isolation. The MEWS feature is an algorithmic calculation based on the measured parameters. The performance of these calculations themselves would be validated against the MEWS algorithm's defined logic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing described:
- EMC and Electrical Safety: Ground truth is defined by the limits and test methods specified in the cited international standards (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2).
- Functional and System Level Performance: Ground truth is the device's technical specifications and the requirements of cited consensus standards (e.g., IEC 80601-2-30 for NIBP, IEC 60601-2-49 for patient monitoring). This generally involves comparison against calibrated reference equipment or methods.
- Software V&V: Ground truth is the software requirements specification and design documents.
8. The sample size for the training set
Not applicable. The document describes a traditional medical device (vital signs monitor), not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
March 27, 2019
Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department
Hi-tech Industrial Park, Nanshan Shenzhen, 518057 CN
Re: K182821
Trade/Device Name: Accutorr 7/VS-900/VS-900c 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 Dated: February 13, 2019 Received: February 19, 2019
Dear Yanhong Bai:
We have reviewed vour 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.
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
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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.html; 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 mediation-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, Shawn W. Forrest -S 2019.03.27 14:23:19 -04'00' 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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Indications for Use
510(k) Number (if known) K182821
Device Name
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Indications for Use (Describe)
The Accutorr 7/VS-900/VS-900c Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
. The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Accutorr 7/VS-900/VS-900c Vital Signs Monitor is provided below.
| Device Common Name: | monitor, physiological, patient (without arrhythmiadetection or alarms) |
|---|---|
| Device Proprietary Name: | Accutorr 7/VS-900/VS-900c Vital Signs Monitor |
| Submitter: | Shenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,Hi-tech Industrial Park, Nanshan,Shenzhen, 518057, P. R. ChinaTel: +86 755 8188 8998Fax: +86 755 2658 2680 |
| Contact: | Ms. Yanhong BaiManager Regulatory AffairsShenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,High-tech Industrial Park, Nanshan, Shenzhen518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | September 30, 2018 |
| Classification Regulation: | 21 CFR 870.2300, Class II, Cardiac monitor (includingcardiotachometer and rate alarm) |
| Panel: | Cardiovascular |
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| Primary | ||||
|---|---|---|---|---|
| ProductCode | RegulationNumber | Panel | Regulation description | Device Common Name |
| MWI | 21 CFR870.2300 | Cardiovascular | Cardiac monitor(includingcardiotachometer and ratealarm) | monitor, physiological,patient (withoutarrhythmia detection oralarms) |
| Secondary | ||||
| ProductCode | RegulationNumber | Panel | Regulation description | Device Common Name |
| CCK | 21 CFR868.1400 | Anesthesiology | Carbon dioxide gasanalyzer | analyzer, gas,carbon-dioxide,gaseous-phase |
| DQA | 21 CFR870.2700 | Anesthesiology | Oximeter | oximeter |
| DXN | 21 CFR870.1130 | Cardiovascular | Noninvasive bloodpressure measurementsystem | system, measurement,blood-pressure,non-invasive |
| FLL | 21 CFR880.2910 | GeneralHospital | Clinical electronicthermometer | thermometer, electronic,clinical |
Classification Regulation, Classification Name and Product Codes:
Primary Predicate Device:
K170712 - Accutorr 7/VS-900 Vital Signs Monitor; SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Secondary Predicate Device:
K011291 - TEMPORALSCANNER THERMOMETER, SENSORTOUCH; EXERGEN CORP.
Indications for Use:
The Accutorr 7/VS-900/VS-900c Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
- The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
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Device Description:
The Accutorr 7/VS-900/VS-900c Vital Signs Monitors are composed of the main unit and parameter modules. The main unit has the following functions:
- Provides operation interface, such as keys, touchscreen, and display screen. ●
- Communicates with the parameter modules. ●
- Delivers the setup commands of parameters to the parameter modules. ●
- Obtains the parameter measurements. ●
- Displays and stores the parameter numeric measurements and waveforms, and sends the data to Mindray's central monitoring system or Mindray's eGateway.
The parameter measurement modules include Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2). Their measurement principles are as follows:
Pulse Oxygen Saturation (SpO2) monitoring is a non-invasive technique used to determine the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detector side of the probe. When the pulse active part of the light signal is examined, the amount of light absorbed by the hemoglobin is measured and the pulse oxygen saturation can be calculated. The SpO2 module processes the electrical signal and displays a waveform and numeric values for SpO2 and pulse rate.
The monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations, which appear as tiny pulsations in cuff pressure. The Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.
CO2 monitoring is based on measuring the absorption of infrared (IR) light of specific wavelengths. CO2 has its own absorption characteristic and the amount of light passing to the gas probe depends on the concentration of the measured CO2. When a specific band of IR light passes through respiratory gas samples, some of the IR light will be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO2 is calculated.
The monitor supports two kinds of TEMP module: Mindray TEMP and Exergen TEMP. Different TEMP modules cannot be used at same time. The customers need to choose one kind of TEMP module before they buy the monitor.
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- Mindray TEMP Module has two measuring modes, Monitor mode and Predictive mode. ● In the Monitor mode, the thermal resistance in the probe reflects the subject's temperature by sensing the temperature change of the subject according to the thermal equilibrium principle. In the Predictive mode, the subject's temperature is predicted by the temperature rise curve (which is obtained by collecting multiple temperature measurements) at the time of initial thermal conduction.
- The Exergen Temperature Module is an infrared thermometer designed for accurate and completely non-invasive temperature assessment by scanning the temporal artery (TA). Temperature is measured by gently swiping the Temporal Scanner across the forehead, and includes a momentary touch of the probe to the neck area behind the ear lobe to account for any cooling of the forehead as a result of diaphoresis. The patented arterial heat balance technology (AHB™) automatically measures the temperature of the skin surface over the artery and the ambient temperature. It samples these readings approximately 1000 times a second, ultimately recording the highest temperature measured (peak) during the course of the measurement. The Temporal Scanner emits nothing - it only senses the natural thermal radiation emitted from the skin.
Non-clinical testing:
EMC and Electrical Safety - To establish the substantial equivalence of the subject Accutorr 7/VS-900/VS-900c Vital Signs Monitor to the previously cleared Accutorr 7/VS-900 Vital Signs Monitor (K170712), Mindray conducted Electromagnetic Compatibility and Electrical Safety testing level testing on the subject device. The testing provides an evaluation of the EMC and electrical safety of the subject devices relevant to each of the modifications since clearance of the predicate Accutorr 7/VS-900 Vital Signs Monitor. The Electromagnetic Compatibility and Electrical Safety testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
- AAMI ANSI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and 0 A2:2010/(R)2012* Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Performance Testing - Bench - To establish the substantial equivalence of the subject Accutorr 7/VS-900/VS-900c Vital Signs Monitor to the previously cleared Accutorr 7/VS-900 Vital Signs Monitor (K170712), Mindray conducted functional and system level testing on the subject devices. The testing provides an evaluation of the performance of the subject devices relevant to each of the modifications since clearance of the Accutorr 7/VS-900 Vital Signs Monitor. The functional and system level testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device. In addition, Mindray has conducted testing to ensure the subject device meets relevant consensus
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standards.
In addition, Mindray has conducted testing to ensure the subject device meets following consensus standards.
- IEC 80601-2-30: 2013-07 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- 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
Software Verification and Validation Testing - Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the subject device (Accutorr 7/VS-900/VS-900c Vital Signs monitors) was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Substantial Equivalence:
Comparison of Indications - Indications of the predicate device (Accutorr 7/VS-900) and the subject device (Accutorr 7/VS-900/VS-900c Vital Signs monitors) are the same except the new model, VS-900c, is added.
Comparison of Technological Characteristics - The table below compares the key technological feature of the subject device (Accutorr 7/VS-900c) to the primary predicate device (Accutorr 7/VS-900) (K170712). The features in gray are the main features that have been modified since their previous clearances.
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Device Comparison Table
| Feature | Primary Predicate Device (K170712) | Subject Devices |
|---|---|---|
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |
| Integrated display andtouchscreen | 8.4" 800*600 pixels | Same |
| Power supply | One rechargeable Lithium-ion battery orAC power supply | Same |
| Battery | Chargeable Lithium-Ion, 11.1VDC,4500 mAh | Same |
| Data Recorder | The thermal recorder can be used to printpatientinformation,measurementnumerics, and waveforms. | Same |
| Speaker | Provide alarm tones (45 to 85 dB), keytones; support PITCH TONEmulti-level tone modulation | Same |
| WiFi | 2.4G/5G dual band WiFi, compatiblewith IEEE 802.11 a/b/g/n | Same |
| Feature | Primary Predicate Device (K170712) | Subject Devices |
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |
| Temperature (Temp) | Mindray Temp Module :Technique: Thermal resistanceMeasurement range:Monitor mode:25 to 44 °C (77 to 111.2 °F)Predictive mode: 35 to 43 °C (95 to 109.4 °F)Accuracy (Monitor mode):25 to 32°C (not include 32°C): ± 0.2 °C32 to 44°C (include 32°C): ±0.1 °C(± 0.2 °F)or77 to 89.6 °F (not include 89.6°F): ± 0.4 °F89.6 to 111.2 °F (include 89.6°F): ± 0.2 °FResponse Time:Monitor mode: <60 sPredictive mode: <20 s (typical test: < 12s ) | Same |
| Feature | Primary Predicate Device (K170712) | Subject Devices |
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |
| Exergen Temperature(Temp)Module | Not supported. | Integrated an optional OEM temp module (the Exergen Temporal Scanner Thermometercleared in K011291)Measurement range:$16.0°C$ to $43.0°C$ ( $61°F~110°F$ )Measurement accuracy: $\pm 0.2°C$ |
| Pulse oxygensaturation (SpO2) | Is compatible with the following 3modules to measure oxygen saturation:• Mindray SpO2 Module• Masimo SpO2 Module• Nellcor SpO2 ModuleMindray SpO2 Module:Measurement range: 0 to 100%Accuracy:70 to 100%: $\pm$ 2% (without motion inadult/pediatric mode)70 to 100%: $\pm$ 3% (without motion inneonate mode)0% to 69%: Not specified. | Same |
| Feature | Primary Predicate Device (K170712) | Subject Devices |
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |
| Masimo SpO2 Module: | ||
| Measurement range: 1 to 100% | ||
| Accuracy:70 to 100%: $\pm$ 2% (without motion in adult/pediatric mode) | ||
| 70 to 100%: $\pm$ 3% (without motion in neonate mode) | ||
| 70 to 100%: $\pm$ 3% (with motion) | ||
| 1% to 69%: Not specified. | ||
| Nellcor SpO2 Module: | ||
| Measurement range: 0 to 100% | ||
| Accuracy: | ||
| 70 to 100%: $\pm$ 2% (adult/pediatric) | ||
| 70 to 100%: $\pm$ 3% (neonate) | ||
| 0% to 69%: Not specified. | ||
| Primary Predicate Device (K170712) | Subject Devices | |
| Feature | Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c |
| Pulse rate (PR) | Pulse rate may be obtained from theSpO2 module or the NIBP module. | |
| PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: ±3 bpm (without motion)PR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpmAccuracy:±3 bpm (without motion) | The Measurement range of PR from the NIBP Module has been expanded to: 30 to 300 bpm | |
| ±5 bpm (with motion) | Other specifications are the same | |
| PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpmAccuracy:20 to 250 bpm: ±3 bpm251 to 300 bpm, not specified | ||
| PR from NIBP ModuleMeasurement range: 40 to 240 bpmAccuracy: ±3bpm or ±3%, whichever isgreater |
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| Feature | Primary Predicate Device (K170712) | Subject Devices | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |||||||||||||||||||||||||||||||||||
| Non-invasive bloodpressure (NIBP) | Uses the oscillometric method formeasuring non-invasive blood pressure(NIBP). This measurement can be usedfor adults, pediatrics and neonates.Measurement range:Adult Pediatric Neonate Systolic: 40 to 270 40 to 200 40 to 135 Diastolic: 10 to 210 10 to 150 10 to 100 Mean: 20 to 230 20 to 165 20 to 110 Accuracy:Maximum average error: ±5 mmHgMaximum standard deviation: 8mmHgMaximum measurement time:Adult, pediatric: 180 s Neonate: 90 sStatic pressure measurement range:0mmHg to 300mmHgStatic pressure measurement accuracy:±3 mmHg | Uses the oscillometric method for measuring non-invasive blood pressure (NIBP). Thismeasurement can be used for adult, pediatric and neonatal patients.Expand the display range of NIBP to comply with IEC 80601-2-30: 2013:Measurement range:Adult Pediatric Neonate Systolic: 25 to 290 25 to 240 25 to 140 Diastolic: 10 to 250 10 to 200 10 to 115 Mean: 15 to 260 15 to 215 15 to 125 All other specifications are the same. |
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| Feature | Primary Predicate Device (K170712) | Subject Devices | |
|---|---|---|---|
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | ||
| Carbon dioxide (CO2) | CO2 parameter measuring.CO2 measurement range: 0-20%Resolution: 1mmHgCO2 Accuracy:After Warm-up (FULL Accuracy):0%≤CO2<1%: $\pm$ 0.1%1%≤CO2<5%: $\pm$ 0.2%5%≤CO2<7%: $\pm$ 0.3%7%≤CO2<12%: $\pm$ 0.4%12%≤CO2≤13%: $\pm$ 0.5%13%<CO2≤20%: $\pm$ (0.43%+8%rel)20%<CO2≤30%, unspecifiedDuring Warm-up(ISO Accuracy):Add $\pm$ 0.3%ABS to the FULL accuracyAccuracy drift: Meet the requirement formeasurement accuracy within 6 hours.Sampling flow rate: 50ml/min | Same | |
| Add a new model named VS-900c | Not supported | Supported |
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| Primary Predicate Device (K170712) | Subject Devices | ||||
|---|---|---|---|---|---|
| Feature | Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |||
| SupportthenewMasimo RD SpO2accessories | Not supported | MindrayPartNo. | Masimo Model | Description | Corresponding510(k) Number |
| 040-003376-00 | 4050 | RD SET DCI, Adult ReusableSensor | K051212 | ||
| 040-003377-00 | 4051 | RD SET DCI, Pediatric Reusable Sensor | K051212 | ||
| 040-003378-00 | 4080 | RD SET MD 14-05, PC 5 ft | K042536 | ||
| 040-003379-00 | 4081 | RD SET MD 14-12, PatientCable 12 ft | K042536 | ||
| 040-003380-00 | 4053 | RD Set TC-I SpO2 ReusableTip-Clip Ear Sensor, 3ft | K051212 | ||
| 040-003381-00 | 4089 | RD to LNC Adapter Cable | K042536 | ||
| 040-003382-00 | 4000 | RD SET Adhesive Sensor | K042346 | ||
| 040-003383-00 | 4001 | RD SET PDT Adhesive Sensor | K042346 | ||
| 040-003384-00 | 4002 | RD Set Infant Adhesive Sensor | K042346 | ||
| 040-003385-00 | 4003 | RD Set Neo Adhesive Sensor | K042346 | ||
| 040-003386-00 | 4004 | RD Set NeoPt Adhesive Sensor | K042346 | ||
| 040-003387-00 | 4005 | RD Set NeoPt-500Non-adhesive sensor | K042346 | ||
| 040-003426-00 | 4092 | LNCS to RD Adapter Cable | K042346 | ||
| 040-003310-00 | 583A | 8pin Masimo Cable ( RD SET ) | / | ||
| Support timer tool | Not supported | Supported |
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| Primary Predicate Device (K170712) | Subject Devices | |
|---|---|---|
| Feature | Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c |
| Support the VisitNumber (VID) of thepatient demographics | Not supported | Supported |
| Support the Facilityof the locationinformation of patientmonitor | Not supported | Supported |
| Support DNS forADT and EMR serveraddress | Not supported | Supported |
| Support authorizationof the user by theLDAP | Not supported | Supported |
| Support passwordprotection foraccessing the AlarmSetup Menu | Not supported | Supported |
| Support encrypting ofpatient privateinformation sent tothe network | Not supported | Supported |
| Feature | Primary Predicate Device (K170712) | Subject Devices |
| Accutorr 7/VS-900 | Accutorr 7/VS-900/VS-900c | |
| Support expandedcleaning anddisinfecting agentslist | Not supported | SupportedPlease refer to Section 12.3.12 for details. |
| Change the materialof the socket on theSpO2/CO2 signalcord | The material of the socket on theSpO2/CO2 signal cord is Polypropylene(PP). | The material of the socket on the SpO2/CO2 signal cord is changed to PolybutyeneTerephthatate (PBT) + Glass Fibre (DR48). |
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Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications for each of the modifications to the primary predicate device (Accutorr 7/VS-900) (K170712) and the secondary predicate device (Exergen Temporal Scanner Thermometer )(K011291), and the performance testing and conformance with applicable standards, the subject device (Accutorr 7/VS-900/VS-900c) can be found substantially equivalent to the primary predicate device.
§ 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).