The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transfering of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.

Device Description

The subject VS series Vital Signs Monitors includes three monitors:

VS 9 Vital Signs Monitor
VS 8 Vital Signs Monitor
VS 8A Vital Signs Monitor .

The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Mindray VS Series Vital Signs Monitors (VS 9/VS 8/VS 8A)
Parameter for Analysis: Temperature (Temp) measurement using the new Mindray Temp Module (TrueTemp) in Predictive mode.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for temperature measurement are based on the requirements of ISO 80601-2-56:2017/Amd.1:2018(E). The summary provides statistical results from a clinical investigation.

Acceptance Criteria (from ISO 80601-2-56:2017/Amd.1:2018(E))	Reported Device Performance (Mindray TrueTemp Module - Predictive Mode)	Body Site
Not explicitly stated in the document, but assessed against ISO standard for clinical accuracy. The "Similar" predicate performance (SmarTemp) provides a point of comparison.	Clinical BIAS (Δcb): 0.03°C	Oral
	Limits of Agreement (LA): 0.37°C	Oral
	Clinical Repeatability (στ): 0.14°C	Oral
	Clinical BIAS (Δcb): 0.03°C	Axilla
	Limits of Agreement (LA): 0.32°C	Axilla
	Clinical Repeatability (στ): 0.12°C	Axilla
	Clinical BIAS (Δcb): -0.06°C	Rectum
	Limits of Agreement (LA): 0.38°C	Rectum
	Clinical Repeatability (στ): 0.14°C	Rectum

Note: The document states that the performance of the TrueTemp module "meets the requirements of ISO 80601-2-56:2017/ Amd.1:2018(E) for temperature measurement and meets the acceptance criteria in clinical protocol." While the specific numerical acceptance criteria from the ISO standard are not explicitly listed in the table, the reported performance metrics are the results of testing against those criteria. The predicate device's performance is also included in the table in the full submission, showing similar statistical results.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- 106 valid cases for oral temperature.
- 110 valid cases for axillary temperature.
- 109 valid cases for rectal temperature.
Data Provenance: The study was a clinical investigation conducted by Mindray. The country of origin is not explicitly stated in the provided abstract, but Mindray is a Chinese company (Shenzhen, Guangdong, P.R. China), suggesting the study likely took place in China. It was a prospective clinical investigation as it aimed to meet specific requirements for validity and accuracy of the new module.
Subject Demographics: The study included subjects in three age groups: infants (newborn to one year), children (greater than one to five years), and adults (greater than five years old). The age of subjects ranged from 4 days to 67 years old. The total number of febrile subjects constituted not less than 30% and not greater than 50% of all subjects in each selected age group and body site.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not explicitly provided in the summary. The ground truth (reference temperature) was established by comparing the TrueTemp module's measurements to the "direct mode of WelchAllyn SureTemp PLUS 690." It's likely that a trained clinical professional operated the reference thermometer, but the specific number and qualifications of experts involved in establishing the "ground truth" are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. Given that the ground truth was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690), it implies a direct comparison rather than an expert consensus requiring an adjudication process.

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 is not applicable. The device is a vital signs monitor that directly measures physiological parameters like temperature. It is not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images/data in a way that would necessitate an MRMC comparative effectiveness study to assess human improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done for the temperature measurement function. The clinical investigation directly assessed the accuracy and validity of the "new Mindray Temp Module (TrueTemp)" in its predictive mode compared to a reference standard (WelchAllyn SureTemp PLUS 690). This evaluation focused on the device's intrinsic measurement capabilities without assessing human interaction or interpretation as part of the core performance metrics discussed here.

7. The Type of Ground Truth Used

The ground truth used was comparison to a legally marketed reference device: the "direct mode of WelchAllyn SureTemp PLUS 690," which is itself a clinical thermometer. This is a form of comparative measurement against a recognized standard in the field.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set for the Mindray TrueTemp module's temperature measurement function. Given that this is a hardware module (thermal resistance technique) with associated algorithms for predictive mode, its development and calibration would typically involve internal technical specifications and potentially laboratory testing, but "training set" in the context of machine learning is not directly applicable or reported for this type of device in the provided summary.

9. How the Ground Truth for the Training Set Was Established

As no training set information is provided, how its ground truth was established is not discussed in this document.

Summary

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December 15, 2022

Shenzhen Mindray Bio-Medcal Electronics Co., LTD Li Lei Manager Regulatory Affairs, Technical Regulation Department Mindrav Building, Keii 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China

Re: K221267

Trade/Device Name: VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 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, CCK, DQA, DXN, FLL Dated: April 19, 2022 Received: May 2, 2022

Dear Li Lei:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director 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) K221267

Device Name VS Series Vital Signs Monitors

Indications for Use (Describe)

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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the VS series Patient Monitors is provided below.

1. SUBMITTER

Applicant:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680
Contact:	Contact Person: Li LeiTitle: Manager Regulatory AffairsPhone: +86 755 81885953Fax: +86 755 26582680E-mail: lilei.js@mindray.com

Date Prepared: April 19, 2022

2. DEVICE

Device Trade Name:	VS Series Vital Signs Monitors (Including VS 9/VS8/VS 8A)
Device Common Name:	Vital Signs Monitor
Classification Name andRegulation	21 CFR 870.2300, Cardiac monitor (includingcardiotachometer and rate alarm)
Primary Product Code:	MWI - Monitor, physiological, patient (withoutarrhythmia detection or alarms)
Regulatory Class	Class II
Panel	Cardiovascular

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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	Cardiovascular	Oximeter	oximeter
DXN	21 CFR870.1130	Cardiovascular	Noninvasive bloodpressure measurementsystem	system, measurement,blood-pressure, non-invasive
FLL	21 CFR880.2910	Cardiovascular	Clinical electronicthermometer	thermometer, electronic,clinical

Table 1: Secondary Product Codes

3. PREDICATE DEVICE

K211475 - VS Series Vital Signs Monitor (SHENZHEN MINDRAY Predicate Device: BIO-MEDICAL ELECTRONICS CO., LTD)

4. DEVICE DESCRIPTION

The subject VS series Vital Signs Monitors includes three monitors:

VS 9 Vital Signs Monitor
VS 8 Vital Signs Monitor ●
VS 8A Vital Signs Monitor .

INTENDED USE/INDICATIONS FOR USE 5.

The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

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SUBSTANTIAL EQUIVALENCE 6.

Comparison of Indications

Indications of the predicate device and the subject device are the same.

Technological Comparisons

Table 2 compares the key technological feature of the subject device to the predicate device (VS series Vital Signs Monitor, K211475). The features in gray are features that have been modified since their previous clearances and that are the subject of this 510(k).

Feature	Predicate Devices (K211475)			Subject Devices
	VS 9	VS 8	VS 8A	VS 9	VS 8	VS 8A
Integrateddisplay andtouchscreen	10.1" 1280*800 pixels	8"pixels	1024*768	Same	Same
Touch screen	Capacitive touch screen			Same
FunctionButton AndRotaryEncoder	Not supported	Support		Same	Same
Power supply	One or two rechargeable Lithium-ion battery orAC power supply			Same
Battery	Chargeable Smart Lithium-Ion, 10.8 VDC, 5600 mAh	Chargeable non-Smart Lithium-Ion, 10.95 VDC,2500 mAhorChargeable non-Smart Lithium-Ion, 10.95 VDC,5000 mAh		Same	Same
DataRecorder	The thermal recorder can be used to print patientinformation, measurement numerics, andwaveforms.			Same
Speaker	Provide alarm tones (45 to 85 dB), key tones;support PITCH TONE and multi-level tonemodulation			Same
WiFi	2.4G/5G dual band WiFi, compatible with IEEE802.11 a/b/g/n/ac			Same
Bluetooth	Bluetooth 5			Same

Table 2: Technological Comparison

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Feature	Predicate Devices (K211475)			Subject Devices
	VS 9	VS 8	VS 8A	VS 9	VS 8	VS 8A
MindrayTemperatureModule	Mindray Temp Module (SmarTemp):Technique: Thermal resistanceMeasurement range:Monitor mode:25 to 44 °C (77 to 111.2 °F)Predictive mode: 34 to 43 °C (93.2 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 °F			Similar.The performance of the module is validated by theclinical trial.New Mindray Temp Module (TrueTemp):Technique: Thermal resistanceMonitor mode:25 to 44 °C (77 to 111.2 °F)Predictive mode: 34 to 42 °C (93.2 to 107.6 °F)Accuracy (Monitor mode):25 to 44°C: ±0.1 °C(± 0.2 °F)Or 77 to 111.2 °F: ± 0.2 °F
	Statistical Results of Clinical InvestigationData(Predictive mode)			Statistical Results of Clinical InvestigationData(Predictive mode)
	Clinical BIAS(△cb)	Limits of Agreement(LA)	Clinical Repeatability(στ)	Clinical BIAS(Acb)	Limits of Agreement(LA)	Clinical Repeatability(στ)
	Oral0.02°C	0.33°C	0.1°C	Oral0.03°C	0.37°C	0.14°C
	Axilla0.06°C	0.38°C	0.13°C	Axilla0.03°C	0.32°C	0.12°C
	Rectum-0.05°C	0.48°C	0.14°C	Rectum-0.06°C	0.38°C	0.14°C
ExergenTemperature(Temp)Module	Integrated an optional OEM temp module (theExergen Temporal Scanner Thermometer, clearedin K011291)Measurement range: 15.5°C to 42°C(60°F~107.6°F)Measurement accuracy: ± 0.2°C or ± 0.4°F			Same
Feature	Predicate Devices (K211475)			Subject Devices
	VS 9	VS 8	VS 8A	VS 9	VS 8	VS 8A
	Is compatible with the following 3 modules tomeasure oxygen saturation:• Mindray SpO2 Module• Masimo SpO2 Module• Nellcor SpO2 Module			Same
Pulse oxygensaturation(SpO2)	Mindray SpO2 Module:Measurement range: 0 to 100%Accuracy:70 to 100%: ±2% ABS (adult/pediatric mode)70 to 100%: ±3% ABS (neonate mode)0% to 69%: Not specified.
	Masimo SpO2 Module:Measurement range: 1 to 100%Accuracy:70 to 100%: ±2% ABS (without motion inadult/pediatric mode)70 to 100%: ±3% ABS (without motion in neonatemode)70 to 100%: ±3% ABS (with motion)1% to 69%: Not specified.
	Nellcor SpO2 Module:Measurement range: 0 to 100%Accuracy:70 to 100%: ±2%ABS (adult/pediatric mode)70 to 100%: ±3% ABS(neonate mode)0% to 69%: Not specified.
	Uses the oscillometric method for measuring non-invasive blood pressure (NIBP), support inflationmeasuring mode. This measurement can be usedfor adults, pediatrics and neonates.			Same
Non-invasivebloodpressure(NIBP)	Measurement range:AdultPediatricSystolic: 25 to 29025 to 240Diastolic: 10 to 25010 to 200Mean: 15 to 26015 to 215		Neonate25 to 14010 to 11515 to 125
	Accuracy:Maximum average error: ±5 mmHgMaximum standard deviation: 8mmHg
NIBPVenipuncture	Uses the NIBP cuff to cause sub-diastolic pressureto block the venous blood vessel and therefore helpvenous puncture			Same
Feature	Predicate Devices (K211475)			Subject Devices
	VS 9	VS 8	VS 8A	VS 9	VS 8	VS 8A
	Pulse rate may be obtained from the SpO2 moduleor the NIBP module.			Same
Pulserate(PR)	PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmResolution: 1bpmAccuracy: ±3 bpm
	PR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpmResolution: 1bpmAccuracy:±3 bpm (without motion)±5 bpm (with motion)
	PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpmResolution: 1bpmAccuracy:20 to 250 bpm: ±3 bpm251 to 300 bpm: not specified
	PR from NIBP ModuleMeasurement range: 30 to 300 bpmResolution: 1bpmAccuracy: ±3bpm or ±3%, whichever is greater
Carbondioxide(CO2)	CO2 parameter measuring.CO2 measurement range: 0-150mmHgResolution: 1mmHgCO2 Accuracy :Full accuracy mode:0~~40 mmHg: ±2mmHg41~~76 mmHg: ±5%ofreading77~~99 mmHg: ±10%ofreading100~~150mmHg: ±(3mmHg+ 8% of reading)> 150mmHg CO2:unspecifiedISO accuracy mode: Add±2mmHg to the full accuracymode	Not supported		Same	Same
Feature	Predicate Devices (K211475)			Subject Devices
	VS 9	VS 8	VS 8A	VS 9	VS 8	VS 8A
NIBPVeniPuncture	Support		Notsupported	Same		Same

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K221267

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Substantial Equivalence Conclusion 6.1.

In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

To establish the substantial equivalence of the subject VS Series Vital Signs Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the software and bench testing show that the subject device meets its specifications and is substantially equivalent to the predicate device.

In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.

7. PERFORMANCE DATA

Biocompatibility Testing

The subject VS Series Vital Signs Monitors are not patient contacting.

The subject VS Series Vital Signs Monitors have a new Mindray Temperature Module (TrueTemp) and TrueTemp temperature probe. The Mindray Temperature Module is non-patient contacting. The only component TrueTemp temperature probe that is patient contacting is the probe cover. Cytotoxicity, Sensitization, and Intracutaneous Reactivity testing was completed and passed.

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 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.

Electrical safety and electromagnetic compatibility (EMC)

The VS Series Vital Signs Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and . A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and ● System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard

Bench Testing

Mindray has conducted testing in accordance with the following standards to establish substantial equivalence, ensure the subject devices meet relevant consensus standards, and the device performs as intended.

. ISO 80601-2-56 Second edition 2017-03 + AMD1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
. ASTM E1112-00 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (Reapproved 2018)
ASTM E1104-98 Standard Specification for Clinical Thermometer Probe Covers . and Sheaths (Reapproved 2016)

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

To meet the requirements for the validity and accuracy of the TEMP measurement of the new Mindray Temp Module (TrueTemp), Mindray conducted clinical investigation according to the requirements of the standard ISO 80601-2-56 Second edition 2017-03 + AMD1:2018 : Medical electrical equipment- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. A clinical accuracy study evaluated 106, 110, 109 valid cases of oral, axillary and rectal temperature, which were performed on the following three age groups: infants (newborn to one year), children (greater than one to five years), and adults (greater than five years old) in accordance with ISO 80601-2-56 :2017/Amd.1:2018(E) to compare the direct mode of WelchAllyn SureTemp PLUS 690. The age of subjects is from 4 days to 67 years old. The total number of febrile subjects are not less than 30 % and not greater than 50 % of all subjects in the selected age group and body site. Statistical results show that, the temperature Measurement function of the TrueTemp module of the VS 9 Vital Signs Monitor in Predictive mode meets the requirements of ISO 80601-2-56:2017/ Amd.1:2018(E) for temperature measurement and meets the acceptance criteria in clinical protocol; the performances of the test device and the RCT are equivalent. During the entire clinical trial, all subjects are in good condition, and none of the subjects have discomfort

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symptoms or adverse reactions due to the use of Mindray VS 9 Vital Signs Monitor for temperature measurement.

CONCLUSION 8.

Based on the detailed comparison between the predicate devices and the subject devices, the performance testing and conformance with applicable standards, the VS Series Vital Signs Monitors can be found substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).