The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, 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.

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 8A Vital Signs Monitors 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

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., LTD VS Series Vital Signs Monitors. It describes the device, its intended use, comparison to predicate devices, and the performance data submitted to demonstrate substantial equivalence.

However, the provided document does not describe an AI/ML software device or a study validating its performance. The "Product Code: MWI, CCK, DQA, DXN, FLL" and "Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" indicate traditional vital signs monitors. The 'software verification and validation testing' mentioned refers to general software engineering practices for medical devices, not specific performance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information because the document does not contain details about:

Acceptance criteria for an AI/ML algorithm.
A study proving an AI/ML device meets acceptance criteria.
Sample sizes for test sets used for AI/ML validation.
Ground truth establishment methods for AI/ML datasets.
MRMC studies for AI/ML.
Standalone performance for AI/ML algorithms.
Training set details for AI/ML.

The document discusses validation for a physical medical device (vital signs monitor) including:

Biocompatibility Testing: For NIBP cuffs due to an ink change.
Software Verification and Validation Testing: General software V&V for the device's embedded software, not an AI/ML algorithm.
Electrical safety and electromagnetic compatibility (EMC): Compliance with relevant standards.
Bench Testing: Functional and system level testing to validate device performance.
Clinical Data: NIBP measurement accuracy validated according to ISO 81060-2:2018 in neonate, infant, child, and adult populations.

If you have a document describing an AI/ML medical device, please provide that, and I will be able to answer your questions.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 5, 2021

Shenzhen Mindray Bio-Medical Electronics Co., LTD Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China

Re: K211475

Trade/Device Name: Vital Signs Monitors 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: September 2, 2021 Received: September 3, 2021

Dear Yanhong Bai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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.

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211475

Device Name 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: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com

Date Prepared: August 1, 2021

2. DEVICE

Device Trade Name:	Vital Signs Monitors
Device Common Name:	VS series Vital Signs Monitors (Including VS 9, VS 8,VS 8A)
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

K191769 - ePM Series Patient Monitors (including ePM 10/ePM 12/ePM Predicate Device: 15/ePM 10M/ePM 12M/ePM 15M) (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)

Reference Device: K182821 - Accutorr 7/VS-900 Vital Signs Monitor (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)

K193391 - TM80 telemetry module component of the BeneVision Central Monitoring System (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)

DEVICE DESCRIPTION 4.

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 ●

5. INTENDED USE/INDICATIONS FOR USE

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

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(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.

SUBSTANTIAL EQUIVALENCE 6.

Comparison of Indications

Both the predicate devices and the subject devices are multi parameter monitors intended to be used under the direction of clinical professionals. The monitoring parameters supported by the VS series are a subset of those supported by the predicate ePM series monitors (K191769).

In conclusion, the minor differences of the indications for use do not change the fundamental intended use of the VS Series as a multiparameter monitor.

Technological Comparisons

The table below compares the key technological feature of the subject device to the primary predicate device (ePM series Patient Monitors, K191769). The features in gray are features which are different between the predicate device and the subject devices.

Note: In order to maintain readability, Table 2 only compares the subject device to the predicate ePM 10 model from K191769.

	Predicate Devices (K191769)	Subject VS Devices
Feature	ePM 10	VS 9	VS 8	VS 8A
Display andtouchscreen	10.1" 1280*800 pixels	10.1" 1280*800 pixels		8" 1024*768 pixels
Wireless	Wifi: The ePM series patientmonitors support the lairdMSD45N WiFi module.	Wifi: VS series monitors support the silex SX-SDMAC-2832S+ WiFi module.Bluetooth: VS series monitors support Bluetooth.
Power supply	Battery or AC power	same
Battery	Rechargeable Lithium-Ion,10.8VDC, 5600 mAhRechargeable Lithium-Ion,10.95 VDC, 4500 mAhRechargeable Lithium-Ion,10.95 VDC, 2600 mA	Only supportRechargeable Lithium-Ion, 10.8VDC, 5600mAhwhich is as sameas ePM 10.	Support soft packageRechargeable Lithium-Ion, 10.95VDC, 5000mAhRechargeable Lithium-Ion, 10.95VDC, 2500mAh.
Data storage	Embedded Multi MediaCard(eMMC)	same
Data Recorder	Supports internal thermalrecorder	same
Speaker	Give alarm tones (45 to 85 dB),key tones, QRS tones; support	same

Table 2: Technological Comparison

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Feature	Predicate Devices (K191769)		Subject VS Devices
	ePM 10	VS 9	VS 8	VS 8A
	PITCH TONE and multi-level tone modulation.
Alarm system	The alarm lamp is cyan, yellow, or red depending on alarm type.Supports Alarm Volume Escalation		same
Temperature (Temp)	Use internal temperature module of MPM 3.0Measurement range: 0 to 50°C (32 to 122°F)Accuracy: ±0.1°C or ±0.2°F (without probe).		Different. Supports 2 types of temperature module, but only one module can be integrated at one time.Mindray Temp Module: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 °FStatistical Results of Clinical Investigation Data (Predictive mode)Clinical BIAS (Δcb) Limits of Agreement (LA) Clinical Repeatability (σr) Oral 0.02°C 0.33°C 0.1°C Axilla 0.06°C 0.38°C 0.13°C Rectum -0.05°C 0.48°C 0.14°C Integrated an optional OEM temp module (the Exergen Temporal Scanner Thermometer, cleared in K011291)Measurement range:16.0°C to 43.0°C (61°F~110°F)

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Feature	Predicate Devices (K191769)ePM 10	VS 9
Pulse oxygensaturation(SpO2)	Supports Mindray SpO2function, Masimo SpO2function and Nellcor SpO2function from multi parametermodule.The specifications for variousSpO2 functions are the same.Mindray SpO2 functionMeasurement range: 0 to100%;Accuracy:70 to 100%: ±2%(adult/pediatric mode);70 to 100%: ±3% (neonatemode);0% to 69%: Not specified.Masimo SpO2 functionMeasurement range: 1 to100%;Accuracy:70 to 100%: ±2%(measured without motion inadult/pediatric mode);70 to 100%: ±3% (measuredwithout motion in neonatemode);70 to 100%: ±3% (measuredwith motion);1% to 69%: Not specified.Nellcor SpO2 functionMeasurement range: 0 to100%;Accuracy:70 to 100%: ±2%(adult/pediatric);70 to 100%: ±3% (neonate);0% to 69%: Not specified.Note: The specifictions of thevarious SpO2 functionsprovided by each manufacturerare the same across platforms.	Supports Mindray SpO2 function, Masimo SpO2function and Nellcor SpO2 function from multiparameter module.The specifications for various SpO2 functions arethe same.The Masimo SpO2 module and the Nellcor SpO2module are identical to the Masimo SpO2 moduleand the Nellcor SpO2 module in K191769.The internal Mindray SpO2 minor circuitboard layout is different compared to theMindray SpO2 module in K191769.
Pulse rate (PR)	PR from built-in MindraySpO2 Module Measurementrange: 20 to 254 bpm;Accuracy: ±3 bpm.	Same
	PR from built-in Masimo SpO2

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Feature	Predicate Devices (K191769)	Subject VS Devices
	ePM 10	VS 9	VS 8	VS 8A
	Module Measurement range:25 to 240 bpm;Accuracy: $\pm$ 3 bpm (measuredwithout motion);$\pm$ 5 bpm (measured withmotion).PR from built-in Nellcor SpO2Module Measurement range:20 to 300 bpm;Accuracy:20 to 250 bpm:$\pm$ 3 bpm;251 to 300 bpm, not specified.
Non- invasivebloodpressure(NIBP)	Measurement range:Adult Pediatric NeonateSystolic 25~~29025~~140 25~~240 Diastolic 10~~25010~~115 10~~200 Mean 15~~26015~~125 15~215 Accuracy:Max mean error: $\pm$ 5 mmHg;Max standard deviation: 8mmHg.Measure in deflation phaseSupports NIBP Venipuncture				The specifications are same as ePM10.Neonate is measured in the deflation phase, suchas in the predicate device,Adult and Pediatric is measured in the inflationphase (inflation measuring mode) If themeasurement fails in the inflation phase, theblood pressure will be measured in deflationphase as the predicate device.The ink used on the cuffs accessories has beenmodified.VS9 and VS8 support NIBP Venipuncture, but VS8A doesn't support the feature.
Carbondioxide(CO2)	Compatible with 3 internalCO2 modules:Sidestream CO2 2.0 moduleMainstream CO2 moduleMicroStream CO2 moduleThe internal CO2 modules areidentical to the external CO2module in K182075Type: Sidestream CO2 Module(CO2 2.0):Measurement range:0~~150mmHg Accuracy:0~~40 mmHg: $\pm$ 2mmHg,41~~76 mmHg: $\pm$ 5% of reading,77~~99 mmHg: $\pm$ 10% ofreading,	Compatible with 1internal CO2 modules:Sidestream CO2 2.0moduleSidestream CO2Module (CO2 2.0):Measurement range:0~~150mmHgAccuracy:0~~40 mmHg:$\pm$ 2mmHg,41~~76 mmHg: $\pm$ 5% ofreading, 77~~99 mmHg:$\pm$ 10% of reading,100~150mmHg:$\pm$ (3mmHg + 8% of		Not supported

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Feature	Predicate Devices (K191769)	Subject VS Devices
	ePM 10	VS 9	VS 8	VS 8A
	100~~150mmHg: ±(3mmHg +8% of reading),ISO accuracy mode:Add ±2mmHg to the fullaccuracy modeAwRR measurement:awRR measurement range:0 to 150rpm;awRR: <60rpm, ±1rpm,60~~150rpm, ±2rpm.	reading),ISO accuracy mode:Add ±2mmHg to thefull accuracy modeAwRR measurement:awRR measurementrange: 0 to 150rpm;awRR: <60rpm,±1rpm, 60~150rpm,±2rpm.Some electroniccomponents havebeen replaced becausethey are nearing endof life or Mindray haschanged suppliers.
EWS	The EWS is a set of earlywarning scores that areintended to assist clinicians inrecognizing the early signs ofdeterioration in patients basedon vital signs and clinicalobservations. The four types ofEWS provided are ModifiedEarly Warning Score (MEWS),National Early Warning Score(NEWS), National EarlyWarning Score2 (NEWS2) anduser configurable CustomScore.	The EWS is a set of early warning scores that areintended to assist clinicians in recognizing theearly signs of deterioration in patients based onvital signs and clinical observations. The fourtypes of EWS provided are Modified EarlyWarning Score (MEWS), National Early WarningScore (NEWS), National Early Warning Score2(NEWS2) and user configurable Custom Score.The VS series monitors remove the Historytotal scores and Operator ID function from theEWS Scores.
Glasgow ComaScale (GCS)	The GCS a well-establishedscoring system used to assessthe state of consciousnessbased three sub- components:eye-opening response, verbalresponse, and limb movement.	The GCS a well-established scoring system used toassess the state of consciousness based three sub-components: eye-opening response, verbalresponse, and limb movementThe VS series monitors have a modify interfaceand does not include the Review and IntervalFunction.
Pain Score	Not support	Support	Support	Support
Vitalslink	Not support	Support	Support	Support
Rolling Stand	without Worktop and PowerSupply	with Worktop and Power Supply

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6.1. Substantial Equivalence Conclusion

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

To establish the substantial equivalence of the VS Series Vital Signs Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the 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.

PERFORMANCE DATA 7.

Biocompatibility Testing

The VS Series Vital Signs Monitors are not patient contacting. The only change to patient contacting devices is an ink change to the NIBP cuffs. Therefore, in accordance with FDA guidance, "Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 4, 2020, cytotoxicity, sensitization and irritation testing were performed.

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 VS Series 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.
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.
. IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems.

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Bench Testing

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

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

IEC 60601-1-6:2010. AMD1:2013 Medical electrical equipment Part 1-6 General requirements for safety - Collateral Standard: Usability (Edition 3.1)
IEC 60601-1-8:2006+Am1:2012 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
IEC 80601-2-30:2018 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
IEC 80601-2-49:2018 Medical electrical equipment -Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-55: 2018 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-56: 2017, AMD1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
. ISO 80601-2-61: 2017, COR1:2018 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment
IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical ● devices

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 NIBP measurement of automated measurement type, Mindray conducted clinical investigation with Reference Invasive Blood Pressure Monitoring Equipment and Auscultation reference sphygmomanometer according to the

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requirements of the standard ISO 81060-2:2018 Non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. Study results demonstrated that the VS Series Vital Signs Monitors comply with the requirements of the standard in the neonate, infant, child and adult populations.

8. CONCLUSION

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).