Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities. The performance studies focus on the accuracy of temperature measurement compared to a predicate device, not on any learning or predictive algorithms.

Therapeutic

No
The device is described as a monitor intended for displaying, storing, alarming, and transferring physiological parameters, which are functions of a diagnostic or monitoring device, not a therapeutic one.

Diagnostic

Yes

Explanation: The device is a vital signs monitor designed for monitoring, displaying, storing, alarming, and transferring multiple physiological parameters (temperature, SpO2, PR, NIBP, CO2). This process of acquiring and interpreting physiological data to assess a patient's health status falls under the definition of diagnostic activity, even if it doesn't directly provide a diagnosis itself. It provides information that clinicians use for diagnosis and ongoing assessment.

SaMD (Software as a Medical Device)

No

The device description explicitly states it includes "three monitors" (VS 9, VS 8, VS 8A Vital Signs Monitors), which are hardware devices used for monitoring physiological parameters. The summary also details clinical studies involving physical temperature measurements (oral, axillary, rectal), further indicating the presence of hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the body (like blood, urine, tissue) to provide information about a person's health.
This device directly measures physiological parameters on the patient's body (Temperature, SpO2, PR, NIBP, CO2). It's a patient monitoring device, not a device that analyzes samples in a lab setting.

The intended use, device description, and the parameters measured all point to it being a vital signs monitor used for direct patient monitoring in a clinical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MWI, CCK, DQA, DXN, FLL

Device Description

The 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.

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

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.

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)

Biocompatibility Testing: The subject VS Series Vital Signs Monitors are not patient contacting. The TrueTemp temperature probe is patient contacting. 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 ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and . A2:2010/(R) 2012; IEC 60601-1-2:2014; and AIM Standard 7351731 Rev. 2.00 2017-02-23. The device was found to comply.
Bench Testing: Testing was conducted in accordance with ISO 80601-2-56 Second edition 2017-03 + AMD1:2018; ASTM E1112-00 (Reapproved 2018); and ASTM E1104-98 (Reapproved 2016).
Clinical Data: Clinical investigation was conducted to meet the requirements for the validity and accuracy of the TEMP measurement of the new Mindray Temp Module (TrueTemp) according to ISO 80601-2-56 Second edition 2017-03 + AMD1:2018. A clinical accuracy study evaluated 106, 110, 109 valid cases of oral, axillary and rectal temperature, which were performed on 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 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. No discomfort symptoms or adverse reactions were observed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Mindray Temp Module (TrueTemp):
- Accuracy (Monitor mode): 25 to 44°C: ±0.1 °C (± 0.2 °F) Or 77 to 111.2 °F: ± 0.2 °F
- Clinical BIAS (△cb): Oral 0.03°C, Axilla 0.03°C, Rectum -0.06°C
- Limits of Agreement (LA): Oral 0.37°C, Axilla 0.32°C, Rectum 0.38°C
- Clinical Repeatability (στ): Oral 0.14°C, Axilla 0.12°C, Rectum 0.14°C
Exergen Temperature (Temp) Module: +/- 0.2°C or +/- 0.4°F
Mindray SpO2 Module:
- Accuracy: 70 to 100%: ±2% ABS (adult/pediatric mode), 70 to 100%: ±3% ABS (neonate mode)
Masimo SpO2 Module:
- Accuracy: 70 to 100%: ±2% ABS (without motion in adult/pediatric mode), 70 to 100%: ±3% ABS (without motion in neonate mode), 70 to 100%: ±3% ABS (with motion)
Nellcor SpO2 Module:
- Accuracy: 70 to 100%: ±2%ABS (adult/pediatric mode), 70 to 100%: ±3% ABS(neonate mode)
NIBP:
- Accuracy: Maximum average error: ±5 mmHg, Maximum standard deviation: 8mmHg
PR from Mindray SpO2 Module:
- Accuracy: ±3 bpm
PR from Masimo SpO2 Module:
- Accuracy: ±3 bpm (without motion), ±5 bpm (with motion)
PR from Nellcor SpO2 Module:
- Accuracy: 20 to 250 bpm: ±3 bpm
PR from NIBP Module:
- Accuracy: ±3bpm or ±3%, whichever is greater
CO2:
- Accuracy Full accuracy mode: 0~~40 mmHg: ±2mmHg; 41~~76 mmHg: ±5% of reading; 77~~99 mmHg: ±10% of reading; 100~~150mmHg: ±(3mmHg + 8% of reading)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211475

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K011291

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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 the FDA logo, which 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.

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

1

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

2

Indications for Use

510(k) Number (if known) K221267

Device Name VS Series Vital Signs Monitors

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Li Lei
Title: Manager Regulatory Affairs
Phone: +86 755 81885953
Fax: +86 755 26582680
E-mail: lilei.js@mindray.com |

Date Prepared: April 19, 2022

2. DEVICE

| Device Trade Name: | VS Series Vital Signs Monitors (Including VS 9/VS
8/VS 8A) |
|---------------------------------------|-----------------------------------------------------------------------------------|
| Device Common Name: | Vital Signs Monitor |
| Classification Name and
Regulation | 21 CFR 870.2300, Cardiac monitor (including
cardiotachometer and rate alarm) |
| Primary Product Code: | MWI - Monitor, physiological, patient (without
arrhythmia detection or alarms) |
| Regulatory Class | Class II |
| Panel | Cardiovascular |

4

| Product
Code | Regulation
Number | Panel | Regulation description | Device Common Name |
|-----------------|----------------------|----------------|-----------------------------------------------------|----------------------------------------------------------|
| CCK | 21 CFR
868.1400 | Anesthesiology | Carbon dioxide gas
analyzer | analyzer, gas, carbon-
dioxide, gaseous-phase |
| DQA | 21 CFR
870.2700 | Cardiovascular | Oximeter | oximeter |
| DXN | 21 CFR
870.1130 | Cardiovascular | Noninvasive blood
pressure measurement
system | system, measurement,
blood-pressure, non-
invasive |
| FLL | 21 CFR
880.2910 | Cardiovascular | Clinical electronic
thermometer | 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 .

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.

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.

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.

5

Page 3 of 9

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
Integrated
display and
touchscreen	10.1" 1280*800 pixels	8"
pixels	1024*768	Same	Same
Touch screen	Capacitive touch screen			Same
Function
Button And
Rotary
Encoder	Not supported	Support		Same	Same
Power supply	One or two rechargeable Lithium-ion battery or
AC power supply			Same
Battery	Chargeable Smart Lithium-
Ion, 10.8 VDC, 5600 mAh	Chargeable non-
Smart Lithium-
Ion, 10.95 VDC,
2500 mAh
or
Chargeable non-
Smart Lithium-
Ion, 10.95 VDC,
5000 mAh		Same	Same
Data
Recorder	The thermal recorder can be used to print patient
information, measurement numerics, and
waveforms.			Same
Speaker	Provide alarm tones (45 to 85 dB), key tones;
support PITCH TONE and multi-level tone
modulation			Same
WiFi	2.4G/5G dual band WiFi, compatible with IEEE
802.11 a/b/g/n/ac			Same
Bluetooth	Bluetooth 5			Same

Table 2: Technological Comparison

6

Feature	Predicate Devices (K211475)			Subject Devices
	VS 9	VS 8	VS 8A	VS 9	VS 8	VS 8A
Mindray
Temperature
Module	Mindray Temp Module (SmarTemp):
Technique: Thermal resistance
Measurement 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 °C
32 to 44°C(include 32°C): ±0.1 °C(± 0.2 °F)
or
77 to 89.6 °F (not include 89.6°F): ± 0.4 °F
89.6 to 111.2 °F (include 89.6°F): ± 0.2 °F			Similar.
The performance of the module is validated by the
clinical trial.
New Mindray Temp Module (TrueTemp):
Technique: Thermal resistance
Monitor 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 Investigation
Data(Predictive mode)			Statistical Results of Clinical Investigation
Data(Predictive mode)
	Clinical BIAS
(△cb)	Limits of Agreement
(LA)	Clinical Repeatability
(στ)	Clinical BIAS
(Acb)	Limits of Agreement
(LA)	Clinical Repeatability
(στ)
	Oral
0.02°C	0.33°C	0.1°C	Oral
0.03°C	0.37°C	0.14°C
	Axilla
0.06°C	0.38°C	0.13°C	Axilla
0.03°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
Exergen
Temperature
(Temp)
Module	Integrated an optional OEM temp module (the
Exergen Temporal Scanner Thermometer, cleared
in 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 to
measure oxygen saturation:
• Mindray SpO2 Module
• Masimo SpO2 Module
• Nellcor SpO2 Module			Same
Pulse oxygen
saturation
(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 in
adult/pediatric mode)
70 to 100%: ±3% ABS (without motion in neonate
mode)
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 inflation
measuring mode. This measurement can be used
for adults, pediatrics and neonates.			Same
Non-invasive
blood
pressure
(NIBP)	Measurement range:
Adult
Pediatric
Systolic: 25 to 290
25 to 240
Diastolic: 10 to 250
10 to 200
Mean: 15 to 260
15 to 215		Neonate
25 to 140
10 to 115
15 to 125
	Accuracy:
Maximum average error: ±5 mmHg
Maximum standard deviation: 8mmHg
NIBP
Venipuncture	Uses the NIBP cuff to cause sub-diastolic pressure
to block the venous blood vessel and therefore help
venous 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 module
or the NIBP module.			Same
Pulse
rate
(PR)	PR from Mindray SpO2 Module
Measurement range: 20 to 254 bpm
Resolution: 1bpm
Accuracy: ±3 bpm
	PR from Masimo SpO2 Module
Measurement range: 25 to 240 bpm
Resolution: 1bpm
Accuracy:
±3 bpm (without motion)
±5 bpm (with motion)
	PR from Nellcor SpO2 Module
Measurement range: 20 to 300 bpm
Resolution: 1bpm
Accuracy:
20 to 250 bpm: ±3 bpm
251 to 300 bpm: not specified
	PR from NIBP Module
Measurement range: 30 to 300 bpm
Resolution: 1bpm
Accuracy: ±3bpm or ±3%, whichever is greater
Carbon
dioxide
(CO2)	CO2 parameter measuring.

CO2 measurement range: 0-
150mmHg

Resolution: 1mmHg

CO2 Accuracy :

Full accuracy mode:

0~40 mmHg: ±2mmHg

41~76 mmHg: ±5%
of
reading

77~99 mmHg: ±10%
of
reading

100~150mmHg: ±(3mmHg

8% of reading)

150mmHg CO2:
unspecified

7

8

K221267

9

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.

10

. 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

11

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.