(146 days)
No
The summary describes standard vital signs monitoring and does not mention any AI/ML capabilities or related concepts like image processing, training/test sets, or specific performance metrics associated with AI/ML models.
No.
The device is described as a "Vital Signs Monitor" intended for monitoring, displaying, storing, alarming, and transferring physiological parameters, which are diagnostic and monitoring functions, not therapeutic ones.
No
Explanation: The device is described as a "Vital Signs Monitor" intended for monitoring, displaying, storing, alarming, and transferring physiological parameters. It does not state that it is used to diagnose a disease or condition.
No
The device description explicitly states it includes "three monitors," which are hardware devices used for monitoring physiological parameters. The summary also mentions clinical investigations comparing the device to "Reference Invasive Blood Pressure Monitoring Equipment and Auscultation reference sphygmomanometer," further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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)." These are all measurements taken directly from the patient's body, not from a sample of the patient's body (like blood, urine, or tissue).
- Device Description: The description reinforces that it's a vital signs monitor used on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This vital signs monitor measures physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, CCK, DQA, DXN, FLL
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.
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.
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 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.
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
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of Temperature: Mindray Temp Module: 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.
Statistical Results of Clinical Investigation Data (Predictive mode) Oral: Clinical BIAS (Δcb) 0.02°C, Limits of Agreement (LA) 0.33°C, Clinical Repeatability (σr) 0.1°C; Axilla: Clinical BIAS (Δcb) 0.06°C, Limits of Agreement (LA) 0.38°C, Clinical Repeatability (σr) 0.13°C; Rectum: Clinical BIAS (Δcb) -0.05°C, Limits of Agreement (LA) 0.48°C, Clinical Repeatability (σr) 0.14°C.
SpO2 Accuracy: Mindray SpO2 function: 70 to 100%: +/-2% (adult/pediatric mode); 70 to 100%: +/-3% (neonate mode); 0% to 69%: Not specified. Masimo SpO2 function: 70 to 100%: +/-2% (measured without motion in adult/pediatric mode); 70 to 100%: +/-3% (measured without motion in neonate mode); 70 to 100%: +/-3% (measured with motion); 1% to 69%: Not specified. Nellcor SpO2 function: 70 to 100%: +/-2% (adult/pediatric); 70 to 100%: +/-3% (neonate); 0% to 69%: Not specified.
PR Accuracy: +/- 3 bpm (PR from built-in Mindray SpO2 Module); +/- 3 bpm (measured without motion), +/- 5 bpm (measured with motion) (PR from built-in Masimo SpO2 Module); 20 to 250 bpm: +/- 3 bpm; 251 to 300 bpm, not specified (PR from built-in Nellcor SpO2 Module).
NIBP Accuracy: Max mean error: +/- 5 mmHg; Max standard deviation: 8 mmHg.
CO2 Accuracy: Sidestream CO2 2.0 module: 040 mmHg: +/- 2mmHg; 4176 mmHg: +/- 5% of reading; 7799 mmHg: +/- 10% of reading; 100150mmHg: +/- (3mmHg + 8% of reading); ISO accuracy mode: Add +/-2mmHg to the full accuracy mode.
AwRR Accuracy:
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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
2
Indications for Use
510(k) Number (if known) K211475
Device Name 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 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.
| 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-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: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-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 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
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 ●
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.
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
5
(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 and | ||||
| touchscreen | 10.1" 1280*800 pixels | 10.1" 1280*800 pixels | 8" 1024*768 pixels | |
| Wireless | Wifi: The ePM series patient | |||
| monitors support the laird | ||||
| MSD45N 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 mAh | ||||
| Rechargeable Lithium-Ion, | ||||
| 10.95 VDC, 4500 mAh | ||||
| Rechargeable Lithium-Ion, | ||||
| 10.95 VDC, 2600 mA | Only support | |||
| Rechargeable Lithium- | ||||
| Ion, 10.8VDC, 5600 | ||||
| mAhwhich is as same | ||||
| as ePM 10. | Support soft package | |||
| Rechargeable Lithium- | ||||
| Ion, 10.95VDC, 5000 | ||||
| mAh | ||||
| Rechargeable Lithium- | ||||
| Ion, 10.95VDC, 2500 | ||||
| mAh. | ||||
| Data storage | Embedded Multi Media | |||
| Card(eMMC) | same | |||
| Data Recorder | Supports internal thermal | |||
| recorder | same | |||
| Speaker | Give alarm tones (45 to 85 dB), | |||
| key tones, QRS tones; support | same |
Table 2: Technological Comparison
6
| 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 3.0 | |||||||||||||||||||
| Measurement 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 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 | ||||||||||||||||||||
| Statistical 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 | VS 8 | VS 8A |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------|
| Pulse oxygen
saturation
(SpO2) | Supports Mindray SpO2
function, Masimo SpO2
function and Nellcor SpO2
function from multi parameter
module.
The specifications for various
SpO2 functions are the same.
Mindray SpO2 function
Measurement range: 0 to
100%;
Accuracy:70 to 100%: ±2%
(adult/pediatric mode);
70 to 100%: ±3% (neonate
mode);
0% to 69%: Not specified.
Masimo SpO2 function
Measurement range: 1 to
100%;
Accuracy:70 to 100%: ±2%
(measured without motion in
adult/pediatric mode);
70 to 100%: ±3% (measured
without motion in neonate
mode);
70 to 100%: ±3% (measured
with motion);
1% to 69%: Not specified.
Nellcor SpO2 function
Measurement range: 0 to
100%;
Accuracy:70 to 100%: ±2%
(adult/pediatric);
70 to 100%: ±3% (neonate);
0% to 69%: Not specified.
Note: The specifictions of the
various SpO2 functions
provided by each manufacturer
are the same across platforms. | Supports Mindray SpO2 function, Masimo SpO2
function and Nellcor SpO2 function from multi
parameter module.
The specifications for various SpO2 functions are
the same.
The Masimo SpO2 module and the Nellcor SpO2
module are identical to the Masimo SpO2 module
and the Nellcor SpO2 module in K191769.
The internal Mindray SpO2 minor circuit
board layout is different compared to the
Mindray SpO2 module in K191769. | | |
| Pulse rate (PR) | PR from built-in Mindray
SpO2 Module Measurement
range: 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 (measured | ||||||||||||||||
| without motion); | ||||||||||||||||
| $\pm$ 5 bpm (measured with | ||||||||||||||||
| motion). |
PR from built-in Nellcor SpO2
Module Measurement range:
20 to 300 bpm;
Accuracy:20 to 250 bpm:
$\pm$ 3 bpm;
251 to 300 bpm, not specified. | | | | | | | | | | | | | | | |
| Non- invasive
blood
pressure(NIBP) | Measurement range:
Adult Pediatric Neonate
Systolic 25290140 25
25240 Diastolic 10250
10115 10200 Mean 15260125 15
15215 Accuracy:150mmHg Accuracy:
Max mean error: $\pm$ 5 mmHg;
Max standard deviation: 8
mmHg.
Measure in deflation phase
Supports NIBP Venipuncture | | | | | | | | | | | | | The specifications are same as ePM10.
Neonate is measured in the deflation phase, such
as in the predicate device,
Adult and Pediatric is measured in the inflation
phase (inflation measuring mode) If the
measurement fails in the inflation phase, the
blood pressure will be measured in deflation
phase as the predicate device.
The ink used on the cuffs accessories has been
modified.
VS9 and VS8 support NIBP Venipuncture, but VS
8A doesn't support the feature. | | |
| Carbon
dioxide(CO2) | Compatible with 3 internal
CO2 modules:
Sidestream CO2 2.0 module
Mainstream CO2 module
MicroStream CO2 module
The internal CO2 modules are
identical to the external CO2
module in K182075
Type: Sidestream CO2 Module
(CO2 2.0):
Measurement range:
0
040 mmHg: $\pm$ 2mmHg,76 mmHg: $\pm$ 5% of reading,
41
7799 mmHg: $\pm$ 10% of150mmHg
reading, | Compatible with 1
internal CO2 modules:
Sidestream CO2 2.0
module
Sidestream CO2
Module (CO2 2.0):
Measurement range:
0
Accuracy:
040 mmHg:76 mmHg: $\pm$ 5% of
$\pm$ 2mmHg,
41
reading, 7799 mmHg:150mmHg:
$\pm$ 10% of reading,
100
$\pm$ (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 full | ||||
| accuracy mode | ||||
| AwRR measurement: | ||||
| awRR measurement range: | ||||
| 0 to 150rpm; | ||||
| awRR: |