(146 days)
The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
This document is a 510(k) Summary for the SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Accutorr 7/VS-900 Vital Signs Monitor. It outlines the device's indications for use, description, performance data, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria. Instead, it details various performance specifications for each physiological parameter (Temperature, SpO2, Pulse Rate, NIBP) found in the "Predicate Device (K132038)" column, and states that the "Subject Devices" (Accutorr 7/VS-900) generally have the "Same" performance characteristics. For CO2 monitoring, it references the characteristics of the reference predicate (K152902).
Here's a compilation of the performance specifications, which act as the de facto acceptance criteria based on established predicate device performance:
| Feature | Acceptance Criteria (Predicate Device K132038 / Reference Predicate K152902) | Reported Device Performance (Accutorr 7/VS-900) |
|---|---|---|
| WiFi | 2.4G band WiFi, compatible with 802.11 b/g/n | 2.4G/5G dual band WiFi compatible with IEEE 802.11 a/b/g/n |
| Temperature (Temp) | Technique: Thermal resistanceMeasurement range: Monitor mode: 25 to 44 °C (77 to 111.2 °F), Predictive mode: 35 to 43 °C (95 to 109.4 °F)Resolution: 0.1°CAccuracy (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 °FResponse Time: Monitor mode: <60 s, Predictive mode: <20 s (typical test: < 12s) | Same as Predicate Device |
| Pulse Oxygen Saturation (SpO2) | Mindray SpO2 Module:Measurement range: 0 to 100%, Resolution: 1%Accuracy: 70 to 100%: ±2% (without motion, adult/pediatric); 70 to 100%: ±3% (without motion, neonate); 0% to 69%: Not specified.Refreshing rate: 1sMasimo SpO2 Module:Measurement range: 1 to 100%, Resolution: 1%Accuracy: 70 to 100%: ±2% (without motion, adult/pediatric); 70 to 100%: ±3% (without motion, neonate); 70 to 100%: ±3% (with motion); 1% to 69%: Not specified.Refreshing rate: 1sNellcor SpO2 Module:Measurement range: 0 to 100%, Resolution: 1%Accuracy: 70 to 100%: ±2% (adult/pediatric); 70 to 100%: ±3% (neonate); 0% to 69%: Not specified.Refreshing rate: 1s | Same as Predicate Device |
| Pulse Rate (PR) | From Mindray SpO2 Module:Measurement range: 20 to 254 bpm, Resolution: 1bpm, Accuracy: ±3 bpm (without motion), Refreshing rate: 1sFrom Masimo SpO2 Module:Measurement range: 25 to 240 bpm, Resolution: 1bpm, Accuracy: ±3 bpm (without motion), ±5 bpm (with motion), Refreshing rate: 1sFrom Nellcor SpO2 Module:Measurement range: 20 to 300 bpm, Resolution: 1bpm, Accuracy: 20 to 250 bpm: ±3 bpm; 251 to 300 bpm: not specified, Refreshing rate: 1sFrom NIBP Module:Measurement range: 40 to 240 bpm, Resolution: 1bpm, Accuracy: ±3bpm or ±3%, whichever is greater | Same as Predicate Device |
| Non-invasive Blood Pressure (NIBP) | Method: OscillometricMeasurement range:Adult: Systolic: 40-270, Diastolic: 10-210, Mean: 20-230Pediatric: Systolic: 40-200, Diastolic: 10-150, Mean: 20-165Neonate: Systolic: 40-135, Diastolic: 10-100, Mean: 20-110Accuracy: Maximum average error: ±5 mmHg, Maximum standard deviation: 8mmHgMax measurement time: Adult, pediatric: 180s; Neonate: 90sStatic pressure measurement range: 0mmHg to 300mmHgStatic pressure measurement accuracy: ±3 mmHg | Same as Predicate Device |
| CO2 | (Based on K152902 - Passport Series Patient Monitors)Monitoring based on calculations from measuring the absorption of infrared (IR) light of specific wavelengths using a photodetector. (No specific numerical performance metrics are provided in this summary for CO2, other than the method). | CO2 monitoring is based on calculations from measuring the absorption of infrared (IR) light of specific wavelengths using a photodetector. (Performance "same" as reference predicate, but no numerical performance is detailed in this document). |
The document states: "The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It broadly mentions "functional and system level testing" and "wireless functionality testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. The document focuses on performance testing against technical specifications and predicate device equivalence, rather than studies involving expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a vital signs monitor, not an AI-assisted diagnostic tool that would typically involve human readers or AI assistance in interpretation. The mention of "Modified Early Warning Score (MEWS)" is a calculated score based on vital signs, not an AI algorithm requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable in the typical sense of AI algorithms for image analysis or diagnosis. The device itself is a standalone monitor. The performance data presented (e.g., accuracy of SpO2, NIBP, Temp, PR) is the standalone performance of the device's measurement capabilities. The "Modified Early Warning Score (MEWS)" is an algorithm within the device that generates a score based on input vital signs, operating without human intervention for its calculation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physiological parameters (SpO2, NIBP, Temp, PR), the "ground truth" implicitly refers to the reference measurement methods used during the functional and system-level testing to determine the device's accuracy against its stated specifications. For example, for NIBP, accuracy is typically assessed against invasive blood pressure measurements or highly accurate non-invasive reference devices. For temperature, it would be against certified temperature standards. The document states the device "continue[s] to meet specifications and the performance of the device is equivalent to the predicate," which implies comparison against established, accurate measurement methods.
8. The sample size for the training set
The device described is a vital signs monitor, not a machine learning or AI-driven system that would typically require a "training set" in the context of deep learning models. Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As the device is not described as utilizing machine learning or AI in a way that would involve a "training set," this question is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2017
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057, P.R. CN
Re: K170712
Trade/Device Name: Accutorr 7/VS-900 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, DQA, DXN, FLL, CCK Dated: March 27, 2017 Received: March 28, 2017
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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
M.A. Willemen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170712
Device Name Accutorr 7/VS-900 Vital Signs Monitor
Indications for Use (Describe)
The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------- |
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Accutorr 7/VS-900 Vital Signs Monitor is provided below.
| Device Common Name: | Vital Signs Monitor |
|---|---|
| Device Trade Name: | Accutorr 7/VS-900 Vital Signs Monitor |
| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICSCO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680 |
| Contact: | Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICSCO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | March 7, 2017 |
| Classification Regulation: | 21 CFR 870.2300, Class II, Cardiovascular |
| Panel: | Cardiovascular |
| Primary Product Code: | MWI |
Secondary Product Codes:
| ProductCode | RegulationNumber | Panel | Regulation Description | Device Common Name |
|---|---|---|---|---|
| DQA | 21 CFR870.2700 | Anesthesiology | Oximeter. | Oximeter |
| DXN | 21 CFR870.1130 | Cardiovascular | Non-Invasive blood pressuremeasurement System. | system, measurement, blood-pressure, non-invasive |
| FLL | 21 CFR880.2910 | GeneralHospital | Clinical Electronic Thermometer. | thermometer, electronic, clinical |
| CCK | 21 CFR868.1400 | Anesthesiology | Carbon dioxide gas analyzer. | analyzer, gas, carbon-dioxide,gaseous-phase |
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| Primary Predicate Device: | K132038 - Accutorr 7 Vital Signs Monitor; Shenzhen MindrayBio-Medical Electronics Co., Ltd |
|---|---|
| Reference Predicate: | K152902 - Passport Series Patient Monitors (Including Passport12M, Passport 17M and T1); Shenzhen Mindray Bio-MedicalElectronics Co., Ltd |
Indication for Use:
The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
Device Description:
The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
Performance Data:
Functional and System Level Testing: To establish the substantial equivalence of the Accutorr 7/VS-900 Vital Signs Monitor, Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
Biocompatibility: Each patient contacting material and gas path material has been tested to comply with applicable requirements per ISO 10993-1.
Software: The Accutorr 7/VS-900 Vital Signs Monitor software has been fully verified and validated and documentation in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: May 11, 2005" has been provided in this submission.
EMC and Electrical Safety: Mindray has been tested for conformance with the following electromagnetic compatibility and electrical safety standards:
- AAMI /ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012
- . IEC 60601-1-2: 2007 & 2014
In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- IEC60601-1-6: 2013 ●
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- AAMI / ANSI / IEC60601−1−8:2006 & A1:2012 ●
- IEC80601-2-30 Edition 1.1 2013 ●
- IEC 60601-2-49: 2011 ●
- ISO80601-2-55: 2011 ●
- ISO80601-2-61: 2011 ●
- ISO80601-2-56: 2009 ●
Wireless Coexistence: Mindray conducted wireless functionality testing to ensure the performance of the Accutorr 7/VS-900 Vital Signs Monitor meets wireless specifications and is equivalent to the predicate device.
Substantial Equivalence:
The table below compares the key technological feature of the subject devices to the primary predicate device (Accutorr 7, K132038). The features highlighted in yellow are the features that have been modified since the previous clearance and that are the subject of this 510(k).
| Predicate Device (K132038) | Subject Devices | ||
|---|---|---|---|
| Feature | Accutorr 7 | Accutorr 7/VS-900 | |
| Integrated display and touchscreen | 8.4" 800*600 pixels | Same | |
| Power supply | One rechargeable Lithium-ion batteries or AC power supply | Same | |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh | Same | |
| Data Recorder | The thermal recorder can be used to print patient information, measurement numerics, and waveforms. | Same | |
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation | Same | |
| WiFi | 2.4G band WiFi, compatible with 802.11 b/g/n | 2.4G/5G dual band WiFi compatible with IEEE 802.11 a/b/g/n | |
| Temperature (Temp) | Mindray Temp Module : Technique: Thermal resistance Measurement range: Monitor mode:25 to 44 °C (77 to 111.2 °F) Predictive mode: 35 to 43 °C (95 to 109.4 °F) Resolution 0.1°C 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 | Same | |
| Predicate Device (K132038) | Subject Devices | ||
| Feature | Accutorr 7 | Accutorr 7/VS-900 | |
| 89.6 to 111.2 °F (include 89.6°F): ±0.2 °F | |||
| Response Time: | |||
| Monitor mode: <60 s | |||
| Predictive mode: <20 s (typical test: < 12s ) | |||
| Pulse oxygensaturation(SpO2) | Is compatible with the following clearedmodules to measure oxygen saturation:Mindray SpO2 ModuleMasimo SpO2 ModuleNellcor SpO2 ModuleMindray SpO2 ModuleMeasurement range: 0 to 100Resolution: 1%Accuracy:70 to 100%: ±2% (measured without motionin adult/pediatric mode)70 to 100%: ±3% (measured without motionin neonate mode)0% to 69%: Not specified.Refreshing rate: 1sMasimo SpO2 Module:Measurement range: 1 to 100%Resolution: 1%Accuracy:70 to 100%: ±2% (measured without motionin adult/pediatric mode)70 to 100%: ±3% (measured without motionin neonate mode)70 to 100%: ±3% (measured with motion)1% to 69%: Not specified.Refreshing rate: 1sNellcor SpO2 Module:Measurement range: 0 to 100%Resolution: 1%Accuracy:70 to 100%: ±2% (adult/pediatric)70 to 100%: ±3% (neonate)0% to 69%: Not specified.Refreshing rate: 1s | Same | |
| Pulse rate (PR) | Pulse rate may be obtained from the SpO2module or the NIBP module.PR from Mindray SpO2 Module | Same | |
| K170712 | |||
| Predicate Device (K132038) | Subject Devices | ||
| Feature | Accutorr 7 | Accutorr 7/VS-900 | |
| Measurement range: 20 to 254 bpm | |||
| Resolution: 1bpm | |||
| Accuracy: $\pm$ 3 bpm (without motion) | |||
| Refreshing rate: 1s | |||
| PR from Masimo SpO2 Module | |||
| Measurement range: 25 to 240 bpm | |||
| Resolution: 1bpm | |||
| Accuracy: | |||
| $\pm$ 3 bpm (without motion) | |||
| $\pm$ 5 bpm (with motion) | |||
| Refreshing rate: 1s | |||
| PR from Nellcor SpO2 Module | |||
| Measurement range: 20 to 300 bpm | |||
| Resolution: 1bpm | |||
| Accuracy: | |||
| 20 to 250 bpm: $\pm$ 3 bpm | |||
| 251 to 300 bpm, not specified | |||
| Refreshing rate: 1s | |||
| PR from NIBP Module | |||
| Measurement range: 40 to 240 bpm | |||
| Resolution: 1bpm | |||
| Accuracy: $\pm$ 3bpm or $\pm$ 3%, whichever is greater | |||
| Non-invasiveblood pressure(NIBP) | Uses the oscillometric method for measuringnon-invasive blood pressure (NIBP). Thismeasurement can be used for adults,pediatrics and neonates. | Same | |
| Measurement range: | |||
| Adult Pediatric Neonate | |||
| Systolic: 40 to 270 40 to 200 40 to 135 | |||
| Diastolic: 10 to 210 10 to 150 10 to 100 | |||
| Mean: 20 to 230 20 to 165 20 to 110 | |||
| Accuracy: | |||
| Maximum average error: $\pm$ 5 mmHg | |||
| Maximum standard deviation: 8mmHg | |||
| Max measurement time: | |||
| Adult, pediatric: 180 sNeonate: 90 s | |||
| Predicate Device (K132038) | Subject Devices | ||
| Feature | Accutorr 7 | Accutorr 7/VS-900 | |
| Static pressure measurement range: 0mmHgto 300mmHg | |||
| Static pressure measurement accuracy: $\pm3$ mmHg | |||
| Carbon dioxide(CO2) | The primary predicate device did not provideCO2 monitoring. This feature is substantiallyequivalent to the reference predicate devicePassport 12m, Passport 17m and T1(K152902). | CO2 monitoring is based on calculations frommeasuring the absorption of infrared (IR) lightof specific wavelengths using a photodetector. |
Device Comparison Table
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Substantial Equivalence Discussion:
The indications for use statement of the subject device has been modified to include the new parameter of CO2. Although this feature is not present in the predicate device, it is present in the cleared Mindray Passport Series Monitors (Passport 17m and T1) (K152902) and thus does not constitute a new intended use for a multi-parameter monitor. The minor changes to the indications for use do not change the fundamental intended use of the Accutorr 7/VS-900 as a multi-parameter monitor and can be found substantially equivalent to the predicate device.
Based on the detailed comparison of specifications for each of the modifications to the previously cleared Accutorr 7/VS-900 (K132038) and relevant reference predicate, as well as the performance testing and conformance with applicable standards, the Accutorr 7/VS-900 can be found substantially equivalent to the predicate device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).