Accutorr 7/VS-900 Vital Signs Monitor

K170712 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · MWI · Aug 2, 2017 · Cardiovascular

Device Facts

• Record ID: K170712
• Device Name: Accutorr 7/VS-900 Vital Signs Monitor
• Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 Story

Compact vital signs monitor; measures SpO2, PR, NIBP, TEMP, and CO2; provides MEWS for adult clinical assessment. Inputs: physiologic signals via patient-contacting accessories. Processing: signal acquisition, processing, and calculation of parameters and MEWS. Outputs: numeric values, waveforms, and alarms on integrated touchscreen display; thermal printer support. Used in professional healthcare facilities by physicians/medical staff. Benefits: facilitates patient monitoring and clinical decision-making through real-time vital sign tracking and early warning scoring.

Clinical Evidence

Bench testing only. Functional and system-level testing confirmed performance specifications. Biocompatibility testing per ISO 10993-1. Wireless coexistence testing performed. Conformance to electrical safety and EMC standards (IEC 60601 series) verified.

Technological Characteristics

Compact monitor with 8.4" touchscreen; rechargeable Li-ion battery or AC power. Parameters: SpO2 (Mindray/Masimo/Nellcor modules), NIBP (oscillometric), Temp (thermal resistance), CO2 (IR absorption). Connectivity: 2.4G/5G dual-band WiFi (IEEE 802.11 a/b/g/n). Standards: ISO 10993-1, AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-55/61/56.

Indications for Use

Indicated for monitoring SpO2, PR, NIBP, TEMP, and CO2 in adult, pediatric, and neonatal patients in professional healthcare settings. Provides MEWS for clinical assessment in adult patients.

Regulatory Classification

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.

Predicate Devices

• Accutorr 7 Vital Signs Monitor (K132038)

Reference Devices

• Passport Series Patient Monitors (Passport 12M, Passport 17M and T1) (K152902)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble waves or fabric.

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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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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 ELECTRONICS<br>CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Yanhong Bai<br>Manager Regulatory Affairs<br>SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS<br>CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | March 7, 2017 |
| Classification Regulation: | 21 CFR 870.2300, Class II, Cardiovascular |
| Panel: | Cardiovascular |
| Primary Product Code: | MWI |

### Secondary Product Codes:

| Product<br>Code | Regulation<br>Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|---------------------|----------------------------------------------------|-------------------------------------------------------|
| DQA | 21 CFR<br>870.2700 | Anesthesiology | Oximeter. | Oximeter |
| DXN | 21 CFR<br>870.1130 | Cardiovascular | Non-Invasive blood pressure<br>measurement System. | system, measurement, blood-<br>pressure, non-invasive |
| FLL | 21 CFR<br>880.2910 | General<br>Hospital | Clinical Electronic Thermometer. | thermometer, electronic, clinical |
| CCK | 21 CFR<br>868.1400 | Anesthesiology | Carbon dioxide gas analyzer. | analyzer, gas, carbon-dioxide,<br>gaseous-phase |

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| Primary Predicate Device: | K132038 - Accutorr 7 Vital Signs Monitor; Shenzhen Mindray<br>Bio-Medical Electronics Co., Ltd |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Predicate: | K152902 - Passport Series Patient Monitors (Including Passport<br>12M, Passport 17M and T1); Shenzhen Mindray Bio-Medical<br>Electronics 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 oxygen<br>saturation<br>(SpO2) | Is compatible with the following cleared<br>modules to measure oxygen saturation:<br>Mindray SpO2 Module<br>Masimo SpO2 Module<br>Nellcor SpO2 Module<br><br>Mindray SpO2 Module<br>Measurement range: 0 to 100<br>Resolution: 1%<br>Accuracy:<br>70 to 100%: ±2% (measured without motion<br>in adult/pediatric mode)<br>70 to 100%: ±3% (measured without motion<br>in neonate mode)<br>0% to 69%: Not specified.<br>Refreshing rate: 1s<br><br>Masimo SpO2 Module:<br>Measurement range: 1 to 100%<br>Resolution: 1%<br>Accuracy:<br>70 to 100%: ±2% (measured without motion<br>in adult/pediatric mode)<br>70 to 100%: ±3% (measured without motion<br>in neonate mode)<br>70 to 100%: ±3% (measured with motion)<br>1% to 69%: Not specified.<br>Refreshing rate: 1s<br><br>Nellcor SpO2 Module:<br>Measurement range: 0 to 100%<br>Resolution: 1%<br>Accuracy:<br>70 to 100%: ±2% (adult/pediatric)<br>70 to 100%: ±3% (neonate)<br>0% to 69%: Not specified.<br>Refreshing rate: 1s | Same | |
| | Pulse rate (PR) | Pulse rate may be obtained from the SpO2<br>module or the NIBP module.<br><br>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-invasive<br>blood pressure<br>(NIBP) | Uses the oscillometric method for measuring<br>non-invasive blood pressure (NIBP). This<br>measurement can be used for adults,<br>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: |…