(146 days)
K132038 - Accutorr 7 Vital Signs Monitor
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard vital signs monitoring. The MEWS score is a rule-based calculation, not typically considered AI/ML.
No
The device is intended for monitoring physiological parameters, not for treating any condition. Its purpose is to provide data for assessment, not therapy.
Yes
The device is intended for "monitoring physiologic parameters" and provides a "Modified Early Warning Score (MEWS) for clinical assessment," which are explicitly diagnostic functions.
No
The device description explicitly states it "consists of a main unit, parameters measurement accessories, peripheral equipments or accessories," indicating it includes hardware components beyond just software.
Based on the provided information, the Accutorr 7/VS-900 Vital Signs Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this monitor is used for monitoring physiologic parameters directly from the patient (Pulse Oximetry, Pulse Rate, Non Invasive Blood Pressure, Temperature, Carbon Dioxide). It does not involve the analysis of blood, urine, tissue, or other bodily fluids or substances in a laboratory setting.
- The device description focuses on the monitoring equipment and its accessories. It does not mention reagents, calibrators, controls, or other components typically associated with IVD tests.
Therefore, the Accutorr 7/VS-900 Vital Signs Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN, FLL, CCK
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.
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
professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
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)
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 ●
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K132038 - Accutorr 7 Vital Signs Monitor; Shenzhen Mindray Bio-Medical Electronics Co., Ltd
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.
K152902 - Passport Series Patient Monitors (Including Passport 12M, Passport 17M and T1); Shenzhen Mindray Bio-Medical Electronics Co., Ltd
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
§ 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).
0
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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
1
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 ELECTRONICS |
| CO., LTD. | |
| Mindray Building, Keji 12th Road South | |
| High-tech Industrial Park, Nanshan | |
| Shenzhen 518057, P.R. China | |
| Tel: +86 755 81885635 | |
| Fax: +86 755 26582680 | |
| Contact: | Yanhong Bai |
| Manager Regulatory Affairs | |
| 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 81885635 | |
| Fax: +86 755 26582680 | |
| E-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:
| Product
Code | Regulation
Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|---------------------|----------------------------------------------------|-------------------------------------------------------|
| DQA | 21 CFR
870.2700 | Anesthesiology | Oximeter. | Oximeter |
| DXN | 21 CFR
870.1130 | Cardiovascular | Non-Invasive blood pressure
measurement System. | system, measurement, blood-
pressure, non-invasive |
| FLL | 21 CFR
880.2910 | General
Hospital | Clinical Electronic Thermometer. | thermometer, electronic, clinical |
| CCK | 21 CFR
868.1400 | Anesthesiology | Carbon dioxide gas analyzer. | analyzer, gas, carbon-dioxide,
gaseous-phase |
4
| Primary Predicate Device: | K132038 - Accutorr 7 Vital Signs Monitor; Shenzhen Mindray
Bio-Medical Electronics Co., Ltd |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Predicate: | K152902 - Passport Series Patient Monitors (Including Passport
12M, Passport 17M and T1); Shenzhen Mindray Bio-Medical
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 ●
5
- 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: |