The monitor is intended for spot-check monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Device Description

The Accutorr 3 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. It consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

The Accutorr 3 Vital Signs Monitor is designed to monitor a fixed set of physiological parameters including Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP) and Temperature (TEMP). This monitor provides 3 different SPO2 modules manufactured by Mindray, Masimo or Nellcor.

AI/ML Overview

The provided text describes the regulatory submission for the "Accutorr 3 Vital Signs Monitor." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies with specific metrics.

The document primarily focuses on:

Device Description: A compact, easy-to-use vital signs monitor for SpO2, PR, NIBP, and TEMP on adult, pediatric, and neonatal patients.
Intended Use: Spot-check monitoring of physiological parameters in healthcare facilities.
Predicated Device: VS-800 Vital Signs Monitor (K072235).
Non-clinical Tests: Compliance with various international and national safety, biocompatibility, electromagnetic compatibility, and performance standards.
Clinical Studies: States that NIBP and TEMP modules were "evaluated for clinical accuracy" and "tested and evaluated under applicable clinical standards" (ISO 80601-2-56 for thermometers and ISO 81060-2 for non-invasive sphygmomanometers). However, it does not provide the results of these clinical studies, specific acceptance criteria, or details of the study design.
Conclusion: Claims the device is "as safe, as effective, and perform as well as the predicate device" based on testing.

Therefore, most of the requested information cannot be extracted from this document because the detailed results of clinical studies and acceptance criteria are not published here.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document only mentions that the NIBP and TEMP modules were evaluated for clinical accuracy against specific standards (ISO 80601-2-56 and ISO 81060-2). It does not list the specific acceptance criteria (e.g., mean difference, standard deviation, accuracy zones) or the reported performance values from those evaluations.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document states clinical accuracy evaluations were performed for NIBP and TEMP but gives no details about the sample size, data origin, or study design (retrospective/prospective).

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)

Not applicable / Cannot be provided. This type of information is typically relevant for studies involving subjective interpretation (e.g., medical imaging). For vital signs monitors, ground truth is usually established via reference methods (e.g., invasive blood pressure, rectal temperature, CO-oximetry for SpO2) rather than expert consensus on interpretive tasks. The document does not specify how ground truth was established, beyond referencing the clinical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Adjudication methods are typically used in studies where multiple human readers assess data and discrepancies need resolving (e.g., image interpretation). This is not relevant for the type of clinical accuracy evaluation performed for a vital signs monitoring device.

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

No. This is not an AI-assisted diagnostic device, but a vital signs monitor. MRMC studies or AI assistance are not applicable in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Partially applicable. The NIBP and TEMP modules underwent "clinical accuracy" evaluations. For a vital signs monitor, these evaluations inherently test the device's "standalone" performance against a reference standard. However, no performance metrics are given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Inferred, but not explicitly stated with details. For NIBP, the standard (ISO 81060-2) typically requires comparing the device's readings against simultaneous readings from a reference method (e.g., intra-arterial blood pressure). For temperature, the standard (ISO 80601-2-56) usually involves comparison against a highly accurate reference thermometer measurement (e.g., rectal or tympanic probe depending on the device's site). The document does not explicitly state these methods were used, only that the device was evaluated under these standards.

8. The sample size for the training set

Not applicable / Cannot be provided. This device is not described as using machine learning or AI that would involve a "training set." Its core functionality relies on established physiological measurement principles.

9. How the ground truth for the training set was established

Not applicable / Cannot be provided. See point 8.

Summary

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510(k) SUMMARY

510(K) SUMMARY

MAY 1 6 2014

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K132037.

Submitter: 1.

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: (86)755-81888998 Fax: (86)755-26582680

Contact Person:

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:

May 13, 2014

2. Name of the devices: Accutorr 3 Vital Signs Monitor

Classification

21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm)	Class II
21 CFR 870.2700 Oximeter	Class II
21 CFR 870.1130 Noninvasive blood pressure measurement system	Class II
21 CFR 880.2910 Clinical electronic thermometer	Class II

3. Device Description:

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4. Intended Use:

છે. Predicate Devices:

The Accutorr 3 Vital Signs Monitor is substantially equivalent to the predicate device VS-800 Vital Signs Monitor (K072235). They have the same intended uses, the same technological characteristics, and are comparable in key safety and effectiveness features.

Non-clinical Tests: 6.

The Accutorr 3 Vital Signs Monitor has been evaluated for biocompatibility, safety, parameter performance and electromagnetic compatibility, and has been designed to comply with applicable medical safety standards. This device has been tested and evaluated under the following standards:

· ISO 14971 Medical device Application of Risk Management to Medical Devices
· IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
· IEC 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility- Requirements and tests
· IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety -Collateral Standard: Programmable electrical medical systems
. ISO 9919 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
· EN 1060-1 Specification for Non-invasive sphygmomanometers Part 1: General requirements
· EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

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510(k) SUMMARY

· EN 1060-4 Non-invasive sphygmomanometers-Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
· ANSI/AAMI SP-10 Manual, electronic, or automated sphygmomanometers
· ASTM E1104 Standard Specification for Clinical Thermometer Probe Covers and Sheaths
· ASTM E1112 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
· ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing
· ISO 15223-1 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied
· IEC 62304 Medical device software Software life-cycle processes
· IEC 62366 Medical devices Application of usability engineering to medical devices
· IEC 60601-1-1 Medical Electrical Equipment- Part 1-1: General Requirements for Safety -Collateral Standard: Safety requirements for medical electrical systems
· EN 1041 Information supplied by the manufacturer of medical devices

7. Clinical Studies

The NIBP and TEMP module of the subject device Accutorr 3 Vital Signs Monitor have been evaluated for clinical accuracy and have been designed to comply with applicable clinical These modules have been tested and evaluated under the following clinical standards. standards:

· ISO 80601-2-56 Particular requirements for basic safety and essential performance of clinical thermometers
· SO 81060-2 Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type

Conclusion: 8.

The results of all testing demonstrate that the Accutorr 3 Vital Signs Monitor is as safe, as effective, and perform as well as the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

May 16, 2014

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Mr. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, Shenzhen 518057 P.R. China

Re: K132037

Trade/Device Name: Accutorr 3 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 Dated: May 08, 2014 Received: May 12, 2014

Dear Mr. 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

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Page 2 - Mr. Yanhong Bai

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Sincerely yours,

Image /page/4/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and overlapping, with a double line underneath the A. The logo is black and white and appears to be a vectorized image.

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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Indications for Use

510(k) Number (if known): _K132037

Device Name: Accutorr 3 Vital Signs Monitor

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/10 description: The image shows a logo with the letters FDA in a stylized font. Above the letters, the word "Date" is written. To the right of the logo, the numbers 2014.06.16 and 04'00' are written. The image is black and white.

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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).