The iMEC Series Patient Monitors, including iMEC8, iMEC10 and iMEC12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: C.O. monitoring is restricted to adult patients only, and PAWP monitoring, arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

The iPM Series Patient Monitors, including iPM 8, iPM 10 and iPM 12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: C.O. monitoring is restricted to adult patients only, and PAWP monitoring, arrhythmia detection and ST Segment analysis are not intended for neonatal patients. 12-lead monitoring and AG monitoring are available for iPM 10 and iPM 12 Patient Monitors only.

The BeneView T1 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: C.O. monitoring is restricted to adult patients only, and PAWP monitoring, arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Device Description

The iMEC Series Patient Monitors (including iMEC10 and iMEC12), iPM Series Patient Monitors (including iPM 8, iPM 10 and iPM 12) and BeneView TI Patient Monitor are the developed new series based on the technical platform of the BeneView T Series patient monitors. The new series, much more compact and flexible with the appearance changes, are the sub-configuration models of the BeneView T Series patient monitors by reducing some parameters monitoring functions such as impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM) monitoring. And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Key Takeaways:

This submission focuses on patient monitors with various physiological parameters, but the core 'new' aspect seems to be the adoption of the "Mindray Monitoring ECG Algorithm" as an optional ECG algorithm. The previous predicate device used the "Mortara ECG algorithm."
The acceptance criteria and performance data are implicitly tied to the general performance and safety requirements for patient monitors and specifically to the performance of the ECG algorithm for arrhythmia detection and ST segment analysis. However, explicit acceptance criteria values (e.g., specific accuracy percentages for arrhythmia detection) are NOT provided in the extracted text. The document states that the devices "comply with the recognized safety, performance and electromagnetic compatibility standards" and that "The results of all testing demonstrate that the iMEC Series Patient Monitors, iPM Series Patient Monitors and BeneView T1 Patient Monitor are as safe, as effective, and perform as well as the predicate devices." This implies that the performance for the Mindray algorithm met the standards expected of the predicate devices, but the precise numbers are not detailed here.

Acceptance Criteria and Reported Device Performance

Parameter/Function	Acceptance Criteria	Reported Device Performance
General Performance & Safety	Compliance with recognized safety, performance, and electromagnetic compatibility standards.	"The iMEC Series Patient Monitors... comply with the recognized safety, performance and electromagnetic compatibility standards." "The results of all testing demonstrate that the iMEC Series Patient Monitors, iPM Series Patient Monitors and BeneView T1 Patient Monitor are as safe, as effective, and perform as well as the predicate devices." (Predicate device: K092449, BeneView T Series patient monitors using Mortara ECG algorithm).
ECG Monitoring	Implied to meet the performance of predicate devices and relevant standards for ECG monitoring. Specific numerical acceptance criteria (e.g., frequency response, amplitude accuracy) are not detailed in this summary.	Not detailed explicitly, but "perform as well as the predicate devices."
Arrhythmia Detection (Mindray ECG Alg.)	Intended for adult and pediatric patients. Implied to meet performance comparable to predicate devices for accuracy in detecting arrhythmias. Specific numerical acceptance criteria (e.g., sensitivity, specificity for various arrhythmia types) are not detailed in this summary.	Not detailed explicitly, but "perform as well as the predicate devices." The device "adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis."
ST Segment Analysis (Mindray ECG Alg.)	Intended for adult patients only. Implied to meet performance comparable to predicate devices for accuracy in ST segment analysis. Specific numerical acceptance criteria (e.g., accuracy of ST elevation/depression measurement) are not detailed in this summary.	Not detailed explicitly, but "perform as well as the predicate devices." The device "adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis."
Other Physiological Parameters (HR, Resp, Temp, SpO2, PR, NIBP, IBP, C.O., CO2, AG)	Implied to meet the performance of predicate devices and relevant standards for each parameter. Specific numerical acceptance criteria are not detailed in this summary.	Not detailed explicitly, but "perform as well as the predicate devices."

Study Information:

The provided text describes a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, detailed clinical study report with specific performance metrics for every algorithm. The studies mentioned are primarily validation and verification activities related to regulatory compliance and equivalence.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document mentions "Hardware and Software validation" and "Performance testing," implying internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not stated. The document simply mentions "Performance testing" without detailing how ground truth was established for algorithmic evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not stated.
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, an MRMC study is not mentioned. The document focuses on the performance of the device/algorithm itself, not on human reader performance with or without AI assistance. This is a standalone patient monitor, not an AI diagnostic aid for human interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The document states, "And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis." This indicates that the Mindray ECG Algorithm itself was evaluated for its performance. The "Performance testing" listed would include evaluating the algorithm's standalone capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For ECG algorithms, ground truth is typically derived from expert-adjudicated ECG recordings or reference databases. The summary does not provide these details.
The sample size for the training set:
- Not stated. The document focuses on regulatory testing/validation rather than the development and training of the algorithm itself.
How the ground truth for the training set was established:
- Not stated.

Summary of Study Type:

The provided text indicates that the submission is for new patient monitor models (iMEC, iPM, BeneView T1) that are "substantially equivalent" to an existing predicate device (BeneView T Series K092449). A key difference highlighted is the inclusion of the "Mindray Monitoring ECG Algorithm" as an optional ECG algorithm, replacing or supplementing the Mortara algorithm used in the predicate.

The studies described are therefore primarily verification and validation activities to demonstrate that these new monitors, including their Mindray ECG algorithm, are as safe and effective as the predicate device and comply with relevant standards. These studies would typically involve:

Bench testing: To verify performance against technical specifications and recognized standards.
Performance testing: Evaluating the accuracy and reliability of the various physiological parameter measurements, including the new ECG algorithm for arrhythmia detection and ST segment analysis. This would involve comparing the algorithm's output against a known or established "ground truth" using relevant testing datasets.
Safety testing: Electrical safety, EMC, etc.
Risk analysis.

The document does not include details of a large-scale clinical trial or comparative effectiveness study between different ECG algorithms, nor does it detail the specific sensitivity/specificity or other performance metrics achieved by the Mindray ECG Algorithm. The statement "perform as well as the predicate devices" is the primary evidence provided for the algorithm's effectiveness in this summary.

Summary

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K123074

510(K) SUMMARY

JUL 0 3 2013

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: __

Submitter:

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 2658 2888 Fax: +86 755 2658 2680

Contact Person:

Ms. Susan D. Goldstein-Falk Official Correspondent for Shenzhen Mindray Bio-Medical Electronics Co., Ltd mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 10021 IN CALIFORNIA: TEL: (949) 706-7456 FAX: (949) 706-7457 EMAIL: sgoldstein@mdiconsultants.com

Alternate Only:

Mr. Rong Liang

Product Approval Engineer of Technical Regulation Dept. 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)-0755-8188 5637 FAX: (86)-0755-2658 2680 EMAIL: rongliang@mindray.com

EMIRATE. TOURIST, IMMIGRATION

Date Prepared:

Sep 21, 2012

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Name of the devices:

●

Trade/Proprietary Name:

iMEC, iPM and BeneView TI Patient Monitors (including models iMEC8, iMEC10, iMEC12, iPM 8, iPM 10, iPM 12, and BeneView T1)

Common Name: Patient Monitor .

. Classification

21 CFR 870.1025	Arrhythmia detector and alarm(including ST-segment measurement and alarm)	Class II
21 CFR 870.1025	Detector and Alarm, Arrhythmia	Class II
21 CFR 870.1025	Monitor, ST Segment with Alarm	Class II
21 CFR 870.2300	Cardiac monitor (including cardiotachometer and rate alarm)	Class II
21 CFR 870.1130	Non-Invasive blood pressure measurement System	Class II
21 CFR 870.1110	Blood pressure computer	Class II
21 CFR 880.2910	Clinical Electronic Thermometers –Temperature Monitor with Probe	Class II
21 CFR 870.2700	Oximeter, Pulse	Class II
21 CFR 870.2710	Ear Oximeter, Pulse	Class II
21 CFR 868.1400	Carbon Dioxide Gas Analyzer	Class II
21 CFR 868.1500	Enflurane gas analyzer	Class II
21 CFR 868.1620	Halothane gas analyzer	Class II
21 CFR 868.1700	Nitrous Oxide gas analyzer	Class II
21 CFR 868.1720	Oxygen gas analyzer	Class II
21 CFR 870.1435	Single-function, preprogrammed diagnostic computer.	Class II

Legally Marketed Predicate Devices:

K092449. BeneView T Series patient monitors (Including Models BeneView T8, BeneView T6 and Bene View TS). Shenzhen Mindray Bio-medical Electronics Co., LTD

Device Description:

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And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis.

Statement of intended Use:

6-4

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K123074

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Technology:

The iMEC Series Patient Monitors (including iMEC10 and iMEC12), iPM Series Patient Monitors (including iPM 8, iPM 10 and iPM 12) and BeneView TI Patient Monitor are substantially equivalent to the predicate devices BeneView T Series Patient Monitors (K092449).

Test Summary:

The iMEC Series Patient Monitors (including iMEC8, iMEC10 and iMEC12), iPM Series Patient Monitors (including iPM 8, iPM 10 and iPM 12) and BeneView TI Patient Monitor comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document . the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:

Requirements specification review Hardware and Software testing Code design and code reviews Environmental EMC testing Safety testing Performance testing Hardware and Software validation

Conclusion:

The results of all testing demonstrate that the iMEC Series Patient Monitors, iPM Series Patient Monitors and BeneView T1 Patient Monitor are as safe, as effective, and perform as well as the predicate devices.

MINDRAY PROPRIETARY Patient Monitors

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-002

Image /page/4/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

July 3, 2013

Shenzhen Mindray Bio-Medical Electronics Co., Ltd Susan Goldstein-Falk 55 Northern Blvd., Suite 200 Great Neck, NY 11021 US

Re:

Trade/Device Name: iMEC, iPM and BeneView T1 Patient Monitors (including models iMEC8 iMEC10,iMEC12, iPM 8, iPM 10, iPM 12, and BeneView T1)

Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II Product Code: MHX Dated: May 24, 2013 Received: June 6, 2013

Dear Susan Goldstein-Falk:

K123074

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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRHs) Office of Compliance. 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.htmfor 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

MA Hilleman

for Bram D. Zuckerman, Ph.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): K123074

Device Name: iMEC, iPM and BeneView T1 Patient Monitors

Indications for Use:

iMEC .

All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:

C.O. monitoring is restricted to adult patients only;
PAWP monitoring is not intended for neonatal patients;
The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.

• iPM

All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:

C.O. monitoring is restricted to adult patients only;
PAWP monitoring is not intended for neonatal patients;
The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
12-lead monitoring and AG monitoring are available for iPM 10 and iPM 12 Patient Monitors only.

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BeneView T1 .

All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:

C.O. monitoring is restricted to adult patients only;
PAWP monitoring is not intended for neonatal patients;
The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for Adult and Pediatric patients, and the Mindray ECG Algorithm ST Seqment analysis is intended for adult patients only.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Prescription Use X 1 Fosonption 0601 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)

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.