(275 days)
Not Found
No
The document describes standard physiological monitoring and analysis algorithms (like arrhythmia detection and ST Segment analysis) but does not mention AI, ML, or any related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices.
No.
The devices are described as "Patient Monitors" used for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters," which indicates a diagnostic or monitoring function rather than a therapeutic one (treatment or intervention).
No
The device is a patient monitor, which is intended for 'monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters'. It provides information about the patient's current state, but it does not make a diagnosis.
No
The device description explicitly mentions "Hardware and Software testing" and "Hardware and Software validation," indicating the presence of hardware components as part of the medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that these are "Patient Monitors" intended for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters" directly from the patient (ECG, respiration, temperature, SpO2, NIBP, IBP, etc.).
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the patient. The monitoring is done on the patient.
Therefore, these patient monitors fall under the category of medical devices used for direct patient monitoring, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
iMEC
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 (SpO>), 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;
- 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
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 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;
- 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.
BeneView T1
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;
- 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.
Product codes
MHX
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.
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.
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.
The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients.
Intended User / Care Setting
The monitors are to be used in 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)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092449. BeneView T Series patient monitors (Including Models BeneView T8, BeneView T6 and Bene View TS).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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:
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.
2
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:
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.
6-4
3
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
4
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:
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.
5
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
6
Indications for Use
510(k) Number (if known): K123074
Device Name: iMEC, iPM and BeneView T1 Patient Monitors
Indications for Use:
iMEC .
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 (SpO>), 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;
-
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
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 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;
-
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.
Page 1 of 2
7
BeneView T1 .
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;
-
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)