BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
Device Facts
| Record ID | K073280 |
|---|---|
| Device Name | BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | MHX · Cardiovascular |
| Decision Date | Jun 23, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and Benc View T5 are intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG(3-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM). The arrhythmia detection, ST Segment analysis, BIS and RM monitoring are not intended for neonatal patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 159kg. Other parameters can be applied to a single adult, pediatric or neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport, hospital ambulance, or home use.
Device Story
BeneView T Series (T8, T6, T5) are multi-parameter patient monitors for high-acuity and anesthesia settings. Devices accept inputs from various sensors (ECG leads, SpO2 probes, NIBP cuffs, IBP transducers, CO2/AG gas analyzers, ICG/BIS sensors). System processes physiological signals to calculate vital signs, detect arrhythmias, and perform ST-segment analysis; outputs displayed on integrated screens. Used in clinical healthcare facilities by physicians/nurses; not for transport or home use. Data storage and alarm generation support clinical decision-making by providing real-time patient status updates. Benefits include continuous monitoring of critical physiological parameters to facilitate timely clinical intervention.
Clinical Evidence
Bench testing only. Validation included software testing, system hazard analysis, biocompatibility, and environmental/EMC testing per FDA guidance. Compliance with published standards verified. No clinical trial data provided.
Technological Characteristics
Modular patient monitoring platform. Parameters: ECG, NIBP, IBP, SpO2, CO2, AG, ICG, BIS, RM. Connectivity: peripheral support (mouse, keyboard, printer). Software: host and module-based firmware. Hardware: main unit with varying display sizes (T8, T6, T5). Sterilization: N/A (non-sterile).
Indications for Use
Indicated for monitoring, displaying, storing, and alarming physiological parameters (ECG, HR, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, AG, ICG, BIS, RM) in adult, pediatric, and neonatal patients. Arrhythmia detection, ST analysis, BIS, and RM are contraindicated for neonates. ICG is restricted to adults (height 122-229cm, weight 30-159kg). For use in healthcare facilities by medical staff.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- PM-9000 Express Patient Monitor (K070791)
- BioZDx Hemodynamic Monitor (K041294)
- BISX (K040183)
- CAPNOSTAT 5 (K042601)
- DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR (K041790)
Submission Summary (Full Text)
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JUN 2 8 2008
# 5 10(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
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### 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: ●
- Li Dongling
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
#### Date Prepared: .
November 8, 2007
Name of the devices:
- Trade/Proprietary Name: BeneView T Series patient monitors (Including Models . BeneView T8, BeneView T6 and BeneView T5)
- Common Name: Patient Monitor
#### . Classification
| 21 CFR 870.1025 Arrhythmia detector and alarm<br>(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 - | 0037 |
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| | 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 882.1400 | Electroencephalograph | Class II |
| 21 CFR 870.2770 | Impedance plethysmograph | Class II |
#### Legally Marketed Predicate Devices:
- PM-9000 Express Patient Monitor, SHENZHEN MINDRAY 1) K070791, BIO-MEDICAL ELECTRONICS CO., LTD.
- BioZDx Hemodynamic Monitor, Cardiodynamics International Corp. K041294, 2)
- BISX, ASPECT MEDICAL SYSTEMS, INC. 3) K040183,
- CAPNOSTAT 5, RESPIRONICS NOVAMETRIX, INC. K042601, 4)
- DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR with K041790, ર) datex-ohmeda
#### Description:
The BeneView T Series patient monitors (including models BeneView T8, T6 and T5) are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of standard vital signs, high-acuity and anesthesia monitoring.
BeneView T8, BeneView T6 and BeneView T5 have same design principle and technical characteristics:
- > Same system framework and components.
- > Same Hardware design principle in main unit.
- Same parameters measurement subsystems (including parameters modules and > accessories).
- Same peripheral equipments or accessories (including mouse, keyboard and printer, ア etc.)
- > Same host software and modules software.
The difference between BeneView T8 and BeneView T6 is the size of display screen. And the differences between BeneView T8 and BeneView T5 are the appearance and interior structure in main unit.
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#### Statement of intended Use:
The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and Benc View T5 are intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG(3-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
The arrhythmia detection, ST Segment analysis, BIS and RM monitoring are not intended for neonatal patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 159kg. Other parameters can be applied to a single adult, pediatric or neonatal patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport, hospital ambulance, or home use.
#### Comparison of Technological Characteristics:
Both the subject devices and the predicate devices provide a means for interfacing with a patient, collecting parameter specific physiological data, and processing the data for alarm generation and display of numeric values and waveforms.
The specifications and technologies for parameters including ECG(3-lead or 12-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulse Rate(PR), Carbon Dioxide (CO2, for Oridion MiniMediCO2 and Mindray CO2 Module) and anesthetic gas (AG) of the device are substantial equivalent to the predicate devices, the cleared PM-9000 Express Patient Monitor (k070791).
The Bispectral Index (BIS), Impedance Cardiograph (ICG) and Carbon Dioxide (CO2) (for CAPNOSTAT mainstream CO2 Module) parameter specifications and technologies are same to the predicate devices.
Both the subject device and the predicate device for RM parameter adopt the same measuring method using flow sensor, but have different parameter specifications. The technological differences do not affect the safety or efficacy of the devices.
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## K073280
Testing:
September 1978 - 1998
Any safety issues that may be raised by software controlled medical devices are addressed in the systems hazard analysis and in the system validation. And testing has been conducted to validate and verify that meet all design specifications.
The testing consisted of software testing, clinical and/or bench performance testing, biocompatibility testing/evaluation and safety/environmental/EMC testing. All environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions' Draft Guidance Document. The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 have also been tested to assure compliance with the requirements of various published standards.
The conclusions drawn from the testing of the BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 demonstrate that the devices are as safe and effective as the legally marketed predicate devices.
#### Conclusion:
The BeneView T Series patient monitors are substantially equivalent to currently marketed predicate devices.
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### 1)EPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, with three stripes above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### JUN 2 3 2008
Shenzhen Mindray Bio-Medical Electronics Co. Ltd. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K073280
Trade/Device Name: BeneView T Series Patient Monitor, including models BeneView T8, BeneView T6 and BeneView T5 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (Two)
Product Code: MHX Dated: June 4, 2008 Received: June 6, 2008
Dear Ms. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Susan D. Goldstein-Falk
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
emee
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): ____ Ko7 3280
Device Name: BeneView T Series patient monitors
(including models BeneView T8, BeneView T6 and BeneView T5)
Indications for Use:
The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 are intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
The arrhythmia detection, ST Segment analysis, BIS and RM monitoring are not intended for neonatal patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 159kg. Other parameters can be applied to a single adult, pediatric or neonatal patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport, hospital ambulance, or home 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)
*[Signature]*
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K073280 |
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| Page | 1 of 1 |
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