(289 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological monitoring parameters and algorithms.
No.
The device is intended for monitoring, displaying, reviewing, alarming, and transferring physiological parameters, which are diagnostic and monitoring functions, not therapeutic interventions.
No
This device is a patient monitor. Its intended use is for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters, which are functions of patient monitoring rather than initial diagnosis of a condition. While the data collected might inform a diagnosis, the device itself performs monitoring, not diagnosis.
No
The device description explicitly states "The Passport M Series Patient Monitors... are the developed new series...". Patient monitors are hardware devices that measure and display physiological parameters. The summary also mentions "Hardware and Software testing" and "Hardware and Software validation," confirming the presence of hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The Passport M Series patient monitors are used for monitoring physiological parameters directly from the patient's body. They measure things like heart rate, blood pressure, oxygen saturation, and temperature through sensors attached to the patient.
- Intended Use: The intended use clearly states "monitoring, displaying, reviewing, alarming and transferring of multiple physiological parameters". This describes a device that interacts with the patient's body to gather real-time data, not a device that analyzes samples in a lab setting.
The device description and intended use consistently point to a patient monitoring system, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Passport M Series patient monitors including models Passport 17M and Passport 12M are intended to be used for monitoring, displaying, reviewing, alarming and transferring of multiple physiological parameters including ECG (3-lead , 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), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation(SvO2/ScvO2), carbon dioxide (CO2), Oxygen(O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.O. is only for use on adult patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBO. CBS, CBR, CCL, DSB, DXG, OLW
Device Description
The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) 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 adding some parameters monitoring functions, such as continuous cardiac output (CCO) and mixed /central venous oxygen saturation (SvO2/ScvO2) 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.
The following are exceptions:
- Arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only.
- ST Segment analysis (Mindray algorithm) is intended for adult patients only.
- C.O. is only for use on adult patients.
- The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
Intended User / Care Setting
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
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 Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) 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 Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) 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): 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.
K092449, K102562, K091786, K071073
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.
Not Found
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
§ 870.1025 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
K132075
Page 1 of 4
510(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.
The assigned 510(k) number is: K132075
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 8188 8998 Fax: +86 755 2658 2680
Contact Person: .
Ms. 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 21, 2014
Name of the devices:
- Trade/Proprietary Name: . Passport M Series Patient Monitors (including models Passport 17M and Passport 12M)
- Common Name: Patient Monitor
1
K132075 Page 2 of 4
. 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 882.1400 | Electroencephalograph | Class II |
| 21 CFR 870.2770 | Impedance plethysmograph | Class II |
| 21 CFR 870.1435 | Single-function, preprogrammed diagnostic computer | Class II |
Legally Marketed Predicate Devices:
| K092449, | BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND |
|---|---|
| T5, Shenzhen Mindray Bio-medical Electronics Co., LTD. | |
| K102562, | INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, |
| MP40, MP50, MP60, MP70, MP80, MP90, & MX800, PHILIPS MEDIZINSYSTEME | |
| BOBLINGEN GMBH. | |
| K091786, | PULSION CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES |
| (PV2022-30 THRU -38, PV2022-46 THRU -48), PULSION MEDICAL SYSTEMS | |
| AG | |
| K071073, | Solar 8000 and Transport Pro with Patient Data Module, GE MEDICAL SYSTEMS |
| INFORMATION TECHNOLOGIES |
2
K132075 Page 3 of 4
Device Description:
The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) 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 adding some parameters monitoring functions, such as continuous cardiac output (CCO) and mixed /central venous oxygen saturation (SvO2/ScvO2) 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.
Statement of intended Use:
The Passport M Series Patient Monitors including models Passport 17M and Passport 12M are intended to be used for monitoring, displaying, reviewing, alarming and transferring 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), cardiac output (C.O.), continuous cardiac output (CCO), mixed /central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen(02), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.O. is only for use on adult patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
3
K132075 Page 4 of 4
Technology:
Based on the technical platform of the BeneView T Series patient monitors, which were previously cleared by FDA under K092449, on AUG 31, 2010, we developed the Passport M Series Patient Monitors including models Passport 17M and Passport 12M.
Test Summary:
The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) 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 Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) are as safe, as effective, and perform as well as the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized caduceus-like design with three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2014
Mindray North America c/o Mr. Russell Olsen VP Quality & Regulatory Affairs 800 Macarthur Blvd Mahwah, NJ 07430 US
Re: K132075
Trade/Device Name: Passport M Series Patient Monitoring (including models Passport 17M and Passport 12M) Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II (two) Product Code: MHX Secondary Product Codes: DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBO. CBS, CBR, CCL, DSB, DXG, OLW Dated: March 13, 2014 Received: March 14, 2014
Dear Mr. Russell Olsen:
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
5
Page 2 - Mr. Russell Olsen
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours
Image /page/5/Picture/6 description: The image shows a logo with the letters FDA. The letters are stylized and have lines drawn through them. The logo is black and white and appears to be a graphic representation of the Food and Drug Administration.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K132075
Indications for Use
510(k) Number (if known):
Device Name: Passport M Series patient monitors
Indications for Use:
The Passport M Series patient monitors including models Passport 17M and Passport 12M are intended to be used for monitoring, displaying, reviewing, alarming and transferring of multiple physiological parameters including ECG (3-lead , 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), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation(SvO2/ScvO2), carbon dioxide (CO2), Oxygen(O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).
All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.O. is only for use on adult patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. 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)
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