(340 days)
Not Found
No
The document describes standard physiological monitoring and analysis (ECG, arrhythmia, ST segment, etc.) and explicitly states "Mentions AI, DNN, or ML: Not Found". The device description focuses on adding WiFi functionality and building on a previous platform, not on incorporating advanced AI/ML algorithms.
No
The device is a patient monitor used for displaying, reviewing, storing, and alarming multiple physiological parameters. It does not provide therapy or treatment.
No
A diagnostic device is used to identify or determine the nature of a disease or condition. The text states the device is "intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters," which describes a patient monitor. While monitoring physiological parameters can aid in diagnosis, the device itself is not described as performing diagnostic functions, but rather as providing data that a clinician would interpret for diagnostic purposes.
No
The device description explicitly states "The Passport Series Patient Monitors... are the developed new series based on the technical platform of the iPM Series patient monitors." and mentions "Hardware and Software testing" and "Hardware and Software validation," indicating the device includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters". These parameters are measured directly from the patient's body (ECG, respiration, temperature, SpO2, NIBP, IBP, etc.).
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Lack of Sample Analysis: The description of the Passport Series Patient Monitors does not mention any analysis of samples taken from the patient. It focuses on real-time physiological measurements.
Therefore, the Passport Series Patient Monitors fall under the category of patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Passport Series Patient Monitors, including Passport 8 and Passport 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;
- · 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 Passport 12 Patient Monitors only.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Product codes
MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DXG
Device Description
The Passport Series Patient Monitors (including Passport 12) are the developed new series based on the technical platform of the iPM Series patient monitors.
Comparing with the cleared iPM Series Patient Monitors, the WiFi function is added on the subject patient monitors.
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 (with exceptions for certain parameters)
Intended User / Care Setting
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
The Passport Series Patient Monitors (including Passport 12) 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 the 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
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping faces.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Shenzhen Mindray Biomedical Electronics Co. Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South, High-tech Industrial Park Nanshan, Shenzhen, 518057 CH
Re: K132662 Trade/Device Name: Passport Series Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DXG Dated: July 8, 2014 Received: July 9, 2014
Dear Yanhong 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 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
Image /page/1/Picture/8 description: The image shows a close-up of three handwritten characters. The characters are black and appear to be written with a thick marker or pen. The first character looks like a stylized letter 'K', the second character resembles a cursive 'l', and the third character is a straight line with a slight curve at the bottom. The background is white and slightly blurred.
Ken Skodacek for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K132662 510(k) Number (if known):
Device Name: Passport Series patient monitors
Indications for Use:
The Passport Series Patient Monitors, including Passport 8 and Passport 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;
- · 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 Passport 12 Patient Monitors only.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Prescription Use × (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/2/Picture/17 description: The image shows a logo with the letters "K" and "I" in a stylized, handwritten font. Below the logo, the text "Ken Skodacek for" is printed in a simple, sans-serif font. The logo is black and white and appears to be a signature or brand mark.
Page 1 of 1
Bram Zuckerman
3
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.
| 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: 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: July 7, 2014
Trade/Proprietary Name: Passport Series Patient Monitors (including Passport 8 and Passport 12)
Common Name: Patient Monitor
Classification:
| MINDDAV® Decement 0 9 42
| Dave d at o | |||
|---|---|---|---|
| 21 CFR 868.1700 | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) (CBR) | Class II | |
| 21 CFR 868.1620 | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) (CBS) | Class II | |
| 21 CFR 868.1500 | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) (CBQ) | Class II | |
| 21 CFR 868.1400 | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) | Class II | |
| 21 CFR 870.2710 | Oximeter, Ear (DPZ) | Class II | |
| 21 CFR 870.2700 Oximeter (DQA) | Class II | ||
| 21 CFR 880.2910 | Thermometer, Electronic, Clinical (FLL) | Class II | |
| 21 CFR 870.1110 | Computer, Blood-Pressure (DSK) | Class II | |
| 21 CFR 870.1130 | System, Measurement, Blood-Pressure, Non-Invasive (DXN) | Class II | |
| 21 CFR 870.2300 | Monitor, cardiac (incl. cardiotachometer & rate alarm) (DRT) | Class II | |
| 21 CFR 870.1025 | Monitor, ST Segment with Alarm (MLD) | Class II | |
| 21 CFR 870.1025 | Monitor, physiological, patient (with arrhythmia detection or alarms) (MHX) Class II | ||
| 21 CFR 870.1025 Detector and alarm, arrhythmia (DSI) | Class II |
4
| 21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase (CCL) | Class II |
|---|---|
| 21 CFR 870.1435 Computer, Diagnostic, Pre-Programmed, Single-Function (DXG) | Class II |
Legally Marketed Predicate Devices:
| K092449 | BeneView T Series patient monitors (Including Models BeneView T8, BeneView T6 |
|---|---|
| andBeneView T5), Shenzhen Mindray Bio-medical Electronics Co., LTD | |
| K123074 | IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS, Shenzhen Mindray |
| Bio-medical Electronics Co., LTD |
Device Description:
The Passport Series Patient Monitors (including Passport 12) are the developed new series based on the technical platform of the iPM Series patient monitors.
Comparing with the cleared iPM Series Patient Monitors, the WiFi function is added on the subject patient monitors.
Indication for Use:
The Passport Series Patient Monitors, including Passport 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;
- · 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 Passport 12 Patient Monitors only.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Technology:
For the parameters (including ECG, arrhythmia detection, ST Segment analysis, HR, RESP, TEMP, SpO2, PR, NIBP, IBP, C.O., CO2 and AG), the subject devices are totally same with the predicate devices iPM Series patient monitors (K123074).
For the WiFi function, the subject devices are substantially equivalent to the Predicate devices BeneView T Series Patient monitors (K092449).
5
Test Summary:
The Passport Series Patient Monitors (including Passport 12) 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 the 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 Series Patient Monitors are as safe, as effective, and perform as well as the predicate devices.