(203 days)
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- · ECG waveform derived from 3, 5 and 12 Lead measurements
- · Heart Rate
- · ST Segment Analysis
- · Arrhythmia Detection
- 12-lead ECG interpretation
- · OT Analysis
- · Pulse Oximetry (SpO2)
- · Pulse Rate (PR)
- · Non Invasive Blood Pressure (NIBP)
- · Invasive Blood Pressure (IBP)
- · Cardiac Output (C.O.)
- · Respiratory Gases (02, CO2)
- · Respiration Rate (RESP)
- · Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O)
- · Temperature (TEMP)
- · Bispectral Index (BIS)
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
-
The target populations are adult, pediatric and neonate with the exception of:
· Arrhythmia detection, ST Segment Analysis, for which the target population are adult and pediatric only. -
· IV Drug Calculations for which the target population is adult only,
-
· Cardiac Output for which the target population are adult and pediatric only, and
-
· Bispectral Index(BIS) for which the target population are adult and pediatric only.
The subject V Series Monitoring System includes two monitors, one incorporating a12" display (V12 Monitor) and the other incorporating a 21" display (V21 Monitor), and includes the following system components:
- Display Control Unit (DCU) Display Control Unit (DCU) includes the system . processor, monitor display, user interface and appropriate connectors for communication to peripheral devices. The 12-inch (V12) monitor display features a touch screen display that accommodates up to 8 waveforms and corresponding numerics. It includes an internal module rack in the back which holds up to 6 modules, depending on their size. It can be removed from the docking station and used as an intra hospital transport monitor. The 21-inch (V21) monitor display features a touch screen display that accommodates up to 12 waveforms and corresponding numerics. It also includes a touch pad as an optional method to interact with the software.
- Docking Station (Model name: V Dock) The Docking Station is a physical mount ● for the DCU. The Docking Station incorporates multiple connectivity ports designed to enable quick connection and release for mobility. It provides power to the monitoring system. It features a quick release mechanism that allows the DCU to be easily and quickly removed and reattached. The docking station also provides connectivity to other external devices and systems such as remote displays or nurse call systems and mounts to a wall mount or rolling stand. The Docking Station used in the subject V Series is referred to in Mindray internal documents as "V Dock" or "Dock".
- Module Rack (Model name: V Hub) The Module Rack is a physical mount for the ● modules capable of holding up to 6 modules, depending on their size. It features a quick release mechanism that allows the Module Rack to be easily and quickly removed and reattached to a wall mount or rolling stand to be used during intra hospital transports. The Module Rack used in the subject V Series is referred to in Mindray internal documents as "V Hub" or "Hub".
- VPS Module - The VPS is the main parameter module of the subject V Series that provides the core parameters: 3/5/12-lead ECG, SpO2, Respiration, NIBP, 2 invasive pressures and 1 temperature channel. The VPS is a parameter acquisition device designed to acquire and store real-time vital sign data. Its modular design allows it to be moved with the patient between V Series Monitoring Systems.
- Modules - Modules are data acquisition devices that add parameter and interface capability to the subject V Series. These modules are parameter specific and include temperature, invasive blood pressure (IBP), cardiac output (C.O.), CO2, and strip recorder. One module, the VDI (V Device Integrator), is configurable to allow interface to other medical devices such as continuous cardiac output (CCO), regional oxymetry saturation (rSO2), respiratory gas, and DIAP (previously cleared under the
predicate V Series K132026). One module, the BIS interface module, is configurable to allow interface to BIS module (Mindray is seeking clearance for this new feature under this 510(k)). - o View 12 (12 lead ECG cable) - The View 12 will monitor 12 lead ECG and respiration through the ECG port connection on the VPS Module.
Here's an analysis of the provided text regarding the acceptance criteria and study for the V Series Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a distinct section with pass/fail metrics. Instead, it presents performance specifications of the subject device and compares them to those of predicate devices to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly the existing performance characteristics and accuracy claims of the predicate devices or the device's own specifications after modifications, and the "Reported Device Performance" is stated by asserting that the subject device meets specifications and that its performance is equivalent to the predicate.
It's important to note that the document focuses on changes from the predicate device and how those changes are still "substantially equivalent." Therefore, the table below will highlight the modified features and their performance metrics. For features that are stated as "Same" as the predicate, it implies they meet the predicate's specifications.
| Feature | Implicit Acceptance Criteria / Predicate Performance (K132026) | Reported Device Performance (Subject V12/V21) |
|---|---|---|
| ECG Waveform Leads | 3-lead, 5-lead, 6-lead, or 12-lead selectable | 3-lead, 5-lead, or 12-lead selectable (6-lead removed for business reasons, declared as not affecting safety/effectiveness) |
| QRS Waveform Detection | Supported, fixed threshold 0.2mV | Supported, adjustable threshold between 0.16mV to 0.48mV |
| Arrhythmia Detection | Supported, fixed leads for arrhythmia analysis | Supported, adjustable leads for arrhythmia analysis, Added Extreme Bradycardia alarms, Extreme Tachycardia alarms, Pacer Failure to Capture alarms, Pacer Failure to Sense alarms |
| 12-lead ECG Interpretation | Supported | Supported, Added Baseline Drift Removal (BDR) filter, Muscle Artifact filter and Beat markers |
| QT Analysis | Not supported | Supported (justified by presence in predicate K101521) |
| Mortara Arrhythmia Algorithm Software Version | 3.3.5 | 4.0.0 |
| Pace Detection | Single Pace detection channel | Dual Pace detection channels |
| NIBP Pressure Range | Adult: Systolic 55-235 mmHg, Diastolic 30-200 mmHg Pediatric: Systolic 55-160 mmHg, Diastolic 30-150 mmHg Neonate: Systolic 45-120 mmHg, Diastolic 20-100 mmHg | Adult: Systolic 55-270 mmHg, Diastolic 30-200 mmHg Pediatric: Systolic 55-170 mmHg, Diastolic 30-150 mmHg Neonate: Systolic 45-130 mmHg, Diastolic 20-100 mmHg (Wider range is an improvement) |
| Bispectral Index (BIS) | Not supported | Supported (justified by presence in predicate K143195) |
| New NIBP Cuffs | None | Supported |
| Wireless Functionality | Not supported | Supported |
For parameters not listed as modified (e.g., Heart Rate Meter, SpO2 Accuracy, IBP Accuracy, CO, Capnography, Respiration Rate, Temperature), the reported device performance is implicitly the "Same" as the predicate device, meaning they meet the predicate's stated specifications and accuracy.
The document states: "The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Mindray conducted system and performance testing on the subject devices."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test sets. The nature of the device (patient monitor for physiological parameters) suggests that ground truth for performance metrics (like heart rate, blood pressure, etc.) would typically be established by established reference methods/equipment, not necessarily human expert consensus on raw data interpretation in the same way an imaging AI might.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with vs. without AI Assistance
A MRMC comparative effectiveness study was not done or reported in this documentation. The device described, a patient physiological monitor, is not an AI-assisted diagnostic tool that would typically involve human readers interpreting output in the MRMC sense. It provides measurements and alarms derived from physiological signals.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The document implies that standalone performance testing was done, as it states: "The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate." This refers to the device's inherent ability to measure and process physiological parameters according to its own algorithms and sensors. No human-in-the-loop performance evaluation is described.
7. The Type of Ground Truth Used
Based on the type of device and parameters measured, the ground truth would likely be established using:
- Reference measurement equipment: For parameters like NIBP, IBP, SpO2, and temperature, a reference standard device or method with certified accuracy would be used.
- Simulated physiological signals: For ECG, arrhythmia detection, heart rate, QRS detection, and pace detection, standardized test signals (e.g., from an ECG simulator) representing various physiological and pathological conditions would likely be used to test the algorithm's accuracy against known inputs.
- Clinical data with expert verification: For features like 12-lead ECG interpretation, the ground truth would typically be established by a consensus of expert cardiologists or clinicians reviewing ECG tracings and relevant patient data. However, the document does not specify this for the training or testing.
The document itself does not explicitly detail the ground truth methodology beyond stating "system and performance testing" and compliance with consensus standards.
8. The Sample Size for the Training Set
The document does not specify the sample size for any training set. This is a medical device clearance document, not a detailed algorithm development paper. While internal algorithms for arrhythmia detection, QRS detection, and 12-lead ECG interpretation would involve training, this document focuses on substantial equivalence for regulatory purposes, not the detailed development process.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how ground truth for any training set was established. Similar to point 8, this level of detail is typically not found in regulatory submission summaries unless it's a novel AI/ML device where the training data and ground truth methodology are critical for demonstrating safety and effectiveness. This device appears to be an iterative update to an existing monitoring system, with modifications to existing algorithms (e.g., Mortara arrhythmia algorithm version update, new NIBP range, QRS threshold adjustment).
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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, Shenzhen 518057, P.R. China
Re: K150352
Trade/Device Name: V Series Monitoring System (including V12 And V21 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, CCK, CBS, CBR, CCL, DXG, DQK, MUD, BWM, NHO, CBQ, NHQ, NHP Dated: July 31, 2015 Received: August 4, 2015
Dear Yanhong Bai:
We have reviewed vour 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
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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 yours,
Mitchell Stein
forBram 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) K150352
Page 1 of 2
Device Name
V Series Monitoring System (including V12 and V21 Monitors)
Indications for Use (Describe)
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- · ECG waveform derived from 3, 5 and 12 Lead measurements
- · Heart Rate
- · ST Segment Analysis
- · Arrhythmia Detection
- 12-lead ECG interpretation
- · OT Analysis
- · Pulse Oximetry (SpO2)
- · Pulse Rate (PR)
- · Non Invasive Blood Pressure (NIBP)
- · Invasive Blood Pressure (IBP)
- · Cardiac Output (C.O.)
- · Respiratory Gases (02, CO2)
- · Respiration Rate (RESP)
- · Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O)
- · Temperature (TEMP)
- · Bispectral Index (BIS)
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
-
The target populations are adult, pediatric and neonate with the exception of:
· Arrhythmia detection, ST Segment Analysis, for which the target population are adult and pediatric only. -
· IV Drug Calculations for which the target population is adult only,
-
· Cardiac Output for which the target population are adult and pediatric only, and
-
· Bispectral Index(BIS) for which the target population are adult and pediatric only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 2 of 2
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5. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the V Series Monitoring System is provided below.
| Device Common Name: | Multi-Parameter Patient Monitor (with arrhythmiadetection or alarms) |
|---|---|
| Device Proprietary Name: | V Series Monitoring System (including V12 and V21Monitors) |
| Submitter: | SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680 |
| Contact: | Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | January 29, 2015 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm(including ST-segment measurement and alarm) |
| Panel: | Cardiovascular |
Classification Regulation, Classification Name and Product Codes:
| ProductCode | RegulationNumber | Panel | Regulation Description | Device Common Name |
|---|---|---|---|---|
| Primary | ||||
| MHX | 21 CFR870.1025 | Cardiovascular | Arrhythmia detector and alarm(includingST-segmentmeasurement and alarm) | Monitor, physiological, patient(with arrhythmia detection oralarms) |
| Secondary | ||||
| ProductCode | RegulationNumber | Panel | Regulation Description | Device Common Name |
| DSI | 21 CFR870.1025 | Cardiovascular | Arrhythmia detector and alarm(including ST-segmentmeasurement and alarm) | Detector and alarm, arrhythmia |
| MLD | 21 CFR870.1025 | Cardiovascular | Arrhythmia detector and alarm(including ST-segmentmeasurement and alarm) | Monitor, st segment with alarm |
| DRT | 21 CFR870.2300 | Cardiovascular | Cardiac Monitor (includingcardiotachometer and rate alarm) | Monitor, cardiac (incl.cardiotachometer & rate alarm) |
| DXN | 21 CFR870.1130 | Cardiovascular | Noninvasive blood pressuremeasurement system | System, measurement, blood-pressure, non-invasive |
| DSK | 21 CFR870.1110 | Cardiovascular | Blood pressure computer | Computer, blood-pressure |
| FLL | 21 CFR880.2910 | Cardiovascular | Clinical electronic thermometer | Thermometer, electronic,clinical |
| DQA | 21 CFR870.2700 | Cardiovascular | Oximeter | Oximeter |
| CCK | 21 CFR868.1400 | Anesthesiology | Carbon dioxide gas analyzer | Analyzer, gas, carbon-dioxide,gaseous-phase |
| CBS | 21 CFR868.1620 | Anesthesiology | Halothane gas analyzer | Analyzer, gas, halothane,gaseous-phase (anestheticconc.) |
| CBR | 21 CFR868.1700 | Anesthesiology | Nitrous oxide gas analyzer | Analyzer, gas, nitrous-oxide,gaseous phase (anestheticconc.) |
| CCL | 21 CFR868.1720 | Anesthesiology | Oxygen gas analyzer | Analyzer, gas, oxygen,gaseous-phase |
| DXG | 21 CFR870.1435 | Cardiovascular | Single-function, preprogrammeddiagnostic computer | Computer, diagnostic, pre-programmed, single-function |
| DQK | 870.1425 | Cardiovascular | Programmable diagnosticcomputer | Computer, diagnostic,programmable |
| MUD | 870.2700 | Cardiovascular | oximeter | Oximeter, tissue saturation |
| GWM | 822.1620 | Neurology | Intracranial pressure monitoringdevice | Device, monitoring,intracranial pressure |
| NHO | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| CBQ | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, enflurane, gaseous-phase (anesthetic concentration) |
| NHQ | 868.1500 | Anesthesiology | Enflurane gas analyzer. | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| ProductCode | RegulationNumber | Panel | Regulation Description | Device Common Name |
| NHP | 868.1500 | Anesthesiology | Enflurane gas analyzer | Analyzer, gas, sevoflurane,(anestheticgaseous-phaseconcentration) |
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{6}------------------------------------------------
Predicate Device:
K132026 - V Series Monitoring System (including V12 and V21), MINDRAY DS USA, INC.
K143195 - Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1), Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
K101521 - ST/AR ST AND ARRHYTHMIA SOFTWARE, PHILIPS MEDICAL SYSTEMS.
Indications for Use:
The V Series Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the V12/V21 Monitor include the continuous monitoring of the following human physiological parameters:
- ECG waveform derived from 3, 5 and 12 Lead measurements
- Heart Rate ●
- ST Segment Analysis
- Arrhythmia Detection ●
- 12-lead ECG interpretation ●
- o OT Analysis
- Pulse Oximetry (SpO2) ●
- Pulse Rate (PR)
- Non Invasive Blood Pressure (NIBP) ●
- Invasive Blood Pressure (IBP)
- Cardiac Output (C.O.) ●
- Respiratory Gases (02, CO2)
- Respiration Rate (RESP) ●
- Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O) ●
- Temperature (TEMP) ●
- Bispectral Index (BIS) ●
The V12/V21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
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- Arrhythmia detection, ST Segment Analysis and QT Analysis, for which the target population are adult and pediatric only,
- IV Drug Calculations for which the target population is adult only,
- Cardiac Output for which the target population are adult and pediatric only, and ●
- Bispectral Index (BIS) for which the target population are adult and pediatric only. o
Device Description:
The subject V Series Monitoring System includes two monitors, one incorporating a12" display (V12 Monitor) and the other incorporating a 21" display (V21 Monitor), and includes the following system components:
- Display Control Unit (DCU) Display Control Unit (DCU) includes the system . processor, monitor display, user interface and appropriate connectors for communication to peripheral devices. The 12-inch (V12) monitor display features a touch screen display that accommodates up to 8 waveforms and corresponding numerics. It includes an internal module rack in the back which holds up to 6 modules, depending on their size. It can be removed from the docking station and used as an intra hospital transport monitor. The 21-inch (V21) monitor display features a touch screen display that accommodates up to 12 waveforms and corresponding numerics. It also includes a touch pad as an optional method to interact with the software.
- Docking Station (Model name: V Dock) The Docking Station is a physical mount ● for the DCU. The Docking Station incorporates multiple connectivity ports designed to enable quick connection and release for mobility. It provides power to the monitoring system. It features a quick release mechanism that allows the DCU to be easily and quickly removed and reattached. The docking station also provides connectivity to other external devices and systems such as remote displays or nurse call systems and mounts to a wall mount or rolling stand. The Docking Station used in the subject V Series is referred to in Mindray internal documents as "V Dock" or "Dock".
- Module Rack (Model name: V Hub) The Module Rack is a physical mount for the ● modules capable of holding up to 6 modules, depending on their size. It features a quick release mechanism that allows the Module Rack to be easily and quickly removed and reattached to a wall mount or rolling stand to be used during intra hospital transports. The Module Rack used in the subject V Series is referred to in Mindray internal documents as "V Hub" or "Hub".
- VPS Module - The VPS is the main parameter module of the subject V Series that provides the core parameters: 3/5/12-lead ECG, SpO2, Respiration, NIBP, 2 invasive pressures and 1 temperature channel. The VPS is a parameter acquisition device designed to acquire and store real-time vital sign data. Its modular design allows it to be moved with the patient between V Series Monitoring Systems.
- Modules - Modules are data acquisition devices that add parameter and interface capability to the subject V Series. These modules are parameter specific and include temperature, invasive blood pressure (IBP), cardiac output (C.O.), CO2, and strip recorder. One module, the VDI (V Device Integrator), is configurable to allow interface to other medical devices such as continuous cardiac output (CCO), regional oxymetry saturation (rSO2), respiratory gas, and DIAP (previously cleared under the
{8}------------------------------------------------
predicate V Series K132026). One module, the BIS interface module, is configurable to allow interface to BIS module (Mindray is seeking clearance for this new feature under this 510(k)).
- o View 12 (12 lead ECG cable) - The View 12 will monitor 12 lead ECG and respiration through the ECG port connection on the VPS Module.
Performance Data:
- o To establish the substantial equivalence of the V Series Monitoring System (including V12 and V21 Monitors), Mindray conducted system and performance testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The system and performance testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
- Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- Mindray has also followed the FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm issues on October 28, 2003.
- o The V Series Monitoring System has been modified to provide wireless functionality. Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device.
Consensus Standards
The subject V Series Monitoring System has been tested and found to be in compliance with the following safety and performance standards:
- ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012,C1:2009/(R)2012 and ● A2:2010/(R)2012
- IEC 60601-2-49:2011 ●
- IEC 60601-1-2:2007 ●
- IEC 60601-1-8:2012 ●
- o IEC 60601-1-6: 2013
- IEC 60601-2-25:2011
- IEC 60601-2-27:2011 ●
- ANSI/AAMI EC57: 2012 ●
- IEC 60601-2-34:2011
- IEC 80601-2-30:2013 ●
- ISO 81060-2: 2013 ●
- ISO 80601-2-56: 2009 ●
- ISO 80601-2-61: 2011 ●
- IEC 60601-2-26:2002 ●
- ISO 80601-2-55: 2011 ●
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Substantial Equivalence:
Comparison of Indications:
Both the predicate and the subject V Series are multi-parameter patient monitors intended to be used in healthcare facilities under the direction of clinical professionals. The indications for use of the subject V Series have been modified to:
- o remove the feature of ECG waveform derived from 6 lead measurements from the subject V Series
- include the addition of a QT analysis feature and the interface to and display of o Bispectural Index (BIS)
For business reasons only, Mindray has decided to remove the feature of ECG waveform derived from 6 lead measurements from the subject V Series. Removal of this feature does not affect the safety and effectiveness of the subject device. So this change does not impact substantial equivalence.
Although the addition of the interface to and display of Bispectral Index (BIS) and QT Analysis feature are not presented in the primary predicate device V Series, the Bispectral Index (BIS) is presented in the cleared Passport Series (K143195), QT Analysis is presented in the cleared Philips (K101521), and thus does not constitute a new intended use for a multi-parameter monitor.
In conclusion, the changes to the indications for use do not change the fundamental intended use of the V Series as multi-parameter monitors.
Comparison of Technological Characteristics:
The table below compares the key technological feature of the subject V Series to the primary predicate V Series (K132026). The features highlighted in grev are the features that have been modified since their previous clearances and that are the subject of this 510(k) for which Mindrav is seeking clearance.
| Predicate Device / V Series(K132026) | Subject Devices | |||
|---|---|---|---|---|
| Feature | V12 | V21 | V12 | V21 |
| Integrated displayandtouchscreen | 12.1" TFT1024 x 768 pixels | 21.3" TFT1600 x 1200pixels | Same | Same |
| Secondarydisplay | Display is linked to integrateddisplay | Same | Same | |
| Predicate Device / V Series(K132026) | Subject Devices | |||
| Feature | V12 | V21 | V12 | V21 |
| Modulerack | Independent ofthe patientmonitor,provides 1integrated and 2extendedmodule slots toextend themeasurementcapabilities ofthe system | Independentof the patientmonitor,provides 3extendedmodule slotsto extend themeasurementcapabilitiesof the system | Same | Same |
| Powersupply | ThreerechargeableLithium-ionbattery(maximum) or AC powersupply | AC powersupply | Same | Same |
| Battery | ChargeableLithium-Ion,11.1 VDC, 4.8Ah (one battery) | Notsupported | Same | Same |
| Externalmemorycard | USB Memory Stick | Same | Same | |
| DataRecorder | The thermal recorder recordspatient information,measurement numerics, up tothree waveforms, etc. | Same | Same | |
| Speaker | Give alarm tones (45 to 85 dB),key tones, QRS tones, warningtone; support PITCH TONE andmulti-level tone modulation. | Same | Same | |
| Printer | Laser Printer and Thermal Printer(the addition of the Strip ChartRecorder Module supports thethermal printer) | Same | Same | |
| ECGwaveform | 3-lead , 5-lead, 6-lead or 12-leadselectable | 3-lead , 5-lead or 12-leadselectable | 3-lead , 5-lead or 12-leadselectable | |
| Predicate Device / V Series(K132026) | Subject Devices | |||
| Feature | V12 | V21 | V12 | V21 |
| HeartRateMeter(ECG) | Measurement range:3, 5 / 6 lead:Adult/Pediatric:30-300 bpm;Neonatal:30-350bmp12 lead:Adult/Pediatric:30-300 bpm;Neonatal: 30-350bpmAccuracy:$± 3 bpm or ± 3%$ in the range of30 to 250 bpm, whichever isgreater$± 5%$ in the range of 251 bpm to350 bpm | Measurement range:3, 5lead:Adult/Pediatric:20-300 bpm;Neonatal:20-350bpm12 lead:Adult/Pediatric:20-300 bpm;Neonatal :20-350bpmAccuracy:$± 3 bpm or ± 3%$ in the range of20 bpm to 250 bpm, whicheveris greater$± 5%$ in the range of 251 bpm to350 bpm | Measurement range:3, 5lead:Adult/Pediatric:20-300 bpm;Neonatal:20-350bpm12 lead:Adult/Pediatric:20-300 bpm;Neonatal :20-350bpmAccuracy:$± 3 bpm or ± 3%$ in the range of20 bpm to 250 bpm, whicheveris greater$± 5%$ in the range of 251 bpm to350 bpm | Measurement range:3, 5lead:Adult/Pediatric:20-300 bpm;Neonatal:20-350bpm12 lead:Adult/Pediatric:20-300 bpm;Neonatal:20-350bpmAccuracy:$± 3 bpm or ± 3%$ in the range of20 bpm to 250 bpm, whicheveris greater$± 5%$ in the range of 251 bpm to350 bpm |
| QRSwaveformdetection | Supported,fixed threshold 0.2mV | Supported, | Supported,adjustable threshold between0.16mV to 0.48mV | Supported,adjustable threshold between0.16mV to 0.48mV |
| STSegmentAnalysis | Supported | Same | Same | Same |
| ArrhythmiaDetection | Supported,fixed leads for arrhythmiaanalysis | Supported,adjustable leads forarrhythmia analysis,Added Extreme Bradycardiaalarms, Extreme Tachycardiaalarms, Pacer Failure toCapture alarms, Pacer Failureto Sense alarms | Supported,adjustable leads forarrhythmia analysis,Added Extreme Bradycardiaalarms, Extreme Tachycardiaalarms, Pacer Failure toCapture alarms, Pacer Failureto Sense alarms | Supported,adjustable leads forarrhythmia analysisAdded Extreme Bradycardiaalarms, Extreme Tachycardiaalarms, Pacer Failure toCapture alarms, Pacer Failureto Sense alarms |
| 12-leadECGinterpretation | Supported | SupportedAdded Baseline Drift Removal(BDR) filter, Muscle Artifactfilter and Beat markers | SupportedAdded Baseline Drift Removal(BDR) filter, Muscle Artifactfilter and Beat markers | SupportedAdded Baseline Drift Removal(BDR) filter, Muscle Artifactfilter and Beat markers |
| QTAnalysis | Not supported | Supported | Supported | Supported |
| Predicate Device / V Series(K132026) | Subject Devices | |||
| Feature | V12 | V21 | V12 | V21 |
| TheversionofMortaraarrhythmiaalgorithmanalysissoftware | 3.3.5 | 4.0.0 | 4.0.0 | |
| PaceDetection | Single Pace detection channel | Dual Pace detection channels | Dual Pace detection channels | |
| Pulseoxygensaturation (SpO2) | SpO2 Range: 70-100%SpO2 AccuracyNellcor:With sensor: MAXAI, MAX-AL,MAXPI, MAXII, MAXNI(Adult), MAXNI (Neonate) 70%to 100% ± 2 digitsWith sensor: OxiCliq A, OxiCliqP, OxiCliq I, OxiCliq N(Adult),OxiCliq N (Neonate) 70% to100% ± 2.5 digitsWith sensor :DS-100A, D-YS(Infant to Adult), OXI-A/N(Adult), OXI-P/I 70% to 100% ±3 digitsWith sensor :D-YS with D-YSEEar Clip, D-YS with D-YSPDSpot Clip 70% to 100% ± 3.5digitsWith sensor :D-YS (Neonate),OXI-A/N (Neonate) 70% to100% ± 4 digitsMasimo:Adult,pediatric:Maximum error of 2% with nomotion Maximum error of 3% inthe presence ofmotion with motion resistantsensors.Neonatal: | Same | Same |
Device Comparison Table
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| Predicate Device / V Series(K132026) | Subject Devices | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | V12 | V21 | V12 | V21 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pulserate (PR) | PR range:Nellcor:20-249 bpmMasimo:26-239 bpmPR Accuracy: ± 3bpm | Same | Same | Same | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Non-invasivebloodpressure(NIBP) | MeasurementTechnique:OscillometricPressure range(mmHg): | MeasurementTechnique:OscillometricPressure range(mmHg): | MeasurementTechnique:OscillometricPressure range(mmHg): | MeasurementTechnique:OscillometricPressure range(mmHg): | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Adult Pediatric Neonate Systolic 55 to 235 55 to 160 45 to 120 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHgPulse Rate Range(bpm):Adult/Pediatric: 35 - 245Neonatal: 70-245 | Adult Pediatric Neonate Systolic 55 to 270 55 to 170 45 to 130 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHgPulse Rate Range(bpm):Adult/Pediatric: 35 - 245Neonatal: 70-245 | Adult Pediatric Neonate Systolic 55 to 270 55 to 170 45 to 130 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHgPulse Rate Range(bpm):Adult/Pediatric: 35 - 245Neonatal: 70-245 | Adult Pediatric Neonate Systolic 55 to 270 55 to 170 45 to 130 Diastolic 30 to 200 30 to 150 20 to 100 Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHgPulse Rate Range(bpm):Adult/Pediatric: 35 - 245Neonatal: 70-245 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Invasivebloodpressure(IBP) | Accuracy:± 2mmHg or 2% whichever isgreaterZero Offset Range:± 120 mmHgIBP Heart Rate range:30 to 300 bpm(Adult/Pediatric),30 to 350 bpm(Neonatal)IBP Heart Rate accuracy:± 3 bpm or ± 3%, whichever isgreater at 30 to 250 bpm,±5 BPM or ±5 from 251 to 350BPM | Same | Same | Same |
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| Predicate Device / V Series(K132026) | Subject Devices | |||
|---|---|---|---|---|
| Feature | V12 | V21 | V12 | V21 |
| Cardiacoutput(C.O.) | The temperature change isdisplayed as a curve in the C.O.split screen, and the monitorcalculates the C.O. value fromthis curve.C.O. Range:0.2 to 20.0 liters/minuteC.O. Accuracy:5% or 0.2 liters/minute,whichever is greaterBlood Temperature Range:17.5 - 43°C (63.5°F - 109.4°F)Blood Temperature Accuracy:$\pm$ 0.2°C ( $\pm$ 0.4°F), exclusive ofprobe errorsInjectate Temperature Range:(-)1.0 to 30.0 °C (30.2° F to 86°F)Injectate Temperature Accuracy:$\pm$ 0.2°C ( $\pm$ 0.4°F), exclusive ofprobe errors | Same | Same | |
| Capnography(EtCO2andFiCO2) | Measurement range:0-99 mmHgAccuracy:0-38 mmHg : $\pm$ 2 mmHg39-99 mmHg : $\pm$ (5% of reading+0.08% for every 1 mmHg over38 mmHg )Accuracy applies for breath ratesof up to 80 bpm. For breath ratesabove 80 bpm, accuracy is 4mmHg or $\pm$ 12% of readingwhichever is greater, for EtCO2values exceeding 18 mmHg.Respiration Rate range(respriations per minute):0 to 150 rpmRespiration Rate Accuracy:$\pm$ 1 rpm from 0 to 70 rpm, $\pm$ 2rpm from 71 to 120 rpm, $\pm$ 3 rpmfrom 121 to 150 rpm | Same | Same | |
| Predicate Device / V Series(K132026) | Subject Devices | |||
| Feature | V12 | V21 | V12 | V21 |
| Respiration rate(Resp) | Measurement range:4 rpm to 199 rpm;Accuracy: $\pm$ 2 or $\pm$ 2%,whichever is greater from 4 to150, $\pm$ 4% from 151 to 199 | Same | Same | |
| Temperature(Temp) | Measurement range:15-45°C(59-113°F)Accuracy:$\pm$ 0.1°C (15°C to 45°C) exclusiveof probe errors or $\pm$ 0.2°F (59°Fto 113°F) exclusive ofprobeerrors | Same | Same | |
| Bispectral index(BIS) | Not supported | Supported | Supported | |
| 14newNIBPcuffs | None | Supported | Supported | |
| Wirelessfunctionality | Not supported | Supported | Supported |
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Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications for each of the modifications to the identified predicate devices, the performance testing and conformance with applicable standards, the subject V Series has been demonstrated performance that is substantially equivalent to the predicate device.
§ 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.