V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
Device Facts
| Record ID | K132026 |
|---|---|
| Device Name | V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 |
| Applicant | Mindray DS USA, Inc. |
| Product Code | MHX · Cardiovascular |
| Decision Date | Dec 20, 2013 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters: - ECG waveform derived from 3, 5, 6 and 12 Lead measurements - Heart Rate - Pulse Oximetry (SpO2) - ST Segment Analysis - Arrhythmia Detection - Non Invasive Blood Pressure (NIBP) - Invasive Blood Pressure (IBP) - Cardiac Output (CO) - Respiratory Gasses - Respiration Rate - Temperature The V Series 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 and ST Segment Analysis, for which the target populations are adult and pediatric only. - IV Drug Calculations for which the target population is adult only, and - Cardiac Output for which the target population is adult and pediatric only.
Device Story
Modular multi-parameter patient monitor for intra-hospital use; operated by licensed healthcare practitioners. Inputs: ECG (3/5/6/12 lead), SpO2, NIBP/IBP, temperature, respiratory gases, cardiac output. System processes physiological signals to provide real-time waveforms, numeric values, trends, and alarms. Features include arrhythmia detection, ST segment analysis, IV drug/hemodynamic calculations, and network connectivity. Output displayed on integrated 12.1" or 21" screens; supports remote viewing, full disclosure, and event logging. Assists clinicians in patient assessment and hemodynamic management; facilitates timely clinical intervention through continuous monitoring and alarm notification.
Clinical Evidence
Bench testing only. Compliance with recognized performance, safety, and electromagnetic compatibility standards (IEC 60601 series, ISO 10993, ISO 9919, ASTM E1112, etc.) was used to demonstrate safety and performance. No clinical data was required.
Technological Characteristics
Modular patient monitoring system. Materials comply with ISO 10993-1. Sensing principles: ECG (electrodes), SpO2 (pulse oximetry), NIBP/IBP (pressure transducers), temperature (thermistor), respiratory gas (spectroscopy). Connectivity: Networked, serial port, eGateway. Software: Programmable electrical medical system. Sterilization: Not applicable (non-invasive/external). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 9919, ASTM E1112, EC13, EC11, EC57.
Indications for Use
Indicated for intra-hospital monitoring of adult, pediatric, and neonate patients. Parameters include ECG, heart rate, SpO2, ST segment, arrhythmia, NIBP, IBP, cardiac output, respiratory gases, respiration rate, and temperature. Arrhythmia/ST analysis limited to adult/pediatric; IV drug calculations limited to adults; cardiac output limited to adult/pediatric.
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
- Endeavour Monitoring System (K102004)
Reference Devices
- Camino Intracranial Pressure Monitor
- Vigilance Monitor
- Vigilance II Monitor
- Vigileo Monitor
- EV1000 Monitor
- Mindray Gas Module III
- INVOS 5100C Cerebral/Somatic Oximeter
Submission Summary (Full Text)
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# 510(k) Summary V Series Monitoring System Monitoring System
This \$10(k) Summary is provided in accordance with the requirements of 21 CFR 807.92
| Date: | June 28, 2013 | | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter: | Mindray DS USA, Inc.<br>800 Mac Arthur Blvd<br>Mahwah, New Jersey 07430 | | |
| Contact: | Russell Olsen<br>Vice President, Quality and Regulatory Affairs<br>Telephone: 201.995.8391<br>Facsimile: 201.995.8605 | | |
| | Device Trade Name: V Series Monitoring System | | |
| Common Name: | Multi-Parameter Patient Monitor (with arrhythmia detection or alarms) | | |
| Device Classification: Primary: | §870.1025- MHX - Physiological, Patient Monitor, with Arrhythmia Detector or<br>Alarms<br>Secondary:<br>§870.1025- DSI - Arrhythmia Detector and Alarm<br>§870.1025- MLD - ST Segment with Alarm Monitor<br>§870.1110- DSK- Blood Pressure Computer<br>§870.1130- DXN - Non-invasive Blood Pressure Measurement System<br>§868.1400- CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase<br>§868.1500- NHO/CBQ/NHQ/NHP - Enflurane Gas Analyzer<br>§868.1620- CBS - Halothane Gas Analyzer<br>§868.1700- CBR - Nitrous Oxide Gas Analyzer<br>§868.1720- CCL - Oxygen Gas Analyzer<br>§870.1425- DQK - Programmable Diagnostic Computer<br>§870.2300- DRT - Cardiac Monitor (Incl. Cardiotachometer and Rate Alarm)<br>§870.2700- DQA- Oximeter Sensor<br>§870.2700- MUD- Oximeter, Tissue Saturation<br>§880.2910- FLL - Clinical Electronic Thermometer<br>§870.1435- DXG - Single-function, Pre-programmed Diagnostic Computer<br>§822.1620- GWM- Intracranial Pressure Monitoring Device | | |
| Predicate Device: | Endeavour Monitoring System/K102004 | | |
Mindray DS USA, Inc. / V Series Monitoring System Monitoring System/ 510(k) Summary
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## K132026 Page 2 of 5
Device Description: The V Series Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows the user to customize monitored parameters based on a patient's need or acuity level. 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 V Series Monitoring System include the monitoring of the following human physiological parameters: -ECG waveform derived from 3, 5, 6 and 12 lead measurements -Heart Rate -Pulse Oximetry (SpO3) -ST Segment Analysis -Arrhythmia Detection -Non Invasive Blood Pressure (NIBP) -Invasive Blood Pressure (IBP) -Cardiac Output (CO) -Respiratory Gasses -Respiration Rate -Temperature The V Series Monitoring System 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 and ST Segment Analysis, for which the target populations are adult and pediatric only, -IV Drug Calculations for which the target population is adult only, and -Cardiac Output for which the target population is adult and pediatric only. The V Series utilizes the following modules for measuring the indicated parameters: ·VPS Module (multi parameter including 3/5/6/12 lead ECG, respiration, pulse oxymetry temperature, non invasive blood pressure and invasive blood pressure) ·Temperature Module ·Invasive Blood Pressure Module Cardiac Output Module · Respiratory Gas Module Technological Comparison to Predicate Device: The V Series Monitoring System is equivalent to predicated device respecting
Mindray DS USA, Inc. / V Series Monitoring System Monitoring System/ 510(k) Summary
indications for use, basic operation, performance specifications and energy
supply.
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The V Series Monitoring System incorporates the new features and non significant system updates relative to the predicate:
- . Alarm Watch
- . Remote View
- V Access .
- . Additional channels for monitoring invasive blood pressure
- Additional channels for monitoring temperature .
- Addition of alternate vendor (Masimo) SpO ي .
- Addition of a serial port V Device Integrator .
- . CO- calibration
- . Module Status Dialogue
- . Connectivity to eGateway
- . Pulmonary Artery Insertion Display
- . Graphic Trends
- . ECG Full Disclosure
- . Events tab
- . Clearing patient history without discharge
- Interface to Camino Intracranial Pressure Monitor .
- Interface to Vigilance/ Vigilance II/Vigileo/EV1000 Monitor .
- VPS Synchronization .
- 21" Display .
- External Module Rack .
- Strip Recorder Module .
- . Interface to Mindray Gas Module III
- Interface to INVOS 5100C Cerebral/Somatic Oximeter �
- . 12 Lead ECG Interpretation
## Summary of Performance Testing:
The V Series Monitoring System has been tested and found to be in compliance with the following recognized performance, safety and electromagnetic compatibility standards:
| IEC 60601-1:1988 +A1:1991 +A2:1995 | Medical electrical Equipment -- General Requirements<br>for Safety |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General<br>requirements for safety - Collateral standard: Safety<br>requirements for medical electrical systems |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General<br>requirements for safety - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests |
Mindray DS USA, Inc. / V Series Monitoring System Monitoring System/ 510(k) Summary
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| IEC 60601-1-4:1996 + A1:1999 | Medical electrical equipment - Part 1-4: General<br>requirements for safety - Collateral standard:<br>Programmable electrical medical systems |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-34:2000 | Medical electrical equipment - Part 2-34: Particular<br>requirements for the safety, including essential<br>performance, of invasive blood pressure<br>monitoring equipment |
| IEC 60601-1-8:2003 +A1 :2006 | Collateral Standard: General requirements, tests<br>and guidance for alarm systems in medical<br>electrical equipment and medical electrical systems |
| IEC 60601-2-27:2005 | Medical electrical equipment, Part 2: Particular<br>requirements for the safety of electrocardiographic<br>monitoring equipment |
| IEC 60601-2-25:1993 + A1:1999 | Medical electrical equipment, Part 2: Particular<br>requirements for the safety of electrocardiographs |
| IEC 60601-2-30:1999 | Medical electrical equipment. Part 2: Particular<br>requirements for the safety, including essential<br>performance, of automatic cycling non-invasive blood<br>pressure monitoring equipment. |
| ISO 10993-1:2003 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing. |
| ISO 15223: 2000 | Medical devices - Symbols to be used with medical<br>device labels, labeling and information to be supplied |
| ISO 14971:2007 | Medical devices -- Application of risk management<br>to medical devices |
| ISO 9919:2005 | Medical electrical equipment - Particular requirements<br>for the basic safety and essential performance of pulse<br>oximeter equipment for medical use |
| ANSPAAMI SP10:2002 + A1:2003 + A2:2006 | Manual, electronic or automated sphygmomanometers |
| ASTM E1112-00 (2006) | Standard Specification for Electronic Thermometers<br>for Intermittent Determination of Patient Temperature |
| EC13: 2002/(R)2007 | Cardiac monitors, heart rate meters, and alarms |
| EC11:1991/(R)2007 | Diagnostic electrocardiographic devices |
| EC57:1998/(R)2003 | Testing and Reporting Performance Results of Cardiac<br>Rhythm and ST-Segment Measurement Algorithms |
Mindray DS USA, Inc. / V Series Monitoring System Monitoring System/ 510(k) Summary
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# K132026 Page 5 of 5
| EN ISO 21647:2004 + Cor 2006 | Medical electrical equipment — Particular requirements for<br>the basic safety and essential performance of respiratory<br>gas monitors |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
### Summary of Clinical Testing: No clinical testing was required to confirm the safety and performance of the new features and non significant modification subject to this 510(k) submission. ﺍ Conclusion: Technological comparison of the V Series Monitoring System relative to the predicate device, compliance with applicable performance, safety and efectromagnetic compatibility standards, the V Series Monitoring System shall be considered substantially equivalent to the legally marketed predicate device (Endeavour Monitoring System / K102004).
Mindray DS USA, Inc. / V Series Monitoring System Monitoring System/ 510(k) Summary
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, representing the department's mission to protect the health of all Americans and provide essential human services. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 20, 2013
Mindray DS USA, Inc. Mr. Russell Olsen Vice President, Quality and Regulatory Affairs 800 Macarthur Blvd Mahwah, NJ 07430
Re: K132026
Trade/Device Name: V Series Monitoring System, 12.1" DCU/V12 and 21.0" DCU/V21 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II (two) Product Code: MHX, DSI, MLD, DSK, DXN, CCK, NHO, CBQ, NHQ, NHP, CBS, CBR, CCL, DQK, DRT, DQA, MUD, FLL, DXG, GWM Dated: November 8, 2013 Received: November 12, 2013
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 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 - Mr. Russell Olsen
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 (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 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 yours,
Owen P. Faris -S
for
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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# K132026 Page 1 of 2
## Indications for Use
510(k) Number (if known):
Device Name: V Series Monitoring System
Indications for Use:
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:
- . ECG waveform derived from 3, 5, 6 and 12 Lead measurements
- . Heart Rate
- . Pulse Oximetry (SpO2)
- ST Segment Analysis ●
- . Arrhythmia Detection
- . Non Invasive Blood Pressure (NIBP)
- Invasive Blood Pressure (IBP) .
- Cardiac Output (CO) .
- . Respiratory Gasses
- . Respiration Rate
- . Temperature
The V Series 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 and ST Segment Analysis, for which the target populations are adult 8 and pediatric only.
- IV Drug Calculations for which the target population is adult only, and 해
- Cardiac Output for which the target population is adult and pediatric only. 트
| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
AND/OR
| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 807 Subpart C) | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
## Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 2
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Indications for Use (continued):
The V Series utilizes the following modules for measuring the indicated parameters:
- VPS Module (multi parameter including 3/5/6/12 lead ECG. respiration, pulse oxymetry . temperature, non invasive blood pressure and invasive blood pressure)
- . Temperature Module
- . Invasive Blood Pressure Module
- Cardiac Output Module .
- . Respiratory Gas Module
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