(172 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 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 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.
The Mindray V Series Monitoring System is a multi-physiological parameter patient monitor. The summary provided does not include specific acceptance criteria values or detailed study results for each parameter. Instead, it states that the device has been tested and found to be in compliance with recognized performance, safety, and electromagnetic compatibility standards.
However, based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not list specific numerical acceptance criteria (e.g., accuracy ranges for SpO2, NIBP, etc.) or quantitative performance results for each physiological parameter. Instead, it states that the device was found "to be in compliance with the following recognized performance, safety and electromagnetic compatibility standards." The listed standards implicitly define the acceptance criteria for each measurement type. For instance, ISO 9919:2005 for pulse oximetry, ANSPAAMI SP10:2002 + A1:2003 + A2:2006 for sphygmomanometers, and EC57:1998/(R)2003 for cardiac rhythm and ST-segment measurement algorithms would each contain detailed performance requirements.
Since specific performance values are not given, a table like the one requested cannot be fully constructed directly from the provided text. The "reported device performance" is implicitly that the device meets the requirements of the cited standards.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "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." This implies that performance was likely evaluated through engineering bench testing and adherence to recognized standards, rather than through extensive clinical trials with a specific "test set" of patient data. Therefore, details about sample size for a test set and data provenance (country of origin, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Given that no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set. The validation relies on compliance with established technical standards.
4. Adjudication Method for the Test Set
As no clinical testing with a specific test set was conducted that would require ground truth establishment by experts, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was reported. This device is a physiological monitoring system, not typically an imaging interpretation device where MRMC studies are common for evaluating AI assistance.
6. Standalone Performance Study
The summary focuses on compliance with recognized performance, safety, and electromagnetic compatibility standards (e.g., IEC 60601 series, ISO 9919). This indicates that the device's performance was evaluated independently against these standards without human intervention in the loop for the core measurements. Therefore, a standalone performance study was implicitly done by demonstrating compliance with these technical standards, which outline specific test methods and performance requirements for the algorithm and hardware.
7. Type of Ground Truth Used
The ground truth used for performance validation is the reference methods and specifications defined within the recognized performance standards (e.g., calibrated instruments for NIBP accuracy, known signal generators for ECG parameters, etc.). It's not based on expert consensus, pathology, or outcomes data from a clinical trial in this context.
8. Sample Size for the Training Set
This device is a hardware-based physiological monitoring system. The concept of a "training set" is primarily relevant to machine learning or AI algorithms that "learn" from data. While the device may employ algorithms for signal processing (e.g., arrhythmia detection, ST-segment analysis), the 510(k) summary does not indicate that these algorithms were developed using a specific machine learning "training set" in the modern AI sense. Therefore, no information on training set sample size is provided.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the machine learning context is mentioned or implied, the method for establishing its ground truth is not applicable and not provided. Algorithm development for such devices typically relies on established signal processing techniques validated against known physiological models or benchmark databases, rather than a "training set" with expert-labeled ground truth as seen in diagnostic AI.
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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.800 Mac Arthur BlvdMahwah, New Jersey 07430 | ||
| Contact: | Russell OlsenVice President, Quality and Regulatory AffairsTelephone: 201.995.8391Facsimile: 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 orAlarmsSecondary:§870.1025- DSI - Arrhythmia Detector and Alarm§870.1025- MLD - ST Segment with Alarm Monitor§870.1110- DSK- Blood Pressure Computer§870.1130- DXN - Non-invasive Blood Pressure Measurement System§868.1400- CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase§868.1500- NHO/CBQ/NHQ/NHP - Enflurane Gas Analyzer§868.1620- CBS - Halothane Gas Analyzer§868.1700- CBR - Nitrous Oxide Gas Analyzer§868.1720- CCL - Oxygen Gas Analyzer§870.1425- DQK - Programmable Diagnostic Computer§870.2300- DRT - Cardiac Monitor (Incl. Cardiotachometer and Rate Alarm)§870.2700- DQA- Oximeter Sensor§870.2700- MUD- Oximeter, Tissue Saturation§880.2910- FLL - Clinical Electronic Thermometer§870.1435- DXG - Single-function, Pre-programmed Diagnostic Computer§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 Requirementsfor Safety |
|---|---|
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: Generalrequirements for safety - Collateral standard: Safetyrequirements for medical electrical systems |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: Generalrequirements for safety - Collateral standard: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: Generalrequirements for safety - Collateral standard:Programmable electrical medical systems |
|---|---|
| IEC 60601-2-34:2000 | Medical electrical equipment - Part 2-34: Particularrequirements for the safety, including essentialperformance, of invasive blood pressuremonitoring equipment |
| IEC 60601-1-8:2003 +A1 :2006 | Collateral Standard: General requirements, testsand guidance for alarm systems in medicalelectrical equipment and medical electrical systems |
| IEC 60601-2-27:2005 | Medical electrical equipment, Part 2: Particularrequirements for the safety of electrocardiographicmonitoring equipment |
| IEC 60601-2-25:1993 + A1:1999 | Medical electrical equipment, Part 2: Particularrequirements for the safety of electrocardiographs |
| IEC 60601-2-30:1999 | Medical electrical equipment. Part 2: Particularrequirements for the safety, including essentialperformance, of automatic cycling non-invasive bloodpressure monitoring equipment. |
| ISO 10993-1:2003 | Biological evaluation of medical devices - Part 1:Evaluation and testing. |
| ISO 15223: 2000 | Medical devices - Symbols to be used with medicaldevice labels, labeling and information to be supplied |
| ISO 14971:2007 | Medical devices -- Application of risk managementto medical devices |
| ISO 9919:2005 | Medical electrical equipment - Particular requirementsfor the basic safety and essential performance of pulseoximeter equipment for medical use |
| ANSPAAMI SP10:2002 + A1:2003 + A2:2006 | Manual, electronic or automated sphygmomanometers |
| ASTM E1112-00 (2006) | Standard Specification for Electronic Thermometersfor 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 CardiacRhythm 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 forthe basic safety and essential performance of respiratorygas 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
Page 4-3
§ 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.