(214 days)
No
The summary explicitly states that the algorithms used are "conventional software ECG analysis techniques" and mentions compliance with standards for testing cardiac rhythm algorithms, not AI/ML specific standards or methodologies. There is no mention of training data, test data, or AI/ML specific performance metrics.
No
This device is a diagnostic tool that measures and monitors cardiac activity and respiration; it does not provide therapy.
Yes
Explanation: The device is intended for "detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation," and provides "limited ECG analysis" which are diagnostic functions.
No
The device description explicitly states that the system consists of a display module, a data acquisition module, and an ECG patient cable, all of which are hardware components. While software is used for processing and display, it is part of a larger hardware system.
Based on the provided text, the Matrix Mini ECG Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the continuous measurement of physiological parameters (heart rate, respiration rate, and detection of cardiac events) in vivo (on a living patient).
- Device Description: The description details how the device connects to the patient's skin via electrodes to acquire electrical signals from the heart and lungs. This is a direct interaction with the patient's body.
- Lack of IVD Characteristics: The description does not mention the analysis of biological samples (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the Matrix Mini ECG Monitor is a medical device used for patient monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and alternate professional healthcare environments. The system is indicated for use in pediatric and adult patients.
Product codes
DSI, DRT, BZQ
Device Description
The Matrix Mini ECG Monitor system provides a cardiac monitor which monitors ECG derived heart rate, ECG electrode impedance respiration rate, and specific ECG arrhythmias (including asystole, ventricular tachycardia, and ventricular fibrillation). The Matrix Mini ECG Monitor system consists of a display module, a data acquisition module and an ECG patient cable.
The display module and the data acquisition module are connected together with a USB interface. The data acquisition module is connected to the patient with the ECG patient cable, which is attached to standard ECG electrodes applied to the patient's skin surface.
The display module consists of a tablet computer which provides the graphical display, user interface, data processing, data reporting/review, data communication, alarm, and data storage functions. The data acquisition module provides the patient electrical isolation, interface to ECG skin surface electrodes attached to patient, conversion of analog ECG electrode data to digital data, data processing, and data communication functions. An accessory ECG patient cable is provided to connect the data acquisitions module to standard skin surface ECG electrodes. The accessory ECG patient cables are available in 3 or 5 ECG lead configurations.
The Matrix Mini ECG Monitor provides an ECG heart rate monitor that includes software capable of limited ECG analysis and ECG electrode impedance respiration rate measurement. The Matrix Mini ECG monitor includes the basic functions of the 3 or 5 lead ECG monitoring system hardware standard to a Cardiac Monitor including a Cardiotachometer and rate alarm (product code DRT). The primary predicate device is a cardiac monitor and has a product code of DRT and also provides functions for ECG electrode impedance respiration rate measurement (product code BZQ).
The Matrix Mini ECG Monitor device software can report asystole, ventricular tachycardia and ventricular fibrillation, which may be thought of as arrhythmias, we selected a supplemental predicate device (K120774) with the product code DSI. Both the software device component and hardware components are presented below compared to the currently marketed predicate devices.
The Matrix Mini ECG Monitor uses software to process and display the ECG electrode derived cardiac information to the user. The analog ECG electrode data is acquired and converted to digital data using conventional, well proven, and widely used, electronic digital data acquisition technology. The technology has operational and performance characteristics that comply with IEC 60601-2-27:2011, "Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment". The asystole, ventricular tachycardia and ventricular fibrillation algorithms use conventional software ECG analysis techniques and have been evaluated using ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms"
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
pediatric and adult patients
Intended User / Care Setting
The Matrix Mini monitoring device is a prescription device to be used by authorized health care professionals using standard institutional procedures and standards of care for patient monitoring. Staff training in the operation of the Matrix Mini ECG Monitor device is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' ECG data. Individuals using the Matrix Mini ECG Monitor should be familiar with its operation as described in the manual, and they should understand all warnings and cautions in the manual.
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and professional healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
Global Instrumentation, LLC Craig Sellers Regulatory Affairs Manager 8104 Cazenovia Road Manlius, New York 13104
Re: K152701
Trade/Device Name: Matrix Mini ECG Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI, DRT, BZO Dated: March 14, 2016 Received: March 17, 2016
Dear Craig Sellers:
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 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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K152701
Device Name Matrix Mini ECG Monitor
Indications for Use (Describe)
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and alternate professional healthcare environments. The system is indicated for use in pediatric and adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
[As described in 21 CFR 807.92]
| Submitted by: | Global Instrumentation LLC.
8104 Cazenovia Road
Manlius, NY 13104 USA |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Craig Sellers
Regulatory Affairs Manager
Phone: (315) 682-0272 Ext. 120
Fax: (315) 685-0278
E-mail: craigs@globalinstrumentation.com |
| Date Prepared: | March 14, 2016 |
| Trade Name: | Matrix Mini ECG Monitor |
| Common Name: | Cardiac monitor
(including Cardiotachometer and rate alarm) |
| Classification Reference: | Class II, 870.3247 Cttj { j o kc F gvgevqt"cpf "Creto (including
ST segment Measurement and alarm)
Classification Product Code – DUK
Subsequent Product Codes – DTV, BZQ |
| Predicate Devices: | Atlas Monitor
(Primary Predicate Device)
Cardiac monitor (including Cardiotachometer and rate alarm)
Product Code – DRT (Atlas also includes BZQ function)
Welch Allyn, Inc.
510(k) Number K984033
Acuity Central Monitoring Station
(Supplemental Predicate Device)
Arrhythmia Detector and Alarm (including ST-segment
measurement and alarm)
Product Code - DSI
Welch Allyn, Inc.
510(k) Number K120774 |
4
Description of the Device:
The Matrix Mini ECG Monitor system provides a cardiac monitor which monitors ECG derived heart rate, ECG electrode impedance respiration rate, and specific ECG arrhythmias (including asystole, ventricular tachycardia, and ventricular fibrillation). The Matrix Mini ECG Monitor system consists of a display module, a data acquisition module and an ECG patient cable.
The display module and the data acquisition module are connected together with a USB interface. The data acquisition module is connected to the patient with the ECG patient cable, which is attached to standard ECG electrodes applied to the patient's skin surface.
The display module consists of a tablet computer which provides the graphical display, user interface, data processing, data reporting/review, data communication, alarm, and data storage functions. The data acquisition module provides the patient electrical isolation, interface to ECG skin surface electrodes attached to patient, conversion of analog ECG electrode data to digital data, data processing, and data communication functions. An accessory ECG patient cable is provided to connect the data acquisitions module to standard skin surface ECG electrodes. The accessory ECG patient cables are available in 3 or 5 ECG lead configurations.
The Matrix Mini ECG Monitor provides an ECG heart rate monitor that includes software capable of limited ECG analysis and ECG electrode impedance respiration rate measurement. The Matrix Mini ECG monitor includes the basic functions of the 3 or 5 lead ECG monitoring system hardware standard to a Cardiac Monitor including a Cardiotachometer and rate alarm (product code DRT). The primary predicate device is a cardiac monitor and has a product code of DRT and also provides functions for ECG electrode impedance respiration rate measurement (product code BZQ).
The Matrix Mini ECG Monitor device software can report asystole, ventricular tachycardia and ventricular fibrillation, which may be thought of as arrhythmias, we selected a supplemental predicate device (K120774) with the product code DSI. Both the software device component and hardware components are presented below compared to the currently marketed predicate devices.
The Matrix Mini ECG Monitor uses software to process and display the ECG electrode derived cardiac information to the user. The analog ECG electrode data is acquired and converted to digital data using conventional, well proven, and widely used, electronic digital data acquisition technology. The technology has operational and performance characteristics that comply with IEC 60601-2-27:2011, "Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment". The asystole, ventricular tachycardia and ventricular fibrillation algorithms use conventional software ECG analysis techniques and have been evaluated using ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms"
5
The Matrix Mini monitoring device is a prescription device to be used by authorized health care professionals using standard institutional procedures and standards of care for patient monitoring. Staff training in the operation of the Matrix Mini ECG Monitor device is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' ECG data. Individuals using the Matrix Mini ECG Monitor should be familiar with its operation as described in the manual, and they should understand all warnings and cautions in the manual.
Shelf Life
The product does not have a shelf life. A shelf-life is not applicable because of low likelihood of time-dependent product degradation. The device uses technologies, components and materials that do not significantly change in characteristics with time when used/stored in the specified operating and storage conditions. The materials and technologies utilized ensure that the specified storage, and usage, conditions are not expected to affect device safety or effectiveness
Indications for Use:
The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and professional healthcare facilities. The system is indicated for use in pediatric and adult patients.
Predicate Device Selection
The primary predicate device selected is the Atlas Monitor (Welch Allyn, K984033, Product Code DRT). The Atlas device also provides the function of ECG electrode impedance respiration rate measurement (product code BZQ). A supplemental predicate device selected is the Acuity Central Monitoring Station Monitor (Welch Allyn, K120774, Product Code DSI). The Acuity device includes detection and alarming for asystole, ventricular tachycardia, and ventricular fibrillation arrhythmias. These devices are presently in commercial distribution globally including the United States of America. The Matrix Mini ECG Monitor has similar technological characteristics, indications for use, and performance characteristics as the predicate devices. The Matrix Mini ECG Monitor is similar in design, function and application to the predicate device. All materials and technologies are currently utilized in in other medical devices therefore, no new issues of safety or effectiveness are introduced by using this device.
Technological Characteristics:
The Matrix Mini ECG Monitor (System) uses conventional electronic digital data acquisition techniques to digitize and process ECG signals from skin surface ECG electrodes attached to a patient. The System consists of the Matrix Mini Display Module and the Matrix Mini Acquisition Module which are connected by an electrically isolated USB communication interface. The display module provides the data/waveform display and the user interface functions of the system. The acquisition module acquires the ECG signal from ECG electrodes on the surface of the patient's skin and provides the electrical isolation required to ensure patient safety. Refer to Table 1 at the end of this document for a detailed comparison
6
of the subject device to the predicate device.
The Matrix Mini ECG monitor uses software to process the ECG electrical signals and display the ECG and respiration information to the user. The technology has operational and performance characteristics that comply with IEC 60601-2-27:2011, "Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment" The asystole, ventricular tachycardia and ventricular fibrillation algorithms use conventional software ECG analysis techniques and have been evaluated using ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms"
The Matrix Mini ECG Monitor uses the same technologies as the predicate devices. The Matrix Mini ECG Monitor is technically equivalent to the Atlas Monitor (K984033) and the Acuity Central Monitoring Station (K120774) with respect to technical and performance characteristic including, data storage, patient management, data review, measured physiological parameters and alarm management.
Non-Clinical Tests:
Verification and validation testing was conducted to ensure expected performance of the Matrix Mini FCG Monitor
The Matrix Mini ECG Monitor was also tested to evaluate its safety and effectiveness based on the following standards and guidance documents:
- IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
- ISO 14971: 2007 Medical devices Application of risk management to medical ● devices
- IEC 62304: 2015 - Medical device software - Software life cycle processes
- . ANSI/AAMI EC57:2012 - Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
- ANSI AAMI EC53:2013 - ECG trunk cables and patient leadwires
- . IEC 60601-1-2:2014 - Medical Electrical Equipment - Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test
- . IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- . FDA guidance Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003), was utilized in the planning and conduct of all performance testing.
- FDA Guidance for the Content of Premarket Submissions for ● Software Contained in Medical Devices (May 11, 2005). The device's software has been validated in accordance with this guidance.
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The Matrix Mini ECG Monitor system has been tested and found to be in compliance with the applicable recognized safety, performance and electromagnetic compatibility standards. The standards used are consistent with the standards and testing used for the predicate devices. The results of the testing demonstrate that the device is as safe, as effective, and performs as well as, or better than, the predicates.
Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Conclusion:
Based on the information presented in this 510(k) premarket notification, the Global Instrumentation LLC Matrix Mini ECG Monitor is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices cited in this submission.
8
TABLE 1
| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| Device Name | Atlas Monitor (primary predicate device) | Matrix Mini ECG Monitor | N/A |
| Manufacturer | Welch Allyn, Inc., | Global Instrumentation, LLC. | N/A |
| 510(k) Number | K984033 | N/A | N/A |
| Product Code | DRT | DRT, DSI, BZQ | Same |
| Regulation Name | 870.2300 Cardiac monitor (including | ||
| Cardiotachometer and rate alarm) | 870.2300 Cardiac monitor (including | ||
| Cardiotachometer and rate alarm) | Same | ||
| Indications for Use | The indications for use for the Atlas | ||
| Monitor, include the monitoring of the | |||
| following human physiological vital signs: | |||
| Blood Oxygenation (SpO2) measurement, | |||
| ECG waveform derived from 3 or 5 lead | |||
| measurement, Respiration rate/waveform | |||
| derived from ECG or CO2, Temperature | |||
| measurement via YSI 400 series probes, | |||
| Noninvasive Blood Pressure (NIBP) | |||
| measurement, CO2, End tidal side | |||
| stream/waveform (ETCO2), Heart Rate | |||
| derived from selected source (ECG, | |||
| SpO2). | |||
| The target populations are adult and | |||
| pediatric populations. The monitor is | |||
| intended for use within the healthcare | |||
| facility setting. | The Matrix Mini ECG Monitor is | ||
| intended for continuous measurement of | |||
| heart rate, respiration rate, and detection | |||
| of cardiac standstill (asystole), | |||
| ventricular tachycardia and ventricular | |||
| fibrillation in general medical and | |||
| surgical floors, general hospital and | |||
| professional healthcare environments. | |||
| The system is indicated for use in | |||
| pediatric and adult patients. | Similar | ||
| The Matrix Mini ECG Monitor is | |||
| equivalent to the Atlas Monitor | |||
| (K984033) in ECG, Respiration and | |||
| heart rate parameter performance. | |||
| The target populations are the same. | |||
| Some functions are removed since | |||
| the subject device is only for heart | |||
| rate, respiration rate, and detection | |||
| of cardiac standstill (asystole), | |||
| ventricular tachycardia and | |||
| ventricular fibrillation | |||
| The Matrix Mini ECG arrhythmia | |||
| analysis is limited to cardiac | |||
| standstill (asystole), ventricular | |||
| tachycardia and ventricular | |||
| Characteristic | Predicate Devices | Subject Device | Differences |
| fibrillation. This is equivalent to | |||
| primary predicate in conjunction | |||
| with Welch Allyn Acuity Central | |||
| Monitoring Station (K120774). | |||
| Target Population | Adult and pediatric populations | Pediatric and adult patients of any | |
| gender. | Same | ||
| Where Used | The monitor is intended for use within the | ||
| healthcare facility setting. | The product is intended for use in a | ||
| clinical environment general medical and | |||
| surgical floors, general hospital, and | |||
| professional healthcare environments. | Similar - more detail added to | ||
| description. | |||
| Design | Multiparameter device used to monitor | ||
| human physiological vital signs. | Multiparameter device used to monitor | ||
| ECG and respiration human | |||
| physiological vital signs. | Similar | ||
| Matrix Mini ECG monitor provides | |||
| the same functions for ECG, heart | |||
| rate, and respiration parameters | |||
| derived from ECG electrodes. | |||
| Matrix Mini does not provide | |||
| monitoring for temperature, SpO2, | |||
| CO2, NIBP or ETCO2. | |||
| The Matrix Mini provides the same | |||
| ECG, heart rate, and respiration | |||
| parameters that is provided by the | |||
| predicate devices. For ECG and | |||
| respiration parameters, the Matrix | |||
| Mini is equivalent to the predicate | |||
| devices. | |||
| Technologies | ECG and ECG respiration sensing with | ||
| conventional patient skin surface applied | |||
| ECG/Respiration | |||
| electrodes. | |||
| data | ECG and ECG respiration sensing with | ||
| conventional patient skin surface applied | |||
| electrodes. ECG/Respiration data | Same | ||
| Characteristic | Predicate Devices | Subject Device | Differences |
| acquisition performed with solid state | |||
| amplifiers, analog to digital converter and | |||
| processing of data controlled by | |||
| microprocessor/microcontroller. Data is | |||
| converted from analog to digital format | |||
| and digital data is then processed and | |||
| analyzed. Microcontroller based system | |||
| provides electronic user interface with | |||
| alarm functions, electronic waveform | |||
| displays and numeric data display. Internal | |||
| battery power supply. External AC power | |||
| supply/battery charging. | acquisition performed with solid state | ||
| amplifiers, analog to digital converter and | |||
| processing of data controlled by | |||
| microprocessor/microcontroller. Data is | |||
| converted from analog to digital format | |||
| and digital data is then processed and | |||
| analyzed. Microcontroller based system | |||
| provides electronic user interface with | |||
| alarm functions, electronic waveform | |||
| displays and numeric data display. | |||
| Internal battery power supply. External | |||
| AC power supply/battery charging. | Similar | ||
| Heart Rate Range | 21 to 249 beats/minute | 20 to 300 beats/minute | Similar |
| Matrix Mini detects wider range of | |||
| heart rates. This will provide | |||
| performance that is equal to, or | |||
| better than, that of the predicate | |||
| devices. | |||
| Heart Rate Accuracy | $\pm$ 3 beats/minute or $\pm$ 3% whichever is | ||
| greater | $\pm$ 3 beats/minute or $\pm$ 3% whichever is | ||
| greater | Same | ||
| Bandwidth, Normal | |||
| Mode | 0.5 to 40 Hz | 0.05 to 70 Hz | Similar |
| Matrix Mini has wider range of | |||
| frequency response bandwidth. This | |||
| will provide performance that is | |||
| equal to, or better than, that of the | |||
| predicate devices. | |||
| Leads | 3 wire or 5 wire, available in AHA or IEC | ||
| colors | 3 wire or 5 wire, available in AHA or IEC | ||
| colors | Same | ||
| Electrodes | Disposable snap electrodes applied to | ||
| patient skin surface | Disposable snap electrodes applied to | Same | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| patient skin surface. | |||
| Gain | 10 mm/mV, adjustable, visual scale | ||
| indicator | 10 mm/mV, adjustable, visual scale | ||
| indicator | Same | ||
| Lead Display | Single, user selectable: I, II, III, V | Single, user selectable: I, II, III, V | Same |
| Heart Rate Display | Numeric | Numeric | Same |
| Waveform Display | One row minimum of ECG waveform | ||
| display | One row minimum of ECG waveform | ||
| display | Same | ||
| Leads Off Condition | Detected and displayed (selected lead | ||
| only) | Detected and displayed (selected lead | ||
| only) | Same | ||
| Heart Rate Alarms | High and Low Heart Rate | High and Low Heart Rate | Same |
| Alarm Ranges | Heart Rate Low Limits: 21 to 245 | ||
| beats/minute Heart Rate High Limits: 25 | |||
| to 249 beats/minute | Heart Rate Low Limits: 20 to 300 | ||
| beats/minute Heart Rate High Limits: 20 | |||
| to 300 beats/minute | Similar | ||
| Matrix Mini supports a wider range | |||
| of alarm limits. This ensures | |||
| performance in this area is equal to, | |||
| or better than, that of the predicate | |||
| devices. | |||
| Data Acquisition | |||
| Technique | Analog to Digital Convertor | Analog to Digital Convertor | Same |
| Characteristic | Predicate Devices | Subject Device | Differences |
| Samples per second | |||
| (sample rate) | 180 samples/sec | 250 samples/sec | Similar |
| Matrix Mini has higher sampling | |||
| rate. This will provide data quality | |||
| that is equal to, or better than, that of | |||
| the predicate devices. | |||
| Input Impedance | >2.5 Megohms at 10Hz | >2.5 Megohms at 10Hz | Same |
| Input Protection | Defibrillator and Electrosurgery protected | Defibrillator and Electrosurgery protected | Same |
| Defibrillator Recovery | |||
| per EC13:1992 Clause | |||
| 3.1.2.1a) | Yes | Yes | Same |
| Pacemaker Display | Pacemaker signals displayed as captured. | Pacemaker signals displayed as captured. | Same |
| Pacemaker Detection | Yes | Yes | Same |
| Pacemaker Reject | Yes | Yes | Same |
| Lead Off Detection | Yes | Yes | Same |
| ECG Respiration/Lead | |||
| Off Detection Current | 50nA max for RA, LA, LL, V; 200nA | ||
| max for RL | 50nA max for RA, LA, LL, V; 200nA | ||
| max for RL | Same | ||
| ECG Respiration | |||
| Measurement | |||
| Technique | Trans-thoracic impedance | Trans-thoracic impedance | Same |
| ECG Respiration # | |||
| Leads | Single | Single | Same |
| ECG Respiration Range | 5 to 100 breaths/minute | 5 to 100 breaths/minute | Same |
| Characteristic | Predicate Devices | Subject Device | Differences |
| ECG Respiration | |||
| Accuracy | $\pm$ 3 breaths/minute | $\pm$ 2 breaths/minute | Similar |
| Matrix Mini has better accuracy. | |||
| This ensures performance in this | |||
| area is equal to, or better than, that | |||
| of the predicate devices. | |||
| Respiration Alarms | High and Low Respiration Rate | High and Low Respiration Rate | Same |
| Respiration Alarm | |||
| Ranges | Respiration Low limits: 5 to 100 | ||
| breaths/minute Respiration High limits: 5 | |||
| to 100 breaths/minute | Respiration Low limits: 5 to 100 | ||
| breaths/minute Respiration High limits: 5 | |||
| to 100 breaths/minute | Same | ||
| Respiration Rate | |||
| Display | Numeric | Numeric | Same |
| ECG analysis and detection of limited arrhythmias similar to Acuity (K120774 supplemental predicate) | |||
| in conjunction with the Atlas Monitor (K984033 primary predicate). The below provides the comparison | |||
| to K120774. | |||
| Device Name | Acuity Central Monitoring Station | ||
| (supplemental predicate device) | Matrix Mini ECG Monitor | N/A | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| Manufacturer | Welch Allyn, Inc., | Global Instrumentation, LLC. | N/A |
| 510(k) Number | K120774 | N/A | N/A |
| Product Code | DSI | DRT, DSI, BZQ | Similar, Acuity and Matrix Mini |
| both include DSI product code. | |||
| Regulation Name | 870.1025, Arrhythmia Detector and Alarm | ||
| (including ST-segment measurement and | |||
| alarm) | 870.2300 Cardiac monitor (including | ||
| Cardiotachometer and rate alarm) | Acuity and Matrix Mini ECG | ||
| Monitor both provide ECG analysis | |||
| and detection of waveforms to detect | |||
| the following arrhythmia: asystole, | |||
| ventricular tachycardia, and | |||
| ventricular fibrillation. | |||
| Indications for Use | The Acuity Central Monitoring Station is | ||
| intended to be used by clinicians for the | |||
| central monitoring of neonatal, pediatric, | |||
| and adult patients in health care facilities. | |||
| In addition to the central monitoring of | |||
| patient data, waveforms, alarms and alerts, | |||
| The Acuity software can include | |||
| operational modules to provide extended | |||
| recording of patient data (Full Disclosure), | |||
| arrhythmia monitoring and ST analysis. |
- Full disclosure stores patient data for up
to 96 hours - Arrhythmia monitoring module provides
real-time monitoring and alarms for
specific changes in cardiac rhythms. The | The Matrix Mini ECG Monitor is
intended for continuous measurement of
heart rate, respiration rate, and detection
of cardiac standstill (asystole),
ventricular tachycardia and ventricular
fibrillation in general medical and
surgical floors, general hospital and
| Similar
The Matrix Mini ECG Monitor is
equivalent to the Atlas Monitor in
ECG, Respiration and heart rate
parameter performance.
The target populations are the same.
Some functions removed since the
subject device is only for ECG.
The Matrix Mini ECG Monitor
includes arrhythmia analysis that is
limited to cardiac standstill
(asystole), ventricular tachycardia
and ventricular fibrillation. This is
equivalent to the Atlas primary
predicate (K984033) in conjunction
with the arrhythmia monitoring |
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| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| clinician is responsible for determining the | |||
| clinical significance of each detected | |||
| arrhythmia event or alarm. The arrhythmia | |||
| module is not intended for use with | |||
| neonatal patients. | module functions of the Welch Allyn | ||
| Acuity Central Monitoring Station. | |||
| (K120774) | |||
| * ST analysis module provides real-time | |||
| monitoring and alarms for ST segment | |||
| deviations, from a reference beat, for | |||
| patients with suspected heart disease and | |||
| anomalies. The clinician is responsible for | |||
| determining the clinical significance of | |||
| each selected ST segment deviation or | |||
| alarm. | |||
| The ST analysis module is not intended | |||
| for use with neonatal patients. | |||
| Target Population | Adult and pediatric populations (for the | ||
| arrhythmia module) which provides the | |||
| asystole, ventricular tachycardia and | |||
| ventricular fibrillation arrhythmia analysis. | Pediatric and adult patients of any | ||
| gender. | Same | ||
| The arrhythmia module of the Allyn | |||
| Acuity Central Monitoring Station is | |||
| intended for pediatric and adult | |||
| patients. The arrhythmia module of | |||
| is not intended for use with neonatal | |||
| patients. | |||
| Where Used | The product is intended for use within | ||
| healthcare facilities. | The product is intended for use in a | ||
| clinical environment general medical and | |||
| surgical floors, general hospital, and | |||
| professional healthcare environments. | Similar – more detail added to | ||
| description for Matrix Mini. No | |||
| significant difference between | |||
| Matrix Mini and predicate devices. | |||
| All devices are intended for use |
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| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| within healthcare facilities. | |||
| Design | Multiparameter device used to monitor | ||
| human physiological vital signs including | |||
| detection of ECG Arrhythmias including | |||
| asystole, ventricular tachycardia, and | |||
| ventricular fibrillation. | Multiparameter device used to monitor | ||
| ECG and respiration human | |||
| physiological vital signs. | Similar | ||
| Matrix Mini does not provide | |||
| monitoring for temperature, SpO2, | |||
| CO2, NIBP or ETCO2. | |||
| The Matrix Mini ECG monitor does | |||
| not perform ST analysis. | |||
| Matrix Mini ECG monitor has the | |||
| same design functions as the | |||
| predicate devices for ECG, heart | |||
| rate, and respiration parameters | |||
| derived from ECG electrodes, | |||
| including detection of asystole, | |||
| ventricular tachycardia, and | |||
| ventricular fibrillation. | |||
| Technologies | Uses software running on computer | ||
| hardware to monitor and analyze digital | |||
| patient physiological data. Uses personal | |||
| computer technologies to provide user | |||
| interface to system. Supports optional | |||
| network and printer connections. | Uses software running on computer | ||
| hardware to monitor and analyze digital | |||
| patient physiological data. Uses personal | |||
| computer technologies to provide user | |||
| interface to system. Supports optional | |||
| network and printer connections. | Same | ||
| Heart Rate Arrhythmia | |||
| detection | Asystole, Ventricular tachycardia and | ||
| Ventricular Fibrillation | Asystole, Ventricular tachycardia and | ||
| Ventricular Fibrillation | Same |
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| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| ST analysis | Yes | No | ST analysis is not required by Matrix |
| Mini ECG monitor indications for | |||
| use. | |||
| Matrix Mini ECG Monitor | |||
| arrhythmia detection limited to | |||
| asystole, ventricular tachycardia and | |||
| ventricular fibrillation. | |||
| Alarms | Can configure, observe, and respond to an | ||
| alarm condition. | Can configure, observe, and respond to an | ||
| alarm condition. | Same | ||
| Heart Rate Arrhythmia | |||
| alarm settings | Yes | Yes | Same |
| Alarm review | Yes | Yes | Same |
| Waveform display | Yes - ECG waveforms | Yes - ECG waveforms | Same |
| Patient Data Source | Central station interfaces with wireless | ||
| and hardwired patient monitors for patient | |||
| data | Matrix Mini ECG Monitor is a hardwired | ||
| patient monitor for patient data. Connects | |||
| directly to patient. | Similar | ||
| The Matrix Mini ECG monitor | |||
| provides for monitoring of the | |||
| patient at the patient location using a | |||
| hardwired interface. The Matrix | |||
| Mini ECG monitor does not provide | |||
| for remote monitoring of the patient. | |||
| The Matrix Mini ECG monitor | |||
| provides all required information at | |||
| the patient location. | |||
| Logs | Waveform and Error logs | Waveform and Error logs | Same |
| Logging capability | Yes-logs a variety of information | ||
| including alarms, alerts, connection and | Yes-logs a variety of information | ||
| including alarms, alerts, connection and | Same |
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| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| disconnection of monitors, significant | |||
| actions by clinicians, etc. Logs provide an | |||
| audit trail for system failures and customer | |||
| complaints. System can be set to capture | |||
| more information for troubleshooting. | disconnection of monitors, significant | ||
| actions by clinicians, etc. Logs provide | |||
| an audit trail for system failures and | |||
| customer complaints. System can be set | |||
| to capture more information for | |||
| troubleshooting. | |||
| Full disclosure data | |||
| storage | Up to 96 hours available to customers | Up to 96 hours available to customers | Same |
| Data interfaces to | |||
| patient data acquisition | |||
| device | RS232 and optional network connections | USB | Similar |
| The Matrix Mini ECG monitor does | |||
| not support use of wireless or remote | |||
| monitoring of the patient. The | |||
| Matrix Mini uses a hard wired serial | |||
| data interface (USB) which is as | |||
| reliable, or more reliable, than the | |||
| data interfaces used by the predicate | |||
| devices. The subject device | |||
| performance in this area is as good | |||
| as, or better than, that of the | |||
| predicate device. | |||
| Optional data interfaces | Optional network connections to external | ||
| devices such as printers. | Optional network connections to external | ||
| devices such as printers. | Same |