(214 days)
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.
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"
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, in pediatric and adult patients.
1. A table of acceptance criteria and the reported device performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Heart Rate | ||
| Range | 21 to 249 beats/minute (Predicate Standard) | 20 to 300 beats/minute |
| Accuracy | ± 3 beats/minute or ± 3% whichever is greater | ± 3 beats/minute or ± 3% whichever is greater |
| Bandwidth, Normal Mode | 0.5 to 40 Hz (Predicate Standard) | 0.05 to 70 Hz |
| Alarm Ranges (Low) | Heart Rate Low Limits: 21 to 245 beats/minute | Heart Rate Low Limits: 20 to 300 beats/minute |
| Alarm Ranges (High) | Heart Rate High Limits: 25 to 249 beats/minute | Heart Rate High Limits: 20 to 300 beats/minute |
| Samples per second | 180 samples/sec (Predicate Standard) | 250 samples/sec |
| Respiration Rate | ||
| Range | 5 to 100 breaths/minute | 5 to 100 breaths/minute |
| Accuracy | ± 3 breaths/minute | ± 2 breaths/minute |
| Alarm Ranges (Low) | Respiration Low limits: 5 to 100 breaths/minute | Respiration Low limits: 5 to 100 breaths/minute |
| Alarm Ranges (High) | Respiration High limits: 5 to 100 breaths/minute | Respiration High limits: 5 to 100 breaths/minute |
| Arrhythmia Detection | ||
| Types Detected | Asystole, Ventricular tachycardia, Ventricular Fibrillation (Predicate Standard) | Asystole, Ventricular tachycardia, Ventricular Fibrillation |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance. It refers to the use of ANSI/AAMI EC57:2012 "Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms" for evaluating the arrhythmia algorithms. This standard typically involves testing against standardized arrhythmia databases, but the specific details of the test set used (e.g., its size, origin, and whether it was retrospective or prospective) are not provided in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not specify the number of experts or their qualifications for establishing the ground truth of any test sets. The mention of ANSI/AAMI EC57:2012 suggests that ground truth would likely be established based on accepted labeled arrhythmia databases, but no details are given regarding expert involvement in this specific context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The submission states, "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This indicates that no studies involving human readers, with or without AI assistance, were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was conducted. The document states that 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'". This standard is for evaluating the performance of the algorithms themselves, without human readers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the reference to ANSI/AAMI EC57:2012, the ground truth for the arrhythmia detection algorithms would likely be derived from a standardized arrhythmia database, which typically uses expert-annotated ECG recordings, forming a type of expert consensus ground truth. However, the document does not explicitly state the type of ground truth used for this specific evaluation.
8. The sample size for the training set
The document does not specify the sample size for the training set of the algorithms.
9. How the ground truth for the training set was established
The document does not specify how the ground truth for the training set was established.
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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
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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
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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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[As described in 21 CFR 807.92]
| Submitted by: | Global Instrumentation LLC.8104 Cazenovia RoadManlius, NY 13104 USA |
|---|---|
| Contact Person: | Craig SellersRegulatory Affairs ManagerPhone: (315) 682-0272 Ext. 120Fax: (315) 685-0278E-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 (includingST segment Measurement and alarm)Classification Product Code – DUKSubsequent 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 K984033Acuity Central Monitoring Station(Supplemental Predicate Device)Arrhythmia Detector and Alarm (including ST-segmentmeasurement and alarm)Product Code - DSIWelch Allyn, Inc.510(k) Number K120774 |
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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"
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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
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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.
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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 (includingCardiotachometer and rate alarm) | 870.2300 Cardiac monitor (includingCardiotachometer and rate alarm) | Same |
| Indications for Use | The indications for use for the AtlasMonitor, include the monitoring of thefollowing human physiological vital signs:Blood Oxygenation (SpO2) measurement,ECG waveform derived from 3 or 5 leadmeasurement, Respiration rate/waveformderived from ECG or CO2, Temperaturemeasurement via YSI 400 series probes,Noninvasive Blood Pressure (NIBP)measurement, CO2, End tidal sidestream/waveform (ETCO2), Heart Ratederived from selected source (ECG,SpO2).The target populations are adult andpediatric populations. The monitor isintended for use within the healthcarefacility setting. | The Matrix Mini ECG Monitor isintended for continuous measurement ofheart rate, respiration rate, and detectionof cardiac standstill (asystole),ventricular tachycardia and ventricularfibrillation in general medical andsurgical floors, general hospital andprofessional healthcare environments.The system is indicated for use inpediatric and adult patients. | SimilarThe Matrix Mini ECG Monitor isequivalent to the Atlas Monitor(K984033) in ECG, Respiration andheart rate parameter performance.The target populations are the same.Some functions are removed sincethe subject device is only for heartrate, respiration rate, and detectionof cardiac standstill (asystole),ventricular tachycardia andventricular fibrillationThe Matrix Mini ECG arrhythmiaanalysis is limited to cardiacstandstill (asystole), ventriculartachycardia and ventricular |
| Characteristic | Predicate Devices | Subject Device | Differences |
| fibrillation. This is equivalent toprimary predicate in conjunctionwith Welch Allyn Acuity CentralMonitoring Station (K120774). | |||
| Target Population | Adult and pediatric populations | Pediatric and adult patients of anygender. | Same |
| Where Used | The monitor is intended for use within thehealthcare facility setting. | The product is intended for use in aclinical environment general medical andsurgical floors, general hospital, andprofessional healthcare environments. | Similar - more detail added todescription. |
| Design | Multiparameter device used to monitorhuman physiological vital signs. | Multiparameter device used to monitorECG and respiration humanphysiological vital signs. | SimilarMatrix Mini ECG monitor providesthe same functions for ECG, heartrate, and respiration parametersderived from ECG electrodes.Matrix Mini does not providemonitoring for temperature, SpO2,CO2, NIBP or ETCO2.The Matrix Mini provides the sameECG, heart rate, and respirationparameters that is provided by thepredicate devices. For ECG andrespiration parameters, the MatrixMini is equivalent to the predicatedevices. |
| Technologies | ECG and ECG respiration sensing withconventional patient skin surface appliedECG/Respirationelectrodes.data | ECG and ECG respiration sensing withconventional patient skin surface appliedelectrodes. ECG/Respiration data | Same |
| Characteristic | Predicate Devices | Subject Device | Differences |
| acquisition performed with solid stateamplifiers, analog to digital converter andprocessing of data controlled bymicroprocessor/microcontroller. Data isconverted from analog to digital formatand digital data is then processed andanalyzed. Microcontroller based systemprovides electronic user interface withalarm functions, electronic waveformdisplays and numeric data display. Internalbattery power supply. External AC powersupply/battery charging. | acquisition performed with solid stateamplifiers, analog to digital converter andprocessing of data controlled bymicroprocessor/microcontroller. Data isconverted from analog to digital formatand digital data is then processed andanalyzed. Microcontroller based systemprovides electronic user interface withalarm functions, electronic waveformdisplays and numeric data display.Internal battery power supply. ExternalAC power supply/battery charging. | Similar | |
| Heart Rate Range | 21 to 249 beats/minute | 20 to 300 beats/minute | SimilarMatrix Mini detects wider range ofheart rates. This will provideperformance that is equal to, orbetter than, that of the predicatedevices. |
| Heart Rate Accuracy | $\pm$ 3 beats/minute or $\pm$ 3% whichever isgreater | $\pm$ 3 beats/minute or $\pm$ 3% whichever isgreater | Same |
| Bandwidth, NormalMode | 0.5 to 40 Hz | 0.05 to 70 Hz | SimilarMatrix Mini has wider range offrequency response bandwidth. Thiswill provide performance that isequal to, or better than, that of thepredicate devices. |
| Leads | 3 wire or 5 wire, available in AHA or IECcolors | 3 wire or 5 wire, available in AHA or IECcolors | Same |
| Electrodes | Disposable snap electrodes applied topatient skin surface | Disposable snap electrodes applied to | Same |
| Characteristic | Predicate Devices | Subject Device | Differences |
| patient skin surface. | |||
| Gain | 10 mm/mV, adjustable, visual scaleindicator | 10 mm/mV, adjustable, visual scaleindicator | 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 waveformdisplay | One row minimum of ECG waveformdisplay | Same |
| Leads Off Condition | Detected and displayed (selected leadonly) | Detected and displayed (selected leadonly) | Same |
| Heart Rate Alarms | High and Low Heart Rate | High and Low Heart Rate | Same |
| Alarm Ranges | Heart Rate Low Limits: 21 to 245beats/minute Heart Rate High Limits: 25to 249 beats/minute | Heart Rate Low Limits: 20 to 300beats/minute Heart Rate High Limits: 20to 300 beats/minute | SimilarMatrix Mini supports a wider rangeof alarm limits. This ensuresperformance in this area is equal to,or better than, that of the predicatedevices. |
| Data AcquisitionTechnique | 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 | SimilarMatrix Mini has higher samplingrate. This will provide data qualitythat is equal to, or better than, that ofthe 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 Recoveryper EC13:1992 Clause3.1.2.1a) | 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/LeadOff Detection Current | 50nA max for RA, LA, LL, V; 200nAmax for RL | 50nA max for RA, LA, LL, V; 200nAmax for RL | Same |
| ECG RespirationMeasurementTechnique | 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 RespirationAccuracy | $\pm$ 3 breaths/minute | $\pm$ 2 breaths/minute | SimilarMatrix Mini has better accuracy.This ensures performance in thisarea is equal to, or better than, thatof the predicate devices. |
| Respiration Alarms | High and Low Respiration Rate | High and Low Respiration Rate | Same |
| Respiration AlarmRanges | Respiration Low limits: 5 to 100breaths/minute Respiration High limits: 5to 100 breaths/minute | Respiration Low limits: 5 to 100breaths/minute Respiration High limits: 5to 100 breaths/minute | Same |
| Respiration RateDisplay | 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 comparisonto 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 Miniboth include DSI product code. |
| Regulation Name | 870.1025, Arrhythmia Detector and Alarm(including ST-segment measurement andalarm) | 870.2300 Cardiac monitor (includingCardiotachometer and rate alarm) | Acuity and Matrix Mini ECGMonitor both provide ECG analysisand detection of waveforms to detectthe following arrhythmia: asystole,ventricular tachycardia, andventricular fibrillation. |
| Indications for Use | The Acuity Central Monitoring Station isintended to be used by clinicians for thecentral monitoring of neonatal, pediatric,and adult patients in health care facilities.In addition to the central monitoring ofpatient data, waveforms, alarms and alerts,The Acuity software can includeoperational modules to provide extendedrecording of patient data (Full Disclosure),arrhythmia monitoring and ST analysis.* Full disclosure stores patient data for upto 96 hours* Arrhythmia monitoring module providesreal-time monitoring and alarms forspecific changes in cardiac rhythms. The | The Matrix Mini ECG Monitor isintended for continuous measurement ofheart rate, respiration rate, and detectionof cardiac standstill (asystole),ventricular tachycardia and ventricularfibrillation in general medical andsurgical floors, general hospital and | SimilarThe Matrix Mini ECG Monitor isequivalent to the Atlas Monitor inECG, Respiration and heart rateparameter performance.The target populations are the same.Some functions removed since thesubject device is only for ECG.The Matrix Mini ECG Monitorincludes arrhythmia analysis that islimited to cardiac standstill(asystole), ventricular tachycardiaand ventricular fibrillation. This isequivalent to the Atlas primarypredicate (K984033) in conjunctionwith the arrhythmia monitoring |
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| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| clinician is responsible for determining theclinical significance of each detectedarrhythmia event or alarm. The arrhythmiamodule is not intended for use withneonatal patients. | module functions of the Welch AllynAcuity Central Monitoring Station.(K120774) | ||
| * ST analysis module provides real-timemonitoring and alarms for ST segmentdeviations, from a reference beat, forpatients with suspected heart disease andanomalies. The clinician is responsible fordetermining the clinical significance ofeach selected ST segment deviation oralarm.The ST analysis module is not intendedfor use with neonatal patients. | |||
| Target Population | Adult and pediatric populations (for thearrhythmia module) which provides theasystole, ventricular tachycardia andventricular fibrillation arrhythmia analysis. | Pediatric and adult patients of anygender. | SameThe arrhythmia module of the AllynAcuity Central Monitoring Station isintended for pediatric and adultpatients. The arrhythmia module ofis not intended for use with neonatalpatients. |
| Where Used | The product is intended for use withinhealthcare facilities. | The product is intended for use in aclinical environment general medical andsurgical floors, general hospital, andprofessional healthcare environments. | Similar – more detail added todescription for Matrix Mini. Nosignificant difference betweenMatrix 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 monitorhuman physiological vital signs includingdetection of ECG Arrhythmias includingasystole, ventricular tachycardia, andventricular fibrillation. | Multiparameter device used to monitorECG and respiration humanphysiological vital signs. | SimilarMatrix Mini does not providemonitoring for temperature, SpO2,CO2, NIBP or ETCO2.The Matrix Mini ECG monitor doesnot perform ST analysis.Matrix Mini ECG monitor has thesame design functions as thepredicate devices for ECG, heartrate, and respiration parametersderived from ECG electrodes,including detection of asystole,ventricular tachycardia, andventricular fibrillation. |
| Technologies | Uses software running on computerhardware to monitor and analyze digitalpatient physiological data. Uses personalcomputer technologies to provide userinterface to system. Supports optionalnetwork and printer connections. | Uses software running on computerhardware to monitor and analyze digitalpatient physiological data. Uses personalcomputer technologies to provide userinterface to system. Supports optionalnetwork and printer connections. | Same |
| Heart Rate Arrhythmiadetection | Asystole, Ventricular tachycardia andVentricular Fibrillation | Asystole, Ventricular tachycardia andVentricular Fibrillation | Same |
{17}------------------------------------------------
| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| ST analysis | Yes | No | ST analysis is not required by MatrixMini ECG monitor indications foruse.Matrix Mini ECG Monitorarrhythmia detection limited toasystole, ventricular tachycardia andventricular fibrillation. |
| Alarms | Can configure, observe, and respond to analarm condition. | Can configure, observe, and respond to analarm condition. | Same |
| Heart Rate Arrhythmiaalarm 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 wirelessand hardwired patient monitors for patientdata | Matrix Mini ECG Monitor is a hardwiredpatient monitor for patient data. Connectsdirectly to patient. | SimilarThe Matrix Mini ECG monitorprovides for monitoring of thepatient at the patient location using ahardwired interface. The MatrixMini ECG monitor does not providefor remote monitoring of the patient.The Matrix Mini ECG monitorprovides all required information atthe patient location. |
| Logs | Waveform and Error logs | Waveform and Error logs | Same |
| Logging capability | Yes-logs a variety of informationincluding alarms, alerts, connection and | Yes-logs a variety of informationincluding alarms, alerts, connection and | Same |
{18}------------------------------------------------
| Characteristic | Predicate Devices | Subject Device | Differences |
|---|---|---|---|
| disconnection of monitors, significantactions by clinicians, etc. Logs provide anaudit trail for system failures and customercomplaints. System can be set to capturemore information for troubleshooting. | disconnection of monitors, significantactions by clinicians, etc. Logs providean audit trail for system failures andcustomer complaints. System can be setto capture more information fortroubleshooting. | ||
| Full disclosure datastorage | Up to 96 hours available to customers | Up to 96 hours available to customers | Same |
| Data interfaces topatient data acquisitiondevice | RS232 and optional network connections | USB | SimilarThe Matrix Mini ECG monitor doesnot support use of wireless or remotemonitoring of the patient. TheMatrix Mini uses a hard wired serialdata interface (USB) which is asreliable, or more reliable, than thedata interfaces used by the predicatedevices. The subject deviceperformance in this area is as goodas, or better than, that of thepredicate device. |
| Optional data interfaces | Optional network connections to externaldevices such as printers. | Optional network connections to externaldevices such as printers. | Same |
§ 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.