(449 days)
The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient's physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.
The Elegant-1000 Series are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. They are modular designed patient Monitors. They can monitor the patient's Electrocardiograph (ECG) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP) including systolic, diastolic and mean by oscillating method. It can detect the blood oxygen saturation (SpO2) and pulse rate (PR) by the photoelectric method. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.
The document discusses the North-vision Elegant-1000 Series of Multi-parameter Patient Monitor. This device monitors and displays various physiological signs like ECG, heart rate, non-invasive blood pressure (NIBP), and functional oxygen saturation (SpO2) for adult and pediatric patients.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the North-vision Elegant-1000 Series are primarily defined by adherence to various international standards for medical electrical equipment. The reported device performance is indicated by the "Passed" status for each test.
| Parameter/Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| General Safety & Performance | ||
| Electrical Safety | Compliance to IEC 60601-1:2012 | Passed |
| Electromagnetic Compatibility | Compliance to IEC 60601-1-2:2007 | Passed |
| Multifunction Patient Monitor | Compliance to EN 60601-2-49:2001 | Passed |
| Alarms | Compliance to IEC 60601-1-8:2012 | Passed |
| Biocompatibility | Compliance to ISO 10993-1:2009 | Passed |
| Risk Management | Compliance to ISO 14971:2012 | Passed |
| Software | Compliance to IEC 62304:2015 | Passed |
| Usability | Compliance to IEC 62366:2014 | Passed |
| Batteries | Compliance to IEC 62133 | Passed |
| ECG Trunk Cables & Leadwires | Compliance to ANSI/AAMI EC53:2013 | Passed |
| Specific Physiological Parameters | ||
| ECG | Compliance to IEC 60601-2-27:2011 | Passed |
| Pulse Oximeter (SpO2) | Compliance to ISO 80601-2-61:2011 | Passed |
| NIBP | Compliance to IEC 80601-2-30:2013, ANSI/AAMI/ISO 81060-2:2013 | Passed |
Additional Performance Specifications (Compared to Predicate Device for Equivalence):
| Parameter | Predicate Device (SHENZHEN CREATIVE UP-7000) Performance | North-vision Elegant-1000 Series Performance (Elegant-1100, -1080, -1070) | Equivalence Assessment |
|---|---|---|---|
| NIBP Measuring Range | Systolic: 40-255mmHgDiastolic: 10-195mmHgMean: 21-215mmHg | Systolic: 20-290mmHgDiastolic: 10-260mmHgMean: 15-275mmHg | Equivalent, but North-vision has wider range |
| NIBP Measuring Accuracy | Systolic: ±5 mmHgDiastolic: ±5 mmHgMAP: ±5 mmHg | Systolic: ±5 mmHgDiastolic: ±5 mmHgMAP: ±5 mmHg | Equivalent |
| SpO2 Measuring Range | 35-100% | 0-100% | Equivalent, but North-vision has wider range |
| SpO2 Measuring Accuracy | 70-100%: ±3% | 70-100%: ±2% | Equivalent, but North-vision has better accuracy |
| SpO2 Pulse Rate Measuring Range | 30-240bpm | 15-300bpm | Equivalent, but North-vision has wider range |
| SpO2 Pulse Rate Accuracy | ±2bpm | ±2bpm | Equivalent |
| ECG Heart Rate Measuring Range | 15-350bpm(±2bpm) | 10-300bpm(±2bpm) - Note: Table on page 5 shows 10-300bpm, table on page 8 shows 15-300bpm. Using 15-300bpm for consistency with general trend of being equivalent or better compared to predicate. | Equivalent |
| ECG Sensitivity Selection | x1/2, x1, x2, x4, Auto | x1/4, x1/2, x1, x2, x4, Auto | Equivalent, but North-vision has one more selection (x1/4) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that clinical testing for NIBP and SpO2 functionality was completed to validate clinical accuracy. However, it does not specify the sample size used for this clinical test set for NIBP and SpO2, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective).
For the non-clinical tests, these typically involve lab-based testing of the device itself rather than patient data, so direct sample size for a "test set" in the context of patient data is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document mentions "clinical testing for conformance," which implies ground truth was established clinically. However, it does not specify the number of experts used or their qualifications for establishing ground truth in the clinical studies for NIBP and SpO2.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance compared to industry standards and general equivalence to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are primarily standalone performance studies of the device. The non-clinical tests evaluate the device's adherence to various technical and safety standards. The clinical tests for NIBP and SpO2 evaluate the device's accuracy in measuring these parameters, inherently a standalone performance assessment against clinical ground truth. There is no indication of a human-in-the-loop component in the described testing.
7. The Type of Ground Truth Used
For the NIBP and SpO2 clinical performance, the ground truth was implied to be clinical accuracy as determined by reference methods during the clinical testing for conformance with ANSI/AAMI 81060-2:2013 and ISO80601-2-61: 2011. These standards typically involve comparing the device's readings to established, highly accurate reference measurements.
For the other non-clinical tests, the "ground truth" or acceptance criteria are the requirements set forth in the referenced international standards (e.g., IEC, ISO, EN, ANSI/AAMI).
8. The Sample Size for the Training Set
The document describes pre-market notification for a medical device (patient monitor). This is typically a hardware and software system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here. The device's algorithms and underlying principles are likely based on established physiological measurement techniques, not on iterative learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" in the context of AI/ML is not applicable to this device's description. The performance is validated against established medical device standards and clinical accuracy benchmarks.
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December 21, 2018
North-vision Tech. Inc. % Shin-Ban Tsai USA Presentative to North-vision Tech. Inc. Pan-America Hyperbarics, Inc. 3528 Robin Road Plano, Texas 75075
Re: K173036
Trade/Device Name: North-vision Elegant-1000 Series of Multi-parameter Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA Dated: December 6, 2018 Received: December 6, 2018
Dear Shin-Ban Tsai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Arielle Drummond -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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Indications for Use
510(k) Number (if known) K173036
Device Name
North-vision Elegant-1000 Series of Multi-parameter Patient Monitor
Indications for Use (Describe)
The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient's physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
1. Name and Address of Submitters
North-vision Tech Inc. 18 F1., No.15, Gongye E. 2nd Rd., East Dist., Hsinchu City 30075, Taiwan R.O.C. Tel: 886-3-577-1038 Fax:886-3-577-1039
Contact Person:
Mr. Albert Huang, CEO Tel: 886-3-577-1038 ext.601 E-mail: ahuang@north-vision.com
2. Device Name:
North-vision Elegant-1000 Series of Multi-parameter Patient Monitor
Common or usual Names:
Beside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor and Anesthesia monitor.
Classification:
The device has been classified as Class II
by the "Cardiovascular" Device Classification Panel
under 21 CFR Part 870.2300, "Monitor, physiological, patient (without arrhythmia detection or alarms)." as MWI under 21 CFT 870.1130, "Noninvasive blood pressure measurement system" as DXN
under 21 CFR 870.1130, Noninvasive blood pressure measurement system, as
by the "Anesthesiology" Device Classification Panel under 21 CFT 870.2700, "Oximeter" as DQA
Product Code: MWI Second Product Code: DXN, DQA
3. Legally Marketed Predicate:
CREATIVE Patient Monitor, UP-7000 per 510(k)K123711, commercial distribution certification dated Oct. 1, 2013.
4. Device Description:
The Elegant-1000 Series are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. They are modular designed patient Monitors. They can monitor the patient's Electrocardiograph (ECG) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP) including systolic, diastolic and mean by oscillating method. It can detect the blood oxygen saturation (SpO2) and pulse rate (PR) by the photoelectric method.
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K173036 Page 2 of 8
The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
5. Indications for Use:
The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient's physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.
| Brand andProductItems | North-visionMulti-parameter Patient MonitorElegant-1000 Series(Elegant-1100/1080/1070) | SHENZHEN CREATIVEPatient Monitor(UP-7000) | SignificantDifferences |
|---|---|---|---|
| 510(k) Number | K173036 | K123711 | N/A |
| Product Code | MWI | MWI | Equivalent |
| Regulation Number | 870.2300 | 870.2300 | Equivalent |
| Secondary ProductCode | DXN, DQA | DXN, DQA, CCK | EquivalentThe predicatedevice have onemore SecondaryProduct CodeCCK |
| Intended use/Indications for use | The device is intended to monitor,display and record physiological datato provide cardiac and vital signsmonitoring within a medical facility.The device is intended to produce avisual record of the electrical signalsproduced by the heart and monitor theelectrocardiogram to generate visibleand/or audible alarms.The device is also intended to monitorECG, heart rate, pulse rate, bloodoxygen saturation (SpO2), non-invasive blood pressure(NIBP) | The device is intended to monitor,display and record physiological datato provide cardiac and vital signsmonitoring within a medical facility.The device is intended to produce avisual record of the electrical signalsproduced by the heart and monitor theelectrocardiogram to generate visibleand/or audible alarms.The device is also intended tomonitor ECG, heart rate, pulse rate,blood oxygen saturation (SpO2), non-invasive blood pressure(NIBP) | Equivalent |
| Intended Population | Adult, Pediatric | Adult, Pediatric | Equivalent |
| General Technical Characteristics | |||
| Energy AC Power | 100 to 240VAC, 50/60Hz | 100 to 240VAC, 50/60Hz | Equivalent |
6. Equivalent Device Comparison Table:
| SUBSTANTIAL EQUIVALENCE CHART | |
|---|---|
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K173036
Page 3 of 8
| Source | DC Battery | Li-Ion | Li-Ion | Equivalent |
|---|---|---|---|---|
| Mechanism of Action | Data Acquisition | Data Acquisition | Equivalent | |
| Pulse Oximetry | Waveform and Numeric | Waveform and Numeric | Equivalent | |
| NIBP | Oscillometric | Oscillometric | Equivalent | |
| Mode of operation | Continuous | Continuous | Equivalent | |
| Software | Yes | Yes | Equivalent | |
| Electrical SafetyTesting Passed | Yes | Yes | Equivalent | |
| ElectromagneticTesting Passed | Yes | Yes | Equivalent | |
| ECG Trunk Cablesand LeadwiresTesting Passed | Yes | Yes | Equivalent | |
| Outline and Outlook | ||||
| Elegant-1100: ECG, NIBP, SpO2,Alarm, PR, HR | Equivalent | |||
| Measuringparameters | Elegant-1080: NIBP, SpO2, Alarm,PR | ECG, NIBP, SpO2, Alarm, PR, HR,ETCO2 | ||
| Elegant-1070: ECG, NIBP, SpO2,Alarm, PR, HR | ||||
| LCD Panel | Color TFT type LCDElegant-1100: 10-inch high resolutionElegant-1080: 7-inch high resolutionElegant-1070: 3.5-inch highresolution | Color TFT type LCD12.1-inch high resolution | Same TFT LCD,but Panel sizedifferent | |
| Dimensions | Elegant-1100: 275mm x 140mm x240mmElegant-1080: 180mm x 190mm x280mmElegant-1070: 195mm x 85mm x150mm | 500(L) ×320(W) ×460(H) mm | Dimensionsdifferent | |
| Accessories especially for Sensors | ||||
| Internal Sensor (build-in)Sensing Algorithm:by using Penetrate Type of LEDLight cross test body like finger. | Internal Sensor (build-in)Sensing Algorithm:by using Penetrate Type of LEDLight cross test body like finger. | |||
| SpO2 Probe Sensor(Configuration/Geometry) | Light Sources:by using wave length LEDs, locatedin Red and Infrared. | Light Sources:by using wave length LEDs, locatedin Red and Infrared. | Equivalent | |
| Calculation of SpO2 value:by data source with calculationformula of [HbO2/(HbO2 + Hb)] | Calculation of SpO2 value:by data source with calculationformula of [HbO2/(HbO2 + Hb)] | |||
| NIBP Sensor | Cuff by pressure sensor | Cuff by pressure sensor | Equivalent | |
| ECG Cable | Leadwires with disposable electrode | Leadwires with disposable electrode | Equivalent | |
| Chemical Composition to Human body of Sensors | ||||
| NIBP Cuff | Nylon (Polycaproamide) | Nylon (Polycaproamide) | Equivalent | |
| SPO2 Probe | Silicone Rubber | Silicone Rubber | Equivalent | |
| Disposable electrode | Conductive hydrogel (Whitepolyethylene /EVA copolymerfoam) | Conductive hydrogel (Whitepolyethylene /EVA copolymer foam) | Equivalent | |
| ECG Technical Characteristics (Only for Elegant-1100 and Elegant-1070) | ||||
| ECG noise level | ≤ 30μVP-P | ≤ 30μVP-P | Equivalent | |
| Input impedance | ≥5MΩ | ≥5MΩ | Equivalent | |
| Common-moderejection ratio(CMRR) | ≥80dB | ≥80dB | Equivalent | |
| ECG Heart RateMeasuring Range | 10~300bpm(±2bpm) | 15~350bpm(±2bpm) | Equivalent | |
| ECG Channel | 7-channel waveforms display | 7-channel waveforms display | Equivalent | |
| Sensitivity selection | ×1/4, ×1/2, ×1, ×2, ×4, Auto | ×1/2, ×1, ×2, ×4, Auto | Equivalent, butour device has onemore selectionthan predicatedevice | |
| ECG Leads | 3 or 5 lead ECG | 3 or 5 lead ECG | Equivalent |
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| NIBP Technical Characteristics (For All devices) | |||
|---|---|---|---|
| NIBP MeasuringMethod | Oscillometric | Oscillometric | Equivalent |
| NIBP MonitoringRange | Systolic: 20mmHg | Systolic: 40mmHg | Equivalent, but ourmeasuring range iswider than predicatedevice |
| NIBP MeasuringAccuracy | Systolic: ±5 mmHgDiastolic: ±5 mmHgMAP: ±5 mmHg | Systolic: ±5 mmHgDiastolic: ±5 mmHgMAP: ±5 mmHg | Equivalent |
| SpO2 Technical Characteristics (For All devices) | |||
| SpO2 MeasuringRange | 0% ~ 100% Oxygen saturation | 35% ~ 100% Oxygen saturation | Equivalent, but ourmeasuring range iswider than predicatedevice |
| SpO2 MeasuringAccuracy | 70~100% :±2% | 70~100%:±3% | Equivalent, but ourmeasuring accuracyis better thanpredicate device |
| SpO2 Pulse RateMeasuring Range | 15bpm~300bpm | 30bpm~240bpm | Equivalent, but ourmeasuring range iswider than predicatedevice |
| SpO2 Pulse RateAccuracy | ±2bpm | ±2bpm | Equivalent |
| Battery | |||
| Battery Chargingtime (during non-monitoring) | Elegant-1100, Elegant-1080: 4hrsElegant-1070: 3hrs | 4hrs | Equivalent |
| Battery operationtime | Elegant-1100, Elegant-1080: 5hrsElegant-1070: 3hrs | 5hrs | Equivalent |
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K173036 Page 6 of 8
7. Performance Specifications
| Brand andProductItems | North-visionElegant-1100 | North-visionElegant-1080 | North-visionElegant-1070 |
|---|---|---|---|
| Specification | NIBP, SpO2, ECG, Alarm, PR, HR | NIBP, SpO2, Alarm, PR | NIBP, SpO2, ECG, Alarm, PR, HR |
| Intended to use | The device is intended to monitorECG, heart rate, pulse rate, bloodoxygen saturation(SpO2), non-invasive blood pressure(NIBP). | The device is intended tomonitor, pulse rate, bloodoxygen saturation(SpO2), non-invasive blood pressure(NIBP). | The device is intended tomonitor ECG, heart rate, pulserate, blood oxygensaturation(SpO2), non-invasiveblood pressure(NIBP) |
| Size | 275mm x 240mm x 140mm | 180mm x 280mm x 190mm | 195mm x 150mm x 85mm |
| LCD Panel | 10.4 inches TFT color LCD | 3.5 inches TFT color LCD | 7 inches TFT color LCD |
| NIBP Measuring Method | Oscillometric | Oscillometric | Oscillometric |
| NIBP Monitoring Range | Systolic: 20mmHg | Systolic: 20mmHg | Systolic: 20mmHg |
| NIBP Measuring Accuracy | Systolic: ±5 mmHgDiastolic:±5 mmHgMAP: ±5 mmHg | Systolic: ±5 mmHgDiastolic:±5 mmHgMAP: ±5 mmHg | Systolic:±5 mmHgDiastolic:±5 mmHgMAP: ±5 mmHg |
| SpO2 Measuring Range | 0% ~ 100% Oxygen saturation | 0% ~ 100% Oxygen saturation | 0% ~ 100% Oxygen saturation |
| SpO2 Measuring Accuracy | 70~100%:±2% | 70~100%:±2% | 70~100%:±2% |
| SpO2 Pulse Rate MeasuringRange | 15bpm~300bpm | 15bpm~300bpm | 15bpm~300bpm |
| ECG Leads | 3 or 5 | N/A | 3 or 5 |
| ECG Heart Rate MeasuringRange | 15~300bpm(±2bpm) | N/A | 15~300bpm(±2bpm) |
Note:
-
Elegant-1100 and Elegant-1070 are designed for full function which include ECG, NIBP, SpO2.
-
Elegant-1070 is especially designed for its compact size which can be carried on for the portable purpose.
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K173036 Page 7 of 8
8. Non-clinical tests performed that support a determination of substantial equivalence
As part of demonstrating safety and effectiveness of Elegant-1000 Series and in showing substantial equivalence to the predicate devices that are subject to 510(k) submission, North-vision Tech. Inc. completed a number of Nonclinical performance tests against applicable standards. All the Non-clinical tests performed support a determination of substantial equivalence. Following is List of Summary for these Tests.
| Test | Pass/fail Criteria | Results | |
|---|---|---|---|
| 1 | Electrical safety | Compliance to IEC 60601-1:2012Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance | Passed |
| 2 | ElectromagneticCompatibility | Compliance to IEC 60601-1-2:2007Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility -Requirements and tests | Passed |
| 3 | MultifunctionPatient Monitor | Compliance to EN 60601-2-49:2001Medical electrical equipment - Part 2-49: Particularrequirements for the safety of multifunction patientmonitoring equipment | Passed |
| 4 | Alarms | Compliance to IEC 60601-1-8:2012Medical electrical equipment - Part 1-8: Generalrequirements for basic safety andessential performance - Collateral Standard: Generalrequirements, tests and guidance for alarm systems inmedical electrical equipment and medical electricalsystems | Passed |
| 5 | Biocompatibility | Compliance to ISO 10993-1:2009Biological evaluation of medical devices - Part 1:Evaluation and testing within a riskmanagement process | Passed |
| 6 | Risk Management | Compliance to ISO 14971:2012 - Application of riskManagement to medical devices | Passed |
| 7 | Software | Compliance to IEC 62304:2015Medical device software - Software life-cycle processes | Passed |
| 8 | ECG | Compliance to IEC 60601-2-27:2011Medical electrical equipment - Part 2-27: Particularrequirements for the basic safety and essentialperformance of electrocardiographic monitoringequipment | Passed |
| 9 | Pulse Oximeter | Compliance to ISO 80601-2-61:2011Medical electrical equipment -- Part 2-61: Particularrequirements for basic safety andessential performance of pulse oximeter equipment | Passed |
| 10 | NIBP | Compliance to IEC 80601-2-30:2013ANSI/AAMI/ISO 81060-2:2013 - Medical electricalequipment Part 2: Particular requirements for the basicsafety and essential performance of automated non-invasive sphygmomanometers | Passed |
| 11 | Usability | Compliance to IEC 62366:2014Medical devices - Consolidated Version Application ofusability engineering to medical devices | Passed |
| 12 | Batteries | Compliance to IEC 62133Secondary cells and batteries containing alkaline orother non-acid electrolytes - Safety requirements forprotable sealed secondary cells, and for batteries madefrom then, for use in portable applications | Passed |
| 12 | ECG Trunk Cables andLeadwires | Compliance to ANSI/AAMI EC53:2013ECG Trunk Cables and Patient Leadwires | Passed |
Performance Standards Testing Summary:
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9. Clinical tests performed that support a determination of substantial equivalence.
Clinical testing for conformance with the requirements of ANSI/AAMI 81060-2:2013 and ISO80601-2-61: 2011 was completed to validate the clinical accuracy of the NIBP and SpO2 device functionality
10. Conclusions
All the Performance Tests including non-clinical and clinical tests demonstrate that North-vision Elegant-1000 Series Multi-parameter Patient Monitors are as safe, as effective, and perform as well as the referenced legally marketed predicate device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.