North-vision Multi-parameter Patient Monitor

K173036 · North-Vision Tech., Inc. · MHX · Dec 21, 2018 · Cardiovascular

Device Facts

• Record ID: K173036
• Device Name: North-vision Multi-parameter Patient Monitor
• Applicant: North-Vision Tech., Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Modular multi-parameter patient monitor (Elegant-1100, 1080, 1070) for hospital/clinic use by qualified professionals. Inputs: ECG (via leadwires/electrodes), NIBP (via cuff/oscillometric method), SpO2 (via LED-based photoelectric sensor). Device amplifies electrical signals; CPU calculates parameters; displays graphical/numeric data on TFT LCD; provides audible/visual alarms for out-of-limit readings. Supports real-time monitoring and recording. Benefits: enables comprehensive physiological analysis and patient status tracking.

Clinical Evidence

Clinical testing performed to validate NIBP and SpO2 accuracy per ANSI/AAMI 81060-2:2013 and ISO 80601-2-61:2011. Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm systems (IEC 60601-1-8), biocompatibility (ISO 10993-1), software lifecycle (IEC 62304), and usability (IEC 62366).

Technological Characteristics

Modular monitor with TFT color LCD (3.5" to 10.4"). Materials: Nylon (NIBP cuff), Silicone Rubber (SpO2 probe), Conductive hydrogel/PE/EVA (electrodes). Sensing: Oscillometric (NIBP), LED-based photoelectric (SpO2), 3/5-lead ECG. Power: 100-240VAC or Li-Ion battery. Connectivity: Standalone. Sterilization: Not specified. Software: IEC 62304 compliant.

Indications for Use

Indicated for adult and pediatric patients in hospitals, clinics, and practitioner's offices for monitoring, displaying, and recording ECG, heart rate, non-invasive blood pressure (NIBP), and functional oxygen saturation (SpO2).

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• CREATIVE Patient Monitor, UP-7000 (K123711)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <svg height="15" width="15"> <rect height="15" style="fill:none;stroke:#000000;stroke-width:2" width="15"></rect> <line style="stroke:#000000;stroke-width:2" x1="2" x2="13" y1="2" y2="13"></line> <line style="stroke:#000000;stroke-width:2" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span> <svg height="15" width="15"> <rect height="15" style="fill:none;stroke:#000000;stroke-width:2" width="15"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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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: [phone] Fax:[phone]

#### Contact Person:

Mr. Albert Huang, CEO Tel: [phone] ext.601 E-mail: [e-mail]

## 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 and<br>Product<br>Items | North-vision<br>Multi-parameter Patient Monitor<br>Elegant-1000 Series<br>(Elegant-1100/1080/1070) | SHENZHEN CREATIVE<br>Patient Monitor<br>(UP-7000) | Significant<br>Differences |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| 510(k) Number | K173036 | K123711 | N/A |
| Product Code | MWI | MWI | Equivalent |
| Regulation Number | 870.2300 | 870.2300 | Equivalent |
| Secondary Product<br>Code | DXN, DQA | DXN, DQA, CCK | Equivalent<br>The predicate<br>device have one<br>more Secondary<br>Product Code<br>CCK |
| Intended use/<br>Indications for use | The device is intended to monitor,<br>display and record physiological data<br>to provide cardiac and vital signs<br>monitoring within a medical facility.<br>The device is intended to produce a<br>visual record of the electrical signals<br>produced by the heart and monitor the<br>electrocardiogram to generate visible<br>and/or audible alarms.<br>The device is also intended to monitor<br>ECG, heart rate, pulse rate, blood<br>oxygen saturation (SpO2), non-<br>invasive blood pressure(NIBP) | The device is intended to monitor,<br>display and record physiological data<br>to provide cardiac and vital signs<br>monitoring within a medical facility.<br>The device is intended to produce a<br>visual record of the electrical signals<br>produced by the heart and monitor the<br>electrocardiogram to generate visible<br>and/or audible alarms.<br>The device is also intended to<br>monitor ECG, heart rate, pulse rate,<br>blood oxygen saturation (SpO2), non-<br>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 Safety<br>Testing Passed | | Yes | Yes | Equivalent |
| Electromagnetic<br>Testing Passed | | Yes | Yes | Equivalent |
| ECG Trunk Cables<br>and Leadwires<br>Testing Passed | | Yes | Yes | Equivalent |
| | Outline and Outlook | | | |
| | | Elegant-1100: ECG, NIBP, SpO2,<br>Alarm, PR, HR | | Equivalent |
| Measuring<br>parameters | | Elegant-1080: NIBP, SpO2, Alarm,<br>PR | ECG, NIBP, SpO2, Alarm, PR, HR,<br>ETCO2 | |
| | | Elegant-1070: ECG, NIBP, SpO2,<br>Alarm, PR, HR | | |
| | | | | |
| LCD Panel | | Color TFT type LCD<br>Elegant-1100: 10-inch high resolution<br>Elegant-1080: 7-inch high resolution<br>Elegant-1070: 3.5-inch high<br>resolution | Color TFT type LCD<br>12.1-inch high resolution | Same TFT LCD,<br>but Panel size<br>different |
| Dimensions | | Elegant-1100: 275mm x 140mm x<br>240mm<br>Elegant-1080: 180mm x 190mm x<br>280mm<br>Elegant-1070: 195mm x 85mm x<br>150mm | 500(L) ×320(W) ×460(H) mm | Dimensions<br>different |
| Accessories especially for Sensors | | | | |
| | Internal Sensor (build-in)<br>Sensing Algorithm:<br>by using Penetrate Type of LED<br>Light cross test body like finger. | Internal Sensor (build-in)<br>Sensing Algorithm:<br>by using Penetrate Type of LED<br>Light cross test body like finger. | | |
| SpO2 Probe Sensor<br>(Configuration/<br>Geometry) | Light Sources:<br>by using wave length LEDs, located<br>in Red and Infrared. | Light Sources:<br>by using wave length LEDs, located<br>in Red and Infrared. | Equivalent | |
| | Calculation of SpO2 value:<br>by data source with calculation<br>formula of [HbO2/(HbO2 + Hb)] | Calculation of SpO2 value:<br>by data source with calculation<br>formula 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 (White<br>polyethylene /EVA copolymer<br>foam) | Conductive hydrogel (White<br>polyethylene /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-mode<br>rejection ratio<br>(CMRR) | ≥80dB | ≥80dB | Equivalent | |
| ECG Heart Rate<br>Measuring 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, but<br>our device has one<br>more selection<br>than predicate<br>device | |
| ECG Leads | 3 or 5 lead ECG | 3 or 5 lead ECG | Equivalent | |

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| | NIBP Technical Characteristics (For All devices) | | |
|------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| NIBP Measuring<br>Method | Oscillometric | Oscillometric | Equivalent |
| NIBP Monitoring<br>Range | Systolic: 20mmHg~290mmHg<br>Diastolic: 10mmHg~260mmHg<br>Mean: 15mmHg~275mmHg | Systolic: 40mmHg~255mmHg<br>Diastolic: 10mmHg~195mmHg<br>Mean: 21mmHg~215mmHg | Equivalent, but our<br>measuring range is<br>wider than predicate<br>device |
| NIBP Measuring<br>Accuracy | Systolic: ±5 mmHg<br>Diastolic: ±5 mmHg<br>MAP: ±5 mmHg | Systolic: ±5 mmHg<br>Diastolic: ±5 mmHg<br>MAP: ±5 mmHg | Equivalent |
| | SpO2 Technical Characteristics (For All devices) | | |
| SpO2 Measuring<br>Range | 0% ~ 100% Oxygen saturation | 35% ~ 100% Oxygen saturation | Equivalent, but our<br>measuring range is<br>wider than predicate<br>device |
| SpO2 Measuring<br>Accuracy | 70~100% :±2% | 70~100%:±3% | Equivalent, but our<br>measuring accuracy<br>is better than<br>predicate device |
| SpO2 Pulse Rate<br>Measuring Range | 15bpm~300bpm | 30bpm~240bpm | Equivalent, but our<br>measuring range is<br>wider than predicate<br>device |
| SpO2 Pulse Rate<br>Accuracy | ±2bpm | ±2bpm | Equivalent |
| Battery | | | |
| Battery Charging<br>time (during non-<br>monitoring) | Elegant-1100, Elegant-1080: 4hrs<br>Elegant-1070: 3hrs | 4hrs | Equivalent |
| Battery operation<br>time | Elegant-1100, Elegant-1080: 5hrs<br>Elegant-1070: 3hrs | 5hrs | Equivalent |

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K173036 Page 6 of 8

## 7. Performance Specifications

| Brand and<br>Product<br>Items | North-vision<br>Elegant-1100 | North-vision<br>Elegant-1080 | North-vision<br>Elegant-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 monitor<br>ECG, heart rate, pulse rate, blood<br>oxygen saturation(SpO2), non-<br>invasive blood pressure(NIBP). | The device is intended to<br>monitor, pulse rate, blood<br>oxygen saturation(SpO2), non-<br>invasive blood pressure(NIBP). | The device is intended to<br>monitor ECG, heart rate, pulse<br>rate, blood oxygen<br>saturation(SpO2), non-invasive<br>blood 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~290mmHg<br>Diastolic: 10mmHg~260mmHg<br>Mean: 15mmHg~275mmHg | Systolic: 20mmHg~290mmHg<br>Diastolic: 10mmHg~260mmHg<br>Mean: 15mmHg~275mmHg | Systolic: 20mmHg~290mmHg<br>Diastolic: 10mmHg~260mmHg<br>Mean: 15mmHg~275mmHg |
| NIBP Measuring Accuracy | Systolic: ±5 mmHg<br>Diastolic:±5 mmHg<br>MAP: ±5 mmHg | Systolic: ±5 mmHg<br>Diastolic:±5 mmHg<br>MAP: ±5 mmHg | Systolic:±5 mmHg<br>Diastolic:±5 mmHg<br>MAP: ±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 Measuring<br>Range | 15bpm~300bpm | 15bpm~300bpm | 15bpm~300bpm |
| ECG Leads | 3 or 5 | N/A | 3 or 5 |
| ECG Heart Rate Measuring<br>Range | 15~300bpm(±2bpm) | N/A | 15~300bpm(±2bpm) |

Note:

1. Elegant-1100 and Elegant-1070 are designed for full function which include ECG, NIBP, SpO2.

2. 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 60601-1:2012<br>Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance | Passed |
| 2 | Electromagnetic<br>Compatibility | Compliance to IEC 60601-1-2:2007<br>Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Electromagnetic compatibility -<br>Requirements and tests | Passed |
| 3 | Multifunction<br>Patient Monitor | Compliance to EN 60601-2-49:2001<br>Medical electrical equipment - Part 2-49: Particular<br>requirements for the safety of multifunction patient<br>monitoring equipment | Passed |
| 4 | Alarms | Compliance to IEC 60601-1-8:2012<br>Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and<br>essential performance - Collateral Standard: General<br>requirements, tests and guidance for alarm systems in<br>medical electrical equipment and medical electrical<br>systems | Passed |
| 5 | Biocompatibility | Compliance to ISO 10993-1:2009<br>Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk<br>management process | Passed |
| 6 | Risk Management | Compliance to ISO 14971:2012 - Application of risk<br>Management to medical devices | Passed |
| 7 | Software | Compliance to IEC 62304:2015<br>Medical device software - Software life-cycle processes | Passed |
| 8 | ECG | Compliance to IEC 60601-2-27:2011<br>Medical electrical equipment - Part 2-27: Particular<br>requirements for the basic safety and essential<br>performance of electrocardiographic monitoring<br>equipment | Passed |
| 9 | Pulse Oximeter | Compliance to ISO 80601-2-61:2011<br>Medical electrical equipment -- Part 2-61: Particular<br>requirements for basic safety and<br>essential performance of pulse oximeter equipment | Passed |
| 10 | NIBP | Compliance to IEC 80601-2-30:2013<br>ANSI/AAMI/ISO 81060-2:2013 - Medical electrical<br>equipment Part 2: Particular requirements for the basic<br>safety and essential performance of automated non-<br>invasive sphygmomanometers | Passed |
| 11 | Usability | Compliance to IEC 62366:2014<br>Medical devices - Consolidated Version Application of<br>usability engineering to medical devices | Passed |
| 12 | Batteries | Compliance to IEC 62133<br>Secondary cells and batteries containing alkaline or<br>other non-acid electrolytes - Safety requirements for<br>protable sealed secondary cells, and for batteries made<br>from then, for use in portable applications | Passed |
| 12 | ECG Trunk Cables and<br>Leadwires | Compliance to ANSI/AAMI EC53:2013<br>ECG 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.