Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard physiological monitoring techniques (oscillating method for NIBP, photoelectric method for SpO2) and basic signal processing and calculation by a CPU. There is no mention of AI, ML, or advanced analytical techniques.

Therapeutic

No
The device is described as a monitor that records and displays physiological signs, not as providing therapy.

Diagnostic

No

The device monitors, displays, and records physiological signs, providing comprehensive analysis of a patient's conditions based on these measurements. It does not state that it provides a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "modular designed patient Monitor" that uses "accessories and the sensors" to transfer physical parameters into electrical signals, which are then processed by "the circuit in the device" and a "CPU". This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for monitoring, displaying, and recording physiological signs (ECG, heart rate, non-invasive blood pressure, functional oxygen saturation) of patients. This involves measuring parameters directly from the patient's body.
Device Description: The description details how the device measures physical parameters (electrical signals from the body, pressure oscillations, photoelectric signals) and converts them into electrical signals for analysis and display. This is consistent with a patient monitoring device that interacts with the patient's body.
Lack of mention of in vitro testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples in a laboratory or clinical setting.

In summary, the North-vision Elegant-1000 Series of Multi-parameter Patient Monitor is a patient monitoring device that measures physiological parameters directly from the patient, which is distinct from an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI, DXN, DQA

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult, pediatric patients

Intended User / Care Setting

hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests performed that support a determination of substantial equivalence:

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

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.

Conclusion: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123711

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

1

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

2

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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3

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.

4

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
Product
Items | North-vision
Multi-parameter Patient Monitor
Elegant-1000 Series
(Elegant-1100/1080/1070) | SHENZHEN CREATIVE
Patient Monitor
(UP-7000) | Significant
Differences |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| 510(k) Number | K173036 | K123711 | N/A |
| Product Code | MWI | MWI | Equivalent |
| Regulation Number | 870.2300 | 870.2300 | Equivalent |
| Secondary Product
Code | DXN, DQA | DXN, DQA, CCK | Equivalent
The predicate
device have one
more Secondary
Product Code
CCK |
| Intended use/
Indications for use | The device is intended to monitor,
display and record physiological data
to provide cardiac and vital signs
monitoring within a medical facility.
The device is intended to produce a
visual record of the electrical signals
produced by the heart and monitor the
electrocardiogram to generate visible
and/or audible alarms.
The device is also intended to monitor
ECG, heart rate, pulse rate, blood
oxygen saturation (SpO2), non-
invasive blood pressure(NIBP) | The device is intended to monitor,
display and record physiological data
to provide cardiac and vital signs
monitoring within a medical facility.
The device is intended to produce a
visual record of the electrical signals
produced by the heart and monitor the
electrocardiogram to generate visible
and/or audible alarms.
The device is also intended to
monitor 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

5

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
Testing Passed		Yes	Yes	Equivalent
Electromagnetic
Testing Passed		Yes	Yes	Equivalent
ECG Trunk Cables
and Leadwires
Testing Passed		Yes	Yes	Equivalent
	Outline and Outlook
		Elegant-1100: ECG, NIBP, SpO2,
Alarm, PR, HR		Equivalent
Measuring
parameters		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 LCD
Elegant-1100: 10-inch high resolution
Elegant-1080: 7-inch high resolution
Elegant-1070: 3.5-inch high
resolution	Color TFT type LCD
12.1-inch high resolution	Same TFT LCD,
but Panel size
different
Dimensions		Elegant-1100: 275mm x 140mm x
240mm
Elegant-1080: 180mm x 190mm x
280mm
Elegant-1070: 195mm x 85mm x
150mm	500(L) ×320(W) ×460(H) mm	Dimensions
different
Accessories especially for Sensors
	Internal Sensor (build-in)
Sensing Algorithm:
by using Penetrate Type of LED
Light cross test body like finger.	Internal Sensor (build-in)
Sensing Algorithm:
by using Penetrate Type of LED
Light cross test body like finger.
SpO2 Probe Sensor
(Configuration/
Geometry)	Light Sources:
by using wave length LEDs, located
in Red and Infrared.	Light Sources:
by using wave length LEDs, located
in Red and Infrared.	Equivalent
	Calculation of SpO2 value:
by data source with calculation
formula of [HbO2/(HbO2 + Hb)]	Calculation of SpO2 value:
by data source with calculation
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
polyethylene /EVA copolymer
foam)	Conductive hydrogel (White
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
rejection ratio
(CMRR)	≥80dB	≥80dB	Equivalent
ECG Heart Rate
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
our device has one
more selection
than predicate
device
ECG Leads	3 or 5 lead ECG	3 or 5 lead ECG	Equivalent

6

7

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

8

K173036 Page 6 of 8

7. Performance Specifications

| Brand and
Product
Items | North-vision
Elegant-1100 | North-vision
Elegant-1080 | North-vision
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
ECG, heart rate, pulse rate, blood
oxygen saturation(SpO2), non-
invasive blood pressure(NIBP). | The device is intended to
monitor, pulse rate, blood
oxygen saturation(SpO2), non-
invasive blood pressure(NIBP). | The device is intended to
monitor ECG, heart rate, pulse
rate, blood oxygen
saturation(SpO2), non-invasive
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: 20mmHg290mmHg
Diastolic: 10mmHg260mmHg
Mean: 15mmHg~~275mmHg | Systolic: 20mmHg~~290mmHg
Diastolic: 10mmHg260mmHg
Mean: 15mmHg275mmHg | Systolic: 20mmHg290mmHg
Diastolic: 10mmHg260mmHg
Mean: 15mmHg275mmHg |
| NIBP Measuring Accuracy | Systolic: ±5 mmHg
Diastolic:±5 mmHg
MAP: ±5 mmHg | Systolic: ±5 mmHg
Diastolic:±5 mmHg
MAP: ±5 mmHg | Systolic:±5 mmHg
Diastolic:±5 mmHg
MAP: ±5 mmHg |
| SpO2 Measuring Range | 0% ~ 100% Oxygen saturation | 0% ~ 100% Oxygen saturation | 0% ~ 100% Oxygen saturation |
| SpO2 Measuring Accuracy | 70100%:±2% | 70~~100%:±2% | 70~~100%:±2% |
| SpO2 Pulse Rate Measuring
Range | 15bpm~~300bpm | 15bpm~~300bpm | 15bpm300bpm |
| ECG Leads | 3 or 5 | N/A | 3 or 5 |
| ECG Heart Rate Measuring
Range | 15300bpm(±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.

9

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
1	Electrical safety	Compliance to IEC 60601-1:2012
Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance	Passed
2	Electromagnetic
Compatibility	Compliance to IEC 60601-1-2:2007
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance

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

Performance Standards Testing Summary:

10

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.