The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Fetal, Abdominal, OB/GYN, Urology, Cardiac.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

Device Description

The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.
The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System includes:

· A commercial off-the-shelf (COTS) Android mobile device
CHISON Ultrasound software is running as an app (Android ) on the COTS device
The SonoEye P5/ SonoEye V5/ SonoEye G5 Convex array USB transducer

AI/ML Overview

This is an FDA 510(k) summary for the SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System. It details the device's substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device needing such validation.

Here's a breakdown of why the requested information is not present and what is provided:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general medical device safety standards. It does not provide specific performance metrics or acceptance criteria for an AI/ML component.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This premarket notification does not involve an AI/ML device that would require clinical validation with a test set of data.
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): Not applicable. Ground truth establishment for an AI/ML test set is not part of this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no mention of a standalone algorithm for diagnostic performance.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. There is no mention of an AI/ML component requiring a training set.
How the ground truth for the training set was established: Not applicable.

Information that is provided in the document:

The document outlines the submission for a Digital Color Doppler Palm Ultrasound System, which is a general diagnostic ultrasound system. It demonstrates substantial equivalence to predicate devices (Lumify Diagnostic Ultrasound System, Clarius Ultrasound System, TE7 Diagnostic Ultrasound System) by comparing:

Indications for Use: The device has similar indications for use (Fetal, Abdominal, OB/GYN, Urology, Cardiac) as the predicate devices.
Design: It uses similar autocorrelation for color processing and FFT for pulse Doppler processing, supporting convex probes, and features like cine playback and image archiving.
Operating Controls: Similar controls such as TGC (STC), Depth Range, shades of gray, Gain, Focus, Color box size/position, Baseline, Cine control, and Freeze control. Some differences in value ranges for depth, gain, etc., are noted but deemed substantially equivalent.
Safety Compliance: The device conforms to applicable medical device safety standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1, which are the same standards adhered to by the predicate devices.
Operation Modes: Similar modes including B mode, PW mode, B/M mode, CFM mode, and Fusion Harmonic Imaging (FHI).
Measurements and Reporting: Similar measurement capabilities (2D distance, area, circumference, volume, M-mode, PW-mode measurements) and reporting packages (Vessel, Abdomen, Obstetrics, Cardiac reports, General report).
Transducer Types: The submission device uses Convex Array USB interface, compared to various array types in the predicate devices.
Users/Sites: Intended for use in hospitals and clinics, similar to predicates.
Acoustic Output: Compliant with Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0, consistent with predicate devices.
Power Requirements: Differences in specific voltage, humidity, and temperature ranges are discussed, but the device passed relevant hardware tests and complies with safety standards, leading to a conclusion of substantial equivalence.

In summary, this FDA 510(k) submission establishes the safety and effectiveness of a conventional ultrasound system by demonstrating its substantial equivalence to already legally marketed devices, focusing on technical specifications, operational features, and compliance with general medical device safety standards, rather than AI/ML performance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

CHISON Medical Technologies Co., Ltd. % Mr. Qifei Liu Regulatory Affairs Manager No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi. Jiangsu 214142 CHINA

February 25, 2021

Re: K201971

Trade/Device Name: SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 13, 2021 Received: January 27, 2021

Dear Mr. Liu:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201971

Device Name

SonoEye P5/SonoEye V5/SonoEye G5 Digital Color Doppler Palm Ultrasound System

Indications for Use (Describe)

The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.

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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K201971

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. Submitter:

Submitter:	CHISON Medical Technologies Co., Ltd.
Address:	No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang
	Industrial Park, Xinwu District, Wuxi, Jiangsu, China 214142
Contact:	Mr. Liu Qifei
Tel:	+86-510-85310019
Fax:	+86-510-85310021
Date Prepared: July 3, 2020

2. Device :

SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Trade Name: Ultrasound System

Common Name: Diagnostic Ultrasound System with Transducers

Classification: Regulatory Class: II Review Category: Tier II

Classfication Name	21 CFR Section	Product Code
Ultrasonic pulsed doppler imaging system	892.1550	90-IYN
Ultrasonic pulsed echo imaging system	892.1560	90-IYO
Diagnostic ultrasonic transducer	892.1570	90-ITX

3. Predicate Device(s):

Device	Model	Product Code	510(k)Number
1.Main predicate device	Lumify DiagnosticUltrasound System	IYN,IYO,ITX	K 192226
2.Reference device	Clarius Ultrasound System	IYN,ITX,IYO	K192107
3.Reference device	TE7 Diagnostic UltrasoundSystem	IYN,ITX,IYO	K 160381

4. Device Description:

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operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications.

The SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System includes:

· A commercial off-the-shelf (COTS) Android mobile device
CHISON Ultrasound software is running as an app (Android ) on the COTS device
The SonoEye P5/ SonoEye V5/ SonoEye G5 Convex array USB transducer
1. The requirement of commercial off-the-shelf (COTS) devices

All models need to comply with IEC55032, IEC60950-1, among which we have selected typical models to do verification testing with SonoEye on ANSI/AAMI ES60601-1 and IEC60601-1-2, such as Samsung Galaxy A70s or Huawei MatePad Pro.

● Electrical Safety

The transducer and software, along with a representative device, have been verified as compliant with IEC 60601-1. The transducers meet Type BF isolated applied part requirements. When the transducer and software are used in conjunction with a device(COTS devices) compliant with IEC 60950-1, the system meets IEC 60601-1 requirements for Class II equipment.

Electromagnetic Compatibility
The transducer and representative Android device are classified as Group 1, Class A equipment in accordance with international standard CISPR 11 for radiated and conducted electromagnetic disturbances. When the transducer and software are used in conjunction with a device(COTS devices) compliant with IEC 55032, the system meets IEC 60601- 1-2 requirements for Group1,Class A equipment.
Android devices' output current and voltage The representative Android devices' output current is 1.5A and voltage is 5V. A COTS device connected to our transducer and system should meet the current and voltage range, the output current is greater than or equal to 1.5A, and the output voltage is 5V±5%.
Full compliance with USB 2.0 standard The representative Android devices are full compliance with USB 2.0 standard. A COTS device connected to our transducer and system should meet the standard.
Representative Android devices Representative Android devices are Samsung Galaxy A70s and Huawei MatePad Pro.The configuration is as follows.

Samsunq Galaxy A70s:

•CPU frequency 2.0GHz (biq quad core). 1.7GHz (small quad core), Eight cores

•RAM capacity 8GB
·ROM capacity 128GB
·Main screen resolution 2400x1080 pixels
•WLAN function Dual-band WIFI, IEEE 802.11 alb/g/n/ac (support 2.4G and 5GHz)
· Operating System: Android 9

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•Support Bluetooth 5.0

•Huawei MatePad Pro:

•CPU frequency 2 x Cortex-A76 Based 2.86 GHz+ 2 x Cortex-A76 Based 2.09 GHz+ 4 x Cortex-A55 1.86 GHz,Eight cores •RAM capacity 8GB ·ROM capacity 128GB •Main screen resolution 2560x1600 pixels

•WiFi function supports dual frequency (2.4GHz+5GHz)

·Bluetooth function supports Bluetooth 5.1 module

· Operating System: Android 9

6. Indications for Use:

The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM,Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Fetal, Abdominal, OB/GYN, Urology, Cardiac. The Digital Color Doppler Palm Ultrasound System is intended for use in environments

where healthcare is provided by healthcare professionals.

7. Summary of Non-Clinical Tests:

The SonoEve P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The product fulfils the requirement of:

ANSI/AAMI ES60601-1:2005Medical Electrical Equipment - Part 1: General Requirements for Safety.

IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

The device has been found to conform to applicable FDA medical device guidance documents titled as followings:

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Document issued on: June 27, 2019)
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005)

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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Document Issued on: October 2, 2014)
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Document issued on: June 16, 2016)

8. Clinical Test:

No clinical testing was required.

Software Documentation for a Moderate Level of Concern, per the FDA guidancedocument,"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005", is also included as part of this submission.

9. Comparison to Predicate Device:

Items	Main predicatedevice	Referencedevice	Reference device	SubmissionDevice	Remark
	LumifyDiagnosticUltrasoundSystem	ClariusUltrasoundSystem	TE7 DiagnosticUltrasoundSystem	DigitalColorDopplerUltrasoundSystem
Indications for Use	Fetal/Obstetric,Abdominal,Pediatric,Cephalic,Urology,Gynecological,Cardiac FetalEcho,Small Organ,MusculoskeletalPeripheralVessel,Carotid,Cardiac.	ophthalmic,fetal,abdominal,intraoperative(non-neurological), pediatric,small organ,cephalic(adult),trans-rectal,transvaginal,musculo-skeletal(conventional,superficial),urology,gynecology,cardiac (adult,pediatric),peripheralvessel, carotid,and proceduralguidanceofneedlesintothe body.	fetal,abdominal,intra-operative(abdominal, thoracic,and vascular),pediatrics,smallorgan(breast,thyroid, testes),neonatal and adultcephalic,trans-esoph.(Cardiac), trans-vaginal,musculo-skeletal(conventional, superficial),urology,peripheral vessel,adult and pediatriccardiac,ophthalmic exams	Fetal,Abdominal,OB/GYN,Urology,Cardiac.	Same
Items	Main predicatedevice	Referencedevice	Reference device	SubmissionDevice	Remark
	LumifyDiagnosticUltrasoundSystem	ClariusUltrasoundSystem	TE7 DiagnosticUltrasoundSystem	Digital ColorDoppler PalmUltrasoundSystem
Design	Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingLinear, Curve,PhasearrayandVolumeprobes.Cine play backcapabilityImagefilearchive	Autocorrelationfor colorprocessingand FFT forpulse Dopplerprocessing.SupportingLinear, PhaseMicroarray, convexarray, Endocavityprobe andVolume probesCine play backcapabilityImagefilearchive	Autocorrelation forcolor processingand FFT for pulseDopplerprocessing.Supporting Linear,convex andphased array.Cine play backcapabilityImage file archive	Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingConvex probe.Cine play backcapabilityImagefilearchive	Same
OperatingControls	TGC	TGC	TGC	STC	Same
	Depth Range:0.003 to >30 cm	Depth Range:5.0 to 10.0cm(Depth dependon probe type)	Depth depend onprobe type	Depth Range:1.0 to 19.5cm	SEAnalysis1
	256 shades ofgray	256 in B-Mode	30-240 in B mode	256 shades ofgray	Same
	Gain	Gain	Gain	Gain:0-255,1/step	Same
	Focus	Focus	Focus	Focus: adjustable	Same
	Color boxsize/positioncan be adjust	ROI adjust	ROI adjust	ROI size/position:adjustable	Same
	N/A	Baseline	Baseline	Baseline	Same
	Cine control:drag scroll bar,press orImage: [arrow]	Tap the cinecapture buttonto capture thecine as part ofthe exam.	Cine control	Cine control:step, playbackward, playcontinuously	Same
	Freeze control:Toggling freezekey	Freeze control:Togglingfreeze key	Freeze control:Togglingfreeze key	Freeze control:Togglingfreeze key	Same
SafetyCompliance	ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1	ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC 60601-1-2ISO 10993-1	ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1	ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1	Same
	Main predicatedevice	Referencedevice	Reference device	SubmissionDevice
Items	LumifyDiagnosticUltrasoundSystem	ClariusUltrasoundSystem	TE7 DiagnosticUltrasoundSystem	Digital ColorDoppler PalmUltrasoundSystem	Remark
	B mode	B mode	B mode	B mode	Same
	N/A	PW mode	Pulsed waveDoppler mode	PW mode	Same
	M mode	M mode	M mode	B/M mode	Same
	Color mode	Color DopplerMode	Color mode	CFM mode	Same
	N/A	N/A	IQ	FHI	Same
	Gain	Gain	Gain	Gain	Same
	Depth	Depth	Depth	Depth	Same
	TGC	TGC	TGC	STC	Same
	N/A	SpatialCompound	Spatial Compound	Compound	Same
	Frequency	Frequency	Frequency	FrequencyScaling	Same
	Freeze	Freeze	Freeze	Freeze/Unfreeze	Same
	Zoom	Zoom	Zoom	Zoom	Same
	2D distance	2D distance	distance	B-distance	Same
	Circumference	Circumference	Circumference	B-Circumference	Same
	Area	Area	Area	B-Area	Same
	N/A	Volume	Volume	B-Volume	Same
	N/A	Distance	Distance	B/M-Distance	Same
perationMode	N/A	M-Time	Time	B/M-Time	Same
	N/A	M-HR	HR	B/M-HR	Same
	N/A	Velocity	Velocity	PW-Velocity	Same
	N/A	Time	Time	PW-Time	Same
	N/A	Vascular	Vascular	Vessel measurepackage	Same
	N/A	Small Organ	Abdomen	Abdomenmeasurepackage	Same
	N/A	N/A	Obstetrics	Obstetricsmeasurepackage	Same
	N/A	N/A	Cardiology	Cardiac measurepackage	Same
	N/A	Report	Report	General report	Same
	N/A	N/A	Vascular ExamReport	Vessel report	Same
	N/A	N/A	Abdomen ExamReport	Abdomen report	Same
	N/A	N/A	Obstetrics ExamReport	Obstetrics report	Same
	N/A	N/A	Cardiac ExamReport	Cardiac report	Same
Items	Main predicatedevice	Referencedevice	Reference device	SubmissionDevice	Remark
LumifyDiagnosticUltrasoundSystem	ClariusUltrasoundSystem	TE7 DiagnosticUltrasoundSystem	Digital ColorDoppler PalmUltrasoundSystem	Same
Languagefollow system	N/A	Multi-languageInterface	Multi-languageInterface	Same
Thumbnail	N/A	Thumbnail window	Clipboard	Same
N/A	N/A	iTouch	Instant AIO	Same
Biopsy GuideLine	Biopsy Guide	Biopsy Guide	Biopsy Guide	Same
Reacts SessionViews	N/A	N/A	SonoRemote	Same
N/A	N/A	iNeedle	SonoNeedle	Same
N/A	NeedleEnhance	iNeedle	SuperNeedle	Same
Save Loop	Save Cine	Save Clip	Save Cine	Same
Save Image	Save Image	Save Image	Save Image	Same
Playing Loops	Cine Loop	CineReview	Cine Loop	Same
Annotation	Annotation	Annotation	Annotation	Same
N/A	Bodymark	Bodymark	Bodymark	Same
N/A	N/A	Arrow	Arrow Mark	Same
PatientDatabase	Patientinformation	Patient information	Patientmanagement	Same
N/A	Angle/Baseline on PW	Angle/Baseline onPW	Voice/Angle/Baseline on PW	Same
N/A	N/A	Physical key	Physical key	Same
Setting	Setting	Setup	Setting	Same
PatientDatabase	Patientinformation	Patient datamanagement	Archives	Same
Walkthrough	Quick StartGuide andVideo Tutorials	Operation Note	Tutorials	Same
Review	Review	Review	Easyview	Same
N/A	Demo	iVisionSysteminformation	Demo	Same
About	N/A	Systeminformation	About	Same
N/A	Adjust sampleGate location	Drag the SV gateto place the SV onthe target	Adjust sampleGate location	Same
N/A	Adjust size ofsample Gatehorizontal	Drag the SV gateto place the SV onthe target	Adjust size ofsample Gatehorizontal	Same
N/A	Adjust size ofsample Gatevertical	Drag the SV gateto place the SV onthe target	Adjust size ofsample Gatevertical	Same
N/A	Adjust PWsample gate	Drag the SV gateto place the SV onthe target	Adjust PWsample gate	Same
Items	Main predicatedevice	Referencedevice	Reference device	SubmissionDevice	Remark
DisplayAnnotations	LumifyDiagnosticUltrasoundSystem	ClariusUltrasoundSystem	TE7 DiagnosticUltrasoundSystem	Digital ColorDoppler PalmUltrasoundSystem	Same
	Logo; HospitalName; Examdate; Examtime; MechanicalI index; Thermalindes; Probemodel; TGCCorve; Focusposition; Imaging parameters;Systemstatus; Gray/Color bar	LogoHospitalName(NA)Examdate;Examtime;End exam; MI;TI; TGC; Probemodel;Imagingparameters;System status;Gray/Color bar	Probemodel,acousticoutputvalue,MI, TI,iNeedle,iTouch,frequency,TGC,Systemstatus,Depth, Gain	Logo; HospitalName; Examdate; Exam time;Mechanicalindex; Thermalindes; Probemodel; STC;Focus position;Imagingparameters;System status;Gray/Color bar	Same
Measurements	2D mode:Depth,Distance ,Area,Circumference	B mode:Depth,Distance,Area,CircumferenceDopplermode:Volume,Velocity, TimeM mode:Distance,Time, HR	2D mode: Depth,Distance,Area,CircumferenceB/C mode:VolumeDopplermode:Velocity, Time,M mode:Distance,Time,HR	2D mode:Depth, Distance,Area, VolumeDoppler mode:D Velocity, Time,B/M mode:Distance, Time,HR	Same
Transducer Types &Connectors	Convex Array,Phased Array,Linear Array,USB interface	Micro convexarray,Endocavityprobe andVolume probes	Linear, convex andphased array.	Convex ArrayUSB interface	Same
Users /Sites	Hospitals,clinics usage	Hospitals,clinics usage	Hospitals,clinicsusage	Hospitals, clinicsusage	Same
AcousticOutput	Track 3;Ispta.3 ≤ 720mW/cm²MI ≤ 1.9TI ≤ 6.0	Track 3(ISPTA) of 720mW/ cm²MI: 0.0 to 1.9,TI: This iscontinuouslydisplayed overthe range of0.0 tomaximumoutput, basedon thescanner andapplication, in	Track 3Ispta.3 ≤ 720mW/cm²MI ≤ 1.9	Track 3;Ispta.3 ≤ 720mW/cm²MI ≤ 1.9TI ≤ 6.0	Same
Items	Main predicatedevice	Referencedevice	Reference device	SubmissionDevice		Remark
	LumifyDiagnosticUltrasoundSystem	ClariusUltrasoundSystem	TE7 DiagnosticUltrasoundSystem	DigitalDopplerUltrasoundSystem	ColorPalm
		increments of0.1
PowerRequirements	Powerrequirements:AC:100V-240V,Frequenzy:50-60HzOperatingtemperature:5-40 ℃ ; relativehumidity15-95%;Barometricpressure:700 to1060 hPa	Input: 12 VDC,11.5 ATemperature:0°C (50°F) to40°C (113°F)Humidity: 15%to 95%s	Voltage:100V-240V Temperature:0°C (50°F) to 40°C(113°F)Humidity: 30% to85%sAtmospherepressure: 700 to1060 hPa	Powerrequirements:DC 5V,Operatingtemperature:10-38 ℃ ; relativehumidity30-75%;Barometricpressure:700 to1060 hPa		SEAnalysis2

Table 1 Substantial Equivalence Comparison

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Comparison Analysis

SE Analysis 1:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in value range. But both of them comply with the requirements of IEC60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

SE Analysis 2:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in presenting voltage, humidity and temperature.

For voltage, the voltage of subject device is different with predicate device since hardware configuration is different. The subject device has passed the hardware test and complied with requirement of IEC60601-1 & IEC60601-2-37 and also meets clinical requirements

For temperature, compared with predicate device, the temperature of subject device is lower than it, but still in a normal range. The subject device has passed temperature test and complied with requirement of IEC60601-1 & IEC60601-2-37 and meet clinical requirements For humidity, compared with predicate device, the humidity of subject device is in a normal range and complied with requirement of IEC60601-1 & IEC60601-2-37 and meet clinical requirements

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Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

10.Substantially Equivalent Conclusion:

In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, CHISON Medical Technologies Co., Ltd. concludes that the SonoEye P5/ SonoEye V5/ SonoEye G5 - Digital Color Doppler Palm Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.

Regulation Number and Section

N/A