C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Description

The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").

AI/ML Overview

This FDA 510(k) premarket notification for the C5 Diagnostic Ultrasound System is for a general-purpose ultrasound device. It is a comparison to a predicate device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML study design is not applicable.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical performance acceptance criteria for diagnostic accuracy. Instead, substantial equivalence is claimed based on meeting various safety and performance standards. The "device performance" in this context refers to its ability to meet these general standards.

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
Electrical Safety (IEC 60601-1)	Fully meets the standards requirement
EMC (IEC 60601-1-2)	Fully meets the standards requirement
Biocompatibility (ISO 10993-5)	Fully meets the standards requirement
Biocompatibility (ISO 10993-10)	Fully meets the standards requirement
Performance Safety and Effectiveness (IEC 60601-2-37)	Fully meets the standards requirement

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical testing was not performed for C5 Diagnostic Ultrasound System as part of the submission." Therefore, there is no test set of patient data, no sample size for such a set, and no data provenance from patients mentioned. Technical performance tests were conducted on the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no clinical testing with patient data or ground truth established by experts was performed for this submission.

4. Adjudication Method

Not applicable, as no clinical testing with patient data was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable, as this is a general-purpose ultrasound system and not an AI-assisted device. The submission explicitly states, "Clinical testing was not performed."

6. Standalone (Algorithm Only) Performance Study

Not applicable, as this is a physical diagnostic ultrasound system, not a standalone algorithm. The submission explicitly states, "Clinical testing was not performed."

7. Type of Ground Truth Used

Not applicable, as no clinical testing with patient data requiring ground truth was performed. Performance was evaluated against recognized industry standards for safety and technical performance.

8. Sample Size for the Training Set

Not applicable, as no AI/ML algorithm requiring a training set is mentioned or evaluated in this submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no AI/ML algorithm or training set is mentioned.

Summary

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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.

Guangzhou Sonostar Technologies Co., Ltd. % Ms. Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou, Zhejiang 325000 CHINA

Re: K171926

Trade/Device Name: C5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 1, 2017 Received: August 14, 2017

Dear Ms. Nan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 27, 2017

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Oaks

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171926

Device Name C5 Diagnostic Ultrasound System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a lightning bolt shape cut out of the top left corner. To the right of the star is the text "SonoStar" in a bold, green font.

System:	C5 Diagnostic Ultrasound System
Transducer:
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Track 1&3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(PDI)
Ophthalmic	Ophthalmic
	Fetal	N				N	N - Note 1N - Note 2N - Note 3	N
	Abdominal	N				N	N - Note 3	N
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric	N				N	N - Note 1	N
	Small Organ(breast, testes, thyroid)	N				N	N - Note 1	N
FetalImaging&Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N				N	N - Note 1	N
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	N						N
	Musculo-skeletal(Superficial)	N						N
	Intravascular
	Other (OB/Gyn)	N	N	N		N	N - Note 1N - Note 2N - Note 3	N
	Other (Urology)	N				N	N - Note 1	N
	Cardiac Adult	N	N	N		N	N - Note 3N - Note 1N - Note 2	N
Cardiac	Cardiac Pediatric	N	N	N		N	N - Note 3N - Note 1N - Note 2	N
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel	N		N		N	N - Note 1N - Note 2	N
	Other (Specify)
System:	C5 Diagnostic Ultrasound System
Transducer:	Convex Array Transducer (3C6C)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Track 1&3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(PDI)
Ophthalmic	Ophthalmic
FetalImaging&Other	Fetal	N	N	N		N	N - Note 1	N
							N - Note 2
							N - Note 3
	Abdominal	N				N	N - Note 1	N
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(breast, testes, thyroid)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (OB/Gyn)	N	N	N		N	N - Note 1	N
							N - Note 2
							N - Note 3
	Other (Urology)	N				N	N - Note 1	N
Cardiac	Cardiac Adult	N	N	N		N	N - Note 3	N
								N - Note 1
								N - Note 2
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel
	Other (Specify)

N=new indication; P=previously cleared by FDA; E=added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/4/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green arrow pointing from the bottom left to the top right. To the right of the star is the text "SonoStar" in a green, bold, sans-serif font.

Diagnostic Ultrasound Indications For Use Format

N=new indication; P=previously cleared by FDA; E=added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/5/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a lightning bolt shape in the upper left corner. To the right of the star is the word "SonoStar" in a stylized, green font.

System:	C5 Diagnostic Ultrasound System
Transducer:	Linear Array Transducer (7L4C)
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(PDI)
(Track 1 Only)	(Track 1&3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric	N				N	N - Note 1	N
	Small Organ	N				N	N - Note 1	N
	(breast, testes, thyroid)
FetalImaging&Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	N
	Musculo-skeletal(Superficial)	N
	Intravascular
	Other (OB/Gyn)
	Other (Urology)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel	N				N	N - Note 1	N
	Other (Specify)

Diagnostic Ultrasound Indications For Use Format

N=new indication; P=previously cleared by FDA; E=added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/6/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green arrow pointing from the bottom left to the top right. To the right of the star is the text "SonoStar" in a green, bold, sans-serif font.

Diagnostic Ultrasound Indications For Use Format
System:	C5 Diagnostic Ultrasound System
Transducer:	Trans-vaginal Transducer (6E1C)
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1&3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(PDI)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N - Note 3	N
							N - Note 1
							N - Note 2
	Abdominal
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(breast, testes, thyroid)
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N				N	N - Note 1	N
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (OB/Gyn)	N	N	N		N	N - Note 1	N
							N - Note 2
							N - Note 3
	Other (Urology)	N				N	N - Note 1	N
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel
	Other (Specify)
System:	C5 Diagnostic Ultrasound System
Transducer:	Micro-Convex Array Transducer (6C15C)
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application				Mode of Operation
General(Track 1 Only)	Specific(Track 1&3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(PDI)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N				N	N - Note 1	N
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric	N		N		N	N - Note 1N - Note 2	N
	Small Organ(breast, testes, thyroid)
	Neonatal Cephalic
FetalImaging&Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (OB/Gyn)	N	N	N		N	N - Note 1N - Note 2N - Note 3	N
	Other (Urology)	N				N	N - Note 1	N
	Cardiac Adult	N	N	N		N	N - Note 3N - Note 1N - Note 2	N
Cardiac	Cardiac Pediatric	N	N	N		N	N - Note 3N - Note 1N - Note 2	N
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel
	Other (Specify)

N=new indication; P=previously cleared by FDA; E=added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Diagnostic Ultrasound Indications For Use Format

N=new indication; P=previously cleared by FDA; E=added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging

Note 1: B and Color Doppler Combined;

Note 2: B, Color Doppler and PWD Combined;

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Image /page/8/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font. The text is slightly bolded and the letters are evenly spaced.

007 510(k) Summary

(As required by 21 CFR 807.92(a))

7.1 Submitter Information

· Company: Guangzhou Sonostar Technologies Co., Ltd.
· Address: 504#, C Building, #27 Yayingshi Road, Science Town,

Guangzhou, Guangdong, 510665, P.R.China

・ Phone: 086-20-32382095
・ Fax: 086-20-62614030
· Contact: Weizhong Cai, General Manager
· Date: May 01, 2017

7.2 Device Information

· Trade/Device Name: Diagnostic Ultrasound System
Model: C5
· Common Name: Diagnostic Ultrasound System and Transducer
· Classification: 1) Device: System, Imaging, Pulsed Doppler, Ultrasonic

Regulation Description: Ultrasonic pulsed doppler

imaging system

Review Panel: Radiology

Product Code: IYN

Submission Type: 510(k)

Regulation Number: 21 CFR 892.1550

Device Class: 2

1. Device: System, Imaging, Pulsed Echo, Ultrasonic
  Regulation Description: Ultrasonic pulsed echo imaging

system

Review Panel: Radiology

Product Code: IYO

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Regulation Number: 21 CFR 892.1560 Device Class: 2 3) Device: Transducer, Ultrasonic, Diagnostic Regulation Description: Diagnostic ultrasonic transducer Review Panel: Radiology Product Code: ITX Regulation Number: 21 CFR 892.1570 Device Class: 2

7.3 Predicate Device Information

S12 Digital Color Doppler Ultrasound System submitted by SonoScape Company Limited 510K Number: K142474

7.4 Device Description

The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

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This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").

7.5 Indications for Use

C5 Diagnostic Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

7.6 Comparison of Technological Characteristics with the Predicate Device

	7.6.1 Comparison Table of Technological Characteristic with the
Predicate Device
Comparison Items	Subject Device:Diagnostic UltrasoundSystem(Model: C5)	Predicate Device:S12 Digital ColorDoppler UltrasoundSystem(K142474)
Classification & Intended Use
Classification	Product Codes:IYN & IYO & ITXClass: 2	Product Codes:IYN & IYO & ITXClass: 2
Intended Use	A general-purposeultrasonic imaging	A general-purposeultrasonic imaging

	instrument intended foruse by a qualifiedphysician forevaluation of Fetal,Abdominal, Pediatric,Small Organ (breast,testes, thyroid),Trans-vaginal,Peripheral Vascular,Musculo-skeletal(Conventional andSuperficial), Cardiac(neonatal and adult),OB/Gyn and Urology.	instrument intended foruse by a qualifiedphysician forevaluation of Fetal,Abdominal, Pediatric,Small Organ (breast,testes, thyroid),Cephalic(neonatal andadult), Trans-rectal,Trans-vaginal,Peripheral Vascular,Musculo-skeletal(Conventional andSuperficial), Cardiac(neonatal and adult),OB/Gyn and Urology.
Technological Characteristics	Based on an embeddedLinux OperatingSystem	Based on an embeddedLinux OperatingSystem
	Autocorrelation forcolor processing andFFT for pulse.	Autocorrelation forcolor processing andFFT for pulse and CWDoppler processing.
Design	Supporting Linearprobes (7.5MHz & 6.5MHz) and Convexarray probes (3.5MHz	Supporting Linear,Curve linear and Phasearray probes from 2 to15MHz
	Cine play back	Cine play back
	capability	capability
	Image file archive	Image file archive
	Software upgrade with	Software upgrade with
	USB flash drive	USB flash drive
		Digital Scan Converter
	1024×768	800×600
	With full keyboard	With full keyboard
	panel	panel
	TGC 8 slider	TGC 8 slider
	Depth Range: 3.6 to	Depth Range: 3 to
	35.1cm	24.8cm
	B Dynamic range	B Dynamic range
	control: 30-165dB	control: 20-280dB
	Gray Scale Control:	Gray Scale Control:
	0,1,2,3,4,5,6,78,9,10,11,12,13,14(14Optional)	1,2,3,4,5,6,7 (7Optional)
Operation Controls	Focal Number:	Focal Number:
	adjustable, max 4	adjustable, max 12
	B persistance: 0-95%	B persistance: 0-95%
	PW sweeping speed	PW sweeping speed
	0,1,2,3,4 sec overdisplay	2,4,6,8 sec over display
	PW Wall filter setting:	PW Wall filter setting:
	0 to 3	35 to 750
	PW sample volume: 0to 7mm	PW sample volume: 0.7to 21mm
	PW angle correction:	PW angle correction:
	adjustable, 0 to 85	adjustable, 0 to 72
	degree	degree
	Spectrum baseline:	Spectrum baseline:
	adjustable	adjustable, such as shift
		and invert
	Color ROI setting:	Color ROI setting:
	trackball to control size	trackball and set key to
	and position	control size and
		position
	Color Wall Filter	Color Wall Filter
	settings: 0 to 7	settings: 35 to 750
	Zoom adjustable	Zoom adjustable
	Freeze control:	Freeze control:
	Toggling freeze key	Toggling freeze key
	Cine control: play/stop,	Cine control: play/stop,
	loop speed, the start,	loop speed, the start,
	the end, Frame by	the end, Frame by
	Frame	Frame
Operation Mode	B, M, PW, Color, PDI,	B, M, PW, CW, CFM,
	Compound Imaging	DPI, TDI, Tissue
	(i.e. B+Color,B+Color+PW, B+M).	Harmonic Image, ColorM Mode, PIH,Compound Imaging,3D/4D ModePanoramic Imaging,Trapezoid Imaging.
Display Modes	B, PDI: Single, Dual,	B, CFM, DPI, TDI,
	Quad	4D: Single, Dual, Quad
	M: V1/3, V1/2(Dual),	B+CFM, B+DPI,
	V2/3, H1/2, H1/4, 01/4	B+TDI: Dual Live
	PW: V1/3, V1/2(Dual),	B/M, CFM/M, TDI/M,
	V2/3, H1/2, H1/4, 01/4	Steer M: V1/3,
		V1/2(Dual), V2/3,
		H1/2, H1/4, 01/4
		PW, CW: V1/3,
		V1/2(Dual), V2/3,
		H1/2, H1/4, 01/4
	B, PDI, Color	B, CFM, DPI, TDI:
	Doppler: Distance,	Area Ratio, Angle,
	Area, Circumference,	Volume, Volume
	Volume, Area Ratio,	L×W×H, Doppler Area,
	Distance Ratio, Angle,	Vascular, Small Part,
	Abdomen, Kidney,	Ortho, OB/GYN,
	Gynecology, Uterus,	Cardiac, URO, VHE;
	Ovary, Follicles,	M: Distance, Time,
	Obstetrics, AFI, Fetal	Slope, HR, Left
Measurement Items	Cardiology, Small	Ventricle, Mitral Valve,
	Parts, Urology,	Aortic Valve;
	Pediatric	PW/CW: Flow
	M: Distance, Time,	Velocity, Acceleration,
	Heart Rate, Slope Rate,	Time, Trace, Auto
	Fetal Cardiology	Trace, HR, Vascular,
	PW: Flow Speed Ratio,	OB/GYN, Cardiac, VE
	Speed, Time, Heart
	Rate, Acceleration,
	Spectral Trace,

	Obstetrics, Vascular
Cine Loop	Automatic	Automatic
	review/manual review	review/manual review
	Review speed can be	Review speed can be
	adjusted	adjusted
Operating Condition	Temperature:5~+40°C	Temperature: 10~40°C
	Relative humidity:	Relative humidity:
	25~80%	30~75%
	Air pressure:	Air pressure:
	700hPa~1060hPa	700hPa~1060hPa
Storage Condition	Temperature:	Temperature: -20~55°C
	-20~+55°C
	Relative humidity:	Relative humidity:
	25~93%	20~90%
	Air pressure:	Air pressure:
	700hPa~1060hPa	700hPa~1060hPa
Power Supply	Voltage: 100-240V AC	Voltage: 100-240V AC
	Frequency: 50/60 Hz	Frequency: 50/60 Hz
	Power Consumption:	Power Consumption:
	100-240V AC, 2.4-1A	100-240V AC,
		2.7-1.1A
Screen Size	15 inch LCD monitor	15 inch LCD monitor
Safety & Effectiveness
Electrical Safety	Evaluated according to	Evaluated according to
	IEC 60601-1	IEC 60601-1
EMC	Evaluated according to	Evaluated according to
	IEC 60601-1-2	IEC 60601-1-2
Bio-compatibility	Evaluated according to	Evaluated according to
	ISO 10993-5 & ISO10993-10	ISO 10993-5 & ISO10993-10
Performance Safety	Evaluated according toIEC 60601-2-37	Evaluated according toIEC 60601-2-37

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Guangzhou Sonostar Technologies Co., Ltd.

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Image /page/12/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star on the left side of the image. To the right of the star is the name of the company, "SonoStar", in green font.

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Image /page/13/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font.

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Image /page/14/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in "SonoStar" being larger than the rest of the letters.

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Image /page/15/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green wordmark to the right of the star. The wordmark reads "SonoStar" in a sans-serif font.

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7.6.2 Brief Summary

First, the subject device enjoys identical classification and similar intended use with the predicate device, which forms the foundation of substantial equivalence between the two devices. Though their intended use are not identical, the intended use of subject device is covered by that of predicate device which has a larger usage scope, thus will not affecting the substantial equivalence comparison between the two devices.

Secondly, the subject device boasts similar technological characteristics with the predicate device: 1) they have identical cine loop setting and screen size; 2) though their operation mode, display modes and measurement items are not identical, the operation mode, display modes and measurement items of subject device are covered by those of predicate device; 3) they share similar design which is almost the same, and the slight difference in digital scan converter will not affect the core usage of devices, thus will not affecting their substantial equivalence comparison; 4) though they are not identical in operating condition and storage condition, their slight difference in operating condition and storage condition will not affect the core usage of subject device as long as users operate according to instruction, thus will not influencing the substantial equivalence comparison between them; 5) although their power supply are slightly different, the electrical safety and EMC of subject device have been tested according to FDA recognized standards - IEC 60601-1 and IEC 60601-1-2, thus will not bringing in new safety concerns; 6) though the two devices are quite different in operation controls, the basic safety and essential performance of subject device has

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been evaluated according to FDA recognized standard - IEC 60601-2-37, thus will not bringing new safety and effectiveness concerns. All of the above facts further support that the two devices are substantially equivalent.

Last but not least, the safety and effectiveness of subject device have been tests according to the same FDA recongized standards as the predicate device - IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10, the result of which displays that subject device fully meets the standards requirement, that subject device will be as safe and effective for usage as the predicate device.

Accordingly, it is reasonable to conclude that two devices are substantially equivalent.

7.7 Discussion of Tests Performed

7.7.1 Clinical Tests

Clinical testing was not performed for C5 Diagnostic Ultrasound System as part of the submission.

7.7.2 Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:

1. Biocompatibility according to ISO 10993-5 and ISO 10993-10;
1. Electrical Safety according to AAMI / ANSI ES60601-1;
1. Electromagnetic Compatibility according to IEC 60601-1-2;
1. Performance Safety and Effectiveness according to IEC 60601-2-37.

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Image /page/18/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in SonoStar being the same green as the star outline and the rest of the word being a darker green.

7.8 Conclusion

From the above analysis, it is reasonable for us to conclude that the subject device - C5 Diagnostic Ultrasound System is substantially equivalent to the predicate device - S12 Digital Color Doppler Ultrasound System (K142474).

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.