The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.

The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.

The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Device Description

The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.

The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.

The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging, wrist wrap.

The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.

The device components are not supplied sterile and do not require sterilization prior to use.

AI/ML Overview

The provided document is a 510(k) summary for the Wireless Probe Type Ultrasound Scanner (Models: UProbe-C, UProbe-L, BProbe). It establishes substantial equivalence to predicate devices rather than providing a study proving performance against acceptance criteria for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, experts, adjudication, and MRMC studies for an AI/ML device is not available in the provided text. The document describes a traditional medical device (ultrasound scanner) and its non-clinical testing for safety and effectiveness to demonstrate equivalence to existing devices.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

This information is not directly provided in the context of device performance metrics against specific acceptance criteria. Instead, the document focuses on demonstrating that the device meets general safety and effectiveness standards comparable to predicate devices. The "reported device performance" is implicitly that it meets the requirements of the standards listed below.

Category	Acceptance Criteria (Stated as adherence to standards)	Reported Device Performance (Stated as compliance)
Biocompatibility	AAMI / ANSI / ISO 10993-5:2009/(R)2014	Evaluated and Complies
	AAMI / ANSI / ISO 10993-10:2010/(R)2014	Evaluated and Complies
Electrical Safety	AAMI / ANSI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (IEC 60601-1:2005, Mod)	Evaluated and Complies
Electromagnetic Comp.	AAMI / ANSI / IEC 60601-1-2:2007/(R)2012 (Edition 3)	Evaluated and Complies
Performance Safety/Eff.	IEC 60601-2-37 Edition 2.0 2007	Evaluated and Complies
FCC Radio Frequency	FCC CFR Title 47 Part 15 Subpart C Section 15.247	Tested and Complies

For the BProbe model, specific accuracy for bladder volume measurement is mentioned:

Category	Acceptance Criteria (Predicate Device 3)	Reported Device Performance (BProbe)
Bladder Accuracy	±25% (60ml≤ volume ≤ 150ml)±15% (150ml< volume ≤ 999ml) (Predicate Device 3)	Assumed to be equivalent or better, as the document states "such slight difference will not affect the core usage...thus will not affecting the substantial equivalence". (Exact reported performance not numerically listed for the subject device).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document states non-clinical tests were performed according to standards. There is no mention of a "test set" in the context of diagnostic performance evaluation with patient data.
Data Provenance: Not applicable, as no clinical data or test sets from patients are described for performance evaluation. The "tests performed" section indicates non-clinical (engineering and safety) tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of expert-established ground truth for a test set, as no clinical performance study involving diagnostic interpretation is described.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

5. 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

No MRMC comparative effectiveness study was done, and the device is an ultrasound scanner, not an AI/ML diagnostic aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical imaging device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. As described in this document, the device itself is an ultrasound imaging system and not an AI/ML algorithm requiring diagnostic ground truth for performance evaluation of its interpretations. The ground truth for the non-clinical tests would be defined by the specifications and protocols of the listed ISO/IEC standards (e.g., electrical parameters, acoustic output measurements, material properties).

8. The sample size for the training set

Not applicable. This document describes an ultrasound scanner, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This document describes an ultrasound scanner, not an AI/ML algorithm requiring a training set.

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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

February 28, 2018

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: K172750

Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model: UProbe-L; BProbe) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 7, 2018 Received: February 7, 2018

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

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,

Mechant D. O'Hara For

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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Indications for Use

510(k) Number (if known) K172750

Device Name Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; U-Probe-L; BProbe)

Indications for Use (Describe)

The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetries (OB). gynecology (GY) and general (abdominal) imaging.

The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.

The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 green outline on the left side of the image. To the right of the star is the text "SonoStar" in green font.

System:	Wireless Probe Type Ultrasound Scanner (Model: UProbe-C)
Transducer:	3.5MHz, Convex
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 - Note 1
	Abdominal	N					N - Note 1
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(breast, thyroid)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
FetalImaging&Other	Other (Gynecology)	N					N - Note 1
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel
	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 M 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 outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font.

System:	Wireless Probe Type Ultrasound Scanner (Model: UProbe-L)
Transducer:	7.5MHz, Linear
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
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(breast, thyroid)	N						N - Note 1
FetalImaging&Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel	N						N - Note 1
	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 M 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 green outline on the left side of the image. To the right of the star is the text "SonoStar" in green font.

System:	Diagnostic Ultrasound Indications For Use FormatWireless Probe Type Ultrasound Scanner (Model: BProbe)
Transducer:	3.5MHz
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
	Intra-operative (Specify)
	Intra-Operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(breast, thyroid)
FetalImaging&Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Gynecology)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-epoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral Vessel
	Other (Bladder)	N

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

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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 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: June 01, 2017

7.2 Device Information

· Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model:

UProbe-C; UProbe-L; BProbe)

· Common Name: Diagnostic Ultrasound System and Transducer
· Classification: 1) Device: System, Imaging, Pulsed Echo, Ultrasonic

Regulation Description: Ultrasonic pulsed echo imaging

system

Review Panel: Radiology

Product Code: IYO

Regulation Number: 21 CFR 892.1560

Device Class: 2

1. Device: Transducer, Ultrasonic, Diagnostic
  Regulation Description: Diagnostic ultrasonic transducer

Review Panel: Radiology

Product Code: ITX

Regulation Number: 21 CFR 892.1570

Device Class: 2

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Image /page/7/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline. To the right of the star is the word "SonoStar" in green, with the first letter capitalized. The logo is simple and clean, and the green color gives it a fresh and modern look.

7.3 Predicate Device Information

Predicate Device 1:

SONON Ultrasound Imaging System (Model: SONON 300C)

submitted by HEALCERION Co., Ltd.

510K Number: K151339

Predicate Device 2:

Penrith Elettra Ultrasound System submitted by Penrith Corporation 510K Number: K100598

Predicate Device 3:

Palm Bladder Scanner - PBSV4.1 submitted by Mianyang Meike Electronic Equipment Co., Ltd. 510K Number: K130229

7.4 Device Description

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Image /page/8/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star on the left side, with the word "SonoStar" in green, bold letters to the right of the star. The star has a thin green outline and is filled with a lighter shade of green.

Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging, wrist wrap.

The device components are not supplied sterile and do not require sterilization prior to use.

7.5 Indications for Use

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Image /page/9/Picture/0 description: The image shows 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 word "SonoStar" in green, sans-serif font.

7.6 Comparison of Technological Characteristics with the Predicate Device

7.6.1 Comparison Table of Technological Characteristic with the Predicate Device for Model: UProbe-C

Comparison Items	Subject Device:Wireless Probe TypeUltrasound Scanner(Model: UProbe-C)	Predicate Device 1:SONON UltrasoundImaging System(Model: SONON300C)(K151339)
Classification & Intended Use
Classification	IYO & ITXClass 2	IYO & ITXClass 2
Intended Use	Intended for diagnosticultrasound echoimaging, measurement,and analysis of thehuman body for generalclinical applicationsincluding obstetrics(OB), gynecology (GY)	Intended for diagnosticultrasound echoimaging, measurement,and analysis of thehuman body for generalclinical applicationsincluding obstetrics(OB), gynecology (GY)
	and general(abdominal) imaging.	and general(abdominal) imaging.
Technological Characteristics
Environment of Use	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings
Acoustic Output Levels	Below Track 3 FDAlimits in accordancewith Sept. 2008ultrasound systemsguidance document	Below Track 3 FDAlimits in accordancewith Sept. 2008ultrasound systemsguidance document
Imaging Capacities	• pulsed-echoultrasound• Mode B (2D) scan• Mode BM scan	• pulsed-echoultrasound• Mode B (2D) scan
Patient Population	For use in all patients	For use in all patients
Anatomic Structures /Clinical applications	General clinicalapplications, includingfetal\obstetrics,gynecology, abdominal	General clinicalapplications, includingfetal\obstetrics,gynecology, abdominal
Users	Healthcareprofessionals	Healthcareprofessionals
Principle / Method ofOperation	Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound waves arereflected back to the	Piezoelectric materialin the transducer isused as an ultrasoundsource to transmitsound waves into thebody. Sound waves arereflected back to the
	transducer and	transducer and
	converted to electrical	converted to electrical
	signals that are	signals that are
	processed and	processed and
	displayed as images of	displayed as images of
	anatomic structures.	anatomic structures.
Image Display Unit	Mobile device (4 to 13	Mobile device (4 to 10
	inches approximately)	inches approximately)
Probe Characteristics	Convex, 3.5 MHz	Convex, 3.5 MHz
	frequency;	frequency
Probe Connection to	Wireless	Wireless
Display
Off-the-shelf operating	iOS	iOS / Android
system
Software	Run as an app on	Run as an app on
	off-the-shelf mobile	off-the-shelf mobile
	device	device
System Components	• Commercial	• Commercial
	off-the-shelf iOS	off-the-shelf iOS or
	mobile device,	Android mobile device,
	• Wireless Probe Type	• SONON Ultrasound
	Ultrasound Scanner	Imaging System
	software that runs as an	software that runs as an
	app on the mobile	app on the mobile
	device,	device,
	• Wireless Probe Type	• SONON Ultrasound
	Ultrasound Scanner	Imaging System
	battery-operated,	battery-operated,
	hand-held ultrasounddiagnostic transducerthat communicateswirelessly with iOSmobile devices	hand-held ultrasounddiagnostic transducerthat communicateswirelessly with iOS orAndroid mobile devices
Safety & Effectiveness
Patient-ContactingMaterials	Evaluated according toFDA recognizedstandards - ISO10993-5 and ISO10993-10	All materials withpatient contact arebiocompatible and canbe disinfected
Electrical Safety	Evaluated according toIEC 60601-1	Evaluated according toIEC 60601-1
EMC	Evaluated according toIEC 60601-1-2	Evaluated according toIEC 60601-1-2
Performance Safety	Evaluated according toIEC 60601-2-37	Evaluated according toIEC 60601-2-37

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Image /page/10/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 other letters.

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Image /page/11/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with the word "SonoStar" written in green, bold font. The star is positioned to the left of the text.

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Image /page/12/Picture/0 description: The image shows 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 text "SonoStar" in a green, sans-serif font.

Brief Summary

First, the subject device (Model: UProbe-C) enjoys identical classification and intended use with the predicate device 1, which forms the foundation of their substantial equivalence.

Secondly, the subject device (Model: UProbe-C) boasts almost the same technological characteristics with the predicate device 1. And their slight differences in imaging capacities, image display unit and off-the-shelf operating system will not affect the core usage of the two devices, thus will not affecting the substantial equivalence comparison between the two devices. Such fact further supports that the two devices are substantial equivalent.

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Image /page/13/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a yellow outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in "Sono" being slightly larger than the rest of the letters.

Last but not least, the safety and effectiveness of the subject device (Model: UProbe-C) have been evaluated according to the same FDA recognized standards as the predicate device 1, which ensures that the subject device will be safe and effective for usage as the predicate device, that the two devices are substantial equivalent.

As a result, it is reasonable to conclude that subject device (Model:

UProbe-C) is substantial equivalent with predicate device 1.

7.6.2 Comparison Table of Technological Characteristic with the Predicate Device for Model: UProbe-L

ComparisonItems	Subject Device:Wireless ProbeTypeUltrasoundScanner(Model:UProbe-L)	PredicateDevice 1:SONONUltrasoundImaging System(Model:SONON 300C)(K151339)	PredicateDevice 2:Penrith ElettraUltrasoundSystem(K100598)
Classification & Intended Use
Classification	IYO & ITXClass 2	IYO & ITXClass 2	IYN & IYO &ITX - Class 2
Intended Use	Intended fordiagnosticultrasound echoimaging,measurement,and analysis ofthe human body	Intended fordiagnosticultrasound echoimaging,measurement,and analysis ofthe human body	Intended fordiagnosticimaging or fluidflow analysis ofthe human bodyincluding: fetal,abdominal,

	for generalclinicalapplicationsincluding smallorgan andperipheral vesselimaging.	for generalclinicalapplicationsincludingobstetrics (OB),gynecology(GY) and general(abdominal)imaging.	intraoperative,intraoperativeneurological,pediatric, smallorgan, neonatal,cephalic, cardiac,peripheral vessel,musculoskeletal(conventional),musculoskeletal(superficial).
Technological Characteristics
Environment ofUse	Hospital, clinic,and medicaloffice settings	Hospital, clinic,and medicaloffice settings	Hospital, clinic,and medicaloffice settings
Acoustic OutputLevels	Below Track 3FDA limits inaccordance withSept. 2008ultrasoundsystemsguidancedocument	Below Track 3FDA limits inaccordance withSept. 2008ultrasoundsystemsguidancedocument	Below Track 3FDA limits inaccordance withSept. 2008ultrasoundsystemsguidancedocument
ImagingCapacities	• pulsed-echoultrasound• Mode B (2D)scan• Mode BM scan	• pulsed-echoultrasound• Mode B (2D)scan	• pulsed-echoand Dopplerultrasound• Mode B (2D),Color, Amplitude
			Doppler
PatientPopulation	For use in allpatients	For use in allpatients	For use in allpatients
AnatomicStructures /Clinicalapplications	General clinicalapplications,including smallorgan andperipheral vessel	General clinicalapplications,includingfetal\obstetrics,gynecology,abdominal	General clinicalapplications,including fetal,abdominal,intraoperative,pediatric, smallorgan, cephalic,cardiac,peripheral vessel,andmusculoskeletal
Users	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals
Principle /Method ofOperation	Piezoelectricmaterial in thetransducer isused as anultrasoundsource totransmit soundwaves into thebody. Soundwaves arereflected back to	Piezoelectricmaterial in thetransducer isused as anultrasoundsource totransmit soundwaves into thebody. Soundwaves arereflected back to	Piezoelectricmaterial in thetransducer isused as anultrasoundsource totransmit soundwaves into thebody. Soundwaves arereflected back to
	the transducerand converted toelectrical signalsthat areprocessed anddisplayed asimages ofanatomicstructures.	the transducerand converted toelectrical signalsthat areprocessed anddisplayed asimages ofanatomicstructures.	the transducerand converted toelectrical signalsthat areprocessed anddisplayed asimages ofanatomicstructures.
Image DisplayUnit	Mobile device (4to 13 inchesapproximately)	Mobile device (4to 10 inchesapproximately)	Video display(unknown size)
ProbeCharacteristics	Linear, 7.5MHzfrequency	Convex, 3.5MHzfrequency	L8-3 linear,L12-5 linear, andC5-2 curvilinear
ProbeConnection toDisplay	Wireless	Wireless	Wireless orwired
Off-the-shelfoperating system	iOS	iOS / Android	Unknown
Software	Run as an app onoff-the-shelfmobile device	Run as an app onoff-the-shelfmobile device	Unknown
SystemComponents	• Commercialoff-the-shelf iOSmobile device,• Wireless ProbeType Ultrasound	• Commercialoff-the-shelf iOSor Androidmobile device,• SONON	• System consolehousingelectroniccircuitry• Video display
	Scanner software	Ultrasound	• Power supply
	that runs as an	Imaging System	• User controls
	app on the	software that	• Transducers
	mobile device,	runs as an app on	(L8-3 linear,
	• Wireless Probe	the mobile	L12-5 linear,
	Type Ultrasound	device,	C5-2 curvilinear)
	Scanner	• SONON	that
	battery-operated,	Ultrasound	communicate
	hand-held	Imaging System	wirelessly or via
	ultrasound	battery-operated,	wire with system
	diagnostic	hand-held	console
	transducer that	ultrasound
	communicates	diagnostic
	wirelessly with	transducer that
	iOS mobile	communicates
	devices	wirelessly with
		iOS or Android
		mobile devices
Safety & Effectiveness
Patient-Contactin	Evaluated	All materials	All materials
g Materials	according to	with patient	with patient
	FDA recognized	contact are	contact are
	standards - ISO	biocompatible	biocompatible
	10993-5 and ISO	and can be
	10993-10	disinfected
Electrical Safety	Evaluated	Evaluated	Unknown
	according to IEC	according to IEC
	60601-1	60601-1
EMC	Evaluatedaccording to IEC60601-1-2	Evaluatedaccording to IEC60601-1-2	Unknown
PerformanceSafety	Evaluatedaccording to IEC60601-2-37	Evaluatedaccording to IEC60601-2-37	Unknown

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Image /page/14/Picture/0 description: The image features the logo for SonoStar. The logo consists of a five-pointed star in a light green color, positioned to the left of the company name. The text "SonoStar" is written in a bold, sans-serif font, also in a matching shade of green, creating a cohesive and recognizable brand identity.

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Image /page/15/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star on the left side, with the word "SonoStar" written in green, bold font to the right of the star. The star has a slight gradient effect, with the top point being a lighter shade of green.

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Image /page/16/Picture/0 description: The image features the logo for SonoStar. The logo consists of a five-pointed star in a light green color, positioned to the left of the text "SonoStar". The text is also in a green color, complementing the star. The overall design is simple and clean, with a focus on the brand name and a symbolic star element.

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Image /page/17/Picture/0 description: The image features the logo for SonoStar. The logo consists of a green star with a thick outline and the word "SonoStar" in a bold, green font. The star is positioned to the left of the text, and the overall design is simple and clean.

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Image /page/18/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with the word "SonoStar" written in green, bold font. The star is positioned to the left of the text, and the overall design is simple and clean.

Brief Summary

First, the subject device (Model: UProbe-L) enjoys similar classification and intended use with predicate device 2. The classification and intended use of the subject device (Model: UProbe-L) is covered by those of the predicate device 2 which has a broader usage scope, which forms the foundation of the substantial equivalence between the two devices.

Secondly, the subject device (Model: UProbe-L) boasts similar technological characteristics with predicate device 2. They have the same environment of use, acoustic output levels, patient population, users and principle/method of operation; they have similar anatomic structure, probe characteristics and probe connection to display, i.e. those 3 aspects of the subject device (Model: UProbe-L) is covered by those of the predicate device 2 which has a broader usage scope; they have similar imaging capacities, i.e. some imaging capacities of subject device (Model: UProbe-L) are covered by that of the predicate device 2, and the different imaging capacities of subject device (Model: UProbe-L) - Model BM Scan is commonly used, not newly developed imaging capacity, thus will not bringing new safety and effectiveness concerns to the substantial equivalence comparison between the two device; although the subject device (Model: UProbe-L) has different image display unit, off-the-shelf operating system, software and system components compared with the predicate device 2, such characteristics have already been adopted by Page 13 of 19

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Image /page/19/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline. To the right of the star is the word "SonoStar" in green, sans-serif font.

predicate device 1, not newly developed, which will bring no new safety and effectiveness concerns. All those facts further supports that the subject device (Model: UProbe-L) and predicate device 2 are substantially equivalent.

Last but not least, the safety and effectiveness of the subject device (Model: UProbe-L) have been further ensured by the following FDA recognized standards - ISO 10993-5 & ISO 10993-10, IEC 60601-1 & IEC 60601-1-2 and IEC 60601-2-37, which shows that the subject device will be safe and effective for usage as the device that has already been on the market.

As a result, it is reasonable to conclude that subject device (Model: UProbe-L) is substantial equivalent with predicate device 2.

7.6.3 Comparison Table of Technological Characteristic with the

Comparison Items	Subject Device:	Predicate Device 3:
	Wireless Probe Type	Palm Bladder Scanner
	Ultrasound Scanner	- PBSV4.1
	(Model: BProbe)	(K130229)
Classification & Intended Use
Classification	IYO & ITX	IYO & ITX
	Class 2	Class 2
Intended Use	Intended to project	Intended to project
	ultrasound energy	ultrasound energy
	through the lower	through the lower
	abdomen of the	abdomen of the
	nonpregnant patient to	nonpregnant patient to
	obtain an image of the	obtain an image of the
		bladder and uses thatimage to calculate thebladder volumenon-invasively.	bladder and uses thatimage to calculate thebladder volumenon-invasively.
Technological Characteristics
Mode of Operation		B	B
TransducerCharacteristics	Type	3.5MHz MechanicalSector Scan	2.6MHz MechanicalSector Scan
	Timefrom 3DScanInitiationto ResultDisplay	4 seconds	4 seconds
	Penetration Depth	≥150mm	≥140mm
Range of Measurement		10-999ml	0-999ml
Accuracy		±10%	•±25% (60ml≤ volume ≤ 150ml)•±15% (150ml< volume ≤ 999ml)
Power Supply		DC3.8V 4200mAlithium battery	7.4v Li IonRechargeable
Screen Display		IPAD or IPHONE	Color LCD
Probe Connection toDisplay		Wireless	Wired
Operation Condition		• Temperature:+5°C~+40°C	• Temperature:+5°C~+40°C
		•Humidity Rate:25%-80%• AtmosphericPressure:700hPa~1060hPa	•Humidity Rate: ≤70%• AtmosphericPressure:700hPa~1060hPa
AcousticOutput	Maximum MI	0.47	0.89
	Maximum TIS	0.037	0.98
Target Population		Adult and Children	Adult and Children
Anatomical Sites		Abdomen	Abdomen
Safety and Effectiveness
Patient-ContactingMaterials		Evaluated according toISO 10993-5 and ISO10993-10	Evaluated according toISO 10993-5 and ISO10993-10
Electrical Safety		Evaluated according toIEC 60601-1	Evaluated according toIEC 60601-1
EMC		Evaluated according toIEC 60601-1-2	Evaluated according toIEC 60601-1-2
Performance Safety		Evaluated according toIEC 60601-2-37	Evaluated according toIEC 60601-2-37
FCC Radio FrequencyTesting		Tested to FCCrequirements and foundto comply with therequirements of FCCCFR Title 47 Part 15Subpart C Section15.247	Not applicable.

Predicate Device for Model: BProbe

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Image /page/21/Picture/0 description: The image features the logo for SonoStar. The logo consists of a five-pointed star in a light green color, positioned to the left of the text "SonoStar". The text is written in a bold, sans-serif font, also in a darker shade of green. The overall design is clean and modern, with the star adding a touch of visual interest to the brand name.

Brief Summary

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Image /page/22/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a yellow outline on the left side. To the right of the star, the word "SonoStar" is written in green, with the "S" in "Sono" being slightly larger than the rest of the letters.

First, the subject device (Model: BProbe) enjoys the same classification and intended use with the predicate device 3, which forms the foundation of the substantial equivalence between the two devices.

Secondly, the subject device (Model: BProbe) boasts similar technological characteristics with the predicate device 3, for example, they have the same mode of operation, transducer type (i.e.Mechanical Sector Scan), target population and anatomical sites. Though they differ in transducer specification, range of measurement, accuracy, operation condition and screen display, such slight difference will not affect the core usage of the subject device (Model: BProbe), thus will not affecting the substantial equivalence between the two devices. Although they do not have the same power supply and acoustic output index, such difference has been verified by FDA recognized standards - IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-37. And though they have different probe connection to display, the wireless connection adopted by the subject device (Model: BProbe) is not newly developed technology, it has already bee adopted by predicate device 1, and its safety has been further ensured by FCC requirements, which will not bring new concerns to the subject device's safety and effectiveness, thus will not affecting the substantial equivalence comparison between the two devices. All of those facts further supports that the two devices are substantial equivalent.

Last but not least, the safety and effectiveness of the subject device (Model: BProbe) have been further ensured by the following FDA recognized standards - ISO 10993-5 & ISO 10993-10, IEC 60601-1 & IEC 60601-1-2 and IEC 60601-2-37, and FCC requirements, which shows that the subject device will be as safe and effective for usage as the device that has already been on the market.

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Image /page/23/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 first letter capitalized.

As a result, it is reasonable to conclude that subject device (Model: BProbe) is substantial equivalent with predicate device 3.

7.7 Discussion of Tests Performed

7.7.1 Clinical Test

Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) 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:

Biocompatibility according to AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility); 2) Electrical Safety according to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC)):
Electromagnetic Compatibility according to AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3). (General II (ES/EMC));
Performance Safety and Effectiveness according to IEC 60601-2-37 Edition 2.0 2007, Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment. (Radiology);

Page 18 of 19

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Image /page/24/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 first letter of each word capitalized. The logo is simple and clean, with a focus on the company name and a star symbol.

FCC Radio Frequency Testing: The Wireless Probe Type Ultrasound Scanner was tested according to FCC requirements and found to comply with the requirements of FCC CFR Title 47 Part 15 Subpart C Section 15.247: Frequency Hopping, Direct Spread Spectrum and Hybrid Systems that are in operation with the bands of 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz.

7.8 Conclusion

From the above analysis, it is proper to conclude that the subject device (Model: UProbe-C; UProbe-L; BProbe) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.