The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) 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 part of this device to contact with the patient is the probe head.

Device Description

The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 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.

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.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to AI performance metrics. This document is a 510(k) summary for a medical device (Wireless Probe Type Ultrasound Scanner) seeking market clearance from the FDA.

The summary focuses on demonstrating substantial equivalence to existing predicate devices based on:

Intended Use: The device has the same diagnostic ultrasound echo imaging, measurement, and analysis indications for general clinical applications (OB, GY, abdominal imaging) as the primary predicate device.
Technological Characteristics: The device employs the same basic operating principles (pulsed-echo ultrasound, B, BM, Color Doppler, PDI, PW modes) and similar features (biopsy guideline, harmonic function) as the predicate devices. Differences mentioned (e.g., image display unit size, specific frequency ranges) are deemed not to affect core usage or substantial equivalence.
Safety and Effectiveness: Compliance with recognized international standards for biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance safety (IEC 60601-2-37), as well as FCC radio frequency testing.

Crucially, the document explicitly states: "Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission." This means there is no performance study evaluating the device's diagnostic accuracy or comparing it with other methods (human readers, AI assistance, etc.) presented in this document.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, standalone performance, or training set details as these are not discussed in the provided text.

Summary

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October 13, 2022

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Guangzhou Sonostar Technologies Co., Ltd. % Weizhong Cai General Manager 504#, C Building,#27 Yayingshi Road, Science Town Guangzhou. Guangdong 510665 CHINA

Re: K211321

Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model: CProbe: Type: Type C. Type L, Type CT, Type CL Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 9, 2022 Received: September 9, 2022

Dear Weizhong Cai:

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,

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K211321

Device Name

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL)

Indications for Use (Describe)

Modes of operation:

Pulsed-echo ultrasound
Mode B (2D) scan
· Mode BM scan
· Doppler mode (COLOR)
· Energy Doppler mode (PDI)
· Pulse Doppler (PW)

Operator qualifications: The operator should be capable to understand the Instructions for Use, The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.

Device use settings: hospital or home use.

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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007_510(k) Summary

(As required by 21 CFR 807.92(a))

K211321

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: Oct. 01, 2020

7.2 Device Information

· Trade/Device Name: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type C, Type CT, Type CT, Type CL)
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: IYN,IYO
- · Regulation Number: 21 CFR 892.1550

21 CFR 892.1560

· Primary product code: IYN (associated regulation: 21 CFR 892.1550)
· Device Class: 2
- 2) Device: Transducer, Ultrasonic, Diagnostic

Regulation Description: Diagnostic ultrasonic transducer

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Review Panel: Radiology

Product Code: ITX Regulation Number: 21 CFR 892.1570 Device Class: 2

7.3 Predicate Device Information

Primary predicate device: Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) submitted by Guangzhou Sonostar Technologies Co., Ltd. 510K Number: K172750 Reference Device: Vscan Air

submitted by GE VINGMED ULTRASOUND AS

(9900 Innovation Drive, wauwatosa, WI 53226)

510K Number: K202035

7.4 Device Description

The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a wirelessultrasound 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: CProbe; Type: Type C, Type L, Type CT, Type CL) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.

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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.

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

7.5 Indications for Use

The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 part of this device that is intended to contact with the patient is the probe head.

Modes of operation:

Pulsed-echo ultrasound
Mode B (2D) scan
Mode BM scan
· Doppler mode (COLOR)
Energy Doppler mode (PDI)

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• Pulse Doppler (PV

Operator qualifications: The operator should be capable to understand the Instructions for Use; The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.

Device use settings: hospital or home use.

7.6 Comparison of Technological Characteristics with the Predicate Device

7.6.1 Comparison Table of Technological Characteristic with the

Predicate Device and Reference device for Model: CProbe

ComparisonItems	Subject Device:Wireless ProbeTypeUltrasoundScanner(Model:CProbe; Type:Type C, TypeL, Type CT,Type CL)	Primarypredicatedevice:Wireless ProbeTypeUltrasoundScanner(Model:UProbe-C)(K172750)	Reference Device:Vscan Air (K202035)
Classification & Intended Use
Classification	ITX & IYN & IYO	IYO & ITX	ITX & IYO & IYN
Class 2	Class 2	Class 2

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		Guangzhou Sonostar Technologies Co., Ltd.
Intended Use	Intended fordiagnosticultrasound echoimaging,measurement, andanalysis of thehuman body forgeneral clinicalapplicationsincluding obstetrics(OB), gynecology(GY) and general(abdominal)imaging.	Intended fordiagnosticultrasound echoimaging,measurement, andanalysis of thehuman body forgeneral clinicalapplicationsincluding obstetrics(OB), gynecology(GY) and general(abdominal)imaging.	The device is enablingvisualization andmeasurement ofanatomical structuresand fluid includingblood flow.

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Technological Characteristics
Environment of Use	Hospital, clinic, andmedical officesettings	Hospital, clinic, andmedical officesettings	Professionalhealthcare facilities(ex. Hospital,clinic, medicaloffice), homeenvironment,road/air ambulanceand otherenvironments
Acoustic OutputLevels	Below Track 3	Below Track 3	Below Track 3
	FDA limits in	FDA limits in	FDA limits in
	accordance	accordance	accordance
	with Sept.	with Sept.	with Sept.
	2008	2008	2008
	ultrasound	ultrasound	ultrasound
	systems	systems	systems
	guidance	guidance	guidance
	document	document	document
Imaging Capacities	• Pulsed-echoultrasound• Mode B (2D) scan	• Pulsed-echoultrasound• Mode B (2D)scan• Mode BMscan	• Black/ white (B-mode)• Harmonicimaging modes(PDI)• Combined (B +Color Doppler /PW mode)• Color flow (Colordoppler),
	• Mode BM scan• Doppler mode(COLOR)• Energy Dopplermode (PDI)• Pulse Doppler(PW)
Feature function	• Biopsy guideline• Harmonicfunction	• Biopsy guideline• Harmonicfunction	• Biopsy guideline• Harmonicfunction
Guangzhou Sonostar Technologies Co., Ltd.
Patient Population	For use in allpatients	For use in allpatients	For use in allpatients
Principle /Mode ofOperation	Piezoelectricmaterial in thetransducer is usedas an ultrasoundsource to transmitsoundwaves intothe body. Soundwaves arereflected back tothe transducerand converted toelectrical signalsthat are processedand displayed asimages ofanatomicstructures.	Piezoelectricmaterial in thetransducer is usedas an ultrasoundsource to transmitsound waves intothe body. Soundwaves arereflected back tothe transducer andconverted toelectrical signalsthat are processedand displayed asimages ofanatomicstructures.	Medicalultrasound imagesare created bycomputer anddigital memoryfrom thetransmission andreception ofmechanical high-frequency wavesapplied through aprobe. Themechanicalultrasound wavesspread through thebody, producingan echo wheredensity changesoccur. The echoesreturn to the probewhere they areconverted backinto electricalsignals.These echosignals areamplified andprocessed byseveral analog anddigital circuitshaving filters withmany frequencyand time responseoptions,transforming thehigh-frequencyelectrical signalsinto a series ofdigital imagesignals which arestored in memory.Once in memory,the image can bedisplayed in real-time on thedisplay device
Guangzhou Sonostar Technologies Co., Ltd.
Image Display Unit	Mobile device (4 to 13 inches approximately)	Mobile device (4 to 10 inches approximately)	Mobile device
Probe Characteristics	Convex, 3.5 MHz frequency;	Convex, 3.5 MHz frequency	Convex, 3.3MHz frequency
Probe Connectionto Display	Wireless	Wireless	Wireless
Off-the-shelf operating system	iOS / Android	iOS / Android	iOS / Android
Software	Run as an app on off-the-shelf mobile device	Run as an app on off-the-shelf mobile device	Run as an app on off-the-shelf mobile device
System Components	• Commercial• off-the-shelf iOS mobile device,• Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device,• Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices	• Commercial off-the-shelf iOS mobile device,• Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device,• Wireless Probe Type Ultrasound Scanner battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices	• Mainframe• Software• Cable charger
Safety & Effectiveness
Patient- ContactingMaterials	Evaluatedaccording to FDArecognizedstandards - ISO10993-5 and ISO10993-10	Evaluatedaccording to FDArecognizedstandards - ISO10993-5 and ISO10993-10	Evaluatedaccording to FDArecognizedstandards - ISO10993-5 and ISO10993-10
Electrical Safety	Evaluatedaccording to IEC60601-1	Evaluatedaccording to IEC60601-1	Evaluatedaccording to IEC60601-1
EMC	Evaluatedaccording to IEC60601-1-2	Evaluatedaccording to IEC60601-1-2	Evaluatedaccording to IEC60601-1-2
Performance Safety	Evaluatedaccording to IEC60601-2-37	Evaluatedaccording to IEC60601-2-37	Evaluatedaccording to IEC60601-2-37

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Brief Summary

First, the subject device (Model: CProbe) enjoys identical classification and intended use with the Primary predicate device and Reference device, which forms the foundation of their substantial equivalence.

Secondly, the subject device (Model: CProbe) boasts almost the same technological characteristics with the Primary predicate device. And their slight differences in imaging capacities, image display unit will not affect the coreusage of the two devices, thus will not affecting the substantial equivalence comparison between the two devices that the difference technological characteristics with the Reference Device on imaging capacities is covered. Such fact further supports that the two devices are substantial equivalent.

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Last but not least, the safety and effectiveness of the subject device (Model: CProbe) have been evaluated according to the same FDA recognized standards as the Primary predicate device and Reference Device, 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: CProbe) is substantial equivalent with Primary predicate device.

7.6.2 Clinical Test

Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission.

7.6.3 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 AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5:Tests For In Vitro Cytotoxicity. (Biocompatibility) and AAMI / ANSI / ISO10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility);
1. 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 (Iec 60601-1:2005, Mod). (General II (ES/EMC));

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1. Electromagnetic Compatibility according to AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition3). (General II (ES/EMC));
1. 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);
1. 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.

7.7 Conclusion

From the above analysis, it is proper to conclude that the subject device (Model: CProbe) 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

§ 892.1550 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.