The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Device Description

The Pocket Ultrasound System C10 is designed to be a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data through an off-the-shelf (OTS) Android device. the system mainly includes the ultrasound equipment and software application components. The ultrasound equipment is used to complete the ultrasonic imaging function and the software application components are used to complete the image display, measurement, patient information management as well as image storage etc. The Pocket Ultrasound System comprises a series of wireless transducers employing Wi-Fi-based technology to communicate with smartphone devices via direct Wi-Fi. One of the software application components is a software APP (MY USG), which is deployed on Android devices which supported Wi-Fi wireless communication. The other one is the software contained in the ultrasound equipment to control operation of the equipment and transfer images via Wi-Fi to the smartphone devices. This allows the user to export ultrasound images and display them across a range of portable personal devices. The communication protocol between the software APP and the other software contained in the equipment is specially defined for unique connection.

The system is only intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology. The Pocket Ultrasound System comprises the following:

• A commercial off-the-shelf (COTS) Android smartphone/tablet device.

· the software application (MY USG) running as an App on the COTS device with Android system.

• The ultrasound equipment/Transducers: C10

• Accessory: Wireless Battery Charger & Power Adapter

Different type transducers are available for the Pocket Ultrasound System C10, the frequencies are 2.5 MHz and 7.5MHz respectively depending on different transducer. The Pocket Ultrasound System C10 is designed with four ultrasound modes of operation, including B-mode, Combination Mode (B+M mode), Color Doppler mode and Pulsed Wave Doppler mode.

Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color Doppler mode and Pulsed Wave Doppler mode. Combination mode B+M-mode is the combination of the B-mode and M-mode of operation, superimposed on the display. Mmode is defined as time motion display of the ultrasound wave along a chosen ultrasound line, so it's usually applied in diagnosis of cardiovascular diseases.

The system provides real-time images for tissues, organs or blood flow via touch screen of the COTS Android smartphone/tablet device, which, in combination with the embedded software system contained in the ultrasound device, provides users a friendly and convenient graphical interface and makes users be able to easily control the whole system.

AI/ML Overview

The provided text is a 510(k) Summary for the Beijing Konted Medical Technology Co., Ltd. Pocket Ultrasound System (C10). It aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria through a clinical or performance study in the way one might for a novel AI/ML device. Therefore, much of the requested information (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test set, training set ground truth establishment) is not present because this document is focused on demonstrating substantial equivalence to an existing cleared device through non-clinical testing and comparison.

The document states:

"No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its primary predicate device." (Page 21)
"Non-clinical testing for Pocket Ultrasound System C10 was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the primary predicate device." (Page 19)

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this specific device based on the provided text, nor can I describe an MRMC comparative effectiveness study or standalone performance data. The "acceptance criteria" here are implied to be the successful demonstration of equivalence through non-clinical testing and comparison to the predicate device, rather than quantitative performance metrics from a diagnostic accuracy study.

However, I can extract information related to the non-clinical performance and the rationale for claiming substantial equivalence:

Acceptance Criteria (Implied by Substantial Equivalence and Non-Clinical Testing):

The implied "acceptance criteria" for this 510(k) submission are that the device:

Has the same intended use as the predicate device.
Has similar technological characteristics, or that differences do not raise new questions of safety or effectiveness.
Meets relevant performance and safety standards.

The "Study" (Non-Clinical Testing and Comparison):

The "study" that proves the device meets (implied) acceptance criteria is a combination of:

Comparison of Technological Characteristics: A detailed comparison table and discussion highlighting similarities and differences between the subject device (Pocket Ultrasound System C10) and the primary predicate device (Philips Lumify Ultrasound System - K162549) and a reference device (GuangDong Youkey Medical Co., Ltd. Pocket Ultrasound System - K211746).
Non-Clinical Performance Testing: Verification against various national and international standards for electrical safety, electromagnetic compatibility, usability, software validation, cybersecurity, wireless coexistence, biocompatibility, and diagnostic ultrasound performance.

Here's the information extracted from the provided text as it relates to your request, noting where the information is not applicable due to the nature of a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document does not present a clinical study with quantitative performance metrics for diagnostic accuracy. The "acceptance criteria" discussed are largely met by demonstrating compliance with standards and equivalence to a predicate.

Category	Acceptance Criteria (Implied from 510(k) process & standards)	Reported Device "Performance" / Compliance Evidence (from Non-Clinical Testing Section)
Intended Use	Same as predicate device (Philips Lumify Ultrasound System)	"The subjective device and the primary predicate device have intended use." (Page 9)
Technological Equivalence	Differences in technological characteristics do not raise new questions regarding safety or effectiveness.	Detailed comparison table (Pages 9-15) and discussions (Pages 17-18) address differences (e.g., intended use environment, depth range, operation modes, frequencies, probe connection, display unit, wireless capability, power source, operating environment, IP degree) and conclude they "will not affect clinical performance and safety of the subject device."
Electrical Safety	Compliance with IEC 60601-1	"Evaluated according to IEC 60601-1:2005 + AMD 1:2012" (Page 19)
EMC	Compliance with IEC 60601-1-2	"Evaluated according to IEC 60601-1-2: 2014" (Page 19)
Home Healthcare Env. Use	Compliance with IEC 60601-1-11 (for home healthcare environment)	"Evaluated according to IEC 60601-1-11: 2015" (Page 19)
Rechargeable Battery Safety	Compliance with IEC 62133-2	"Safety test for Rechargeable Li-ion battery...IEC 62133-2: 2017" (Page 19)
Usability	Compliance with IEC 60601-1-6 and IEC 62366-1	"Usability Evaluation...IEC 60601-1-6: 2010 + A1:2013 and IEC 62366-1: 2014 + A1: 2020" (Page 19)
Software Validation	Compliance with FDA guidance for moderate concern software	"Software validation was conducted with a moderate concern according to the FDA guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (Document issued on: May 11, 2005)." (Page 19)
Cybersecurity	Compliance with FDA draft guidance	"Cybersecurity is evaluated according to the FDA draft guidance document 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices' (Document issued on October 2, 2014)" (Page 20)
Wireless Coexistence	Compliance with ANSI C63.27 and AAMI TIR69	"Wireless Coexistence...evaluated according to...ANSI C63.27: 2017 and AAMI TIR69: 2017" (Page 20)
Biocompatibility Safety	Compliance with ISO 10993 series	"Biocompatibility Safety is evaluated according to...ISO 10993-1, ISO 10993-5: 2009, ISO 10993-10: 2010" (Page 20)
Diagnostic Ultrasound Perf.	Compliance with IEC 60601-2-37 and FDA guidance	"Evaluated according to IEC 60601-2-37: 2007 + A1:2015" and "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Document issued on: June 27, 2019)" (Page 20)
Acoustic Output Levels	Within specified safety limits (e.g., Ispta.3 ≤ 720mW/cm2, MI ≤ 1.9, TI ≤ 6.0)	Subject device and predicate device show "Same" acoustic output levels: "Track 3 Ispta.3 ≤ 720mW/cm2 MI ≤ 1.9 TI ≤ 6.0" (Page 15) This implies testing confirmed the device operates within these limits.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. The document explicitly states "No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence..." (Page 21). The testing described is non-clinical performance and safety testing.
Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed by Beijing Konted Medical Technology Co., Ltd. (China) or by test labs they contracted for standard compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set with human-established ground truth was used for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set was used.

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. This is not an AI/ML device, but a medical imaging hardware/software system.

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

Not applicable. This is not an AI/ML diagnostic algorithm product.

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

Not applicable. Clinical ground truth was not established as no clinical studies were performed. The "ground truth" for the non-clinical testing refers to the established standards and specifications that the device's performance was compared against.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set for model development.

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

Not applicable. No training set was used.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 22, 2024

Beijing Konted Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K231354

Trade/Device Name: Pocket Ultrasound System (C10) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX

Dear Ivy Wang:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 20, 2023. Specifically, FDA is updating this SE Letter for a typo in the Indications for Use (IFU) statement as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yanna Kang, OHT8: Office of Radiological Health, 301-796-6704, Yanna.Kang@fda.hhs.gov.

Sincerely,

YANNA S. KANG -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: 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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Beijing Konted Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai. Shanghai 200122 CHINA

Re: K231354

Trade/Device Name: Pocket Ultrasound System (C10) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 10, 2023 Received: November 15, 2023

Dear Ivy Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

December 20, 2023

{2}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 S. Kang -S

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K231354

Device Name Pocket Ultrasound System (C10)

Indications for Use (Describe)

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

SECTION 2 510(k) Summary

{5}------------------------------------------------

510(k) Summary

I. SUBMITTER

Name: Beijing Konted Medical Technology Co., Ltd.

Address: Room 111,1F, Building 3, No. 27, Yong wang Road, Daxing Biological

Pharmaceutical Industry Base, Daxing District, Beijing, 102629 PEOPLE'S

REPUBLIC OF CHINA

Name of contact person: Deyi Zhu

Tel: +86 10-60219113

Fax: +86 10-60219213

E-Mail: 3245132464@qq.com

Submission date: 2024-01-12

II. Subject Device

Device trade name: Pocket Ultrasound System (Model: C10) Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation class: II Panel: Radiology Product code: IYN, IYO, ITX

III. Primary Predicative Device & Reference Device Primary Predicative Device

Submission Number: K162549 Device Trade Name: Lumify Ultrasound System Applicant: Philips Healthcare Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation class: II Panel: Radiology Product code: IYN, IYO, ITX

{6}------------------------------------------------

Reference Device

Submission Number: K211746 Device Trade Name: Pocket Ultrasound System Applicant: GuangDong Youkey Medical Co., Ltd. Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation class: II Panel: Radiology Product code: IYN, IYO, ITX

IV. Device Description

{7}------------------------------------------------

• A commercial off-the-shelf (COTS) Android smartphone/tablet device.

· the software application (MY USG) running as an App on the COTS device with Android system.

• The ultrasound equipment/Transducers: C10

• Accessory: Wireless Battery Charger & Power Adapter

V. Indication For Use

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Page 4 of 18

{8}------------------------------------------------

Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric

Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

{9}------------------------------------------------

VI. Comparison of Technological Characteristics with The Primary Predicate Device

The subjective device and the primary predicate device have intended use. The subject device and the primary predicate device have similar technological characteristics as evidenced by the differences in technological characteristics do not raise new questions regarding safety or effectiveness of the subject device.

Attribute	Subject device	Primary (K162549)	Predicative device	Reference device (K211746)	Discussion/ Conclusion
Product picture					/
Manufacturer	Beijing Konted Medical Technology Co., Ltd.	Philips Healthcare		GuangDong Youkey Medical Co., Ltd.	/
Proprietary name, model	Pocket Ultrasound System C10	Lumify Ultrasound System		Pocket Ultrasound System	/
Regulation name	Ultrasonic pulsed doppler imaging system	Ultrasonic pulsed doppler imaging system		Ultrasonic pulsed doppler imaging system	Same
Regulatory	Class II	Class II		Class II	Same
Attribute	Subject device	Primary Predicative device (K162549)	Reference device (K211746)	Discussion/Conclusion
Class
Product code	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	Same
Clinical characteristics
Indications for Use	The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes: Fetal/Obstetrics, Gynecological, Cardiac Fetal Echo, Abdominal, Small Parts (breast, thyroid), Cardiology, Carotid, Peripheral Vessel, Muscular-Skeletal, Urology and Pediatric.Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, UrologyLinear array probe - Small Parts (breast, thyroid), Carotid	Philips Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B + Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.	Pocket Ultrasound System (Model: P50, P51, P52, P53, P54, P55, P56) is intended for use by an appropriately trained, qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc), Peripheral Vascular, Urology. This system is suitable for use in hospital and clinical settings.	Same
Attribute	Subject device	Primary(K162549)	Predicative device	Reference device (K211746)	Discussion/Conclusion
	Peripheral Vessel, Muscular-Skeletal, PediatricPhase array probe - Cardiology,Cardiac Fetal Echo.The Pocket Ultrasound SystemC10 is a transportable ultrasoundsystem intended for use inenvironments where healthcare isprovided by healthcareprofessionals.
Intendedpatientpopulation	For use in all patients	For use in all patients		For use in all patients	Same
Intended useenvironment	Hospital, clinics, home for use byhealthcare professionals	Hospital, clinics, home andtransport for use by healthcareprofessionals		Hospitals, clinics	Different, seediscussion 1
General technological characteristics
Workingprinciple	Principle of operation of thePocket Ultrasound System is basedon ultrasonic echo imaging, whichis a common medical imagingtechnology to use the transmission	The system and transducers functionin a manner identical to allultrasound systems and transducers.The system circuitry generates anelectronic voltage pulse, which is		The transducers inside the probe areresponsible to emitting andreceiving ultrasonic waves. Whenthe host pushes pulse with a certainfrequency and magnitude onto the	Same
Attribute	Subject device	Primary(K162549)	Predicative device	Reference device (K211746)	Discussion/Conclusion
	speed of ultrasound in differenttissues and reflection degreedifferences, to get images throughcomputer processing for diagnosisand treatment.	transmitted to the transducer. In the	transducer, a piezo-electric arrayconverts the electronic pulse into anultrasonic pressure wave. Whencoupled to the body, the pressurewave transmits through bodytissues. The differing acousticproperties of the tissues in the bodyreflect some of the transmittedenergy back to the transducer, whereit is converted back to electricalsignals and sent back to the system.In the system, advanced signalprocessing technologies convert thereturned signals into images of thetissues. The Doppler functions ofthis system process the Doppler shiftfrequencies from the echoes ofmoving targets (such as blood), to	transducers, a short burst ofultrasound is emitted fromtransducers and directed into tissue.Echoes are produced as a result ofthe interaction of sound with tissue,and some of back to the transducers.Echoes come back is then convertedinto electric signals by transducersand handed to host for furtherprocess.The host is mainly responsible forthe following: data processing, inresponse to user instructions. Byreceiving the echo pulsetransmitting time and timingbetween the transducer and the echosignal can be calculated by thedistance between the structure, formthe brightness degree of adjacent
	The transducers inside the probeare responsible to emitting andreceiving ultrasonic waves. Whena pulse with a certain frequencyand magnitude onto thetransducers, then ultrasonic wavesare generated through the inversepiezoelectric effect andtransmitted to the human bodytissue through the probe. When theultrasonic wave meets the tissueinterface, it will generate echoes,which are scattered in differenttissues or blood flow and received
Attribute	Subject device	Primary Predicative device (K162549)	Reference device (K211746)	Discussion/ Conclusion
	by the probe and converted intoelectrical signals. The receiveramplifies and processes theseelectrical signals beforetransmitting them to theprocessing unit. Based on thesignals received, the processingunit will calculate the intensity andtiming of the echoes to form animage.	detect and graphically display theDoppler shifts of these tissues asflow.	image materials. The inherentacoustic impedance difference in theimage are different. And through theWIFI transmission and instructionimaging data.
Design	Autocorrelation for colorprocessing and FFT for pulseDoppler processing.Supporting Linear, Convex andPhase array probes.Cine play back capability Imagefile archive.	Autocorrelation for color processingand FFT for pulse Dopplerprocessing.Supporting Linear, Curve, Phasearray and Volume probes.Cine play back capability Image filearchive.	Not specified	Same
OperatingControls	Convex: 90~~305mmLinear: 20~~100mmCardiac: 90~160mmGain	Depth Range: 0.003 to >30 cmGain	Not specified	Different, seediscussion 2Same
Attribute	Subject device	Primary Predicative device (K162549)	Reference device (K211746)	Discussion/ Conclusion
	Focus	Focus	Not specified	Same
	Color box size/position can be adjust	Color box size/position can be adjust	Not specified	Same
	Baseline	N/A	Not specified	Same
	Cine control: drag scroll bar	Cine control: drag scroll bar, press	Not specified	Same
	Freeze control: Toggling freeze key	Freeze control: Toggling freeze key	Not specified	Same
Operation Mode	B mode	B mode	B mode	Different, see discussion 3
	B/M mode	M mode	M mode
	Color Doppler Mode	Color Doppler Mode	Color Doppler
	Pulsed Wave mode	B+C mode	Power DopplerPWD and Combined (B+M; B+CD; B+PD; B+PWD mode)
Transducers	Convex Array; Phase Array; Linear Array;	Convex Array, Phased Array, Linear Array	Convex Array, Linear Array, Phase Array, Intracavity	Same
Frequency	2.5MHz (phase); 3.2MHz(convex); 7.5MHz(linear)	curvilinear 5-2MHz; linear 12-4MHz	3.5-7.5MHz	Difference, see discussion 4
Probe connection to display unit	Wireless connection via Wi-Fi	Wire connection via USB	Wire connection via USB or Wireless connection via Wi-Fi	Difference, see discussion 5
Attribute	Subject device	PrimaryPredicative device(K162549)	Reference device (K211746)	Discussion/Conclusion
Device andOperatingsystem for thesoftware APP	A commercial off-the-shelfAndroid device (COTS)	A commercial off-the-shelf Androiddevice (COTS)	A commercial off-the-shelf (COTS)Android mobile deviceA commercial off-the-shelf (COTS)Windows device	Same
Image displayunit	CPU Clock Speed: ≥2GHz;Memory: ≥2GScreen size: ≥4.7 inch;Screen resolution: ≥1334x750Brightness: capable of ambientlight detection and brightnesscorrection.Android version 8.0 or newer	Minimum 50 MB of storage space(plus more for patient data storage)• Color display, minimum 14 cm(5.5 in)• Touch interface• Internally mounted speakers• 1280 x 800 resolution (minimum)• Android 5.0 or later operatingsystem	Windows environment (13.3inches);Android environment (9.6 inches)	Difference,see discussion6
Wirelessnetworkcapability	Communication via Wi-Fi (IEEE802.11n, 2.4 GHz & 5 G ISMband)	Wireless or cellular networkingcapability	Wi-Fi	Difference,see discussion7
Acousticoutput levels	Track 3Ispta.3 ≤ 720mW/cm2MI ≤ 1.9TI ≤ 6.0	Track 3Ispta.3 ≤ 720mW/cm2MI ≤ 1.9TI ≤ 6.0	Track 3Ispta.3 = 720mW/cm2MI max.= 1.9MI displayTI display	Same
Power sourceand powerrequirement	Rechargeable battery (Li-ion)DC 5V	AC :100V-240V,Frequenzy:50-60Hz	Rechargeable battery (Li-ion)DC 5V	Difference,see discussion8
Attribute	Subject device	Primary Predicative device(K162549)	Reference device (K211746)	Discussion/Conclusion
Operatingenvironment	Operating temperature: 0-40 °C;relative humidity 30-85%;Barometric pressure:700 to 1060 hPa	Operatingtemperature:5-40 °C;relative humidity 15-95%;Barometric pressure:700 to 1060 hPa	Not specified	Difference,see discussion9
IngressProtectiondegree	Host part of the ultrasound device:IP22probe part of the ultrasounddevice: IP27	probe part of the ultrasound device:IP47	Not specified	Difference,see discussion10
Safety and Effectiveness
Patientcontactingmaterial	Per ISO 10993-5 and ISO 10993-10	Per ISO 10993-5 and ISO 10993-10	Per ISO 10993-5 and ISO 10993-10	Same
ElectricalSafety	Evaluated according to IEC60601-1	Evaluated according to IEC 60601-1	Evaluated according to IEC 60601-1	Same
EMC	Evaluated according to IEC60601-1-2	Evaluated according to IEC 60601-1-2	Evaluated according to IEC 60601-1-2	Same
PerformanceSafety	Evaluated according to IEC60601-2-37	Evaluated according to IEC 60601-2-37	Evaluated according to IEC 60601-2-37	Same

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

{16}------------------------------------------------

Discussion on differences between the subject device and the primary predicate device

Discussion 1: The subject device is not intended to be used in the transport condition, which is applicable in the primary predicate device. As the subject device has restricted use condition the primary predicate device, such difference will not affect clinical performance and safety of the

{17}------------------------------------------------

subject device.

Discussion 2: The depth range of the subject device is different from the primary predicate device. As the depth size is depending on the type of the probe and the image is able to be enlarged and shunk by adjusting the depth. Such difference will not affect clinical performance and safety of the subject device.

Discussion 3: The subject device has the B-M mode while the primary predicate device has no such two modes, while both B-M mode and PW mode are well-established ultrassund modes on the market, like the reference device and all modes have been tested acording to standard IEC 60601-2-37. Therefore, will not affect clinical performance and safety of the subject device. Discussion 4: Quality of the image is mainly determined by the array number of transducer elements in principle. There is no image quality when the same body site is detected via the same array elements under specific frequency range 2-5MHz for convex array or 4-12MHz range for linear array. As frequency of the subject device are within the frequency range of the primary predicate device, such difference will not affect clinical performance and safety of the subject device.

Discussion 5: Although the subject device is connection while the primary predicate device is connected via USB wire connection, all wireless connection performance and safety have been evaluated accordingly. Therefore will not affect clinical performance and safety of the subject device.

Discussion 6: Although requirement for image display unit of the subject device is different from the min. resolution requirement for both devices is same in actual use, touch screen/speaker function is same, better memory performance and higher operating system is used on the subject device than the primary predicate devill not impact image quality as zoom and focus functions

{18}------------------------------------------------

are available. Therefore, such difference will not affect clinical performance and safety of the subject device.

Discussion 7: Although wireless network capability of the subject device is different from the primary predicate device, all wireless comection performance and safety have been evaluated accordingly. Therefore, will not affect clinical performance and safety of the subject device.

Discussion 8: The subject device is supplied by rechareable battery while the primary predicate device is supplied by power adapter. All safety requirement for the power adapter and battery used have been tested respectively according to applicable standards, such difference will affect clinical performance and safety of the subject device.

Discussion 9: Operating temperature and relaive humice is sightly different from the primary predicate device, while the safety and essential performance of the been evaluated under specific operational environment. Therefore, such difference will not affect clinical performance and safety of the subject device.

Discussion 10: IP degree for the subject device probe is IP27, which is different from IP47 of the primary probe, while both devices are intended to be used for indoor condition, ingress protect against dust with IP2X is enough. As for ingress water protection, both devices are in conformity with IPX degree. Therefore, such difference will not affect clinical performance and safety of the subject device.

{19}------------------------------------------------

VII. Summary of Non-clinical Performance

Non-clinical testing for Pocket Ultrasound System C10 was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the primary predicate device. The following tests were performed.

A Electric Safety and Electromagnetic Compatibility
- AAMI/IEC 60601-1:2005 + AMD 1:2012 Medical electrical equipment Part . 1 : General requirements for basic safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests
- IEC 60601-1-11: 2015 Medical electrical equipment. Part 1-11: General requirements for basic safety and essential performance. Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Safety test for Rechargeable Li-ion battery
- . IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
A Usability Evaluation
- . IEC 60601-1-6: 2010 + A1:2013 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 62366-1: 2014 + A1: 2020 Medical devices - Application of usability engineering to medical devices
Software validation

Software validation was conducted with a moderate concern according to the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Document issued on: May 11, 2005).

{20}------------------------------------------------

> Cybersecurity

Cybersecurity is evaluated according to the FDA draft guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Document issued on October 2, 2014)

A Wireless Coexistence
Wireless Coexistence of the subject device is evaluated according to the following two standards:
. ANSI C63.27: 2017 American National Standard for Evaluation of Wireless Coexistence
AAMI TIR69: 2017 Risk Management of Radio-frequency Wireless . Coexistence for Medical Devices and Systems
Biocompatibility Safety A

Biocompatibility Safety is evaluated according to the following standards and guidance:

. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Document issued on: September 4, 2020)
. ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests . for irritation and sensitization
Non-clinical Performance
- IEC 60601-2-37: 2007 + A1:2015 Medical electrical equipment Part 2-37: . Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Document issued on: June 27, 2019)
Performance Data Animal >

N/A, no animal studies are available for the subject device.

VIII. Summary of Clinical Performance

{21}------------------------------------------------

No clinical studies are available for the subject device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its primary predicate device.

IX. Conclusions

In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device substantially equivalent to the primary predicate device quoted above. The differences between the subjective device and its primary predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed primary predicate device.

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.