U-Lite PRO

• K Number: K232285
• Device Name: U-Lite PRO
• Manufacturer: Sonoscanner SARL
• Date Cleared: 2024-01-11 ( 164 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K171164 , K202856 , K231301 , K201988
• Predicate For: N/A

Intended Use

U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.

It can therefore be used in different configurations, especially:

• In medical offices (general practitioner's office)
• In clinics & hospitals (incl. in emergency and critical care units)
• In a field hospital

It is used in imaging or examinations rooms.

It can be used at the bedside. It is not intended for direct use in a sterile environment.

The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system.

U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:

• ophthalmic
• fetal/obstetric,
• gynecological,
• abdominal,
• pediatric,
• neonatal cephalic
• adult cephalic
• small organ,
• trans-vaginal,
• trans-rectal,
• cardiac adult & pediatric
• peripheral vascular,
• urology (including prostate)
• musculoskeletal (both conventional and superficial)

Note : The application fields are dependent on the selected probes and the modes of operations.

Modes of operations include:

• B-Mode (B)
• M-Mode (M)
• Color Doppler (CD)
• Power Doppler (PD)
• Spectral Pulsed-Wave Doppler (PWD)
• Continous Wave Doppler (CWD)
• Combined :(B+M; B+CD; B+ PD; B+PWD)

Device Description

U-Lite PRO is a compact, ultralight battery powered general purpose diagnostic ultrasound scanner. The U-Lite PRO is a notebook-size, battery-operated, generalpurpose track 3 diagnostic ultrasound system. The U-Lite PRO can be handheld measuring 180mm x 115mm x 20mm and weighing 0.7 kg (approximately 1.54 lbs.). The unit is a handheld ultrasound (HHU) imaging system with interchangeable probes with optional stand.

The U-Lite PRO is used to acquire and display high-resolution LED screen images, realtime ultrasound data and display the data as B Mode, M Mode, PWD Mode, CWD Mode, Color Doppler Mode, Power Doppler, Tissue Harmonic Imaging Mode, and Combined (B +M; B+CD; B+PD; B+PWD).

AI/ML Overview

The provided text is a 510(k) summary for the U-Lite PRO ultrasonic pulsed Doppler imaging system. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with various standards, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for an AI/CADe (Computer-Aided Detection/Diagnosis) component.

Therefore, the document does not contain the information required to populate a table of acceptance criteria for AI performance, nor does it describe a study proving an AI/CADe device meets such criteria. Specifically:

• No acceptance criteria for AI were provided. The document describes acoustic output limits and measurement accuracy for the ultrasound system itself, but not for any AI/CADe features.
• No specific study proving AI performance was described. The document states, "No clinical studies were conducted," and the "Non-clinical Performance Testing" sections focus on electrical safety, EMC, usability, biocompatibility, and software verification/validation, along with acoustic output and measurement range/accuracy of the ultrasound hardware. There is no mention of a study to assess the performance of an AI algorithm in detection, diagnosis, or reader assistance.

Given the information provided in the document, it is not possible to complete the requested table or describe a study proving the device meets AI/CADe acceptance criteria, as the submission does not detail any AI component or its performance evaluation. The device described appears to be an ultrasound imaging device, not explicitly an AI/CADe system for image analysis.

Summary

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January 11, 2024

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

Sonoscanner SARL % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave. CROFTON MD 21114

Re: K232285

Trade/Device Name: U-Lite PRO Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 11, 2023 Received: December 11, 2023

Dear Yolanda Smith:

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).

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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 ([e-mail]) or phone [phone] or 301-796-7100).

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

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Indications for Use

510(k) Number (if known) K232285

Device Name U Lite PRO

Indications for Use (Describe)

U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.

It can therefore be used in different configurations, especially:

• In medical offices (general practitioner's office)

• In clinics & hospitals (incl. in emergency and critical care units)

• In a field hospital

It is used in imaging or examinations rooms.

It can be used at the bedside. It is not intended for direct use in a sterile environment.

The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system.

U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:

• · ophthalmic
• · fetal/obstetric,
• · gynecological,
• · abdominal,
• · pediatric,
• · neonatal cephalic
• · adult cephalic
• · small organ,
• · trans-vaginal,
• · trans-rectal,
• · cardiac adult & pediatric
• · peripheral vascular,
• · urology (including prostate)
• · musculoskeletal (both conventional and superficial)

Note : The application fields are dependent on the selected probes and the modes of operations.

Modes of operations include:

• · B-Mode (B)
• · M-Mode (M)
• · Color Doppler (CD)
• · Power Doppler (PD)
• · Spectral Pulsed-Wave Doppler (PWD)
• · Continous Wave Doppler (CWD)
• · Combined :(B+M; B+CD; B+ PD; B+PWD)

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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)

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K232285 510(k) Summary

1. SUBMITTER:	Sonoscanner SARL
Address:	6, rue Andre Voguet94200 Ivry Sur SeineFrance
Contact Person :	Vincent LuxQuality Assurance & Regulatory Affairs Manager
Telephone:	+ 33 1 84 77 19 72
Email:	[e-mail]
Date Prepared:	January 4, 2023

2. DEVICE

Trade Name:	U-Lite PRO
Classification Name:	System, Imaging, Pulsed Doppler, Ultrasonic
Common Name:	Ultrasonic Pulsed Doppler System
Regulation Number:	21 C.F.R. 892.1550
Product Code:	IYN, IYO & ITX
Device Class:	Class II
Classification Panel:	Radiology

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3. PREDICATE DEVICE

Predicate Devices:

	Manufacturer	Brand Name	510(k) Number
Primary Predicate	Sonoscanner	T Lite	K201988
Reference Predicate	Sonoscanner	U-Lite Exp	K171164
Reference Predicate	Edan Instruments,Inc.	Diagnostic UltrasoundSystem, Models:Acclarix AX3, AcclarixAX3 Exp, AcclarixAX3 Super, AcclarixAX25, Acclarix AX28,Acclarix AX2, AcclarixAX2 Exp, AcclarixAX2 Super, AcclarixAX15, Acclarix AX18,Acclarix LX3, AcclarixLX3 Exp, Acclarix LX3Super, Acclarix LX25and Acclarix LX28	K202856
Reference Predicate	GE MedicalSystemsUltrasound andPrimaryCareDiagnostics	Vscan Air	K231301

4. DEVICE DESCRIPTION

Device Description:

U-Lite PRO is a compact, ultralight battery powered general purpose diagnostic ultrasound scanner. The U-Lite PRO is a notebook-size, battery-operated, generalpurpose track 3 diagnostic ultrasound system. The U-Lite PRO can be handheld measuring 180mm x 115mm x 20mm and weighing 0.7 kg (approximately 1.54 lbs.). The unit is a handheld ultrasound (HHU) imaging system with interchangeable probes with optional stand.

The U-Lite PRO is used to acquire and display high-resolution LED screen images, realtime ultrasound data and display the data as B Mode, M Mode, PWD Mode, CWD Mode, Color Doppler Mode, Power Doppler, Tissue Harmonic Imaging Mode, and Combined (B +M; B+CD; B+PD; B+PWD).

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5. INDICATIONS FOR USE

Indications for Use

U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.

It can therefore be used in different configurations, especially:

• → In medical offices (general practitioner's office)
• → In clinics & hospitals (incl. in emergency and critical care units)
• → In a field hospital

It is used in imaging or examinations rooms.

It can be used at the bedside. It is not intended for direct use in a sterile environment.

The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system.

U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:

• ophthalmic ●
• fetal/obstetric, ●
• gynecological, ●
• abdominal, ●
• pediatric, ●
• neonatal cephalic ●
• adult cephalic ●
• small organ, ●
• trans-vaginal,
• trans-rectal, ●
• cardiac adult & pediatric ●
• peripheral vascular, ●
• urology (including prostate)
• musculoskeletal (both conventional and superficial) .

Note : The application fields are dependent on the selected probes and the modes of operations.

Modes of operations include:

• · B-Mode (B)
• · M-Mode (M)
• · Color Doppler (CD)
• · Power Doppler (PD)
• · Spectral Pulsed-Wave Doppler (PWD)

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• Continous Wave Doppler (CWD)
• Combined :(B+M; B+CD; B+ PD; B+PWD)

6. APPLICATIONS

The applications fields are dependent on the selected probes and the modes of operations:

Transducer	Indications	Mode
PR50 Convex Probe	Fetal, abdominal, pediatric, musculo-skeletal (conventional), other (gynecological), Urology (including prostate)	B, M, PWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, Combined (B + Color Doppler)
PR51 Linear 40mm Probe	Ophthalmic, Pediatric, small organ (breast, testes, thyroid), Neonatal Cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), Peripheral Vessel	B, M, PWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, Combined (B + Color Doppler)
PR52 Linear 50mm Probe	Ophthalmic, Pediatric, small organ (breast, testes, thyroid), musculo-skeletal (conventional), musculo-skeletal (superficial), Peripheral Vessel	B, M, PWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, Combined (B + Color Doppler)
PR53 Endocavitary Probe	Fetal, trans-rectal, trans-vaginal, other (gynecological), urology (including prostate)	B, M, PWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, Combined (B + Color Doppler)
Transducer	Indications	Mode
PR54Phased Array Probe	Fetal, abdominal, pediatric, Adultcephalic musculo-skeletal(conventional), cardiac adult,cardiac Pediatric, other(gynecological), urology (includingprostate)	B, M, PWD, CWD, ColorDoppler, Power Doppler,Tissue Harmonic Imaging,Combined (B + ColorDoppler)
PR55Microconvex Probe	Fetal, abdominal, small organ(breast, testes, thyroid, neonatalcephalic, musculo-skeletal(conventional), musculo-skeletal(superficial), Peripheral Vessel,urology (including prostate)	B, M, PWD, Color DopplerPower Doppler, TissueHarmonic Imaging,Combined (B + ColorDoppler)
PR56Convex Probe Access	Fetal, abdominal, Pediatrics,musculo-skeletal (conventional),other (Gynecological), Urology	B, M, PWD, Color DopplerPower Doppler, TissueHarmonic Imaging,Combined (B + ColorDoppler)
PR57Linear Probe Access	Ophthalmic, Pediatrics, smallorgan (breast, testes, thyroid),Neonatal Cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), PeripheralVessel	B, M, PWD, Color DopplerPower Doppler, TissueHarmonic Imaging,Combined (B + ColorDoppler)
PR58Microconvex Probe	Fetal, abdominal, Pediatrics, smallorgan (breast, testes, thyroid),Neonatal Cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), PeripheralVessel, urology (includingprostate)	B, M, PWD, Color DopplerPower Doppler, TissueHarmonic Imaging,Combined (B + ColorDoppler)
PR59Convex Probe SingleCrystal	Fetal, abdominal, Pediatrics,musculo-skeletal (conventional),other (Gynecological), urology(including prostate)	B, M, PWD, Color DopplerPower Doppler, TissueHarmonic Imaging,Combined (B + ColorDoppler)
PR60Hockey Stick Probe	Pediatrics, small organ (breast,testes, thyroid), NeonatalCephalic, musculo-skeletal(conventional), musculo-skeletal(superficial), Peripheral Vessel	B, M, PWD, Color DopplerPower Doppler, TissueHarmonic Imaging,Combined (B + ColorDoppler)

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7. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Predicate Comparison Table

Parameters	U Lite PROSubject	T-LitePrimary	U-Lite EXPReference	Vscan AirReference	Acclarix AX3Reference	Comment
510(k)Number		K201988	K171164	K231301	K202856	/
Manufacturer	Sonoscanner	Sonoscanner	Sonoscanner	GE MedicalSystems	EdanInstruments	/
RegulationNumbers	21 CFR892.155021 CFR892.156021 CFR893.1570	21 CFR892.155021 CFR892.156021 CFR893.1570	21 CFR892.155021 CFR892.156021 CFR893.1570	21 CFR892.155021 CFR892.156021 CFR893.1570	21 CFR892.155021 CFR892.156021 CFR893.1570	Same
ProductCodes	IYNITXIYO	IYNITXIYO	IYNITXIYO	IYNITXIYO	IYNITXIYO	Same
Parameters	U Lite PRO	T-Lite	U-Lite EXP	Vscan Air Reference	Acclarix AX3	Comm
	Subject	Primary	Reference		Reference	ent
	U-Lite PRO is	T-Lite is indicated	U-Lite EXP is	Vscan Air is	The Acclarix AX3
	indicated for the	for the	indicated for the	enabling	series/Acclarix
	visualization of	visualization of	visualization of	visualization and	LX3 series
	structures and	structures and	structures and	measurement of	Diagnostic
	dynamic processes in	dynamic	dynamic processes	anatomical	Ultrasound
	the human body using	processes in the	in the human body	structures and fluid	System is
	ultrasound imaging	human body	using ultrasound	including	intended for use
	and fluid flow analysis	using ultrasound	imaging and fluid	blood flow.	by a qualified
	for diagnosis in the	imaging and fluid	analysis for		physician or allied
	following clinical	flow analysis fordiagnosis in the	diagnosis in thefollowing clinical	abdominal,	healthprofessional for
	applications:• ophthalmic•	following clinical	applications:	fetal/obstetrics,gynecological,	ultrasound
	fetal/obstetric,•	applications:		urology,	evaluations in
	gynecological,•		• Abdominal	thoracic/lung,	hospitals and
	abdominal,	• Fetal/obstetri	• Small parts	cardiac (adult and	clinics. General
	• pediatric,•	c	• Vascular	pediatric, 40 kg and	clinical
	neonatal	• gynecological	• Cardiac	above).	applications
Indications	• cephalic	• abdominal	• Obstetrics	vascular/peripheral	include:
for use	• adult cephalic•	• pediatric	• Gynecology	vascular,	• Abdominal,
	small organ,	• Small	• Fetal	musculoskeletal	• Gynecology,
	• trans-	organ	• Pediatri	(conventional),	• Obstetric,
	vaginal,• trans-rectal,•	• Trans	cs	pediatrics,interventional	• Cardiac.
		vaginal		guidance (includes	• Small parts,
	cardiac adult &•pediatric	• Trans		free hand	• Urology,
	peripheral•	rectal• Cardiac		needle/catheter	• Musculoskele
	vascular,	Peripheral		placement, fluid	tal
	• urology	vascular		drainage, nerve	• Periph
	(including	• Urology		block and biopsy).	eral
	prostate)	Musculos			vascul
	• musculoskel etal	keletal (both			ar,
	(both conventional	conventional		vascular/peripheralvascular,	• Intra-
	and superficial)	and		musculoskeletal	operative,
	Note : The application	superficial		(conventional and	• Pediatric,
	fields are dependent	)		superficial), small	• Neonatal ,
	on the selected probes	• Neonatal		organs,	Adult
	and the modes ofoperations.	cephalic		thoracic/lung,	Cephalic.
				ophthalmic,
	Modes of operations			pediatrics, neonatal
	include:			cephalic,
	• B-Mode (B)			interventionalguidance (includes
	• M-Mode (M)			free hand
	• Color Doppler (CD)			needle/catheter
	• Power Doppler (PD)			placement, fluid
	• Spectral Pulsed-			drainage, nerve
	Wave Doppler (PWD)			block, vascular
	• Continous Wave			access and
	Doppler (CWD)			biopsy).
	• Combined :(B+M;
	B+CD; B+ PD;B+PWD)
Intended		Intended for	Intended for	Intended for	Intended for
Use	Intended for diagnostic	diagnostic	diagnosticultrasound analysis	diagnostic	diagnostic
	ultrasound analysis andfluid flow analysis	ultrasound analysisand	and fluid flow	ultrasound analysisand fluid flow	ultrasoundanalysis and fluid	Same
		fluid flow analysis	analysis	analysis	flow analysis
Track	Track 3	Track 3	Track 3	Track 3	Track 3	Same
Parameters	U Lite PROSubject	T-LitePrimary	U-Lite EXPReference	Vscan AirReference	Acclarix AX3Reference	Comment
Dimensions	180 x 115 x 20 mm7.09 x 4.53 x0.79"	253 x 174 x19mm9.96 x 6.85x0.7"	190 x 135 x20mm7.5 x 5.3 x0.8"	131 x 64 x 31 mm	375 ×380 ×58 mm	Different
Weight	1.4 lbs	2.20 lbs	1.8 lbs	0.45 lbs	9.92 lbs	Different
Configuration/Design	Notebook,handheld	Notebook,handheld	Notebook,handheld	dual headedprobes withapp (mobiledevice)	Portable	Different
Battery Life	2 hours	3 hours	1hr 30mins	50 min.	2 hours	Different
Display Size	7 in	10.1in	7in	na	10.1 in	Different
TabletopDocking	Yes	Yes	Yes	No	No	Same
Mobile Cart	Yes	Yes	Yes	No	Yes	Same
ScanningModes
B MODE	Y	Y	Y	Y	Y	Same
M MODE orTM-mode	Y	Y	Y	Y	Y	Same
HARMONIC	Y	Y	Y	Y	Y	Same
3D	N	N	N	N	N	Same
4D	N	N	N	N	N	Same
COLORDOPPLERMODE	Y	Y	Y	Y	Y	Same
PULSEWAVEDOPPLER	Y	Y	Y	Y	Y	Same
CONTINUOUSS WAVEDOPPLER	Y	N	N	N	Y	Same(Acclarix)
POWERDOPPLER	Y	Y	Y	Y	Y	Same
TISSUEDOPPLER	Y	Y	Y	Y	Y	Same
DIRECTIONALPOWERDOPPLER	Y	N	N	N	Y	Same(Acclarix)
Parameters	U Lite PROSubject	T-LitePrimary	U-Lite EXPReference	Vscan AirReference	Acclarix AX3Reference	Comment
BIOPSYATTACHMENT	Y	Y	Y	Y	Y	Same
Indications
Ophthalmic	Y	N	N	Y	N	Same
Fetal	Y	Y	Y	Y	Y	Same
Abdominal	Y	Y	Y	Y	Y	Same
Intra- operative(Specify)	N	N	N	N	Y	Same
Intra- operative(Neuro)	N	N	N	N	N	Same
Laparoscopic	N	N	N	N	N	Same
Pediatric	Y	Y	Y	Y	Y	Same
Small Organ	Y	Y	Y	Y	Y	Same
NeonatalCephalic	Y	Y	Y	Y	Y	Same
Adult Cephalic	Y	N	N	Y	Y	Same(Vscan &Acclarix)
Trans-rectal	Y	Y	Y	Y	Y	Same
Trans-vaginal	Y	Y	Y	Y	Y	Same
Trans-urethral	N	N	N	N	N	Same
Trans-esoph.(Non-Card.)	N	N	N	N	N	Same
Musculo-skeletal(Conventional)	Y	Y	Y	Y	Y	Same
Musculo-skeletal(Superficial)	Y	Y	Y	Y	Y	Same
Intravascular	N	N	N	N	N	Same
Cardiac Adult	Y	Y	Y	N	Y	Same
Parameters	U Lite PROSubject	T-LitePrimary	U-Lite EXPReference	Vscan AirReference	Acclarix AX3Reference	Comment
CardiacPediatric	Y	Y	Y	N	Y	Same
Intravascular(Cardiac)	N	N	N	N	N	Same
Trans-esoph.(Cardiac)	N	N	N	N	N	Same
Intra-cardiac	N	N	N	N	N	Same
Gynecological	Y	Y	Y	Y	Y	Same
PeripheralVessel	Y	Y	Y	Y	Y	Same
Urology(Includingprostate)	Y	Y	Y	Y	Y	Same
IntegratedSpeaker	Y	Y	Y	Y	Y	Same
DICOM	Y	Y	Y	Y	Y	Same

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Discussion of Technological Difference

The U-Lite PRO is comparable to primary predicate T-Lite (K201988) in technological characteristics and operating principle. It uses the same beamformer and the same exchangeable probes. Both devices transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on- screen display of anatomic structures and fluid flow within the body and have similar intended use and basic operating modes. Both systems allow for specialized measurements of structures and flow and calculations.

The proposed U Lite PRO and T Lite (K201988) have the similar clinical intended use and clinical applications. However, the following clinical applications are added to the proposed U Lite PRO: Ophthalmic & Adult cephalic which can be found in the reference predicate, VScan Air (K231301).

Non-clinical performance testing showed that the subject device is as safe and effective as the predicate device.

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For ophthalmic clinical applications

Acoustic output testing was conducted with PR51, PR52, and PR57 probes with "Ophthalmic" preset.

Results confirms that the maximum values for ophthalmic application are respected i.e

• · ISPTA less than or equal to 50 mW/cm2
• · MI less than or equal to 0.23
• · TI=Max (TIS as,TIC) as less than or equal to 1

Results confirms that the system complies with IEC 60601-2-37 standard

For adult cephalic clinical application

Acoustic output testing was conducted with PR54 probe to support the Transcranial Doppler Ultrasound (TCD) application in PW operating mode.

Results confirms that the maximum values (track 3) for adult cephalic application are respected i.e

• · ISPTA less than or equal to 720 mW/cm2
• · MI less than or equal to 1.9

Results confirms that the system complies with IEC 60601-2-37 standard

Modes and Transducers

The proposed U Lite PRO and the primary T Lite (K201988) support B-mode, B Mode, M Mode or TM-mode, Harmonic, Color Doppler Mode, Pulse Wave Doppler, Power Doppler, Tissue Doppler. In addition, the proposed U Lite PRO also supports Continuous Wave Doppler (CW) and Directional Power Doppler (DPD) modes which are cleared in the reference predicate, Acclarix AX3 (K202856).

The U Lite PRO comes with 11, previously cleared, exchangeable probes, PR50, PR51, PR52, PR53, PR54, PR55 PR56, PR57, PR58, PR59 PR60 (K171164 & K201988) which have been evaluated and found to be safe for the intended use of the device.

All these probes can be used with all U-Lite and T-Lite models.

All these probes were tested with the subject device in accordance with IEC 60601-2-37 standard and results do not raise any safety and performance issue.

Hardware

The hardware difference is to use one electronic component with faster CPU and faster GPU at the same power consumption, combined with more RAM, the new component can provide either more processing power for demanding applications, or lower average power consumption for the same processing tasks. The proposed change will therefore add Continuous – Wave (CW) Doppler interrogation methods to the modes of operation of the device.

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The power supply of the U-Lite PRO is 15V DC similar to the predicate T Lite and batteries support operation for 2 hours continuous scanning.

Electrical safety and EMC testing were conducted on the U Lite PRO. The system complies with the IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC.

8. PERFORMANCE DATA

Non-Clinical Tests

The U Lite PRO was tested to EN 60601-

1:2006+A1:2013+AC:2014+A12:2014+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 60601-1:2006 + A1:2013 Medical electrical equipment - Part 1: General requirements for safety and final report stated the U-Lite PRO complies with requirements of the test performed.

The U Lite PRO was tested to EN 60601-1-2:2015+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests and final report stated the U-Lite PRO complies with requirements of the test performed.

The differences between the U-Lite PRO versus the predicate does not raise any new safety issues

Nonclinical Performance Testing:

EN 60601-1:2006+A1:2013+AC:2014+A12:2014+A2:2020 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005+AMD1:2012+AMD2:2020)

EN 60601-1-2:2015+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2014+AMD1:2020)

EN 60601-1-6:2010+A1:2015+A2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010+AMD1:2013+AMD2:2020)

EN 60601-2-37:2008/A1:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2015)

EN ISO 14971:2019/A11:2021Medical devices - Application of risk management to medical devices (ISO 14971:2019)

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EN 62304:2006+A1:2015 Medical device software - Software life-cycle processes (IEC 62304:2006+AMD1:2015)

EN 62366-1:2015+AC:2016+AC:2016+A1:2020 Medical devices - Application of usability engineering to medical devices (IEC 62366-1:2015+AMD1:2020)

EN ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018)

EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10: 2010)

EN ISO 10993-11:2009 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for requlatory purposes (ISO 13485:2016)

Summary of Testing:

Biocompatibility:

The proposed U Lite PRO transducers are the same as the primary predicate device T Lite already cleared (K201988) and materials are ISO 10993-1 compliant. The U Lite PRO probes are manufactured using the exact same material, suppliers and exact manufacturing processes as the U-Lite Probes cleared under (K171164) and T Lite Probes (K201988)

Software Verification & Validation:

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices ... The software for this device was considered as a "moderate" level of concern.

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Acoustic Measurement Summaries

2D Measurement Range and Accuracy

2D Measurement Range and Accuracy Table 11.5

Measurement	Accuracy	Range
Axial Distance	$\leq \pm 3%$	0-30.0 cm
Lateral Distance	$\leq \pm 3%$	0-30.0 cm
Diagonal Distance	$\leq \pm 3%$	0-40.0 cm
Area	$<\pm 7%$	0.1-720 cm2
Circumference	$<\pm 5%$	0.1-96 cm
Contour	$<\pm 5%$	0.1-96 cm

M Mode Measurement and Accuracy

Table 11.6 M Mode Measurement and Accuracy
--------------------------------------------	--	--

Measurement	Accuracy	Range
Distance	$\leq \pm 3%$	30.0 cm
Time	$\leq \pm 2%$	0.02 to >4.0 s

PW Mode Measurement and Accuracy

Table 11.7 PW & CW Mode Measurement and Accuracy

Measurement	Accuracy	Range
Velocity	≤ ± 12%	0.04 – 1.6 m/s
Time	≤ ± 2%	0.02 to >4.0 s

Clinical Studies:

No clinical studies were conducted.

9. CONCLUSIONS

Conclusion:

Based upon the testing and comparison to the predicate device, the Sonoscanner U Lite PRO Diagnostic Ultrasound Device has similar intended use, identical technological characteristics, and operating principle. The U Lite PRO is substantially equivalent to the predicate device and does not raise any new safety and effectiveness issues.

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.