The T-Lite ultrasound system is intended for use by an appropriately- trained healthcare professional. We recommend that all users receive proper training by an authorized Sonoscanner representative before attempting to use the scanner. You must also follow corresponding local government rules and guidelines at all times.

T-Lite 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:

fetal/obstetric. gynecological, abdominal. pediatric, small organ, trans-vaginal, trans-rectal, cardiac. peripheral vascular. urology, musculoskeletal (both conventional and superficial), neonatal cephalic
NOTE : The application fields are dependent on the selected probe.

NOTE : T-Lite is a general-purpose ultrasound. It can therefore be used in different configurations, especially:

in medical offices,
in clinics,
in hospitals.

It is used in imaging or examination rooms.

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

NOTE : The T-Lite is not compatible with the use of the HF surgery device or in an MRI system.

Modes of operation include:

· B-Mode

· B-Mode + M-Mode
· B-Mode + Color Doppler
· B-Mode + Power Doppler
· Spectral Pulsed-Wave Doppler

Device Description

T-Lite is a compact, ultralight, battery powered general purpose diagnostic ultrasound scanner. The T-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. The T-Lite can be handheld measuring 253mm x 19mm and weighing just 1kg (approximately 2.2lbs). The unit has a built-in kick stand or optional stand.

The T-Lite is used to acquire and display high-resolution LED screen images, real-time ultrasound data and display the data as B Mode, M Mode, PWD Mode, Color Doppler Mode, Color Power Doppler, Duplex Mode, Tissue Harmonic Imaging Mode, Tissue Doppler and Combined (B + Color Doppler Mode).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "T-Lite" ultrasound system. It is a submission to the FDA demonstrating that the T-Lite is substantially equivalent to a previously cleared predicate device, the "U-Lite Exp".

This type of submission focuses on substantial equivalence rather than proving a device meets specific acceptance criteria based on studies demonstrating clinical performance or diagnostic accuracy of an AI algorithm. The core of this document is a comparison of technical specifications and performance against a predicate device, along with non-clinical (engineering and safety) testing.

Therefore, many of the requested points regarding acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this document. This submission does not involve an AI algorithm for diagnostic interpretation that would require such studies.

Here's a breakdown of the information available in the document that relates to your request:

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

Since this is a substantial equivalence claim for a general diagnostic ultrasound system and not an AI-driven interpretive device, there isn't a table of specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) for an algorithm. Instead, the "acceptance criteria" are implied by the standards of "substantial equivalence" to the predicate device and compliance with relevant medical device safety and performance standards.

The document demonstrates equivalence through a "Predicate Product Comparison Table" (on page 5-6), which shows that the T-Lite has similar:

Regulation Numbers (21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 893.1570) - Same
Product Codes (IYN, ITX, IYO) - Same
Intended Use (diagnostic ultrasound analysis and fluid flow analysis) - Same
Track (Track 3) - Same
Configuration/Design (Notebook, handheld) - Same
Scanning Modes (B Mode, Color Mode, Power Doppler, M Mode, Pulse Wave Doppler) - Same
Indications for Use (a comprehensive list of clinical applications like fetal, abdominal, cardiac, etc.) - Same

Differences are noted for:

Dimensions and Weight (T-Lite is slightly larger/heavier)
Battery Life (T-Lite has longer battery life: 3 hours vs 1hr 30mins)
Display Size (T-Lite has larger display: 10.1in vs 7in)
Power Supply (T-Lite is 15V DC vs 5V DC for predicate)

The manufacturer states that these differences do not raise any new safety issues and were tested to relevant safety standards (listed under Nonclinical Performance Testing).

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

Sample size for test set: Not applicable. This document is not performing a diagnostic accuracy study on a test set of patient data for an AI algorithm. Its evaluation is based on engineering and performance testing against a predicate device and adherence to international safety standards.
Data provenance: Not applicable.

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

Not applicable. Ground truth establishment for a test set of patient data is not described as part of this 510(k) submission, as it relates to an AI diagnostic performance study, which was not performed or required for this device.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This device is a general-purpose ultrasound system, not an AI-assisted diagnostic tool for image interpretation that would require an MRMC study.

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

Not applicable.

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

The "ground truth" for this submission is effectively the established performance and safety profile of the predicate device (U-Lite Exp) and compliance with international consensus standards for medical electrical equipment. No clinical ground truth derived from patient studies is mentioned or required for this type of submission.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an AI algorithm.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 30, 2020

Sonoscanner % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114

Re: K201988

Trade/Device Name: T-Lite Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 13, 2020 Received: October 14, 2020

Dear E.J. 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 (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 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

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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 medical devices and radiation-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.

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K201988

Device Name T-Lite

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Indications for Use (Describe)

T-Lite 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:

fetal/obstetric. gynecological, abdominal. pediatric, small organ, trans-vaginal, trans-rectal, cardiac. peripheral vascular. urology, musculoskeletal (both conventional and superficial), neonatal cephalic
NOTE : The application fields are dependent on the selected probe.

NOTE : T-Lite is a general-purpose ultrasound. It can therefore be used in different configurations, especially:

in medical offices,
in clinics,
in hospitals.

It is used in imaging or examination rooms.

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

NOTE : The T-Lite is not compatible with the use of the HF surgery device or in an MRI system.

Modes of operation include:

· B-Mode

· B-Mode + M-Mode
· B-Mode + Color Doppler
· B-Mode + Power Doppler
· Spectral Pulsed-Wave Doppler

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Sponsor:	Sonoscanner	K201988
Address:	6, rue André Voguet94200 Ivry-Sur SeineFrance
Phone:	33 954 971 557
Fax:	33 954 971 557
Contact Person:	Bruno RichardScientific Director, Quality Manager
Email:	richard@sonoscanner.com

Summary Preparation Date: October 30, 2020

Device Name

Trade Name:	T-Lite
Common/Usual Name:	Ultrasonic Pulse Doppler Imaging System
Classification Name:	System, Imaging, Pulsed Doppler, Ultrasonic
Establishment:	3011688715
Registration Number	3011688715
Product Code:	IYN, IYO and ITX
Device Class:	Class II
Code of Federal Regulation:	21 CFR 892.1550, 21 CFR 892.1560 and 21 CFR 892.1570

Code of Federal Regulation: 21 CFR 892.1550, 21 CFR 892.1560 and 21 CFR 892.1570

Predicate Device:

	Manufacturer	Brand Name	510(k) Number
Primary Predicate	Sonoscanner	U-Lite Exp	K171164

Device Description:

T-Lite is a compact, ultralight, battery powered general purpose diagnostic ultrasound scanner. The T-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound

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system. The T-Lite can be handheld measuring 253mm x 19mm and weighing just 1kg (approximately 2.2lbs). The unit has a built-in kick stand or optional stand.

Indications for Use:

You must also follow corresponding local government rules and guidelines at all times.

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

fetal/obstetric,
qynecological,
abdominal, ●
pediatric,
small organ,
trans-vaginal,
. trans-rectal,
cardiac,
peripheral vascular,
. urology.
. musculoskeletal (both conventional and superficial),
neonatal cephalic .

NOTE: The application fields are dependent on the selected probe.

NOTE: T-Lite is a general-purpose ultrasound. It can therefore be used in different configurations, especially:

. in medical offices,
in clinics, ●
in hospitals. .

It is used in imaging or examination rooms.

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

NOTE: The T-Lite is not compatible with the use of the HF surgery device or in an MRI system.

Modes of operation include:

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B-Mode .
B-Mode + M-Mode •
B-Mode + Color Doppler .
. B-Mode + Power Doppler
. Spectral Pulsed-Wave Doppler

Predicate Product Comparison Table

Parameters	U-Lite EXP	T-Lite	Comment
510(k) Number	K171164
Regulation Numbers	21 CFR 892.155021 CFR 892.156021 CFR 893.1570	21 CFR 892.155021 CFR 892.156021 CFR 893.1570	Same
Product Codes	IYNITXIYO	IYNITXIYO	Same
Intended Use	Intended for diagnosticultrasound analysis andfluid flow analysis	Intended for diagnosticultrasound analysis andfluid flow analysis	Same
Track	Track 3	Track 3	Same
Dimensions	7.5 x 5.3 x 0.8 inches	253 x 174 x 19mm9.96 x 6.85 x 0.7"	Different
Weight	1.8 lbs	2.20 lbs	Different
Configuration/Design	Notebook, handheld	Notebook, handheld	Same
Battery Life	1hr 30mins	3 hours	Different
Display Size	7in	10.1in	Different
Table Top Docking	Yes	Yes	Same
Mobile Cart	Yes	Yes	Same
Scanning Modes
B Mode	Y	Y	Same
Color Mode	Y	Y	Same
Power Doppler	Y	Y	Same
M Mode	Y	Y	Same
Pulse Wave Doppler	Y	Y	Same
Parameters	U-Lite EXP	T-Lite	Comment
Indications
Ophthalmic	N	N	Same
Fetal	Y	Y	Same
Abdominal	Y	Y	Same
Intra-operative (Specify)	N	N	Same
Intra-operative (Neuro)	N	N	Same
Laparoscopic	N	N	Same
Pediatric	Y	Y	Same
Small Organ	Y	Y	Same
Neonatal Cephalic	Y	Y	Same
Adult Cephalic	N	N	Same
Trans-rectal	Y	Y	Same
Trans-vaginal	Y	Y	Same
Trans-urethral	N	N	Same
Trans-esoph. (Non-Card.)	N	N	Same
Musculo-skeletal(Conventional)	Y	Y	Same
Musculo-skeletal	Y	Y	Same
Intravascular	N	N	Same
Cardiac Adult	Y	Y	Same
Cardiac Pediatric	Y	Y	Same
Intravascular (Cardiac)	N	N	Same
Trans-esoph. (Cardiac)	N	N	Same
Intra-cardiac	N	N	Same
Gynecological	Y	Y	Same
Peripheral Vessel	Y	Y	Same
Urology (Including prostate)	Y	Y	Same
Integrated Speaker	Y	Y	Same
DICOM	Y	Y	Same

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Discussions of Technological Differences

The T-Lite is comparable to the predicate U-Lite-EXP(K171164) 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

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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 T-Lite comes with 5 new exchangeable probes, PR56, PR57, PR58, PR59 PR60, in addition to the previously cleared probes PR50, PR51, PR52, PR53, PR54, PR55 (K171164). All these probes can be used with U-Lite and T-Lite models.

The differences are in the dimension and weight of the T-Lite offering a larger screen (10 inches vs 7 inches for the U-Lite) and a bigger battery (3 hours of function vs 1h30 hour for the U-Lite).

The power supply of the T-Lite is 15V DC vs 5V DC for the predicate U-Lite The new direct current, power consumption and power adapter changes were tested to EN 60601-1:2006 + A1:2013 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:2005, IEC 60601-1:2005/A1:2012) standard and final report stated the T-Lite complies with requirements of the test performed.

The differences between the T-Lite versus the predicate does not raise any new safety issues.

Nonclinical Performance Testing:

EN 60601-1:2006 + A1:2013 Medical electrical equipment Part 1: General . requirements for safety (IEC 60601-1:2005, IEC 60601-1:2005/A1:2012)
. EN 60601-1-1:2001 + A1:2006 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
. EN 60601-1-2:2015 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)
. EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
. 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 14971:2012 Medical devices Application of risk management to medical . devices (ISO 14971:2007)
EN 62304:2006 Medical device software Software life-cycle processes (IEC . 62304:2006)
. EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)
EN ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity (ISO 10993-5:2009)

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. 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)

Clinical Study:

No clinical study was conducted.

Conclusion:

Based upon the testing and comparison to the predicate device, the Sonoscanner T-Lite Diagnostic Ultrasound Device has similar intended use, identical technological characteristics and operating principle. The T-Lite is substantially equivalent to the predicate U-Lite EXP 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.