(105 days)
Not Found
No
The document describes standard ultrasound imaging modes and post-processing techniques, but there is no mention of AI or ML in the intended use, device description, or any other section.
No.
The T-Lite ultrasound system is indicated for diagnosis through visualization of structures and dynamic processes using ultrasound imaging and fluid flow analysis, rather than for treatment of any conditions.
Yes
The "Intended Use / Indications for Use" section states that "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". Additionally, the "Device Description" explicitly calls it a "general purpose diagnostic ultrasound scanner" and a "general purpose track 3 diagnostic ultrasound system."
No
The device description explicitly states that the T-Lite is a "compact, ultralight, battery powered general purpose diagnostic ultrasound scanner" and a "notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system." It also mentions physical dimensions and weight, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The T-Lite ultrasound system uses ultrasound imaging to visualize structures and dynamic processes within the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states visualization of structures and processes in the human body for diagnosis.
Therefore, the T-Lite ultrasound system is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Models of operation include:
- B-Mode
- B-Mode + M-Mode
- B-Mode + Color Doppler
- B-Mode + Power Doppler
- Spectral Pulsed-Wave Doppler
Product codes
IYN, IYO, ITX
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
fetal, obstetric, gynecological, abdominal, pediatric, small organ, trans-vaginal, trans-rectal, cardiac, peripheral vascular, urology, musculoskeletal (both conventional and superficial), neonatal cephalic.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately-trained healthcare professional; in medical offices, in clinics, in hospitals, imaging or examination rooms, at the bedside.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical study was conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
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
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.
3
510(k) Summary
| Sponsor: | Sonoscanner | K201988 |
|---|---|---|
| Address: | 6, rue André Voguet | |
| 94200 Ivry-Sur Seine | ||
| France | ||
| Phone: | 33 954 971 557 | |
| Fax: | 33 954 971 557 | |
| Contact Person: | Bruno Richard | |
| Scientific 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
4
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).
Indications for Use:
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 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:
5
- 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 892.1550 | ||
| 21 CFR 892.1560 | |||
| 21 CFR 893.1570 | 21 CFR 892.1550 | ||
| 21 CFR 892.1560 | |||
| 21 CFR 893.1570 | Same | ||
| Product Codes | IYN | ||
| ITX | |||
| IYO | IYN | ||
| ITX | |||
| IYO | Same | ||
| Intended Use | Intended for diagnostic | ||
| ultrasound analysis and | |||
| fluid flow analysis | Intended for diagnostic | ||
| ultrasound analysis and | |||
| fluid flow analysis | Same | ||
| Track | Track 3 | Track 3 | Same |
| Dimensions | 7.5 x 5.3 x 0.8 inches | 253 x 174 x 19mm | |
| 9.96 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 |
6
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
7
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)
8
- . 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.