(90 days)
Not Found
No
The document describes standard ultrasound imaging and processing techniques and does not mention AI, ML, or related terms.
No.
The device is clearly indicated for "diagnosis" and "diagnostic ultrasound imaging" and not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Sonoscanner U-Lite ultrasound diagnostic device is intended for use by trained health care professionals... for diagnostic ultrasound imaging and fluid flow analysis of the human body." Additionally, the "Device Description" calls it a "track 3 diagnostic ultrasound system."
No
The device description explicitly states it is a "notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system" and mentions hardware components like a display, controls, and battery, in addition to utilizing various probes. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the U-Lite 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. They are used outside of the body.
- U-Lite Function: The U-Lite is an ultrasound system that uses sound waves to create images of structures and processes within the human body. It is a non-invasive imaging device used for diagnosis in vivo.
The description clearly states that the U-Lite is used for "visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis." This is the core function of an ultrasound machine, which is not an IVD.
N/A
Intended Use / Indications for Use
U-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, and musculoskeletal (both conventional and superficial).
The Sonoscanner U-Lite ultrasound diagnostic device is intended for use by trained health care professionals (physician, sonographer, etc.) for diagnostic ultrasound imaging and fluid flow analysis of the human body. Utilizing curved, linear, phased array, and endocavitary probes, the U-Lite allows for a wide range of clinical applications: Fetal/obstetric, gynecological, abdominal, pediatric, small organ, transvaginal, trans-rectal, cardiac, peripheral vascular, and musculoskeletal.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
U-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and to display the data as B Mode, M Mode, Color Mode, Power Doppler imaging, and Pulse Wave Doppler spectrum. The U-Lite device utilizes a standard range of probes, including curved array (convex), linear array, phased array (sector), and endocavitary transducers.
The handheld U-Lite tablet's display is a high-resolution 7 inch color LED screen, and the controls are intuitive and easy to use. Controls are touch-activated - there are no knobs or switches. The U-Lite is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning 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 (breast, testes, thyroid), trans-vaginal, trans-rectal, cardiac, peripheral vascular, urology (including prostate), and musculoskeletal (both conventional and superficial).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals (physician, sonographer, etc.)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, biocompatibility, as well as for thermal, electrical, electromagnetic and mechanical safety, and has been found to conform to applicable medical device safety standards. The U-Lite complies with voluntary standards:
- IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for 0 Safety
- IEC/EN 60601-1-1 Safety Requirements for Medical Electrical Systems
- IEC/EN 60601-1-2 Amendment A1:2006, General Requirements for Safety -9 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC/EN 60601-1-6 General Requirements for Safety Collateral Standard: 0 Usability
- 0 IEC/EN 60601-2-37 Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The profiles are black and have a stylized, flowing appearance. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2015
Sonoscanner SARL % Mr. Frank Ferguson CEO Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 VIRGINIA BEACH VA 23451
Re: K143601
Trade/Device Name: U-Lite Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 3, 2015 Received: February 5, 2015
Dear Mr. Ferguson:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
K143601 510(k) Number (If known): _
Device Name: U-Lite
Indications for Use:
U-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, and musculoskeletal (both conventional and superficial).
Prescription Use ________XX (21 CFR 801 Subpart D)
OR
Over-The- Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image shows the logo for "sonoscanner". The logo consists of a stylized letter "K" on the left, followed by the word "sonoscanner" in a light blue, sans-serif font. A thin line is located underneath the word "sonoscanner".
U-Lite with VI-1 Convex Array Transducer
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B + Color | |||||||||
| Doppler) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Gynecological) | N | N | N | N | N | ||||
| Peripheral Vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under appendix
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
4
Image /page/4/Picture/1 description: The image contains the word "sonoscanner" in a stylized font, with a curved line graphic to the left of the word. The word is written in a light blue color, and there is a thin line underneath the word. The font appears to be a serif font, and the overall design is clean and modern.
U-Lite with VI-2 Phased Array Transducer
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B + Color | |||||||||
| Doppler) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | |||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | ||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | |||
| Cardiac Pediatric | N | N | N | N | N | N | |||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Gynecological) | N | N | N | N | N | ||||
| Peripheral Vessel | N | N | N | N | N | ||||
| Urology (including prostate) | N | N | N | N | N |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under appendix
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
5
Image /page/5/Picture/1 description: The image contains the word "sonoscanner" in a stylized font. The word is in lowercase letters and is a light blue color. To the left of the word is a stylized graphic that looks like a sideways "K".
U-Lite with VI-3 Linear Array Transducer
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B + Color | |||||||||
| Doppler) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | |||
| Small Organ | |||||||||
| (breast, testes, thyroid) | N | N | N | N | N | N | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | N | N | N | N | N | N |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under appendix
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
6
Image /page/6/Picture/1 description: The image contains the word "sonoscanner" in a stylized font. The word is in blue and is underlined. To the left of the word is a blue abstract symbol that looks like a stylized letter K.
U-Lite with VI-4 Endocavitary (Curved) Transducer
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (B + Color | |||||||||
| Doppler) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | N | N | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Gynecological) | N | N | N | N | N | N | |||
| Peripheral Vessel |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under appendix
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
7
Image /page/7/Picture/0 description: The image features the word "sonoscanner" in a stylized, light blue font. To the left of the word is a graphic element that resembles a stylized letter "K" or an abstract design. The overall impression is clean and modern, suggesting a brand identity for a company or product named "sonoscanner."
59, rue de la Sante 75013 PARIS - FRANCE Tel .: +33 (0)9 54 97 15 57 Fax: +33 (0)9 59 97 15 57 contact@sonoscanner.com
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Sonoscanner U-Lite Diagnostic Ultrasound Device.
DATE PREPARED: 12 December 2014
APPLICANTS NAME AND ADDRESS:
Sonoscanner SARL Attn: Bruno Richard, MD, PhD, Scientific Director, Quality Manager 59, rue de la Santé 75013 Paris France Phone: 33.9.5497.1557; FAX: 33.9.5497.1557 richard@sonoscanner.com
APPLICANTS CONTACT PERSON IN THE USA:
Ferguson Medical International Device Consultants LLC Attn: Frank Ferguson, CEO 332 Laskin Road Suite 437 Virginia Beach, VA 23451 Phone: 757.286.4383; FAX: 801.749.0451 frankf@fergusonmedical-idc.com
DEVICE NAME:
Trade Name: U-Lite
8
Common Name: Ultrasound Scanner
Classification Name: System, Imaging, Pulsed Doppler Ultrasonic Product Code:
Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892-1570, 90-ITX
LEGALLY MARKETED DEVICE TO WHICH SONOSCANNER IS CLAIMING SUBSTANTIAL EQUIVALENCE:
Device Name: Venue 50 510(k) Reference: (K133431) Manufacturer: GE Healthcare
DEVICE DESCRIPTION:
U-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and to display the data as B Mode, M Mode, Color Mode, Power Doppler imaging, and Pulse Wave Doppler spectrum. The U-Lite device utilizes a standard range of probes, including curved array (convex), linear array, phased array (sector), and endocavitary transducers.
The handheld U-Lite tablet's display is a high-resolution 7 inch color LED screen, and the controls are intuitive and easy to use. Controls are touch-activated - there are no knobs or switches. The U-Lite is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.
INTENDED USE:
The Sonoscanner U-Lite ultrasound diagnostic device is intended for use by trained health care professionals (physician, sonographer, etc.) for diagnostic ultrasound imaging and fluid flow analysis of the human body. Utilizing curved, linear, phased array, and endocavitary probes, the U-Lite allows for a wide range of clinical applications: Fetal/obstetric, gynecological, abdominal, pediatric, small organ, transvaginal, trans-rectal, cardiac, peripheral vascular, and musculoskeletal.
9
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE:
The U-Lite is of comparable type and substantially equivalent to the GE Venue 50 diagnostic ultrasound system (K133431). 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 the same intended use and basic operating modes. Both systems allow for specialized measurements of structures and flow, and calculations.
PERFORMANCE DATA:
The device has been evaluated for acoustic output, biocompatibility, as well as for thermal, electrical, electromagnetic and mechanical safety, and has been found to conform to applicable medical device safety standards. The U-Lite complies with voluntary standards:
- IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for 0 Safety
- IEC/EN 60601-1-1 Safety Requirements for Medical Electrical Systems ●
- IEC/EN 60601-1-2 Amendment A1:2006, General Requirements for Safety -9 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC/EN 60601-1-6 General Requirements for Safety Collateral Standard: 0 Usability
- 0 IEC/EN 60601-2-37 Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
CONCLUSIONS:
Based upon the testing and comparison to the predicate device, the Sonoscanner U-Lite Diagnostic Ultrasound Device has the same intended use and similar technological characteristics. The device performs as intended and does not raise and new safety or effectiveness issues.