(164 days)
No
The summary does not mention AI, ML, or any related terms, and the performance metrics and studies described are typical for traditional ultrasound devices.
No
Explanation: The U-Lite PRO is described as a "diagnostic ultrasound scanner" and its intended use is for "visualization of structures and dynamic processes" and "diagnosis" in various clinical applications. It performs imaging and fluid flow analysis, but does not provide therapy.
Yes
The device description explicitly states, "U-Lite PRO is a compact, ultralight battery powered general purpose diagnostic ultrasound scanner." Furthermore, its intended use includes "diagnosis in the following clinical applications."
No
The device description explicitly states it is a "Handheld Ultrasound system" and a "compact, ultralight battery powered general purpose diagnostic ultrasound scanner," including physical dimensions and weight, indicating it is a hardware device with integrated software.
Based on the provided information, the U-Lite PRO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- U-Lite PRO Function: The U-Lite PRO is an ultrasound system that uses sound waves to create images of structures and processes within the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis." This is consistent with in-vivo imaging, not in-vitro analysis.
Therefore, the U-Lite PRO falls under the category of medical imaging devices, specifically ultrasound systems, and is not an IVD.
N/A
Intended 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)
- · Continous Wave Doppler (CWD)
- · Combined :(B+M; B+CD; B+ PD; B+PWD)
Product codes
IYN, IYO, ITX
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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).
Indicated Patient Age Range
Pediatric, Neonatal, Adult
Intended User / Care Setting
Qualified and trained healthcare professionals.
In medical offices (general practitioner's office), In clinics & hospitals (incl. in emergency and critical care units), In a field hospital.
Imaging or examinations rooms, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing showed that the subject device is as safe and effective as the predicate device.
Acoustic output testing was conducted for ophthalmic applications with PR51, PR52, and PR57 probes, confirming compliance with ISO/IEC standards (ISPTA less than or equal to 50 mW/cm2, MI less than or equal to 0.23, TI less than or equal to 1).
Acoustic output testing was conducted for adult cephalic clinical applications with the PR54 probe for Transcranial Doppler Ultrasound (TCD) in PW operating mode, confirming compliance with standards (ISPTA less than or equal to 720 mW/cm2, MI less than or equal to 1.9).
Electrical safety and EMC testing were conducted; the system complies with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2.
Software verification and validation testing were performed, addressing a "moderate" level of concern.
No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Axial Distance Accuracy: 4.0 s)
PW Mode Velocity Accuracy: 4.0 s)
Predicate Device(s)
Reference Device(s)
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
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).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
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
2
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)
3
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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4
K232285 510(k) Summary
| 1. SUBMITTER: | Sonoscanner SARL |
|---|---|
| Address: | 6, rue Andre Voguet |
| 94200 Ivry Sur Seine | |
| France | |
| Contact Person : | Vincent Lux |
| Quality Assurance & Regulatory Affairs Manager | |
| Telephone: | + 33 1 84 77 19 72 |
| Email: | qara@sonoscanner.com |
| 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 |
5
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 Ultrasound | ||
| System, Models: | |||
| Acclarix AX3, Acclarix | |||
| AX3 Exp, Acclarix | |||
| AX3 Super, Acclarix | |||
| AX25, Acclarix AX28, | |||
| Acclarix AX2, Acclarix | |||
| AX2 Exp, Acclarix | |||
| AX2 Super, Acclarix | |||
| AX15, Acclarix AX18, | |||
| Acclarix LX3, Acclarix | |||
| LX3 Exp, Acclarix LX3 | |||
| Super, Acclarix LX25 | |||
| and Acclarix LX28 | K202856 | ||
| Reference Predicate | GE Medical | ||
| Systems | |||
| Ultrasound and | |||
| Primary | |||
| Care | |||
| Diagnostics | 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).
6
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)
7
- 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 |
| PR54 | ||
| Phased Array Probe | Fetal, abdominal, pediatric, Adult | |
| cephalic musculo-skeletal | ||
| (conventional), cardiac adult, | ||
| cardiac Pediatric, other | ||
| (gynecological), urology (including | ||
| prostate) | B, M, PWD, CWD, Color | |
| Doppler, Power Doppler, | ||
| Tissue Harmonic Imaging, | ||
| Combined (B + Color | ||
| Doppler) | ||
| PR55 | ||
| Microconvex Probe | Fetal, abdominal, small organ | |
| (breast, testes, thyroid, neonatal | ||
| cephalic, musculo-skeletal | ||
| (conventional), musculo-skeletal | ||
| (superficial), Peripheral Vessel, | ||
| urology (including prostate) | B, M, PWD, Color Doppler | |
| Power Doppler, Tissue | ||
| Harmonic Imaging, | ||
| Combined (B + Color | ||
| Doppler) | ||
| PR56 | ||
| Convex Probe Access | Fetal, abdominal, Pediatrics, | |
| musculo-skeletal (conventional), | ||
| other (Gynecological), Urology | B, M, PWD, Color Doppler | |
| Power Doppler, Tissue | ||
| Harmonic Imaging, | ||
| Combined (B + Color | ||
| Doppler) | ||
| PR57 | ||
| Linear Probe Access | Ophthalmic, Pediatrics, 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) | ||
| PR58 | ||
| Microconvex Probe | Fetal, abdominal, Pediatrics, small | |
| organ (breast, testes, thyroid), | ||
| Neonatal Cephalic, musculo- | ||
| skeletal (conventional), musculo- | ||
| skeletal (superficial), Peripheral | ||
| Vessel, urology (including | ||
| prostate) | B, M, PWD, Color Doppler | |
| Power Doppler, Tissue | ||
| Harmonic Imaging, | ||
| Combined (B + Color | ||
| Doppler) | ||
| PR59 | ||
| Convex Probe Single | ||
| Crystal | Fetal, abdominal, Pediatrics, | |
| musculo-skeletal (conventional), | ||
| other (Gynecological), urology | ||
| (including prostate) | B, M, PWD, Color Doppler | |
| Power Doppler, Tissue | ||
| Harmonic Imaging, | ||
| Combined (B + Color | ||
| Doppler) | ||
| PR60 | ||
| Hockey Stick Probe | Pediatrics, 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) |
8
9
7. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Predicate Comparison Table
| Parameters | U Lite PRO
Subject | T-Lite
Primary | U-Lite EXP
Reference | Vscan Air
Reference | Acclarix AX3
Reference | Comment |
|----------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|-------------------------------|
| 510(k)
Number | | K201988 | K171164 | K231301 | K202856 | / |
| Manufacturer | Sonoscanner | Sonoscanner | Sonoscanner | GE Medical
Systems | Edan
Instruments | / |
| 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 | 21 CFR
892.1550
21 CFR
892.1560
21 CFR
893.1570 | 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 | IYN
ITX
IYO | IYN
ITX
IYO | IYN
ITX
IYO | 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 for
diagnosis in the | diagnosis in the
following clinical | abdominal, | health
professional 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/peripheral
vascular, | • 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 of
operations. | cephalic | | thoracic/lung, | Cephalic. | |
| | | | | ophthalmic, | | |
| | Modes of operations | | | pediatrics, neonatal | | |
| | include: | | | cephalic, | | |
| | • B-Mode (B) | | | interventional
guidance (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 | diagnostic
ultrasound analysis | diagnostic | diagnostic | |
| | ultrasound analysis and
fluid flow analysis | ultrasound analysis
and | and fluid flow | ultrasound analysis
and fluid flow | ultrasound
analysis 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 PRO
Subject | T-Lite
Primary | U-Lite EXP
Reference | Vscan Air
Reference | Acclarix AX3
Reference | Comment |
| Dimensions | 180 x 115 x 20 mm
7.09 x 4.53 x0.79" | 253 x 174 x19mm
9.96 x 6.85x0.7" | 190 x 135 x20mm
7.5 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 headed
probes with
app (mobile
device) | 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 |
| Tabletop
Docking | Yes | Yes | Yes | No | No | Same |
| Mobile Cart | Yes | Yes | Yes | No | Yes | Same |
| Scanning
Modes | | | | | | |
| B MODE | Y | Y | Y | Y | Y | Same |
| M MODE or
TM-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 |
| COLOR
DOPPLER
MODE | Y | Y | Y | Y | Y | Same |
| PULSE
WAVE
DOPPLER | Y | Y | Y | Y | Y | Same |
| CONTINUOUS
S WAVE
DOPPLER | Y | N | N | N | Y | Same
(Acclarix) |
| POWER
DOPPLER | Y | Y | Y | Y | Y | Same |
| TISSUE
DOPPLER | Y | Y | Y | Y | Y | Same |
| DIRECTIONAL
POWER
DOPPLER | Y | N | N | N | Y | Same
(Acclarix) |
| Parameters | U Lite PRO
Subject | T-Lite
Primary | U-Lite EXP
Reference | Vscan Air
Reference | Acclarix AX3
Reference | Comment |
| BIOPSY
ATTACHMENT | 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 |
| Neonatal
Cephalic | 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 PRO
Subject | T-Lite
Primary | U-Lite EXP
Reference | Vscan Air
Reference | Acclarix AX3
Reference | Comment |
| Cardiac
Pediatric | 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 |
| Peripheral
Vessel | Y | Y | Y | Y | Y | Same |
| Urology
(Including
prostate) | Y | Y | Y | Y | Y | Same |
| Integrated
Speaker | Y | Y | Y | Y | Y | Same |
| DICOM | Y | Y | Y | Y | Y | Same |
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11
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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 | $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.