(221 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features that are typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or quantitative analysis beyond standard ultrasound measurements). The performance studies focus on compliance with standards and substantial equivalence, not AI/ML model performance metrics.
No.
The device is described as an "ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body," which indicates a diagnostic rather than therapeutic purpose.
No
The device is described as an "ultrasound imaging system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body." While it produces images that can be used in diagnosis, its primary function is imaging and analysis, not providing a diagnostic conclusion itself. The "Summary of Performance Studies" section also refers to it as a "Diagnostic Ultrasound System," but this typically refers to its application in diagnostics, not that it performs diagnosis.
No
The device description explicitly states it consists of a system console (containing hardware like a display, touch screen, control panel, and electronics) and transducers, which are physical components.
Based on the provided information, the ImSonic TR-1 Ultrasonic pulsed doppler imaging system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The ImSonic TR-1 is an ultrasound system that performs imaging and fluid flow analysis directly on the human body.
- The intended use and device description clearly state it's for imaging and analysis of the human body. There is no mention of analyzing samples or specimens.
- The clinical applications listed are all related to imaging and assessing internal structures and blood flow within the body.
Therefore, the ImSonic TR-1 falls under the category of a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include:
Fetal/obstetric
Gynecological /Pelvic
Abdominal
Renal
Cardiac
Pediatric
Small organ (thyroid, breast, testes, etc.)
Musculoskeletal (conventional & superficial)
Peripheral vascular
Ophthalmic
Modes of operation include B, M, PWD(PW), Color Doppler (C), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The ImSonic TR-1 is a general purpose, mobile Ultrasonic Pulsed Doppler Imaging System. The function is to acquire ultrasound data and to display in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, a touch screen, a control panel, system electronics and optional peripherals (barcode scanner, printer). The removable transducers are connected to the system using a standard technology, multipin connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physicians and healthcare professionals / hospital or clinic setting.
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 has been performed on the ImSonic TR-1 Diagnostic Ultrasound System and demonstrates compliance with the following FDA recognized consensus standards: ANSI/AAMI ES 60601-1:2005/(R)2012 +A1:2012+C1:2009/(R) 2012+A2:2010/(R)2012, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 60601-1-6, IEC 62304, ISO 14971, NEMA UD 2-2004, NEMA PS 3.15. The ImSonic TR-1 Diagnostic Ultrasound System also complies with the FDA ultrasound specific guidance for Industry and FDA Staff -Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (June 27, 2019). Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use as well as usability testing with representative intended users. All these tests were used to support substantial equivalence of the subject device and demonstrate that the ImSonic Diagnostic Ultrasound System complies with the aforementioned international and FDA-recognized consensus standards and FDA ultrasound guidance document, and meets the acceptance criteria and is adequate for its intended use. The system acoustic output limits are: Ispta 3
§ 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
November 11, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ImSonic Medical China, INC. % Xiaohui Hao CEO No. 168 Yuanfeng Road Kunshan, Jiangsu Province 215300 CHINA
Re: K220983
Trade/Device Name: ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 11, 2022 Received: October 12, 2022
Dear Xiaohui Hao:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K220983
Device Name
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
Indications for Use (Describe)
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include:
Fetal/obstetric Gynecological /Pelvic Abdominal Renal Cardiac Pediatric Small organ (thyroid, breast, testes, etc.) Musculoskeletal (conventional & superficial) Peripheral vascular Ophthalmic
Modes of operation include B, M, PWD(PW), Color Doppler (C), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
ImSonic TR-1
K220983
This summary of safety and effectiveness information is submitted in accordance with 21CFR $807.92
| Date Prepared: | 10/11/22 | |
|---|---|---|
| Manufacturer: | ImSonic Medical China, INC. | |
| 168 Yuanfeng Road, Kunshan City, Jiangsu Province, China | ||
| Establishment Registration Number: TBD | ||
| Primary | ||
| Contact | ||
| Person: | Xiaohui Hao | |
| CEO | ||
| Phone: +86 13718322801 | ||
| E-mail: xiaohui.hao@imsonicmedical.com | ||
| Device: | Common/usual name: | Diagnostic Ultrasound System and Transducers |
| Proprietary name: | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging | |
| System | ||
| Classification Regulation: | 21CFR §892.1550 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | IYN (System, Imaging, Pulsed Doppler, Ultrasonic) | |
| Secondary Product Code: | ITX (Transducer, Ultrasonic, Diagnostic) | |
| IYO (Ultrasonic Pulsed Echo Imaging System) | ||
| Primary | ||
| Predicate | ||
| Device: | Trade Name: | FUJIFILM SonoSite X-Porte Ultrasound System |
| Manufacturer: | FUJIFILM Sonosite, Inc. | |
| 510(k) Clearance: | K152209 (08/19/2015) | |
| Reference | ||
| device: | Trade Name: | CX50 Diagnostic Ultrasound System |
| Manufacturer: | Philips Ultrasound, Inc. | |
| 510(k) Clearance: | K162329 (09/14/2016) |
4
The ImSonic TR-1 is a general purpose, mobile Ultrasonic Pulsed Doppler Imaging Device description: System. The function is to acquire ultrasound data and to display in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, a touch screen, a control panel, system electronics and optional peripherals (barcode scanner, printer). The removable transducers are connected to the system using a standard technology, multipin connectors.
Indications for The ImSonic TR-1 is intended to be used by qualified physicians and healthcare professionals for the evaluation or fluid flow analysis of the human body, contrast-Use: enhanced sonography and guidance of puncture and biopsy. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include: Fetal/obstetric
Gynecological /Pelvic Abdominal Renal Cardiac Pediatric Small organ (thyroid, breast, testes, etc.) Musculoskeletal (conventional & superficial) Peripheral vascular Ophthalmic
Modes of operation include B, M, PWD(PW), Color Doppler (C ), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
Technological The ImSonic TR-1 Diagnostic Ultrasound System and the predicate, SonoSite X-Pore characteristics: Ultrasound System cleared in K152209, are Track 3 systems and employ similar fundamental scientific technology. They are similar in materials, type of transducers, optimization, accessories and imaging modes. The primary differences between the ImSonic Diagnostic Ultrasound Systems and the predicate device is the additional transducer.
| Standard
Feature | ImSonic TR-1
(proposed device) | SonoSite X-Porte
Ultrasound System
(K152209)
(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ImSonic TR-1 is intended to
be used by qualified physicians
and healthcare professionals for
the evaluation or fluid flow
analysis of the human body,
contrast-enhanced sonography
and guidance in biopsy. The
system is intended to be used in a | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body. The system is
intended to be used in a
hospital or clinic setting. |
| | hospital or clinic setting. | |
| Indications for
Use | Fetal/obstetrics | Ophthalmic |
| | Gynecological /Pelvic | Fetal-OB/GYN |
| | Abdominal | Abdominal |
| | Renal | Intra-operative
(abdominal organs and
vascular) |
| | Cardiac | Pediatric |
| | Pediatric | Small Organ (breast,
thyroid, testicle, prostate) |
| | Small organ (thyroid, breast,
testes, etc.) | Neonatal Cephalic |
| | Musculoskeletal (conventional &
superficial) | Adult Cephalic |
| | Peripheral vascular | Trans-Vaginal |
| | Ophthalmic | Musculo-skeletal
(Conventional) |
| | | |
| | | |
| | | Adult Cardiac |
| | | Pediatric Trans-
esophageal (cardiac)
Peripheral Vessel |
| | | Needle guidance |
| Transducer Types | | Linear Array |
| | | Curved Linear Array |
| | | Intracavitary |
| | Phased Array | Phased Array |
| Transducer
Frequency | 1.5 - 20.0MHz | 1.0 - 15.0 MHz |
| Acoustic Output
Display & FDA
Limits | ISTPA.3 $≤$ 720 (mW/cm2) | ISTPA.3 $≤$ 720 (mW/cm2) |
| | TI $≤$ 6.0 | TI $≤$ 4.0 |
| | MI $≤$ 1.9 | MI $≤$ 1.9 |
| | Display Feature for Higher
Outputs | Display Feature for
Higher
Outputs |
| | MI Output Display | MI Output Display |
| | TI Output Display | TI Output Display |
| Modes of
Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging | B- mode Grayscale
Imaging
Tissue Harmonic Imaging |
| | M mode (including Simultaneous
M mode) | M-mode
Simultaneous M-Mode |
| | Combination Modes | Color Power Doppler
Zoom |
| | PW mode (Pulsed Wave
Doppler) | Combination Modes
Pulsed Wave (PW)
Doppler |
| | C mode(Color Doppler) | Continuous Wave (CW)
Doppler |
| | CPS (Contrast Pulse
Sequence) mode imaging | SonoHD2 Noise
Reduction |
| | SSC (B Steer Spatial
Compounding) | SonoMB/MBe Image
Compounding |
| | Biopsy | Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI) |
| PW Doppler | Available | Available |
| CW Doppler | Not available | Available |
| Velocity Color
Doppler | Available | Available |
| Elastography
(Strain), and
Strain Rate
Imaging | Not available | Not available |
| CPS | Available for contrast imaging | Not available |
| ECG Feature | Not available | 3-lead ECG input |
| DICOM | DICOM 3.0 | DICOM 3.0 |
| IMT
Measurement | Not available | Not available |
| | | |
| | | |
| Patient Contact
Materials | Transducers:
Plastic housing:PA757
Bonding material:KE45
C5-2, PA5-2 and LN14-4 Lens
material: RTV630
L13-3 Lens material: RTV615 | Transducers:
Acrylonitrile-butadien-
styrene (ABS)
Cycoloy Dow Medical
Adhesive,
Type A Epoxy paste
adhesive Polyethylene
(PE)
Ionomer
Polyetheretherketone
(PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride
(PVC) Silicone
RTV Adhesive Silicone |
| | | Rubber Urethane |
| | | Needle Guides: Acetal
copolymer Acrylonitrile-
butadien-styrene (ABS) |
| System
Characteristics | ImSonic TR-1 (stand
configuration) :
Beam former 128/128 using SA
(configurable) :
Display:
23.8" TFT Liquid Crystal
Display module with WLED
Backlight unit and 30 pins 2ch-
LVDS interface.
1920 x 1080 Full HD mode and
can display up to 16.7M colors.
Touchscreen:
13.3"Capacitive touch screen
interface
Physical Dimensions:
Height: 1,470 – 1,830mm (with
Display)
Width: 774mm
Depth: 576mm
Weight of Main system:60Kg
(with monitor)
Main Power box with battery:
6Kg
Measurement Packages:
Abdomen, Aorta, Biliary,
Bladder, Cardiac, Lt. Kidney, Rt.
Kidney, MSK, Obstetrical, Left
Ovary Right Ovary Pelvic and | X-Porte (stand
configuration):
Beam former 128/128
using SA
(configurable)
12.1” Capacitive touch
screen interface
19" LED LCD HD
monitor 256 gray shades
on LED LCD
6 USB 2.0 ports
Stand Base Dimensions:
26.4" L x 21.2" W
Stand Height (max): 64"
(monitor up)
Stand Height (min): 42.2"
(monitor down) Weight:
149.35 lbs (fully
configured w/ 3
transducers System
operates via battery or AC
power
Battery life: 1 hour
operational - 3 days idle
Input: 100 – 240 VAC,
50/60 Hz
Output 1: 24VDC output,
275 W max
Output 2: 100-240VAC, |
| | | |
| | Testicular. | 50-60 Hz (AC Printer) |
| | Trackball operation of multiple
cursors
Distance, Area, Volume and
Angle measurements in all
imaging modes, Heart Rate (HR)
and Time measurements in PW
mode and M mode, and Velocity
measurements in PW mode.
Support to use annotation tools:
Text, arrow, body mark | Various obstetrical,
cardiac, volume, M-mode,
PW and CW Doppler
measurement and
calculation packages ECG
acquisition and display
capabilities CW/PW
Doppler Audio Spectral
Doppler Audio and image
storage on removable
media |
| | | 1 USB 3.0ports |
| | 1 DVI-D port
Ethernet port: 10/100/1000 Mbps | Wireless 802.11 (a/b/g/n)
support for image transfer |
| | Transducers System operates via
battery or AC power | X-Porte (desktop
configuration): |
| | Battery life: 2.0 hour operational
Input: AC100 – 240 V options,
50/60 Hz
Internal power:14.4V/30Ah | Same software
features/capabilities as the
stand configuration. Does
not have the stand, touch
panel interface, DVR, and
mobile power unit. |
| | | Weight: 32.80 lbs (w/ 1
transducer) |
| | | AC power only. 100 –
240V options, 50/60 Hz |
| 510(k) Track | Track 3 | Track 3 |
5
6
7
8
9
Summary of Non-Clinical Performance Data:
Non-clinical performance testing has been performed on the ImSonic TR-1 Diagnostic Ultrasound System and demonstrates compliance with the following FDA recognized consensus standards:
- . ANSI/AAMI ES 60601-1:2005/(R)2012 +A1:2012+C1:2009/(R) 2012+A2:2010/(R)2012: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements . Basic Safety and Essential Performance - Collateral Standard for Electromagnetic Compatibility, 2014
10
- IEC 60601-2-37: Medical electrical equipment. Particular requirements for the ● basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2015
- . ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance - Collateral standard: Usability, 2010+A1:2013
- IEC 62304: Medical device software Software life cycle processes, 2015 ●
- ISO 14971: Medical devices - Application of risk management to medical devices, 2019
- . NEMA UD 2-2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- . NEMA PS 3.15: Digital Imaging and Communications in Medicine (DICOM), Part 15: Security and System Management Profiles, 2021e
The ImSonic TR-1 Diagnostic Ultrasound System also complies with the FDA ultrasound specific guidance for Industry and FDA Staff -Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (June 27, 2019)
Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use as well as usability testing with representative intended users.
All these tests were used to support substantial equivalence of the subject device and demonstrate that the ImSonic Diagnostic Ultrasound System:
- complies with the aforementioned international and FDA-recognized consensus . standards and FDA ultrasound guidance document, and
- meets the acceptance criteria and is adequate for its intended use.
The system acoustic output limits are:
- . Ispta 3