ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

K220983 · Imsonic Medical China, Inc. · IYN · Nov 11, 2022 · Radiology

Device Facts

• Record ID: K220983
• Device Name: ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
• Applicant: Imsonic Medical China, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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

Device Story

Mobile diagnostic ultrasound system; acquires ultrasound data via removable transducers; displays images in various modes (B, M, PWD, Color Doppler, Harmonics, Contrast Imaging, Steered Spatial Compounding). System console includes user interface, touchscreen, display, and electronics. Operated by physicians/healthcare professionals in hospitals/clinics. Provides real-time visualization and measurements (distance, area, volume, angle, velocity, heart rate) to assist in clinical evaluation, fluid flow analysis, and biopsy guidance. Benefits include non-invasive diagnostic imaging and procedural guidance.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including system-level verification, risk control measure validation, and usability testing with representative users. Acoustic output parameters (Ispta.3, MI, TI) confirmed within FDA limits.

Technological Characteristics

Mobile ultrasound system; 128/128 beamformer; 23.8" TFT LCD display; 13.3" capacitive touchscreen. Transducers use PA757 plastic housing, KE45 bonding, and RTV630/RTV615 lens materials. Modes: B, M, PWD, Color Doppler, Harmonics, CPS, SSC. Connectivity: DICOM 3.0, Ethernet, DVI-D. Power: Battery or AC. Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62304, ISO 14971, NEMA UD 2, NEMA PS 3.15.

Indications for Use

Indicated for fetal/obstetric, gynecological/pelvic, abdominal, renal, cardiac, pediatric, small organ (thyroid, breast, testes), musculoskeletal, peripheral vascular, and ophthalmic ultrasound imaging and fluid flow analysis in hospital or clinic settings by qualified healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• FUJIFILM SonoSite X-Porte Ultrasound System (K152209)

Reference Devices

• CX50 Diagnostic Ultrasound System (K162329)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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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# 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.<br>168 Yuanfeng Road, Kunshan City, Jiangsu Province, China<br>Establishment Registration Number: TBD | |
| Primary<br>Contact<br>Person: | Xiaohui Hao<br>CEO<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Device: | Common/usual name: | Diagnostic Ultrasound System and Transducers |
| | Proprietary name: | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging<br>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<br>Predicate<br>Device: | Trade Name: | FUJIFILM SonoSite X-Porte Ultrasound System |
| | Manufacturer: | FUJIFILM Sonosite, Inc. |
| | 510(k) Clearance: | K152209 (08/19/2015) |
| Reference<br>device: | Trade Name: | CX50 Diagnostic Ultrasound System |
| | Manufacturer: | Philips Ultrasound, Inc. |
| | 510(k) Clearance: | K162329 (09/14/2016) |

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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<br>Feature | ImSonic TR-1<br>(proposed device) | SonoSite X-Porte<br>Ultrasound System<br>(K152209)<br>(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ImSonic TR-1 is intended to<br>be used by qualified physicians<br>and healthcare professionals for<br>the evaluation or fluid flow<br>analysis of the human body,<br>contrast-enhanced sonography<br>and guidance in biopsy. The<br>system is intended to be used in a | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body. The system is<br>intended to be used in a<br>hospital or clinic setting. |
| | hospital or clinic setting. | |
| Indications for<br>Use | Fetal/obstetrics | Ophthalmic |
| | Gynecological /Pelvic | Fetal-OB/GYN |
| | Abdominal | Abdominal |
| | Renal | Intra-operative<br>(abdominal organs and<br>vascular) |
| | Cardiac | Pediatric |
| | Pediatric | Small Organ (breast,<br>thyroid, testicle, prostate) |
| | Small organ (thyroid, breast,<br>testes, etc.) | Neonatal Cephalic |
| | Musculoskeletal (conventional &<br>superficial) | Adult Cephalic |
| | Peripheral vascular | Trans-Vaginal |
| | Ophthalmic | Musculo-skeletal<br>(Conventional) |
| | | |
| | | |
| | | Adult Cardiac |
| | | Pediatric Trans-<br>esophageal (cardiac)<br>Peripheral Vessel |
| | | Needle guidance |
| Transducer Types | | Linear Array |
| | | Curved Linear Array |
| | | Intracavitary |
| | Phased Array | Phased Array |
| Transducer<br>Frequency | 1.5 - 20.0MHz | 1.0 - 15.0 MHz |
| Acoustic Output<br>Display & FDA<br>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<br>Outputs | Display Feature for<br>Higher<br>Outputs |
| | MI Output Display | MI Output Display |
| | TI Output Display | TI Output Display |
| Modes of<br>Operation | B-mode Grayscale Imaging<br>Tissue Harmonic Imaging | B- mode Grayscale<br>Imaging<br>Tissue Harmonic Imaging |
| | M mode (including Simultaneous<br>M mode) | M-mode<br>Simultaneous M-Mode |
| | Combination Modes | Color Power Doppler<br>Zoom |
| | PW mode (Pulsed Wave<br>Doppler) | Combination Modes<br>Pulsed Wave (PW)<br>Doppler |
| | C mode(Color Doppler) | Continuous Wave (CW)<br>Doppler |
| | CPS (Contrast Pulse<br>Sequence) mode imaging | SonoHD2 Noise<br>Reduction |
| | SSC (B Steer Spatial<br>Compounding) | SonoMB/MBe Image<br>Compounding |
| | Biopsy | Steered CW Doppler<br>Velocity Color Doppler<br>Tissue Doppler Imaging<br>(TDI) |
| PW Doppler | Available | Available |
| CW Doppler | Not available | Available |
| Velocity Color<br>Doppler | Available | Available |
| Elastography<br>(Strain), and<br>Strain Rate<br>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<br>Measurement | Not available | Not available |
| |…