(221 days)
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).
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.
The provided text describes the ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System, which is a general-purpose ultrasound system. However, the document is an FDA 510(k) clearance letter and summary, primarily focusing on demonstrating substantial equivalence to a predicate device.
*Crucially, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics in a clinical or AI-assisted context, as would be expected for a device incorporating AI/ML.
The document states: "The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require clinical data to support the determination of substantial equivalence." This means there was no clinical study performed (or at least, none submitted to the FDA for this clearance) that would establish the type of performance metrics typically associated with AI/ML devices such as sensitivity, specificity, accuracy, or reader improvement.
The non-clinical performance data section refers to compliance with consensus standards for safety, electromagnetic compatibility, usability, software life cycle, and risk management, along with acoustic output limits. These are general device standards, not specific performance metrics against a clinical ground truth for diagnostic accuracy.
Therefore,Based on the provided text, I cannot fulfill your request for the following reasons:
-
Acceptance Criteria and Reported Performance (Table): The document does not define specific performance acceptance criteria for diagnostic capabilities, nor does it report device performance against such metrics. It primarily focuses on compliance with general safety and performance standards relevant to ultrasound systems and substantial equivalence to a predicate device.
-
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): The document explicitly states that "The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require clinical data to support the determination of substantial equivalence." This signifies that the type of clinical performance study (with test sets, ground truth establishment, expert readers, etc.) typically performed for AI/ML devices to demonstrate diagnostic accuracy was not conducted or presented here.
-
Training Set (Size, Ground Truth Establishment): As no clinical study was described for performance evaluation, there is no information about an AI/ML model's training set, its size, or how ground truth for that training set was established.
In summary, the provided document is a regulatory submission for a general-purpose ultrasound system based on demonstrating substantial equivalence to existing devices through compliance with established safety and operational standards. It does not describe the development or validation of an AI/ML component with specific diagnostic performance claims against clinical ground truth.
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November 11, 2022
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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 (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
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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.168 Yuanfeng Road, Kunshan City, Jiangsu Province, ChinaEstablishment Registration Number: TBD | |
| PrimaryContactPerson: | Xiaohui HaoCEOPhone: +86 13718322801E-mail: xiaohui.hao@imsonicmedical.com | |
| Device: | Common/usual name: | Diagnostic Ultrasound System and Transducers |
| Proprietary name: | ImSonic TR-1 Ultrasonic Pulsed Doppler ImagingSystem | |
| 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) | ||
| PrimaryPredicateDevice: | Trade Name: | FUJIFILM SonoSite X-Porte Ultrasound System |
| Manufacturer: | FUJIFILM Sonosite, Inc. | |
| 510(k) Clearance: | K152209 (08/19/2015) | |
| Referencedevice: | 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.
| StandardFeature | ImSonic TR-1(proposed device) | SonoSite X-PorteUltrasound System(K152209)(Predicate Device) |
|---|---|---|
| Intended Use | The ImSonic TR-1 is intended tobe used by qualified physiciansand healthcare professionals forthe evaluation or fluid flowanalysis of the human body,contrast-enhanced sonographyand guidance in biopsy. Thesystem is intended to be used in a | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody. The system isintended to be used in ahospital or clinic setting. |
| hospital or clinic setting. | ||
| Indications forUse | Fetal/obstetrics | Ophthalmic |
| Gynecological /Pelvic | Fetal-OB/GYN | |
| Abdominal | Abdominal | |
| Renal | Intra-operative(abdominal organs andvascular) | |
| 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 | |
| TransducerFrequency | 1.5 - 20.0MHz | 1.0 - 15.0 MHz |
| Acoustic OutputDisplay & FDALimits | 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 HigherOutputs | Display Feature forHigherOutputs | |
| MI Output Display | MI Output Display | |
| TI Output Display | TI Output Display | |
| Modes ofOperation | B-mode Grayscale ImagingTissue Harmonic Imaging | B- mode GrayscaleImagingTissue Harmonic Imaging |
| M mode (including SimultaneousM mode) | M-modeSimultaneous M-Mode | |
| Combination Modes | Color Power DopplerZoom | |
| PW mode (Pulsed WaveDoppler) | Combination ModesPulsed Wave (PW)Doppler | |
| C mode(Color Doppler) | Continuous Wave (CW)Doppler | |
| CPS (Contrast PulseSequence) mode imaging | SonoHD2 NoiseReduction | |
| SSC (B Steer SpatialCompounding) | SonoMB/MBe ImageCompounding | |
| Biopsy | Steered CW DopplerVelocity Color DopplerTissue Doppler Imaging(TDI) | |
| PW Doppler | Available | Available |
| CW Doppler | Not available | Available |
| Velocity ColorDoppler | Available | Available |
| Elastography(Strain), andStrain RateImaging | 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 |
| IMTMeasurement | Not available | Not available |
| Patient ContactMaterials | Transducers:Plastic housing:PA757Bonding material:KE45C5-2, PA5-2 and LN14-4 Lensmaterial: RTV630L13-3 Lens material: RTV615 | Transducers:Acrylonitrile-butadien-styrene (ABS)Cycoloy Dow MedicalAdhesive,Type A Epoxy pasteadhesive Polyethylene(PE)IonomerPolyetheretherketone(PEEK)Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride(PVC) SiliconeRTV Adhesive Silicone |
| Rubber Urethane | ||
| Needle Guides: Acetalcopolymer Acrylonitrile-butadien-styrene (ABS) | ||
| SystemCharacteristics | ImSonic TR-1 (standconfiguration) :Beam former 128/128 using SA(configurable) :Display:23.8" TFT Liquid CrystalDisplay module with WLEDBacklight unit and 30 pins 2ch-LVDS interface.1920 x 1080 Full HD mode andcan display up to 16.7M colors.Touchscreen:13.3"Capacitive touch screeninterfacePhysical Dimensions:Height: 1,470 – 1,830mm (withDisplay)Width: 774mmDepth: 576mmWeight of Main system:60Kg(with monitor)Main Power box with battery:6KgMeasurement Packages:Abdomen, Aorta, Biliary,Bladder, Cardiac, Lt. Kidney, Rt.Kidney, MSK, Obstetrical, LeftOvary Right Ovary Pelvic and | X-Porte (standconfiguration):Beam former 128/128using SA(configurable)12.1” Capacitive touchscreen interface19" LED LCD HDmonitor 256 gray shadeson LED LCD6 USB 2.0 portsStand Base Dimensions:26.4" L x 21.2" WStand Height (max): 64"(monitor up)Stand Height (min): 42.2"(monitor down) Weight:149.35 lbs (fullyconfigured w/ 3transducers Systemoperates via battery or ACpowerBattery life: 1 houroperational - 3 days idleInput: 100 – 240 VAC,50/60 HzOutput 1: 24VDC output,275 W maxOutput 2: 100-240VAC, |
| Testicular. | 50-60 Hz (AC Printer) | |
| Trackball operation of multiplecursorsDistance, Area, Volume andAngle measurements in allimaging modes, Heart Rate (HR)and Time measurements in PWmode and M mode, and Velocitymeasurements in PW mode.Support to use annotation tools:Text, arrow, body mark | Various obstetrical,cardiac, volume, M-mode,PW and CW Dopplermeasurement andcalculation packages ECGacquisition and displaycapabilities CW/PWDoppler Audio SpectralDoppler Audio and imagestorage on removablemedia | |
| 1 USB 3.0ports | ||
| 1 DVI-D portEthernet port: 10/100/1000 Mbps | Wireless 802.11 (a/b/g/n)support for image transfer | |
| Transducers System operates viabattery or AC power | X-Porte (desktopconfiguration): | |
| Battery life: 2.0 hour operationalInput: AC100 – 240 V options,50/60 HzInternal power:14.4V/30Ah | Same softwarefeatures/capabilities as thestand configuration. Doesnot have the stand, touchpanel interface, DVR, andmobile power unit. | |
| Weight: 32.80 lbs (w/ 1transducer) | ||
| AC power only. 100 –240V options, 50/60 Hz | ||
| 510(k) Track | Track 3 | Track 3 |
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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
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- 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< 720 MW/cm2
- MI < 1.9
- TI < 6.0 ●
Therefore, ImSonic TR-1 Diagnostic Ultrasound System is substantially equivalent to the predicate FUJIFILM SonoSite X-Porte Ultrasound System in terms of safety and effectiveness.
Summary of The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require Clinical clinical data to support the determination of substantial equivalence. Performance Data:
Substantial In conclusion, the predicate device and subject device have same intended use and Equivalence similar technological features. The nonclinical tests conducted, demonstrate that the Conclusion: ImSonic TR-1 meets applicable requirements and standards for safety and effectiveness of the device for its intended use. Therefore, the subject device is as safe
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and effective and substantially equivalent to the primary predicate device that is
currently marketed for the same intended use.
§ 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.