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510(k) Data Aggregation
(114 days)
Jiangsu Tingsn Technology Co., Ltd.
TINGS FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power.
The device is intended for use in Professional healthcare facility environment including echo lab, other hospital settings, operating room, Cath lab and EP lab.
The intended users of the Device is to be used exclusively by physicians who are appropriately trained personnel in a fully equipped electrophysiology or catheterization room or under their direct supervision.
The proposed TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is a Track 3 diagnostic device designed for imaging intracardiac anatomical structures and blood flow dynamics in adult patients. It comprises two primary components: the ultrasound console and the TINGSN Sonic Eyes 10 Eco Disposable Intracardiac Echocardiography Catheter. The console features a 17.3-inch touch-enabled LCD screen, a control panel, and interfaces for connectivity, powered by a rechargeable battery or AC adapter, with optional peripherals including a cart and foot switch. The catheter, a sterile, single-use device with a 95 cm insertable length and 10Fr diameter, is equipped with a 64-element phased array transducer at its tip for high-resolution imaging. It connects to the console via the Finders 2 Sonic Eyes Connector, featuring a locking mechanism to ensure secure attachment during procedures. The system supports multiple imaging modes—B-Mode, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, Power Doppler, and combined modes —along with advanced functionalities, displayed with real-time thermal (TI) and mechanical (MI) indices.
The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System. This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.
Crucially, the document explicitly states under "8. CLINICAL DATA": "No clinical data was included in this submission."
Therefore, based on the provided text, a study that proves the device meets acceptance criteria through clinical data (either standalone or MRMC comparative effectiveness) was not performed, or at least, not included in this submission. The entire submission relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.
As the request specifically asks for information about a "study that proves the device meets the acceptance criteria" and mentions clinical outcomes, it is impossible to provide the requested details from the given text.
However, I can extract the information related to the non-clinical tests that were performed to verify the device met design specifications and was substantially equivalent, which serve as the basis for clearance in lieu of clinical data.
Here's an interpretation based on the non-clinical data presented:
Device Acceptance Criteria and Performance (Based on Non-Clinical Data)
The TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System established its substantial equivalence (SE) based primarily on non-clinical testing and comparison to predicate devices, as no clinical data was included in the submission. The acceptance criteria and "performance" are therefore framed in terms of compliance with relevant standards and demonstration of functional equivalence.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Demonstrated via Compliance with Standards / Equivalence) | Reported Device Performance (Demonstrated via Non-Clinical Testing) |
|---|---|
| Safety & Essential Performance: Compliance with general medical electrical equipment safety standards. (IEC 60601-1 Ed 3.2) | Met: Non-clinical tests demonstrated compliance with IEC 60601-1 Edition 3.2. |
| Electromagnetic Compatibility (EMC): Compliance with EMC requirements for medical devices. (IEC 60601-1-2) | Met: Non-clinical tests demonstrated compliance with IEC 60601-1-2. |
| Specific Safety/Performance for Ultrasonic Equipment: Compliance with specific requirements for diagnostic ultrasound. (IEC 60601-2-37) | Met: Non-clinical tests demonstrated compliance with IEC 60601-2-37. |
| Acoustic Output Characterization: Compliance with methods for determining thermal and mechanical indices. (IEC 62359, NEMA UD2) | Met: Non-clinical tests demonstrated compliance with IEC 62359 and NEMA UD2. The device is a "Track 3" device, implying its acoustic output is within regulatory limits (global maximum derated ISPTA ≤720 mW/cm², MI ≤1.9 or ISPPA ≤ 190 W/cm²). |
| Intravascular Catheter Requirements: Compliance with standards for sterile, single-use intravascular catheters. (ISO 10555-1) | Met: Non-clinical tests demonstrated compliance with ISO 10555-1. |
| Biocompatibility: Evaluation and testing within a risk management process for medical devices. (ISO 10993-1) | Met: Non-clinical tests demonstrated compliance with ISO 10993-1 (specifically, Patient contact materials of the catheter shaft are "Pebax series Comply with ISO 10993-1"). |
| Packaging & Shipping Performance: Performance testing of shipping containers and systems. (ASTM D4169-2022) | Met: Non-clinical tests demonstrated compliance with ASTM D4169-2022. |
| Risk Management: Application of risk management to medical devices. (ISO 14971:2019) | Met: A thorough risk analysis was conducted, and risk controls were implemented to mitigate identified hazards. |
| Software Functionality & Safety: Compliance with FDA guidance for device software functions, meeting specifications and mitigating risks. (FDA Guidance for Device Software Functions) | Met: Software documentation included. Non-clinical tests (integration and functional) conducted. Test results support that all software specifications met acceptance criteria. Verification and validation testing found acceptable. |
| Functional Equivalence to Predicate Device (GE Vivid iq console): Similar intended use, imaging modes, principle of operation, and overall performance. | Demonstrated: The proposed device's indications for use are encompassed by the predicate. Technical differences in imaging modes, software, and compatible probes do not impact safety or effectiveness. Risk analysis assessed potential software-related risks. |
| Functional Equivalence to Predicate Device (SOUNDSTAR 3D Ultrasound Catheter): Similar indications for use, principle of operation, patient population, sterility, diameter, and transducer configuration. | Demonstrated: Slight differences in insertable length, imaging frequency range, and shelf life were determined not to impact safety or effectiveness. The proposed device's indications are encompassed by the predicate. |
| Shelf Life: Verification of product stability and packaging integrity for claimed shelf life. | Met: A 2-year shelf-life study was performed, verifying the claimed 2-year shelf life is scientifically reliable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific non-clinical tests. General statements indicate "non-clinical tests were conducted."
- Data Provenance: The tests were conducted internally by Jiangsu Tingsn Technology Co., Ltd. The document refers to "non-clinical tests (integration and functional) were conducted on the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System during product development."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable for non-clinical testing. The "ground truth" for non-clinical tests typically refers to engineering specifications, regulatory standards, and established physical principles, not expert interpretations of clinical data.
4. Adjudication Method for the Test Set
- Not applicable for non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth or compare diagnostic performance, which was not part of this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The submission explicitly states: "No clinical data was included in this submission." MRMC studies inherently involve human readers evaluating clinical cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance)
- Not applicable as an AI/algorithm-only device. The TINGSN FINDERS 2 is a diagnostic ultrasound system that produces images for human interpretation, not an AI algorithm performing diagnosis independently. The software features listed are for image optimization, measurements, and display, assisting the human user, not replacing them in a "standalone" diagnostic role.
7. The Type of Ground Truth Used
- For non-clinical testing: The "ground truth" was established by performance specifications, engineering requirements, and compliance with the international and national standards listed (e.g., IEC, ISO, NEMA, ASTM, FDA guidance). This includes electrical safety, mechanical robustness, image quality parameters (resolution, penetration, consistency), acoustic output levels, and software functionality validation against design requirements.
8. The Sample Size for the Training Set
- Not applicable. This device is a traditional ultrasound system, not an AI/ML product that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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