(28 days)
Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.
The 50L Tringa ultrasound system is a lightweight, low-output, portable, real-time, ultrasound scanner used to acquire and display images in 2D, M or a combination of these modes. The 50L Tringa system has one linear probe and can be operated via rechargeable battery and/or mains connection.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Ko33604 device:
Based on the provided 510(k) summary for the 50L Tringa Ultrasound Imaging System (K033604), there is no specific information detailing acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or studies designed to prove the device meets such criteria in terms of diagnostic capability.
This document primarily focuses on establishing substantial equivalence to predicate devices. Substantial equivalence is determined by demonstrating that the new device has the same intended use as a legally marketed predicate device and has either the same technological characteristics or, if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. This often involves comparing technical specifications and safety standards rather than new clinical outcome studies.
Therefore, many of the requested elements for a detailed study description are not present in this type of 510(k) submission.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable or available in this document. The submission establishes equivalence based on intended use and technological characteristics compared to predicate devices. Performance is implied to be equivalent to the predicate devices and compliant with safety standards.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (as implied by equivalence) |
|---|---|
| Intended Use Equivalence: | The 50L Tringa matches the intended uses of the predicate devices for the specified clinical applications (see comparison table below). |
| Technological Characteristics Equivalence: | The 50L Tringa's features (e.g., imaging modes, transducer type, display, digital archival) are comparable to the predicate devices. |
| Safety Standard Compliance: | EN60601-1 (Electrical Safety), Track 1 (Ultrasound Safety) |
| Clinical Applications: | The system is indicated for: Abdominal, Neonatal cephalic, Pediatric, Peripheral vascular, Small organs, Intraoperative abdominal, Intraoperative vascular, and Musculoskeletal (conventional and superficial). As per the "Indications for Use" forms. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission does not describe a clinical performance study with a test set of patient data to measure diagnostic accuracy. Instead, it relies on demonstrating equivalence to predicate devices, which generally means no new clinical data is presented for diagnostic performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No test set requiring ground truth establishment by experts is described in this regulatory submission.
4. Adjudication Method for the Test Set
Not applicable. No test set or expert ground truth establishment is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done or reported in this document. The submission is for substantial equivalence, not a comparative effectiveness study that measures the improvement of human readers with AI assistance. Ultrasound systems like this are tools, not AI assistants.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ultrasound imaging system, a hardware and software system that provides images for a human operator (physician) to interpret. It's not an AI algorithm that produces a standalone diagnostic output.
7. The Type of Ground Truth Used
Not applicable. No diagnostic performance study is described that would require a ground truth. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. The device is an ultrasound imaging system, not an AI model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device is an ultrasound imaging system.
Summary of How the Device Meets Acceptance Criteria (and Substantial Equivalence)
The primary method for "proving" the device meets implied acceptance criteria is through demonstrating substantial equivalence to legally marketed predicate devices, as allowed under the 510(k) pathway.
The core of the submission involves a comparison:
Reference: Section 807.92(a)(3) and the "Additional Substantial Equivalence Information" table.
| Feature / Indication | 50L Tringa (This Submission) | Pie Medical 50S Tringa (K020112 - Predicate 1) | SonoSite iLook 25 (K021628 - Predicate 2) |
|---|---|---|---|
| Intended Use: | General diagnostic ultrasound imaging studies (as listed) + guidance for needle/catheter placement. | Similar, but fewer specific clinical applications listed. | Similar, encompassing the listed clinical applications + guidance. |
| Clinical Applications: | Pediatric, Small Organs, Intraoperative (abdominal & vascular), Peripheral Vascular, Musculoskeletal (Conventional & Superficial), Abdominal, Neonatal Cephalic. | Less comprehensive than 50L Tringa (e.g., no Pediatric, Neonatal Cephalic, Intraoperative). | Very similar to 50L Tringa. |
| Transducer Type: | Linear | No (implied different type or not specified) | Yes (Linear) |
| 2D Freq MHz: | 10 - 5 | 3.5/5.0/7.5 | 10 - 5 |
| Biopsy Guidance: | Yes | No | Yes |
| Free-Hand Vascular Access: | Yes | No | Yes |
| Display Type: | LCD | LCD | LCD |
| Imaging Modes: | 2D / M-mode | 2D / M-mode | 2D - Color Doppler |
| Monitor Size: | 5 inch | 5 inch | 5 inch |
| Digital Archival capabilities: | Yes | Yes | Yes |
| VCR: | Yes | Yes | Yes |
| Electrical Safety: | EN60601-1 | EN60601-1 | EN60601-1 |
| Ultrasound Safety: | Track 1 | Track 1 | Track 3 |
Conclusion from Equivalence:
The 50L Tringa demonstrates substantial equivalence by offering similar or expanded clinical applications and technological characteristics compared to the predicate devices. Where there are differences (e.g., expanded intended uses like "Pediatric," "Neonatal Cephalic," "Intraoperative" relative to Predicate 1, or differences in imaging modes compared to Predicate 2's Color Doppler), the submission implies these do not raise new questions of safety or effectiveness, or that the device is at least as safe and effective. The compliance with recognized safety standards (EN60601-1, Track 1) is a key part of demonstrating safety.
The FDA's letter (K033604) confirms this by stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
The "study" used to "prove" acceptability is the substantial equivalence comparison against predicate devices, and adherence to recognized electrical and ultrasound safety standards, rather than a clinical performance study for diagnostic accuracy.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.