(89 days)
The BSC Imaging Wire is intended to be used for the ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The Imaging Wire is specifically indicated for use with diagnostic or interventional devices which are compatible with 0.035" guidewires.
The Intravascular Ultrasound Imaging Wire consists of an imaging wire and a detachable or fixed adapter. The Imaging Wire is a 0.035" inch diameter, 180 cm long imaging wire that functions in a manner similar to a 0.035 inch exchange wire and includes ultrasonic imaging capabilities. The Imaging Wire consists of an outer sheath and an imaging core with a 20 MHz ultrasonic transducer. The distal tip coil and the transducer are radiopaque. Both the fixed and detachable adapters have electro-mechanical connectors that interface between the Imaging Wire and the BSC Motor Drive Unit/BSC Ultrasound Instrument System. The Imaging Wire allows up to 15 cm of linear movement of the imaging core for visualization through the outer sheath without moving the distal tip. The Imaging Wire is intended for use with the BSC ClearView Ultra™ and BSC Galaxy™ Ultrasound Instrument Systems.
This looks like a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with formal acceptance criteria and detailed study designs in the way an IDE or PMA might.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of explicit acceptance criteria with quantitative performance metrics for the device. Instead, it makes general statements about meeting performance requirements and specifications.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Functional Performance | "Performance testing on the Intravascular Ultrasound Imaging Wire demonstrated that the device meets or exceeds the performance requirements for the intended clinical use of the device." |
| "Laboratory/Bench Testing was conducted and the results demonstrated that the Intravascular Ultrasound Imaging Wire satisfies all of its performance specifications, which are designed to ensure that the device is safe and effective for its intended use." | |
| (Implied functioning as an imaging wire, allowing 15 cm linear movement of imaging core, and ensuring proper operation with BSC ClearView Ultra™ and BSC Galaxy™ Ultrasound Instrument Systems). | |
| Biocompatibility | "Biocompatibility testing was conducted in accordance with International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995).' The results of these tests demonstrate that the BSC Imaging Wire is biocompatible." |
| Safety and Effectiveness (Overall) | "Laboratory/Bench and biocompatibility testing demonstrate that the BSC Intravascular Ultrasound Imaging Wire is safe and effective for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data. The performance claims are based on "Laboratory/Bench Testing" and "biocompatibility testing."
- Sample Size: Not specified for any test.
- Data Provenance: Laboratory/Bench testing and biocompatibility testing. No country of origin for data is mentioned, but the manufacturer is Boston Scientific Corporation in San Jose, CA, USA. The studies are retrospective in the sense that they are internal validation tests, not prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided as the submission relies on bench testing and biocompatibility testing rather than expert-adjudicated clinical data to establish "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human-adjudicated test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned or implied in this 510(k) submission. This type of study is more common for assessing the impact of AI on human performance, which is not the focus here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an "Intravascular Ultrasound Imaging Wire." This is a physical medical device that inherently requires a human operator (physician) to use it for imaging. Therefore, a standalone algorithm only performance study, in the sense of an AI interpreting images without human input, is not applicable to this device's function. The "standalone" performance here refers to the device's physical and imaging capabilities as tested in the lab.
7. Type of Ground Truth Used
For the "performance specifications" tested, the ground truth would be based on:
- Engineering specifications and measurements: For mechanical, electrical, and imaging performance characteristics (e.g., image resolution, wire maneuverability, flush port function).
- Established biological safety standards: For biocompatibility testing (ISO-10993).
8. Sample Size for the Training Set
This information is not applicable. This device is a physical diagnostic tool for ultrasound imaging, not an AI/machine learning algorithm requiring a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.