(51 days)
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
Urological Balloon Dilatation Catheter
The provided document is a 510(k) premarket notification for a medical device, specifically the BD-3 Urological Balloon Dilatation Catheters. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data that would establish novel safety and effectiveness.
Therefore, the document does NOT contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria in the way a clinical trial might. It explicitly states: "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." This implies that the device's performance is being benchmarked against existing devices rather than a new set of predefined acceptance criteria for novel claims.
However, I can extract the information available from the document that is relevant to your request, indicating where information is missing for a full answer to your questions.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" for the BD-3 Catheters are implicitly tied to demonstrating Substantial Equivalence to legally marketed predicate devices. The performance reported is that it meets this equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices for indications of use (urological dilatation; ureteral and urethral). | "The proposed modified devices are Substantially Equivalent to devices previously cleared by the FDA via the 510(k) Notification process and indicated for dilatation of the urinary tract." |
| Substantial Equivalence to predicate devices in terms of performance characteristics tested. | "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a prospective clinical study with human subjects or a defined dataset for algorithm evaluation. The "performance characteristics tested" would typically refer to bench testing or animal studies demonstrating the physical and functional properties of the catheter (e.g., burst pressure, durability, guidewire compatibility), but the specific details (sample sizes, results, and provenance) are not included in this summary.
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Given the nature of a 510(k) for a well-established device type, it's likely to involve internal bench testing or possibly data from previous 510(k) clearances for similar predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. A 510(k) notification for a physical device like a catheter typically relies on engineering specifications, bench testing, and potentially animal studies to demonstrate safety and performance equivalent to existing devices, not expert human assessment of a "test set" to establish ground truth in the way it would for an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable and not provided. See explanation for point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of a 510(k) for a physical medical catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic algorithms is not directly applicable here. For this device, "truth" would involve demonstrating that the catheter can withstand intended pressures, navigate the urinary tract, and perform its dilatation function as expected and without causing undue harm, similar to predicate devices. This is typically established through:
- Engineering specifications and design verification.
- Bench testing (e.g., burst pressure, tensile strength, fatigue testing).
- Biocompatibility testing.
- Potentially animal studies for in-vivo performance.
- Comparison to the known performance and safety profiles of the predicate devices.
The document states the device is "Substantially Equivalent to the predicate devices in terms of performance characteristics tested," implying that the "truth" is established by matching the performance of already-approved devices, rather than establishing a completely new medical "ground truth."
8. Sample Size for the Training Set
Not applicable and not provided. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable and not provided. This is a physical device, not an AI model.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).