(22 days)
Indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
The Boston Scientific Extractor™ RX Retrieval Balloon is a stone retrieval balloon catheter used for biliary stone retrieval.
Here's an analysis of the provided text regarding the Boston Scientific Extractor™ RX Retrieval Balloon, focusing on the acceptance criteria and the study proving its performance.
Overview:
The submission K041606 for the Extractor™ RX Retrieval Balloon is a 510(k) premarket notification. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information provided focuses on this comparative approach.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in operating principle and intended use. | "The modified device is substantially equivalent to the predicate device, as they have the same operating principal and intended use." |
| Absence of new issues of safety or effectiveness compared to predicate. | "In addition, the results of design control activities do not raise any new issues of safety or effectiveness." |
| Performance characteristics similar to predicate. | "The results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device." |
| "The modified device is substantially equivalent to the currently marketed Boston Scientific Extractor™ RX Retrieval Catheter in terms of performance characteristics, biocompatibility, and intended use." | |
| Biocompatibility similar to predicate. | "The modified device is substantially equivalent to the currently marketed Boston Scientific Extractor™ RX Retrieval Catheter in terms of... biocompatibility..." |
| Intended Use for removing stones from the biliary system or facilitating contrast injection. | "The Boston Scientific Extractor™ RX Retrieval Balloon is intended to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon." (This is the stated intended use, and substantial equivalence implies the modified device performs this as effectively as the predicate). |
Note: For 510(k) submissions demonstrating substantial equivalence, explicit acceptance criteria in the sense of numerical targets for accuracy, sensitivity, or specificity are typically not provided. Instead, the "acceptance criteria" are demonstrating similarity to a predicate device across various aspects (design, materials, performance, intended use).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "physical comparison and functional testing" and "design control activities" but does not detail the number of devices or components tested.
- Data Provenance: The testing appears to be internal to Boston Scientific Corporation ("results of design control activities," "physical comparison and functional testing"). No information on country of origin of data or whether it was retrospective or prospective is provided. Given the nature of medical device testing (e.g., sterilization validation, material strength, balloon inflation tests), it's generally prospective in design and conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided. For this type of 510(k) submission, ground truth typically refers to objective measurements of physical and functional properties against specifications, rather than expert interpretation of a diagnostic outcome. Clinical experts would be involved in defining the predicates and intended use, but not typically in establishing "ground truth" for the engineering performance tests cited.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. This document describes physical and functional testing of a mechanical device, not diagnostic image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human readers' performance is being evaluated with and without assistance from the device. The Extractor™ RX Retrieval Balloon is a mechanical device for stone retrieval and contrast injection, not an AI or diagnostic imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a manual catheter operated by a human clinician for a physical intervention. There is no "algorithm only" performance to evaluate. The device's performance is intrinsically linked to its operation by a human, and its functionality relies on its physical characteristics.
7. Type of Ground Truth Used
- The "ground truth" for the functional and physical testing would be established by engineering specifications, material standards, and validated test methods. For example, balloon inflation pressures, burst strength, shaft flexibility, or biocompatibility test results against established safety limits. It would not typically be based on expert consensus, pathology, or outcomes data in the context of device performance testing for a 510(k).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the computational sense. Device design and manufacturing processes are refined through engineering, materials science, and iterative testing, not by training a model on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.