(82 days)
The Modified Olbert@ Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope. The recommended application is printed on the label. *
- The recommended application on the label may refer to any combination of transpapillary, pyloric, colonic, anastomotic, and/or esophageal dilatation.
Boston Scientific Corporation believes that the Modified Olbert® Balloon Catheter is substantially equivalent to the currently-marketed predicate devices. Table 9-1 compares the descriptive characteristics of these products.
The provided text describes a 510(k) premarket notification for the Modified Olbert® Balloon Catheter. This document is a regulatory submission for a medical device and thus focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might expect for a novel AI/software-as-a-medical-device (SaMD) product.
Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or available in this type of submission.
The document primarily focuses on performance characteristics in terms of verifying safety through laboratory testing and biocompatibility assessments, and demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the safety and performance standards expected of a medical device and the demonstration of substantial equivalence to predicate devices, rather than explicit numerical thresholds. The "performance" is the device's ability to meet these general safety and equivalence requirements.
| Acceptance Criteria (Implicit) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety: Biocompatibility | "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Olbert® Balloon Catheter with satisfactory results." |
| Safety: Sterilization Efficacy | "The Modified Olbert® Balloon Catheter will be sterilized using... ethylene oxide sterilization." (Implied efficacy through standard sterilization methods.) |
| Safety: Pyrogenicity (endotoxin levels) | "Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels." (Implied meeting pyrogenicity standards.) |
| Performance: Functionality (e.g., inflation, deflation) | "Laboratory testing regarding characteristics was performed on Modified Olbert® Balloon Catheter to verify its safety and performance." (Specific characteristics not detailed but implied to meet functional requirements.) |
| Equivalence: Indication for Use | "The Modified Olbert® Balloon Catherer is equivalent in its indications for use... The Modified Olbert® Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope." (Matches or is similar to predicate devices, as shown in Table 9-1). |
| Equivalence: Design/Materials | "The Modified Olbert® Balloon Catherer is equivalent in its indications for use, while being very similar in design and materials." (Table 9-1 comparing design features like diameter, length, pressure, material, catheter shaft length/diameter, shows substantial similarity or justifiable differences to predicates). Example: Balloon material is Polyurethane, same as many predicates; Catheter shaft length 180cm, same as one predicate and within range of others; Diameter 4-14mm, same as one predicate and overlapping with others. |
| Overall Conclusion (Substantial Equivalence to Predicates) | "Boston Scientific Corporation believes that Modified Olbert® Balloon Catherer is substantially equivalent to the currently-marketed predicate devices... The information presented provides assurance that the Modified Olbert® Balloon Catheter will meet the minimum requirements that are considered acceptable for its intended use." |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/not specified. The "testing" referred to is laboratory testing of the physical device, not a human reader or clinical trial involving a "test set" of cases or data.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in this context would refer to clinical outcomes or diagnoses, which are not part of this type of premarket submission for a physical device.
4. Adjudication method for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a premarket notification for a physical medical device (balloon catheter), not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used
- For the laboratory testing and biocompatibility assessment, the "ground truth" implicitly would be established industry standards and test methodologies for material safety, sterility, and mechanical performance. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.
8. The sample size for the training set
- Not applicable. No training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.