(171 days)
The SC 35 Balloon Dilatation Catheter is indicated for stent deployment/optimization of the J&J Palmaz Biliary Stent and for the treatment of biliary strictures.
The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter designed to be placed over guidewires which have outer diameters of .035" or smaller.
Here's an analysis of the provided text regarding the SC 35 Balloon Dilatation Catheter's acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance | Comments / Supporting Evidence |
|---|---|---|---|
| Safety | Biocompatibility | Met ISO-10993 requirements | "biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed" |
| Performance | Functional integrity | Demonstrated safety and effectiveness | "Functional and integrity bench testing were performed, and the data supported the substantial equivalence..." |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate devices | "data supported the substantial equivalence of the SC 35 Balloon Dilatation Catheter to the Ultra-thin Diamond Balloon Dilatation Catheter and the Courier ST Balloon Dilatation Catheter." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or human subjects. The testing described is bench testing for functional, integrity, and biocompatibility. Therefore, details about sample size (in terms of human subjects or cases) and data provenance (country, retrospective/prospective) are not applicable or provided for this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the "test set" was not based on expert-adjudicated clinical cases. The ground truth for bench testing is typically defined by engineering standards, specifications, and established biocompatibility protocols.
4. Adjudication method for the test set
This information is not applicable as there was no clinical test set requiring adjudication.
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
No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this device. This device is a physical medical instrument (a balloon catheter), not an AI-powered diagnostic or decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not performed as this is not an AI/algorithm-based device.
7. The type of ground truth used
The "ground truth" for the safety and performance evaluation largely relied on:
- Engineering specifications and standards: For functional and integrity bench testing.
- International biological evaluation standards: Specifically ISO-10993 for biocompatibility.
- Comparison to predicate devices: The "substantial equivalence" claim is a form of ground truth established by demonstrating similar performance to already approved devices.
8. The sample size for the training set
This information is not applicable as this device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this device is not an AI/machine learning model.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the SC 35 Balloon Dilatation Catheter meets its acceptance criteria was primarily a bench testing and biocompatibility testing program.
- Study Type: Functional and integrity bench testing, and biocompatibility testing.
- Methodology:
- Functional and Integrity Bench Testing: The document states that "Functional and integrity bench testing... were performed." While specific parameters (e.g., burst pressure, inflation/deflation times, guidewire compatibility) are not detailed, these tests would assess the physical properties and operational reliability of the catheter.
- Biocompatibility Testing: This was conducted "according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." This standard outlines a series of tests to evaluate biological responses to medical devices, such as cytotoxicity, sensitization, irritation, and hemocompatibility.
- Conclusion: The results of these tests "supported the substantial equivalence of the SC 35 Balloon Dilatation Catheter to the Ultra-thin Diamond Balloon Dilatation Catheter and the Courier ST Balloon Dilatation Catheter." This means the device demonstrated comparable safety and performance characteristics to previously approved predicate devices, satisfying the regulatory requirement for substantial equivalence for a Class II device.
The FDA's 510(k) clearance letter (K993303) confirms that based on this information, the device was deemed "substantially equivalent" and could be marketed.
§ 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.