(31 days)
The Medtronic, Inc. RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The RACER Biliary Stent System consists of a MP35N (Cobalt, Nickel, Chromium, Molybdenum Alloy) stent mounted on an over-the-wire delivery system. The device is equipped with an AV100 balloon mounted on the distal portion of the catheter. Diameters of the device include 4.0, 5.0, 6.0, and 7.0mm and the lengths are either 12mm or 18mm, all premounted on 80cm or 130cm catheters.
The Medtronic, Inc. RACER Biliary Stent System received 510(k) clearance based on substantial equivalence to a predicate device, the Bridge Constant Biliary Stent System (K030633). This type of clearance typically relies on a comparison of device characteristics and performance to a legally marketed device rather than a comprehensive study with pre-defined acceptance criteria for a new clinical endpoint.
However, based on the provided text, here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a new clinical outcome study as might be found for a PMA (Pre-Market Approval). Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as the predicate device. The "performance" is therefore measured against the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as described in the 510(k) summary) |
|---|---|
| Material Identity: Materials are identical to predicate. | Constructed from identical biocompatible materials (MP35N alloy). |
| Technological Identity: Technology is identical to predicate. | Balloon expandable and premounted on a sheathless delivery system, identical to predicate technology. |
| Intended Use Equivalence: Same indications for use as predicate. | Indicated for use in the palliation of malignant neoplasm in the biliary tree, same as predicate. |
| Clinical Needs Equivalence: Meets clinical needs as well as predicate. | Meets the clinical needs of physicians (assertion of substantial equivalence). |
| Safety and Effectiveness Equivalence: Safe and effective performance comparable to predicate. | Preclinical testing conducted to confirm safe and effective performance and biocompatibility. |
| Lower Crossing Profile: The subject device should offer a lower crossing profile. | The subject device offers a lower crossing profile (stated as a minor difference not relevant to the ability to palliate malignant neoplasms). |
| Sterilization: Provided sterile and not intended for reuse or resterilization. | Provided sterile. Not intended for reuse or resterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of human subjects or patient data. The basis for clearance is preclinical testing and comparison to an existing device.
- Sample Size for Test Set: Not applicable in the context of a human clinical test set for this 510(k) submission. Preclinical testing was mentioned but no sample sizes for those tests are provided.
- Data Provenance: Not applicable in the context of a human clinical test set for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This 510(k) submission relies on preclinical testing and comparison to a predicate device, not on expert-adjudicated ground truth from a clinical test set.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication in the context described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document describes a 510(k) submission for a medical device based on substantial equivalence, not an MRMC study comparing human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. This device is a physical medical device (stent system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- The performance and safety profile of the predicate device (Bridge Constant Biliary Stent System, K030633) which has already been deemed safe and effective.
- Preclinical testing results demonstrating the device's safe and effective mechanical and biological performance (e.g., biocompatibility, mechanical integrity).
8. The Sample Size for the Training Set
No "training set" in the context of AI/ML or a clinical study is mentioned. The device's design and manufacturing are based on established engineering principles and materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the described context. The performance and safety of the device are benchmarked against an existing, cleared predicate device and supported by standard preclinical engineering and biocompatibility tests.
§ 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.