(60 days)
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System represents a line extension to the original Cordis premounted PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System (ref. 510(k) #K012590) with no change to the indication for use or to the fundamental scientific technology of the predecessor device.
Stent:
The PALMAZ GENESIS Transhepatic Biliary stent is a balloon expandable, laser cut stent mounted on a Cordis balloon catheter (OPTA PRO) and is currently provided in ten (10) nominal unexpanded stent lengths from 12mm to 79 mm. The stent is designed for expansion to diameters from 4mm to 10 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ Genesis stent is laser cut from a 316L stainless steel tube that meets the chemical analysis requirements of American Society for Testing Materials (ASTM) standard F138.
Delivery system:
The delivery system features the same OPTA PRO PTA balloon catheter, which was recently cleared by FDA via 510(k) #K032737, determined substantially equivalent on October 02, 2003), which incorporated this modified hub.
Accessory:
The delivery system features the same accessory (a 304 stainless steel Introducer Tube), which is packaged in the device packaging.
This is a 510(k) premarket notification for a medical device (a stent and its delivery system), not an AI/ML device. Therefore, the concepts of acceptance criteria, device performance, sample sizes for test and training sets, expert adjudication, MRMC studies, or standalone performance as they relate to AI/ML models are not applicable in this context.
The document discusses the substantial equivalence of the "Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System" to an existing predicate device. The "acceptance criteria" in this context are related to the device's physical and biological properties and its intended use, rather than a quantifiable performance metric for an AI algorithm.
Here's a breakdown of the relevant information provided, adapted to the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with specific numerical targets and results for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/ML device. Instead, it relies on demonstrating that the new device is substantially equivalent to a legally marketed predicate device.
| Acceptance Criteria Category (Implied by 510(k)) | Reported Device "Performance" (Evidence provided) |
|---|---|
| Biocompatibility | All materials tested according to ISO-10993, Part 1, and found biocompatible. |
| Functional Equivalence | Same stent design (PALMAZ GENESIS) and delivery system (OPTA PRO PTA balloon catheter) as the predicate device (K012590 and K032737). |
| Mechanical/Design Verification | Data collected from non-clinical design verification tests and analyses. |
| Intended Use | Maintains the identical Intended Use as the predicate: "The Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree". |
| Material Composition | Stent made from 316L stainless steel meeting ASTM standard F138. |
2. Sample size used for the test set and the data provenance:
- Test Set/Clinical Data: The document explicitly states that the safety and effectiveness were demonstrated "via data collected from non-clinical design verification tests and analyses." This means there was no clinical test set in the sense of patient data. The "tests" here refer to in-vitro or ex-vivo engineering and material tests, not observations on human subjects.
- Data Provenance: Not applicable as it's non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for a medical device's physical performance is established through engineering and material science standards and testing protocols, not expert clinical interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for AI/ML performance evaluation where human experts might disagree. For device engineering tests, results are typically objective and measured against established specifications.
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 for AI/ML devices involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for AI/ML algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be the engineering specifications, material standards (e.g., ASTM F138, ISO-10993), and predetermined test outcomes to ensure the device performs as intended (e.g., stent expansion diameter, material strength, biocompatibility).
8. The sample size for the training set:
- Not applicable. This is a medical device, not an AI/ML model that undergoes a "training" phase with data.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary: This 510(k) submission for the PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through non-clinical design verification tests and biocompatibility testing. It does not involve AI/ML technology, and therefore, the questions posed in the prompt regarding AI/ML performance evaluation are not applicable. The "study" proving it meets criteria refers to these non-clinical tests and the comparison to an already approved 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.