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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, laser- cut stent made from 316L Stainless Steel tubing. The stent is sold mounted on a Cordis SLALOM percutaneous transluminal angioplasty (PTA) balloon catheter. The stent is provided in nominal, unexpanded stent lengths from 12 – 39 mm. The stent is designed for expansion to diameters from 3 - 8 mm, depending on the diameter of the associated balloon upon which it is mounted with system lengths of 80 cm and 135 cm. The delivery system utilizes an over-the-wire (OTW) dual lumen design and is a PTA balloon catheter with a distal DURALYN™ balloon and a proximal Y-connector. The balloon has two radiopaque markers that aid in stent placement within the stenosis and is designed with a known diameter and length. The Y-connector has an injectate lumen (marked "THRU") that is used to inject contrast medium via hand injection and to track the catheter over a guide wire up to .018". The inflation lumen (marked "BALLOON") is used to inflate and deflate the balloon with a contrast medium/saline mixture. The nominal balloon size and length is printed on the Y-connector. A metal introducer tube is included in the packaging. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile (via ethylene oxide) and is intended for single use only

The provided text describes a 510(k) premarket notification for the PALMAZ® GENESIS™ Transhepatic Biliary Stent. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically found for AI/ML-driven devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicit, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics given for this medical device. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical design verification tests and analyses.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not report any clinical test set or patient data (retrospective or prospective) used to evaluate the device's performance in the context of its intended use. The performance data is stated to be derived from "non-clinical design verification tests and analyses."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical test set or human-in-the-loop study is described, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set:

As no clinical test set is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study was done or reported. The submission does not involve AI assistance, so a comparison of human readers with vs. without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is a physical medical stent, not an AI algorithm. Therefore, a "standalone algorithm-only performance" study is not applicable.

7. The Type of Ground Truth Used:

The document states that the "safety and effectiveness... has been demonstrated via data collected from non-clinical design verification tests and analyses." This implies that the 'ground truth' for these tests would be based on engineering specifications, material science properties, and physical testing standards for devices of this type, rather than clinical outcomes, pathology, or expert consensus on patient data.

8. The Sample Size for the Training Set:

This device is a physical stent and its approval is based on substantial equivalence and non-clinical testing. It is not an AI/ML device that requires a training set in the computational sense.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary based on the document:

The 510(k) submission for the PALMAZ® GENESIS™ Transhepatic Biliary Stent is a premarket notification for a physical medical device. The acceptance criteria and proof of performance are based on non-clinical design verification tests and analyses demonstrating that the device is substantially equivalent to an existing predicate device. The document does not contain information about clinical studies with patient data, expert review, or AI/ML performance metrics.

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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to diameters from 3 to 6 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System), not a study that establishes acceptance criteria and proves the device meets those criteria.

The 510(k) process is used to demonstrate that a device is substantially equivalent to a predicate device, meaning it is at least as safe and effective. It does not typically involve the establishment of new acceptance criteria through clinical studies in the same way an investigational device exemption (IDE) or premarket approval (PMA) application would for novel devices.

Here's a breakdown based on the provided text, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable/Not provided. The document refers to "non-clinical design verification tests and analyses," which are typically bench testing and engineering verification, not human clinical trials with 'sample size' in the traditional sense of patient numbers.
• Data Provenance: Not applicable/Not provided. Since it's described as "non-clinical design verification," there is no country of origin for patient data or retrospective/prospective classification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable/Not provided. This information pertains to studies where human experts evaluate cases to establish a "ground truth" (e.g., diagnosing disease from images). The provided text describes engineering verification tests, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. Pertains to expert review, which is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not mention any MRMC study, human reader performance, or AI assistance. The device in question is a physical medical device (stent), not a diagnostic AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This question is also not applicable as the device is a physical stent, not an algorithm.

7. Type of Ground Truth Used:

• Not explicitly stated in terms of "ground truth" for a clinical outcome. The "effectiveness" is demonstrated through "non-clinical design verification tests and analyses." This would imply that the "ground truth" for these tests would be compliance with engineering specifications, material properties, mechanical performance, etc., as determined by validated test methods.

8. Sample Size for the Training Set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/algorithm-based device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not provided. (Refer to point 8).

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical design verification tests and analyses for a physical medical device (biliary stent). It explicitly states that "Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act." Therefore, the document does not contain the information about acceptance criteria, clinical study designs, sample sizes for patient data, expert ground truth establishment, or AI-related metrics that your prompt requests.

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