(125 days)
The Ultraflex ™Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms.
The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch. The proposed stent diameter is 25mm along the body and 30mm at the flared distal section; the lengths are 6cm, 9cm, and 12cm.
This document describes the Ultraflex™ Precision™ Colonic Stent System, a self-expanding metal stent indicated for the palliative treatment of malignant colonic strictures. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Premarket Pathway | Substantial equivalence to a legally marketed predicate device (C.R. Bard Memotherm® Colorectal Stent). | BSC has demonstrated that Ultraflex Precision Colonic Stent System is substantially equivalent to C.R. Bard's currently marketed Memotherm® Colorectal Stent. |
| Material & Design | Nitinol, self-expanding stent mounted on a delivery catheter. Specific dimensions: 25mm body diameter, 30mm flared distal section, 6cm, 9cm, or 12cm lengths. | The proposed Ultraflex™ Precision™ Colonic Stent System is a Nitinol, self-expanding stent mounted on a delivery catheter. The proposed stent diameter is 25mm along the body and 30mm at the flared distal section; the lengths are 6cm, 9cm, and 12cm. |
| Intended Use | Palliative treatment of colonic strictures in the descending colon, sigmoid colon, and rectum caused by malignant neoplasms. | The device is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms. |
| Performance Testing | Comparative performance testing against predicate device. Additional performance data on tensile strength, fatigue, and corrosion resistance. Safety and effectiveness demonstrate through in vivo testing. | Comparative performance testing was performed, where appropriate, between the proposed Ultraflex Precision Colonic Stent System and the Bard Memotherm Colorectal Stent System to establish substantial equivalence. Additional performance data, such as tensile strength, fatigue, and corrosion resistance testing was also performed. In vivo testing of the proposed Ultraflex Precision Colonic Stent System demonstrates that the device is safe and effective for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for any test sets related to human data or clinical studies. The performance data section vaguely mentions "in vivo testing" but provides no details on the number of subjects, the type of study (e.g., human clinical trial, animal study), or the data provenance (e.g., country of origin, retrospective/prospective). Given this is a 510(k) submission, the primary focus is on bench testing and comparison to predicates, with human clinical trial data often not required unless significant differences from the predicate exist.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts or ground truth establishment for any clinical test set. The evaluation is based on substantial equivalence to a predicate device, which relies heavily on engineering and material performance comparisons, not human expert interpretation of clinical data in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
As there's no mention of a clinical test set with specific ground truth established by experts, there is no adjudication method described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically associated with diagnostic devices where human readers interpret medical images or data, often with and without AI assistance, to measure the AI's impact on human performance. This submission is for a medical device (stent) and does not involve AI for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone performance study of an algorithm was done. This device is a physical stent with a delivery system, not an AI algorithm.
7. The Type of Ground Truth Used
For the bench and in vivo (likely animal) testing, the "ground truth" would be the engineering specifications and measurements for tensile strength, fatigue, corrosion resistance, and successful deployment/functionality of the stent within a physiological environment. For the "in vivo testing," the ground truth would be the observation of safety and effectiveness (e.g., stent patency, lack of severe adverse events) in a living organism. These are not explicitly defined as "ground truth" in the AI sense, but rather as successful outcomes meeting design requirements.
8. The Sample Size for the Training Set
Not applicable. This device is hardware; there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI component, there is no training set and therefore no ground truth established for it.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”