(92 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 and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
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.
This document describes a 510(k) submission for the Ultraflex™ Precision™ Colonic Stent System. It is an application for an expanded indication for a device that is already on the market. Therefore, the information provided focuses on the substantial equivalence to predicate devices and clinical data for the new indication, rather than detailed performance studies for the device itself.
Here's an analysis based on the provided text, addressing the requested information points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a tabular format. The submission relies on demonstrating substantial equivalence to existing predicate devices for its technological characteristics and presenting clinical data to support the new indication.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the provided text. The document mentions "Clinical data in support of the proposed indication has been collected and is presented within this submission." However, the exact number of patients or cases is not detailed here.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given text.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not mentioned or implied. The submission focuses on device performance and clinical effectiveness for a palliative indication, not on the improvement of human reader performance with AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (stent system), not an AI algorithm. The performance data refers to the device's functional characteristics and clinical outcomes.
7. Type of Ground Truth Used
- Given the context of a colonic stent for malignant strictures, the "ground truth" for the clinical data would likely be based on clinical observation, patient outcomes, medical diagnoses (e.g., confirmed malignant neoplasms), and potentially imaging or endoscopic confirmation of stricture palliation. The text itself does not explicitly define the "type of ground truth," but these are standard for such medical devices.
8. Sample Size for the Training Set
- This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
Summary based on the document:
The submission for the Ultraflex™ Precision™ Colonic Stent System asserts substantial equivalence based on:
- Technological Characteristics: The proposed device has identical materials, construction, and manufacturing processes as the currently marketed Ultraflex Precision Colonic Stent (K030769).
- Performance Data: For the new indication, "Clinical data in support of the proposed indication has been collected and is presented within this submission." The document explicitly states that performance testing from the prior K030769 submission was not repeated because there are no new materials or design changes.
The focus is on demonstrating that the new indication is safe and effective and that the device is substantially equivalent to legally marketed predicate devices (K030769 and K000281). Detailed breakdowns of clinical study methodology (sample sizes, expert qualifications, adjudication, specific metrics) are not provided in this summary document.
§ 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.”