(120 days)
The OPTICON™ Female Uninary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage rube adaptors, tubes and bags.
The OPTICON™ Female Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular device that is inserted through the urethra and is used to pass urine from the uningry tract when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone and comes in only one size (18 French) and leagth, 10.8 cm (4.3 inches). When inserted, all that is visible ouside of the body is a microvalve for balloon inflation and retainer ring. The device is to be used only with standard urinary drainage tube adaptors, tubes and bags.
Below is a summary of the acceptance criteria and the study proving the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| Met all performance requirements of ASTM Standard F623-89, "Standard Performance Specification for Foley Catheter" | "was found to meet all performance requirements" |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the study conducted to meet ASTM Standard F623-89.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The provided document does not mention the use of experts to establish ground truth for the test set. The study refers to testing against a technical standard (ASTM F623-89), which implies objective physical and performance measurements rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
The provided document does not describe any adjudication method. Given the nature of a performance standard test, it's unlikely an adjudication process involving human reviewers would be applicable in the same way as, for example, for image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. The document describes testing against a technical standard for a medical device (catheter), not an AI algorithm requiring human-in-the-loop performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of a "standalone" performance typically applies to algorithms. This device is a physical catheter, and the evaluation was against a performance standard for that physical device. Therefore, a "standalone algorithm performance" study is not applicable and was not performed.
7. The Type of Ground Truth Used:
The ground truth used was compliance with the technical specifications and performance requirements outlined in ASTM Standard F623-89, "Standard Performance Specification for Foley Catheter." This standard sets objective, measurable parameters for catheter performance.
8. The Sample Size for the Training Set:
The concept of a "training set" and "ground truth for a training set" is applicable to machine learning algorithms. This document describes a physical medical device (a catheter) and its testing against a predefined standard. Therefore, there is no concept of a training set in the context of this submission.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this device evaluation described in the provided document, the establishment of its ground truth is not applicable.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.