(78 days)
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage tube adaptors, tubes and bags.
The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular catheter that is inserted through the urethra to pass urine from the urinary bladder, when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone. The male catheter requires an introducer for insertion. OPTICON™ Medical currently recommends the use of a commonly available introducer, (such as the Bard 0420 Wire Stylet) to aid in insertion. This introducer is not sold by OPTICON™ Medical, nor is the introducer included in the packaging for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage Catheter. The catheter is to be used only with standard urinary drainage tubes, drainage tube adaptors, tubes and bags.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OPTICON™ Direct Male Urinary Catheter for Continuous Drainage:
This document is a 510(k) Summary from 1997, which means it describes a medical device seeking market clearance in the US, generally based on substantial equivalence to a predicate device. For devices seeking clearance in this manner, the level of clinical study and detailed performance reporting is typically less extensive than for novel devices requiring PMA approval.
Based on the provided text, here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Device Performance | Unit/Specification |
|---|---|---|
| Performance requirements of ASTM Standard F623-89, "Standard Performance Specification for Foley Catheter" | "was found to meet all performance requirements" | Met |
Explanation: The document explicitly states that the device was tested against and met "all performance requirements" of ASTM Standard F623-89. However, the specific criteria within that standard (e.g., balloon inflation, flow rate, biocompatibility, tip strength) and the quantifiable results for each are not provided in this summary. To get those details, one would need to consult ASTM Standard F623-89 itself.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document states "The OPTICON™ Direct Male Urinary Catheter for Continuous Drainage has been tested," implying a physical test rather than a clinical study with human subjects for performance evaluation in this context.
- Data Provenance: Not applicable in the context of human data. The testing refers to laboratory or bench testing against an engineering standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable to the type of testing described in the document. ASTM F623-89 is an engineering standard for device performance, not a standard requiring expert clinical judgment for "ground truth" establishment in a diagnostic or clinical outcome sense. The 'ground truth' is the standard's defined pass/fail criteria for physical properties.
4. Adjudication Method for the Test Set
- Not applicable. This was a bench test against a standard, not a clinical study involving multiple reviewers or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. The document describes bench testing against an ASTM standard, not a clinical study involving human readers or comparative effectiveness with or without AI. AI assistance is not mentioned as part of this device or its testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a urinary catheter, not an algorithm or AI-driven system.
7. The Type of Ground Truth Used
- Bench Test Standard (ASTM F623-89): The "ground truth" or reference for evaluating performance was the set of predefined performance specifications and test methods outlined in ASTM Standard F623-89 for Foley Catheters. The device either met these objective physical/mechanical criteria or it did not.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used for this device.
§ 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.