(28 days)
The LoFric® Plus Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
The LoFric® Plus Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating. The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes.
The provided document is a 510(k) summary for the LoFric® Plus Single Use Urinary Catheter, focusing on its substantial equivalence to a previously marketed device. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study that proves the device meets those criteria. The document states that "Laboratory data demonstrates this" but does not provide specifics about the studies performed or their results.
Here's a breakdown of what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary. The document mentions "Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements." However, it does not specify what those "design input requirements" or their corresponding acceptance criteria were, nor does it report the specific performance metrics achieved.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "Laboratory data" but does not detail the sample sizes used for any testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes a medical device (catheter) for drainage, not a diagnostic device that would typically involve expert ground truth for interpretation of results. The "ground truth" would likely be based on physical properties or biological tests.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable. An MRMC study is typically used for diagnostic imaging devices where multiple readers interpret images to assess inter-reader variability and the effectiveness of a diagnostic tool, often with and without AI assistance. This document pertains to a physical medical device (catheter).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. Standalone performance refers to the accuracy of an AI algorithm without human involvement, which is not relevant for a physical medical catheter.
7. The Type of Ground Truth Used
The document broadly mentions "Laboratory testing and biocompatibility testing." This implies the "ground truth" would be based on:
- Physical Property Measurements: E.g., dimensions, coating slipperiness, strength, flow rates.
- Biocompatibility Standards: Meeting established ISO or other regulatory standards for material safety in contact with human tissue.
Specific details about the ground truth (e.g., specific tests, their methodologies, and the standards they adhered to) are not provided.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device; there is no "training set" in the context of an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
Summary of Study Information Provided:
- Study Name: "Laboratory testing and biocompatibility testing"
- Purpose: To "determine device functionality and conformance to design input requirements."
- Key Finding: "Laboratory data demonstrates" that the only difference (addition of a 15 cm size length) "do[es] not raise new questions of safety and effectiveness." This implies the new size length performs comparably to existing lengths according to the unspecified acceptance criteria.
Key Missing Information:
The document is a high-level summary for regulatory submission. It does not provide:
- Specific quantitative acceptance criteria (e.g., "Coating friction must be X Pascals," or "Tensile strength must be Y Newtons").
- Specific performance results against those criteria.
- Detailed methodologies of the "laboratory testing and biocompatibility testing."
- Sample sizes or statistical analyses from these tests.
§ 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.