(151 days)
The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUSguided brachytherapy by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.
The Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter. In addition to a lumen for inflating the Foley balloon and a urine drainage lumen, the Lighthouse has a third lumen for filling 0.1cc - 1cc of air in a 4-cm length bladder along the shaft of the catheter. The Urethral Identification Bladder (UIB) has a maximum outer diameter of 24F (i.e. smaller than other urinary catheters that meet ASTM F623-99) when filled with a maximum 1cc volume described in the instructions for use (IFU) and provides echogenicity when viewed by a Transrectal Ultrasound (TRUS). The non-inflated UIB contains a narrow air space between the catheter shaft and the urethra, which provides an echogenic marker under TRUS and when necessary can be increased by adding 0.1cc - 1.0cc of volume via syringe.
Here's an analysis of the acceptance criteria and study information for the Lighthouse™ Urinary Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Specification | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1.) Sterilization | Not explicitly stated, but implied to meet standards for a sterile medical device. | Performed. Results demonstrate substantial equivalence. |
| 2.) Shelf Life | Not explicitly stated, but implied to meet standards for device effectiveness and sterility over time. | Performed. Results demonstrate substantial equivalence. |
| 3.) Biocompatibility | Not explicitly stated, but implied to meet standards for materials used in medical devices with patient contact. | Performed. Results demonstrate substantial equivalence. |
| 4.) Device Performance Specifications (General) | Not explicitly stated but implied to meet relevant performance and safety standards for urinary catheters and visualization. This would include aspects addressed by ASTM F623-99. | Performed. Results demonstrate substantial equivalence. Specific tests include: |
| Visual Inspection | Not explicitly stated, but generally involves confirming the device's physical appearance, integrity, and absence of defects. | Performed. |
| Dimensional Analysis | Not explicitly stated, but would involve verifying the dimensions (e.g., catheter size, UIB outer diameter) against design specifications. Specifically, UIB max outer diameter 24F. | Performed. The Urethral Identification Bladder (UIB) has a maximum outer diameter of 24F (i.e. smaller than other urinary catheters that meet ASTM F623-99) when filled with a maximum 1cc volume. |
| ASTM F623-99 | Compliance with ASTM F623-99 (Standard Specification for Foley Catheter). | Performed. The text states the Lighthouse UIB is "smaller than other urinary catheters that meet ASTM F623-99" directly implying compliance with, or exceeding requirements of, this standard for overall catheter size. |
| Echogenicity Testing (UIB) | The UIB provides echogenicity when viewed by Transrectal Ultrasound (TRUS) and creates an acoustic interface during TRUS-guided brachytherapy to enhance identification of the posterior aspect of the prostatic urethra. | Performed "in a Phantom Model." The non-inflated UIB contains a narrow air space between the catheter shaft and the urethra, which provides an echogenic marker under TRUS and when necessary can be increased by adding 0.1cc - 1.0cc of volume via syringe. The study concluded that "enhanced visualization of Substantial under external imaging is equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any of the bench tests (Sterilization and Shelf Life, Biocompatibility, Device Performance, Visual Inspection, Dimensional Analysis, ASTM F623-99, Echogenicity Testing).
- Data Provenance: Not specified. The tests are described as "bench tests," implying they were conducted in a laboratory setting. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided. The performance testing appears to be primarily bench testing against engineering specifications and industry standards rather than an assessment requiring clinical expert interpretation or a "ground truth" derived from expert consensus. For the Echogenicity Testing, while it involved a "Phantom Model" and aimed to demonstrate "enhanced visualization," it doesn't specify if expert radiologists/urologists were involved in establishing a ground truth for "enhanced visualization."
4. Adjudication Method for the Test Set
- No adjudication method is mentioned, as the tests described are bench tests with objective outcomes (e.g., meeting dimensional specs, compliance with ASTM standards, visual confirmation of echogenicity in a phantom). Adjudication methods are typically relevant for clinical studies involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or described. The study focuses on demonstrating substantial equivalence through bench testing, comparing the device's characteristics and performance to predicate devices and industry standards. There is no mention of human readers or AI assistance in the context of this submission.
- Effect Size of AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this device is a physical urinary catheter, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
- For most tests, the "ground truth" was based on engineering specifications, industry standards (e.g., ASTM F623-99), and objective measurements.
- For Echogenicity Testing, the ground truth was the observable "echogenic marker" and "acoustic interface" within a "Phantom Model." This relies on basic physics and the known properties of air creating acoustic impedance differences visible on ultrasound.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set 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.