(47 days)
The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate biopsy and 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 TRUS-guided prostate biopsy and brachytherapy procedures 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 System 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.
This document, a 510(k) summary for the Lighthouse™ Urinary Catheter, describes the device and its intended use, but it does not contain acceptance criteria for device performance or a study demonstrating that it meets those criteria in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical characteristics and biocompatibility.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing in the context of an AI/SaMD performance study:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Sterilization and Shelf Life | Performed with results demonstrating substantial equivalence |
| Biocompatibility | Performed with results demonstrating substantial equivalence |
| Device Performance Specifications | Performed with results demonstrating substantial equivalence (e.g., Visual Inspection, Dimensional Analysis, ASTM F623-99, Echogenicity Testing in a Phantom Model) |
Important Note: These "acceptance criteria" are not performance metrics like accuracy, sensitivity, or specificity that would be used to evaluate an AI algorithm's diagnostic or predictive capabilities. They are standard engineering and material science tests for a physical medical device. The "device performance specifications" are general claims, not quantifiable criteria with thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical performance study with a test set. The described "tests" are bench tests on the physical catheter.
- Data Provenance: Not applicable for the type of tests described. The "echogenicity testing" was done "in a phantom model," which is not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No human expert "ground truth" was established for a clinical test set because no clinical performance study involving human data or interpretations was conducted or reported here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not done. The device is a physical catheter, not an AI or software assistant for human readers. Its function is to create an acoustic interface for TRUS imaging, not to interpret images or assist human interpretation in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. Its "performance" is its physical characteristics and how it appears on TRUS, not an independent interpretation of data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical ground truth. The "ground truth" for the bench tests would be the measurement standards (e.g., ASTM F623-99) and the physical properties of the materials and design. For echogenicity, the "ground truth" is whether it effectively creates an acoustic interface in a phantom model.
8. The sample size for the training set
- Not applicable. There is no AI algorithm to train.
9. How the ground truth for the training set was established
- Not applicable. There is no AI algorithm requiring a training set with established ground truth.
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document describes a technical and bench testing study designed to demonstrate the substantial equivalence of the Lighthouse™ Urinary Catheter to legally marketed predicate devices. The "study" (series of tests) focused on:
- Sterilization and Shelf Life: Not detailed, but claims results demonstrated substantial equivalence.
- Biocompatibility: Not detailed, but claims results demonstrated substantial equivalence.
- Device Performance Specifications: Evaluated through:
- Visual Inspection: To confirm the device's physical appearance and integrity.
- Dimensional Analysis: To ensure the catheter's dimensions (e.g., 24F max OD for the UIB) meet design specifications and are comparable to predicates.
- ASTM F623-99: A standard for urological catheters, indicating testing against established physical performance requirements (e.g., balloon inflation, flow rates).
- Echogenicity Testing in a Phantom Model: This is the most "performance-oriented" test related to its unique feature. It demonstrated the catheter's ability to create an acoustic interface for TRUS imaging in a simulated environment.
The conclusion of the submission is that these bench tests, along with the device's design and intended use, establish its substantial equivalence to the predicate devices, not that it met specific quantitative diagnostic performance criteria in a clinical setting with human data. The submission asserts that the risks are outweighed by benefits and do not raise new questions of safety and effectiveness, based on comparison to existing devices and the nature of the bench 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.