(65 days)
The dual lumen ureteral catheter is designed for percutaneous and THC uddi lamon aretoral os indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, including, but not limited tial/anesthetic agents and guidewire placement.
Like the predicate Flexible Tip (open or closed) Ureteral Catheter, the Dual Lumen Catheter is a ureteral catheter with a flexible tip used for guidewire placement and for contrast injection. The Dual Lumen Catheter incorporates the same technological characteristics as the predicate device. The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness. Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns. The method of manufacture (extrusion) is the same for both the predicate and the proposed device. The new material used in the Dual Lumen Catheter has been used in other legally marketed devices within the same classification regulation for the same intended use and has had an established history of successful clinical application in Urology. Like the predicate device, the Dual Lumen Catheter features a hollow plastic tube placed inside the ureter, which, as in the predicate device, allows for the passage of guidewires and for the injection of fluid. Both catheters are fitted with female luer lock Tuohy-Borst adaptors, and feature soft tips to ensure protection of tissue during passage. This Special 510(k) proposes an addition of the second lumen to the catheter, a modification of the material characteristics, shortening of the working length and a change of color of the device. The indications for use, principles of operation, and diameter of the Dual Lumen Catheter remain the same as in the predicate device.
The provided document is a 510(k) Summary of Safety and Effectiveness for the ACMI Corporation's Dual Lumen Catheter. This type of document is for a medical device seeking premarket clearance through the FDA's 510(k) pathway, which establishes substantial equivalence to a predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.
Therefore, the document does not contain the kind of detailed information about acceptance criteria, statistical studies, ground truth establishment, sample sizes, or expert involvement that would be present for a new, high-risk device requiring a PMA or a comparative effectiveness study for AI/software.
Based on the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than defining new performance acceptance criteria. It states that the proposed modifications "are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available. The document does not describe a "test set" in the context of a clinical performance study. The evaluation likely involved engineering testing and a review of existing clinical data for the modified materials. The mention of "Biocompatibility testing confirms that the different materials of construction (from polyurethane to polyethylene) present no new safety concerns" suggests some testing, but details on sample size, design, or provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. There is no "ground truth" establishment described in the context of a clinical performance study with expert review, as this is not a diagnostic device or a study involving interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No adjudication method is mentioned, as no multi-reader or expert consensus study is described.
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
This information is not available. This is a physical medical device (catheter), not an AI-assisted diagnostic or decision support tool. Therefore, an MRMC study with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available. As explained above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. There is no ground truth described as this device did not involve diagnostic or interpretive tasks. The "ground truth" for a device like this would be its physical properties and functionality meeting manufacturing specifications, and its biocompatibility, which is briefly mentioned as having been tested.
8. The sample size for the training set
This information is not available. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This information is not available. No training set or associated ground truth establishment is mentioned.
Summary of what the document does convey regarding acceptance criteria (implicitly) and safety/effectiveness:
The primary "acceptance criterion" for this 510(k) notification is substantial equivalence to the predicate device (K930483, Ureteral Catheter, "The Flexible Tip (open or closed) Ureteral Catheter").
The study that "proves" the device meets this acceptance criterion is the 510(k) submission itself, which argues and presents evidence for substantial equivalence. This is demonstrated by:
- Similarity in Intended Uses: The Dual Lumen Catheter has the same indications for use as the predicate (ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safe wire/guidewire placement).
- Similarity in Technological Characteristics: Both are ureteral catheters with flexible tips for guidewire and contrast injection, hollow plastic tubes for fluid/guidewire passage, and fitted with female luer lock Tuohy-Borst adaptors and soft tips.
- Evaluation of Modifications:
- Addition of a second lumen: The document implies this does not fundamentally alter the device's mechanism or safety profile in a way that would raise new questions of safety or effectiveness.
- Modification of material characteristics (polyurethane to polyethylene): Biocompatibility testing was performed to confirm no new safety concerns. The new material has a "history of successful clinical application in Urology" in other legally marketed devices.
- Shortening of working length and change of color: These are considered minor aesthetic or dimensional changes that do not impact safety or efficacy.
- Manufacturing Method: The method (extrusion) remains the same.
In conclusion, for this type of medical device 510(k) submission, the "study" is the comparison to a legally marketed predicate device, and the "acceptance criterion" is proving that the new device is substantially equivalent, meaning it is as safe and effective as the predicate. The document states, "The proposed Dual Lumen Catheter raises no new questions of safety or effectiveness," and "The proposed modification in design specifications, performance specifications, and dimensional specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." The FDA's clearance letter confirms their agreement with this assessment.
§ 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.