(122 days)
The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.
The DirectVision® Catheter,-Uncoated is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. It is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a straight or angled council tip to facilitate insertion. The DirectVision® Catheter, Uncoated is composed of a silicone tube that trifurcates into three (3) lumens, a silicone balloon, and a two-way valve. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. This catheter device will be available with a single or double drainage eyelet, 14 through 24 French shafts, and either a 10 cc or 30 cc balloon. The DirectVision® Catheter, Uncoated is designed to be usable with the PercuVision DirectVision™ Guide System (K091600). In the DirectVision™ Guide System, the DirectVision® Catheter, Uncoated provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use.
The provided text is a 510(k) premarket notification for the PercuVision DirectVision® Catheter, Uncoated. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo clinical study data with detailed acceptance criteria and performance metrics.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance data.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document highlights the device's substantial equivalence to predicate devices, focusing on design, intended use, and materials.
Here's what can be extracted from the document:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't define specific quantitative performance acceptance criteria in the context of a clinical study. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicate devices and does not raise new questions of safety or effectiveness.
The core of the "study" is a comparison to predicate devices as detailed in the "Comparison to Predicate Device(s)" table and the "Substantial Equivalence Discussion."
| Feature/Criterion | DirectVision® Catheter, Uncoated (Proposed Device) | PercuCath™ Urinary Catheter (Predicate 1) | Dover Foley Catheter (Predicate 2) | Substantial Equivalence Claim |
|---|---|---|---|---|
| Indication for Use | For use in the drainage and/or collection and/or measurement of urine. | For use in the drainage and/or collection and/or measurement of urine. | For use in the drainage and/or collection and/or measurement of urine. | Identical to Predicate 1, Identical to Predicate 2. |
| Intended Use | Urological catheter inserted through the urethra for draining urine and other fluids (also suprapubic/nephrostomy tract placement). | Urological catheter inserted through the urethra for draining urine and other fluids (also suprapubic/nephrostomy tract placement). | Not available (but implicit in "Indication for Use") | Identical to Predicate 1. |
| Design: Coating | Uncoated | Coated | Uncoated | Different from Predicate 1 (uncoated vs. coated), Similar to Predicate 2 (both uncoated). The submission argues this difference does not raise new safety/effectiveness issues. |
| Sterility | Supplied sterile | Supplied sterile | Supplied sterile | Identical to both predicates. |
| Biocompatible | Yes | Yes | Yes | Identical to both predicates. |
| Basic Design Concept | Same as predicates | Same as predicates | Same as predicates | Substantially equivalent. |
| Biomechanical Properties | Same as predicates | Same as predicates | Same as predicates | Substantially equivalent. |
| Materials | Silicone (100% silicone, latex-free) | Not explicitly detailed in the table but indicated as similar in the discussion. | Not explicitly detailed in the table but indicated as similar in the discussion. | Substantially equivalent to predicates. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not describe a clinical "test set" in the context of device performance evaluation with a ground truth, as it is a special 510(k) based on substantial equivalence. It likely relies on non-clinical (e.g., bench) testing to demonstrate material properties and functionality are comparable to the uncoated predicate, but this is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with expert-established ground truth is described.
4. Adjudication method for the test set:
- Not applicable. No clinical test set demanding adjudication 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:
- Not applicable. This device is a urological catheter, not an AI-driven diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) is the established safety and effectiveness profile of the predicate devices. The applicant is demonstrating that the new device, despite being uncoated (unlike one predicate), is fundamentally similar enough not to introduce new safety or effectiveness concerns. This is based on the history of the predicate devices and any non-clinical testing performed (which details are not provided in this summary).
8. The sample size for the training set:
- Not applicable. This submission does not involve an algorithm with a training set.
9. How the ground truth for the training set was established:
- Not applicable. This submission does not involve an algorithm with a training set.
§ 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.