(26 days)
The Wiygul Catheter is intended for use in the neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter.
The Wiygul Catheter intended for use in neonatal and pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter. The Wiygul Catheter is comprised of a two-layer design, including an inner sampling catheter and protective outer sheath to minimize contamination of the eyelets. The tip will be atraumatic. The handle of the device will utilize a slider to facilitate the retraction of the outer sheath once inserted into the bladder to expose eyelets for sampling. This catheter is a6Fr catheter with a working length of 300mm +/- 5mm. Material composition of the catheter is provided in in Table 5-1 below.
The Wiygul Catheter is provided in a box containing the main device (sampling catheter), a cleared syringe and Instructions for Use.
The mechanism of action will be mechanical for pulling back the outer sheathe and negative pressure from the attached syringe to withdraw a urine sample.
This FDA 510(k) summary describes the Wiygul Catheter but does not provide the detailed acceptance criteria or results of a study in the format requested. The document states "All tests met the pre-determined acceptance criteria" for various performance tests, but it does not specify what those criteria were or provide quantitative results beyond this general statement.
Therefore, many of the requested fields cannot be extracted directly from this document.
Here's an attempt to answer based on the provided text, highlighting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document mentions several performance tests were conducted and states: "All tests met the pre-determined acceptance criteria." However, the specific acceptance criteria and the detailed reported device performance for each test are not provided in this summary.
| Test Name | Acceptance Criteria (Not Specified) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Pouch Sealing | Not specified | Met pre-determined criteria |
| Visual Inspection | Not specified | Met pre-determined criteria |
| Dimensional Inspection | Not specified | Met pre-determined criteria |
| Simulated Use Testing | Not specified | Met pre-determined criteria |
| Flow Rate Testing | Not specified | Met pre-determined criteria |
| Kink Testing | Not specified | Met pre-determined criteria |
| Tensile Testing | Not specified | Met pre-determined criteria |
| Luer Testing per BBB ISO 80369-7 | Not specified | Met pre-determined criteria |
| Package Distribution Simulation Testing per ASTM 4169-16 | Not specified | Met pre-determined criteria |
| Package Integrity Visual Inspection | Not specified | Met pre-determined criteria |
| Package Integrity Bubble Leak Testing per ASTM F2096-11 | Not specified | Met pre-determined criteria |
| Package Strength Testing per ASTM F88/F88M-15 | Not specified | Met pre-determined criteria |
| Bend Radius Test | Not specified | Met pre-determined criteria |
| KY Jelly Compatibility Test | Not specified | Met pre-determined criteria |
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 provided in the document. The document primarily focuses on non-clinical performance testing of the device itself (e.g., mechanical properties, packaging) rather than clinical study data from a patient test set.
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 applicable as the provided document details non-clinical laboratory testing, not a study involving expert assessment of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the provided document details non-clinical laboratory testing.
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 applicable. The document describes a medical device (catheter), not an AI-powered diagnostic tool, and it does not include any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" would be established by the specific engineering and material science standards and methodologies used for each test (e.g., ISO, ASTM standards, internal specifications). For example, for "Dimensional Inspection," the ground truth would be the design specifications for the catheter's dimensions. However, the document does not elaborate on these specific ground truth definitions for each test.
8. The sample size for the training set
This information is not applicable as the document describes a medical device (catheter) and its non-clinical performance testing. It does not refer to a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" mentioned in the context of this device's documentation.
§ 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.