(114 days)
The PercuCath™ Catheter 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 PercuCath™ Urinary Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. The PercuCath™ Urinary Catheter is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a lubricious hydrophilic coating and a straight or angled council tip to facilitate insertion. It is composed of a silicone tube that trifurcates into three lumens, a silicone balloon, and a two-way valve. When activated, the valve permits flow in either of two directions, i.e., for inflation or deflation of the balloon. 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. The PercuCath™ Urinary Catheter will be available with a single eyelet or double eyelet, 14 through 24 Fr. Shafts (i.e.,14, 16, 18, 20, 22, and 24), and either a 10 cc or 30 cc balloon.
The PercuCath™ Urinary Catheter is a urological Foley catheter. The provided text indicates the device underwent mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not provide explicit acceptance criteria in a quantitative or qualitative manner other than "met the design specifications" and "substantially equivalent to the predicate devices."
Here's an attempt to structure the information based on your request, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design specifications met | Mechanical testing results demonstrated the PercuCath™ Urinary Catheter met the design specifications. |
| Substantially equivalent to predicate devices | Mechanical testing results demonstrated substantial equivalence to predicate devices (Bardex® Lubri-Sil® 3-Way Foley Catheter and Dover® 100% Silicone Foley Council Tip Catheter). |
Note: The document does not define specific numerical or descriptive design specifications or performance metrics for the acceptance criteria.
The study conducted was mechanical testing. The purpose was to show that the PercuCath™ Urinary Catheter met its design specifications and was substantially equivalent to its predicate devices.
Here's the breakdown of the other requested information based on the provided text. Much of this information is not detailed or available in the provided 510(k) summary.
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 specified. The document only mentions "Mechanical testing was performed."
- Data provenance: Not specified. It's unclear if this refers to physical device testing in a lab or data collected from a particular region. Given it's mechanical testing, it's likely lab-based and not geographically specific in the sense of patient data.
- Retrospective or Prospective: Not applicable for mechanical testing of a device's physical properties.
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)
- Not applicable as this was mechanical testing, not a study requiring expert clinical assessment or ground truth establishment in a medical context. The "ground truth" would be the engineering specifications the device was tested against.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or subjective data, not for mechanical testing of device performance against specifications.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (urinary catheter), not an AI-powered diagnostic tool.
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.)
- For mechanical testing, the "ground truth" would be the predetermined design specifications and performance standards for urological catheters, and potentially the performance characteristics of the predicate devices. These standards are typically based on engineering principles and regulatory requirements, rather than clinical "ground truth" from patients or expert consensus in an imaging context.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires 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.