(83 days)
The SLIP Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device is indicated for providing increased lubricity during the catheter's advancement.
The SLIP Urology Catheter consists of a catheter, a sheath, a snap ring, and a guide ring. The catheter is pre-loaded with a membrane sheath for increased lubricity.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The SLIP Urology Catheter is identical to the Memcath Urology Catheter (except for the trade name). It has the same intended use, indications for use, technological characteristics, and principles of operation. Therefore, it is considered substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or data provenance (country of origin, retrospective/prospective) is mentioned in the provided text, as no performance data was provided for clinical testing of the device itself. The primary argument for clearance is substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No direct performance data or test set requiring expert ground truth establishment was conducted for the SLIP Urology Catheter, as its clearance was based on substantial equivalence.
4. Adjudication Method for the Test Set
Not applicable. No direct performance data or test set requiring adjudication was conducted for the SLIP Urology Catheter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (urology catheter), not an algorithm or AI-driven system.
7. The Type of Ground Truth Used
Not applicable. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics established against a ground truth.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI or algorithm-driven system that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a medical device, not an AI or algorithm-driven system that would require a ground truth for 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.