(83 days)
The SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
The SLIP Urology Catheter consists of a sheath, pusher tube, a twist ring, and a guide ring. The pusher tube is pre-loaded with the sheath.
This 510(k) summary is for a medical device (SLIP Urology Introducer Sheath) seeking substantial equivalence to a predicate device, not for an AI/ML-driven device that typically undergoes performance studies with acceptance criteria, test sets, and ground truth establishment.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not applicable to this document.
Here's an explanation based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts "identicality" to a predicate device rather than presenting new performance data against specific criteria.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): Not applicable. No performance study, as typically understood for new AI/ML devices, was conducted or presented.
- Type of Ground Truth: Not applicable. This concept is relevant for performance studies where a reference standard is needed to evaluate the device's output. Since no new performance data was provided, no ground truth was established for the SLIP Urology Introducer Sheath.
- Training Set Sample Size and Ground Truth Establishment (for training): Not applicable. This device is not an AI/ML model requiring a training set.
Summary of what can be extracted from the document:
The core of this 510(k) submission is based on substantial equivalence.
- Device: SLIP Urology Introducer Sheath
- Predicate Device: Memcath's Urology Introducer Sheath
- Key Argument for Substantial Equivalence: The submitter states: "The SLIP Urology Introduction Sheath is identical to the Memcath Urology Introduction Sheath (except for the trade name). The SLIP Urology Introduction Sheath has the same intended use, indications for use, technological characteristics, and principles of operation."
- Performance Data: "No performance data were provided" because the device is claimed to be identical to the predicate.
In a traditional 510(k) for a device like this, the 'study' to prove it meets acceptance criteria is often a comparison to a legally marketed predicate device demonstrating that it's just as safe and effective, without raising new questions of safety or effectiveness. For an identical device, the "acceptance criteria" can implicitly be considered "is identical to the predicate."
§ 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.