(137 days)
The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED 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 UPDATED SLIP Urology Introducer Sheath consists of a membrane sheath, outer tube, stabilizing ring, and an obturator. The outer tube is pre-loaded with the membrane sheath.
The provided text describes a 510(k) premarket notification for a medical device, the "UPDATED SLIP Urology Introducer Sheath." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a detailed clinical study with acceptance criteria, sample sizes, and expert evaluations as typically seen for novel or higher-risk devices.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this specific submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics with numerical targets. The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states: "Performance data demonstrated no significant difference in the performance of the UPDATED SLIP Urology Sheath and the predicate device." This is a qualitative statement, not a numerical performance value against a defined criterion.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | No significant difference in performance compared to the predicate device (PSI SLIP Urology Introducer Sheath). |
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 refers to "Performance data" but does not detail the nature, size, or methodology of any testing that generated this data.
- Data Provenance: Not specified.
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. This type of expert assessment to establish ground truth for a test set is not typically part of a 510(k) submission for a device like an introducer sheath, which is focused on physical and functional equivalence rather than diagnostic accuracy or specific clinical outcomes requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no specific "test set" and expert ground truth establishment are described, there is no adjudication method.
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. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance. This device is an introducer sheath, a different class of medical device, and does not involve AI or human readers in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this type of device and submission, the "ground truth" equivalent would be the established performance and safety profile of the predicate device, against which the new device is compared in terms of its technological characteristics and the absence of new safety/effectiveness questions.
8. The sample size for the training set
- Not Applicable. Training sets are relevant for AI/machine learning models. This device is not an AI/ML product.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
Summary of what is known from the document regarding "performance data":
The document explicitly states: "Performance data demonstrated no significant difference in the performance of the UPDATED SLIP Urology Sheath and the predicate device." This indicates that some form of comparative evaluation was conducted to support the claim of substantial equivalence. However, the details of what kind of performance data (e.g., mechanical strength, lubricity, insertion force, biocompatibility), how it was collected, the sample size, or the specific methodology are not provided in this summary. For a 510(k), this level of detail is typically found in the full submission, not necessarily in the brief summary provided. The focus of the 510(k) is on the device's technical characteristics and intended use being similar to a legally marketed predicate device, ensuring no new questions of safety or effectiveness are raised.
§ 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.