(116 days)
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.
The International Medsurg Connections Irrigation Sets.
This is a 510(k) premarket notification for a medical device (Irrigation Sets), not an AI/ML device. Therefore, the questions related to AI/ML performance, ground truth, expert adjudication, and training/test sets are not applicable.
The document describes the device's characteristics and its substantial equivalence to a predicate device based on intended use, configurations, and materials. It also outlines a summary of testing conducted to ensure the materials and components meet certain standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a list of evaluations performed on the "Joined Tubing 5" and 20"" and "Irrigation Sets*". These can be considered the acceptance criteria for material and component properties. The document states that "All materials used in the fabrication... were evaluated for" these characteristics, implying they met specified acceptance levels, although the specific performance values or pass/fail thresholds are not detailed in this summary.
| Acceptance Criteria (Evaluated For) | Device Performance (Implied) |
|---|---|
| For Joined Tubing 5" and 20" | |
| Oxidizable Matter | Evaluated (Implied to meet acceptable range) |
| Acidity and Alkalinity | Evaluated (Implied to meet acceptable range) |
| UV Absorbancy | Evaluated (Implied to meet acceptable range) |
| Metallic ions | Evaluated (Implied to meet acceptable range) |
| Evaporated Residual | Evaluated (Implied to meet acceptable range) |
| Diameter of the end conical fitting | Evaluated (Implied to meet specifications) |
| Length of conical fitting | Evaluated (Implied to meet specifications) |
| Taper of conical fitting | Evaluated (Implied to meet specifications) |
| Separate force of conical fitting | Evaluated (Implied to meet specifications) |
| Tightness of conical fitting | Evaluated (Implied to meet specifications) |
| Force of split the conical fitting | Evaluated (Implied to meet specifications) |
| Diameter of conical aperature | Evaluated (Implied to meet specifications) |
| Depth of conical aperature | Evaluated (Implied to meet specifications) |
| Taper of conical aperature | Evaluated (Implied to meet specifications) |
| Separate force of conical aperature | Evaluated (Implied to meet specifications) |
| Tightness of conical aperature | Evaluated (Implied to meet specifications) |
| Force of split the conical aperature | Evaluated (Implied to meet specifications) |
| Outer diameter of conical fitting on outstanding position | Evaluated (Implied to meet specifications) |
| Angle of conical fitting on outstanding position | Evaluated (Implied to meet specifications) |
| Length of tubing | Evaluated (Implied to meet specifications) |
| Connection Strength | Evaluated (Implied to meet specifications) |
| Integrity | Evaluated (Implied to meet specifications) |
| For Irrigation Sets* | |
| Oxidizable Matter | Evaluated (Implied to meet acceptable range) |
| Acidity and Alkalinity | Evaluated (Implied to meet acceptable range) |
| UV Absorbancy | Evaluated (Implied to meet acceptable range) |
| Metallic ions | Evaluated (Implied to meet acceptable range) |
| Evaporated Residual | Evaluated (Implied to meet acceptable range) |
| Integrity | Evaluated (Implied to meet specifications) |
| Connection between components | Evaluated (Implied to meet specifications) |
| Closure-piecing device | Evaluated (Implied to meet specifications) |
| Tubing | Evaluated (Implied to meet specifications) |
| Drip chamber and drip tubing | Evaluated (Implied to meet specifications) |
| Flow rate of infusion | Evaluated (Implied to meet specifications) |
| Flow regulator | Evaluated (Implied to meet specifications) |
| Self-sealing injection site | Evaluated (Implied to meet specifications) |
| Protective caps | Evaluated (Implied to meet specifications) |
| Symbol | Evaluated (Implied to meet specifications) |
| Packing | Evaluated (Implied to meet specifications) |
| Chemical property | Evaluated (Implied to meet acceptable properties) |
2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the context of AI/ML evaluation. The "testing" refers to material and component evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, and no "ground truth" for diagnostic or predictive performance is being established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This device is an irrigation set, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be engineering specifications and material standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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.