(78 days)
Baxter's line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Baxter's line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures. The subject of this submission is a material change in the distal tubing segment of the irrigation set from natural rubber latex to styrene ethylene butadiene styrene (SEBS). This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee joint. The change from latex to SEBS is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.
The provided text describes a 510(k) Premarket Notification for Irrigation Sets with a modified tubing segment. The submission focuses on a material change from natural rubber latex to styrene ethylene butadiene styrene (SEBS) in the distal tubing segment to improve user safety by eliminating potential sensitivity reactions to natural rubber proteins.
However, the provided text does not contain information about:
- Acceptance criteria and reported device performance in a specific table with quantitative metrics.
- Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, training set size, or ground truth establishment for a study that proves the device meets specific acceptance criteria related to a diagnostic or AI-driven medical device.
The document is a 510(k) summary for a material change in a medical device (irrigation sets). The "studies" mentioned are non-clinical tests to verify the biocompatibility and functional performance of the new material, not a clinical study to assess diagnostic accuracy or the effectiveness of an AI algorithm in a healthcare setting.
Based only on the provided text, I can infer the following about the acceptance criteria and the "study" mentioned, though it does not fit the typical format for AI/diagnostic device evaluation:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Biological/Chemical Reactivity | "The material was found to be acceptable for its intended use." (Assessed using ISO Standard 10993-1 and USP Physicochemical tests). |
| Functional Performance | "Performance testing indicate that the proposed irrigation set meets or exceeds all functional requirements and support its suitability for use." (Included kink testing, pull testing and pressure testing). |
| User Safety (Material Change) | "Eliminating the potential for sensitivity reactions associated with natural rubber proteins." (Implicitly, the SEBS material achieved this safety goal). |
| Design/Dimensions/Intended Use | "The proposed irrigation sets are identical to current Baxter irrigation sets except for the material change... The design and dimensions... will remain unchanged. Also, all other materials... as well as overall product design and intended use will remain unchanged." (Implies meeting predicate device's established performance in these areas). |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests (kink, pull, pressure, biological).
- Data Provenance: Not specified. These are likely in-house laboratory tests conducted by Baxter Healthcare Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submitter is for a material change in a physical medical device. There is no "ground truth" in the diagnostic sense, nor clinical experts establishing diagnostic accuracy. The "truth" is established by adherence to physical and biological testing standards.
4. Adjudication method for the test set:
- Not applicable. This refers to diagnostic/AI studies. The tests mentioned are objective physical and biological assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is not a diagnostic device or an AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This refers to AI algorithms.
7. The type of ground truth used:
- Not applicable in the diagnostic sense. The "ground truth" for the material and functional performance is based on established ISO and USP standards for biocompatibility and engineering specifications for functional requirements.
8. The sample size for the training set:
- Not applicable. There is no "training set" for an AI algorithm mentioned.
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.