(311 days)
The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder.
The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.
The provided document is a 510(k) Summary for the Rusch Silicone Foley Catheter, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific efficacy or diagnostic performance acceptance criteria through clinical studies. Therefore, much of the information requested about acceptance criteria and detailed study design for diagnostic performance is not present in this document.
However, I can extract information related to the non-clinical performance testing which served to demonstrate substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria (e.g., a specific peel strength in Newtons) or reported numerical performance data for the subject device. It states what was tested and the conclusion that the subject device is substantially equivalent.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Peel Strength | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to meet equivalence) |
| Balloon Security | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to meet equivalence) |
| Deflation Reliability | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to meet equivalence) |
| Shaft Pull Test | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to meet equivalence) |
| Tip Detachment | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to meet equivalence) |
| Funnel Detachment | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to meet equivalence) |
| Biocompatibility | Per ISO 10993 | Materials tested per ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the individual non-clinical performance tests.
- Data Provenance: The tests are "bench testing" which are conducted in a laboratory setting. No country of origin is specified for these tests, but the applicant is Teleflex Medical, Inc. in the USA. The data is retrospective in the sense that the tests were performed and analyzed to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the non-clinical performance (bench testing) described. Bench tests do not involve expert interpretation or ground truth establishment in the way a clinical diagnostic study would.
4. Adjudication Method for the Test Set
This is not applicable as there were no expert interpretations requiring adjudication for these bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This document describes a medical device (catheter) for drainage, not an AI or diagnostic imaging device that would typically involve an MRMC study.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm was done. This is a physical medical device.
7. Type of Ground Truth Used
For the bench tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards, internal company standards) for measuring properties like peel strength, security, and reliability. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. For biocompatibility, the ground truth is established by the successful completion of tests adhering to ISO 10993.
8. Sample Size for the Training Set
No training set is mentioned or applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no 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.