(155 days)
The Rusch-BRILLANT Balloon Catheter is used to drain the fluids to and from the urinary tract.
The silicon catheter is a balloon retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile, with a retention balloon, which is attached to the silicone two lumen shaft. One lumen is for drainage and the other lumen for inflation and deflation of the balloon. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the opposing end of the shaft, are a connecting funnel and a luer activated valve. This product is used with a wire stylet that is inserted prior to catheter placement. This product is available in 6F.
The provided 510(k) summary for the Rüsch-BRILLANT Balloon Catheter (K971643) does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This summary focuses on establishing substantial equivalence to a legally marketed predicate device, as opposed to providing detailed performance study results.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not specified in the document beyond a description of its intended function.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/not provided. This document focuses on substantial equivalence based on technological characteristics, not on a performance study with a test set of data.
- Data Provenance: Not applicable/not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/not provided.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices, whereas this device is a urological catheter.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study: No, a standalone study demonstrating algorithm performance was not done or reported. This device is a physical medical device (catheter), not an algorithm or AI.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. The "ground truth" concept is relevant for algorithm performance evaluation, which is not the subject of this 510(k) summary. The basis for clearance is substantial equivalence to a predicate device.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth was Established: Not applicable/not provided.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (based on the provided document):
The document does not describe a performance study with acceptance criteria. Instead, the "study" demonstrating the device's suitability for market is the 510(k) process for demonstrating substantial equivalence to a legally marketed predicate device.
- The Device in Question: Rüsch-BRILLANT Balloon Catheter.
- The Predicate Device: Porgés FOLYSIL Catheter.
- Methodology: The submission highlights that the Rüsch-BRILLANT Balloon Catheter is "substantially equivalent to the Porgés FOLYSIL Catheter" based on "technological characteristics."
- Key Technological Characteristics Identified as Equivalent: "The silicone catheter with silicone balloon, ported distal tip and silicone hub is equivalent to predicate devices."
- Conclusion: The FDA reviewed the submission and determined that the device is substantially equivalent to a pre-amendments device (or reclassified device) for the stated indications for use (draining fluids to and from the urinary tract). This substantial equivalence determination allows the device to be marketed.
In essence, the "proof" in this context is the FDA's finding of substantial equivalence, which is based on a comparison of the new device's design and materials to an already cleared device, rather than a performance study against specific acceptance criteria.
§ 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.