(72 days)
The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.
The FLUME catheter is intended for the drainage of urine from the bladder. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethanebased polymers. The catheter has an inflatable retention balloon attached to the catheter shaft. The catheter has a dual lumen tube. The larger lumen is for urine drainage. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in standard sizes. The catheter may be placed following the institutions' standard practice for either urethral bladder drainage or via percutaneous suprapubic access to the bladder.
This document is a 510(k) summary for the FLUME catheter, which seeks to expand its indications for use to include suprapubic drainage. This is a special 510(k) submission, meaning it relies heavily on the predicate device (FLUME catheter K212151) as the current device has no changes in design, materials, or manufacturing processes.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria for the expanded indication of suprapubic use. Instead, it relies on the predicate device's established performance and extensive non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Biocompatibility): | |
| The device should not cause adverse biological reactions when in contact with the body. | Biocompatibility testing from the predicate device (FLUME catheter K212151) was leveraged. |
| The performed tests include: | |
| • Cytotoxicity | |
| • Sensitization | |
| • Irritation | |
| • Acute Systemic Toxicity | |
| • Subacute Systemic Toxicity | |
| • Material Mediated Pyrogenicity | |
| • Subcutaneous Implantation | |
| • Genotoxicity | |
| All tests align with ISO 10993-1. | |
| Conclusion: Biocompatibility evaluation expectations for suprapubic use are met. | |
| Pyrogenicity: | |
| The device should be free of pyrogens to prevent fever. | Bacterial Endotoxin Testing (BET) was conducted and confirmed the device meets pyrogen limit specifications. |
| Functional Equivalence: | |
| The FLUME catheter, when used for suprapubic drainage, should function equivalently to its previously cleared urethral use and to the predicate device. | The submission states: "There are no changes or differences made to the FLUME catheter to extend the indication for use to include suprapubic drainage. The only change in this Special 510(k) is to the current indication for use and instructions for use." And "According to the risk assessment, there is no difference to the patient when the FLUME catheter is placed suprapubic." This implies that the existing performance (drainage, retention, material integrity) is considered adequate for the new route of administration due to the lack of device changes. |
| The device maintains the following features of the predicate: | |
| • Sterile indwelling urinary catheter for single use. | |
| • Made of polyurethane-based polymers. | |
| • Inflatable retention balloon. | |
| • Dual lumen (larger for urine drainage, smaller for balloon inflation/deflation). | |
| • Two opposite eye holes for drainage. | |
| • Available in standard sizes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new "test set" in the traditional sense of a clinical or ex-vivo study with a defined sample size for the expanded indication.
- Sample Size: Not applicable/not provided for a specific test set related to the suprapubic indication as it's a Special 510(k) leveraging prior data.
- Data Provenance: The biocompatibility data is "leveraged from the predicate device." This suggests the data was generated previously for the predicate device, but its original provenance (e.g., country, retrospective/prospective) is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert-established ground truth for a test set. The submission relies on non-clinical data and risk assessment.
4. Adjudication Method for the Test Set
Not applicable. There is no described test set requiring adjudication in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "SUMMARY of NON-CLINICAL TESTING." There is no mention of an MRMC comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical urological catheter, not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" for the safety aspects (biocompatibility, pyrogenicity) is based on standardized testing protocols (e.g., ISO 10993-1 for biocompatibility, bacterial endotoxin testing for pyrogenicity) and internal risk assessments concluding equivalence. For functional equivalence, the ground truth is the established performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a 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.