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510(k) Data Aggregation
(220 days)
Hydrophilic-Antibacterial Intermittent Catheter is intended for urological use only. The Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, neurogenic bladder dysfunction, and surgical procedures in adult males and females requiring catheterization. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection.
Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.
The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial coated single lumen catheter with either two or four drainage eyes on the proximal tip. It is constructed from medical grade elastomers.
The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter (Hydrophilic-Antibacterial Intermittent Catheter, Hydrophilic Personal® Catheter K000723, or Antibacterial Personal® Catheter K001143) in a closed system-in-a-bag configuration with an introducer tip and insertion supplies.
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Acceptance Criteria and Study for Rochester Medical Corporation's Urological Catheter and Accessories
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through showing similar technological and performance characteristics, and biocompatibility testing. It doesn't present specific quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy for a diagnostic device) or provide a study demonstrating a direct comparison against such criteria for the Hydrophilic-Antibacterial Intermittent Catheter or the Intermittent Catheter Closed System Kit.
Instead, the "acceptance criteria" can be inferred from the regulatory pathway: proving substantial equivalence through comparison with existing legally marketed devices and demonstrating that the new device does not raise new questions of safety or effectiveness. The "study" in this context refers to the biocompatibility testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Summary of Biocompatibility Testing) |
|---|---|
| Biocompatibility: Device materials must not cause adverse biological reactions. This broadly includes: | Cytotoxicity Study (ISO Elution Method): Test extracts showed a cytotoxic effect. Conclusion: Acceptable because the antibacterial agent is topically applied, acts locally, and is exposed to the bladder's mucous membrane in small doses. |
| - Lack of significant cytotoxicity | ISO Intracutaneous Study (Saline and Sesame Oil Extracts): No evidence of significant irritation. |
| - Lack of significant irritation (skin/tissue) | USP and ISO Systemic Toxicity Study (Saline and Sesame Oil Extracts): No mortality or evidence of systemic toxicity. |
| - Lack of systemic toxicity | ISO Sensitization Test (Guinea Pigs - Maximization Method): No evidence of delayed dermal contact sensitization. |
| - Lack of sensitization | Urinary Bladder Irritation Study with Histopathology: Considered to be a non-irritant to the urinary bladder. |
| - Non-irritant to urinary bladder | ISO Muscle Implantation Study - 4 Week with Histopathology: Macroscopic reaction not significant compared to negative control. Microscopically classified as a slight irritant compared to negative control. |
| Technological and Performance Equivalence: Device should have similar characteristics to predicate devices. | The catheters described in the 510(k) have similar technological and performance characteristics to many predicate devices. They are constructed from the same materials as the predicate devices, use similar manufacturing methods, and have a hydrophilic and antibacterial coating. Supplied in the same sizes (12 to 18 French, male and female lengths) as the Antibacterial Personal® Catheter. The Closed System Kit is substantially equivalent to specified predicate kits. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The document provides details on the methods used for biocompatibility testing but does not specify the sample sizes for each test (e.g., how many cells for cytotoxicity, how many animals for in-vivo tests).
- Data Provenance: The biocompatibility tests are laboratory-based, performed by Rochester Medical Corporation. The document does not indicate country of origin for patients or animals, nor does it classify the data as retrospective or prospective clinical data, as this is pre-market testing.
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 this 510(k) submission. Biocompatibility testing relies on standardized laboratory protocols (e.g., ISO and USP standards) rather than expert interpretation of clinical ground truth in the way a diagnostic device might require. The "ground truth" for these tests is the outcome of the biological assay itself based on predefined criteria (e.g., cell viability, presence of irritation, mortality).
4. Adjudication Method for the Test Set
This is not applicable. The biocompatibility tests follow standardized, objective laboratory methods. There is no mention of a human adjudication process for interpreting these test outcomes beyond the standard analysis and reporting by the testing personnel.
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
No, an MRMC comparative effectiveness study was not done. This device is a urological catheter, not a diagnostic imaging device typically associated with AI assistance or human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a medical product (catheter), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's safety (biocompatibility) and performance (similarity to predicates) relies on:
- Standardized Laboratory Protocols and Results: For biocompatibility, the truth is established by the factual biological outcomes of in-vitro and in-vivo tests as per ISO and USP standards.
- Engineering and Material Specifications: For technological equivalence, the ground truth is established by comparing the physical, material, and design specifications of the new device against those of legally marketed predicate devices.
8. The Sample Size for the Training Set
There is no mention of a training set in this context. Training sets are relevant for machine learning algorithms or complex diagnostics, not for the submission of a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence and biocompatibility.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set mentioned or implied in the provided document.
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