(210 days)
The ContiDrain™ Catheter is indicated for continuous urine drainage.
The ContiDrain™ Catheter is an indwelling urinary catheter with the same indication for use and function as a conventional Foley catheter. Like a Foley catheter, the ContiDrain™ Catheter is indicated for continuous urine drainage. Both devices use a tubular catheter to pass urine from the bladder through the urethra and meatus into a urinary drainage bag. Both devices also have a mechanism for retention in the bladder. The ContiDrain™ Catheter has two design features that are different from the conventional Foley catheter. The ContiDrain™ Catheter incorporates two design features found in conventional ureteral stents. These features involve the methods of urine flow and of retention in the bladder.
This submission for the ContiDrain™ Catheter outlines a device intended for continuous urine drainage, comparable to a conventional Foley catheter but with modifications for urine flow and bladder retention. The provided information details a feasibility study rather than a comprehensive comparative effectiveness study or a standalone algorithm performance study.
Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Reported Device Performance
The provided document describes a "Feasibility Study" rather than explicitly defined acceptance criteria with numerical targets. However, the study aimed to evaluate specific aspects of the device's performance. Based on the "Clinical Evaluation" section, we can infer the following:
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (from Clinical Evaluation) |
|---|---|
| Healthcare Professional Insertion | "healthcare professional can insert" - Satisfactory |
| Healthcare Professional Removal | "healthcare professional can remove" - Satisfactory |
| Catheter Retention in Bladder | "catheter will remain in place" - Adequate |
| Patient Acceptance | "generally favorable acceptance from the patients" |
| Urine Drainage | "found to be good" (in one patient) |
Note: The "acceptance criteria" are inferred from the study's stated goals and reported outcomes. Specific numerical benchmarks for "satisfactory," "adequate," or "good" are not provided in this document.
Detailed Study Information:
2. Sample size used for the test set and the data provenance:
- Sample Size: 9 adult male patients.
- Data Provenance: Clinical study conducted across three Institutional Review Board (IRB)-approved centers. The country of origin is not explicitly stated, but given the FDA clearance and submission to a U.S. regulatory body, it is likely the U.S. This was a prospective feasibility study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three investigators (who were presumably healthcare professionals involved in the study sites).
- Qualifications: Not explicitly stated, but given their role as "investigators" in a clinical study involving catheter insertion and removal, it's reasonable to assume they were clinicians (e.g., urologists, nurses, or other medical professionals) experienced in urological procedures. Specific years of experience or board certifications are not provided.
4. Adjudication method for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical evaluation. The "investigators" at each of the three centers likely assessed the outcomes individually or as part of their standard clinical practice, and their reports were aggregated. There is no mention of an independent review panel or a system for resolving discrepancies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The study described is a feasibility study focused on the device's basic function (insertion, removal, retention, initial drainage, and patient acceptance) in a small cohort of patients. It did not compare the ContiDrain™ Catheter's performance against a predicate device or a control group involving multiple readers assessing cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The ContiDrain™ Catheter is a physical medical device (a catheter), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not relevant.
7. The type of ground truth used:
- The "ground truth" for the feasibility study was primarily clinical observation and professional judgment by the healthcare professionals (investigators) involved in the study.
- Retention: Assessed by investigators.
- Insertion/Removal: Reported by healthcare professionals as "satisfactory."
- Patient Acceptance: Reported based on patient feedback to the professionals.
- Urine Drainage: Directly observed in one patient as "good."
- This is closest to "expert consensus" or "clinical assessment" by the treating/evaluating professionals. It is not based on pathology, imaging, or long-term outcomes data described in this summary.
8. The sample size for the training set:
- Not applicable. This device is not an AI/algorithm that requires a training set. The "bench testing" mentioned involved physical methods and fixtures derived from ASTM standards, which are not related to data-driven training.
9. How the ground truth for the training set was established:
- Not applicable. As stated in point 8, there is no training set for this type of medical device.
§ 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.