(130 days)
CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non- neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
The provided document describes the CompactCath Intermittent Urinary Catheter and its substantial equivalence to a predicate device, K100878 Self Cath Catheter Coloplast A/S. The information about the acceptance criteria and the study that proves the device meets them is limited, as the document focuses on demonstrating substantial equivalence rather than presenting a detailed clinical study report with, for example, a standalone algorithm performance, or an MRMC study.
However, based on the Testing section and the Performance specifications & testing summary (avg.) table, we can extract the following information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test Parameter | Acceptance Criteria (from predicate) | Reported Device Performance (CompactCath) |
|---|---|---|---|
| Performance Specifications | Insertion Force (Female) | 0.06 lbf | 0.08 lbf |
| Insertion Force (Male) | 1.38 lbf | 1.08 lbf | |
| Flow Test | 520 ml/min | 504 ml/min | |
| Hub Pull | 14.96 (lbf, {N}) | 17.97 (lbf, {N}) | |
| Biocompatibility | Per ISO10993 | "All materials suitable for this use" | "All materials were found to be biocompatible and suitable for this use." |
| Sterilization | Validation | "Validated cycle" (for radiation) | "Sterilization validation... were also completed." |
| Shelf Life | 2 Years | 6 months | |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 (Assumed for predicate, explicitly stated for CompactCath) | |
| Material Equivalence | Direct Patient Contacting Material | Silicone | Silicone |
| Catheter Material | PVC | PVC | |
| Physical Dimensions | Length (adults) | 16" | 16" |
| Length (pediatric) | 10" | 10" | |
| Diameter | 8-18FR | 8-12FR | |
| Number of Eyelets | 2 | 2 |
Note on Acceptance Criteria: The document states "Product testing was completed and met the acceptance criteria." The table above extrapolates the "acceptance criteria" from the reported performance of the predicate device (Coloplast) as the basis for comparison to demonstrate substantial equivalence. The CompactCath performance is then compared directly against these values. For some criteria, the CompactCath matches or is within an acceptable range, while for others (like shelf life), the difference is acknowledged and deemed equivalent in the context of substantial equivalence, not necessarily identical.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the sample sizes used for the various tests (flow measurements, bond strength, deployment, insertion force, biocompatibility, sterilization validation, expiry dating). It only mentions that testing was completed.
- Data Provenance: Not specified. The studies appear to be in-house laboratory testing of the devices, not human clinical trials or data from specific countries of origin. They are therefore prospective in nature, as they involve testing the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests performed are engineering and laboratory tests (e.g., flow rate, force measurement, biocompatibility, sterilization validation), not subjective assessments requiring expert consensus on a "ground truth" in the way a medical image or diagnostic test would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as point 3.
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. This type of study (MRMC for AI assistance) is not relevant to this medical device, which is a physical intermittent urinary catheter, not an AI-powered diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as it's a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests appears to be the measured performance data of the legally marketed predicate device (Coloplast Self Cath Catheter). For other tests like biocompatibility, the ground truth is adherence to recognized standards (ISO10993). For sterilization, the ground truth is validated sterilization cycles achieving a specific SAL (10^-6).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as explained in point 8.
§ 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.