(300 days)
For intermittent urinary catheterization.
The proposed device: LoFric® Elle™, is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheter is prelubricated with a hydrophilic coating and immersed in water-based wetting fluid within its primary package. The primary package contains a sealed water container from which the wetting fluid migrates to the catheter tubing and activates the catheter surface. This results in minimal steps for preparation prior to use.
LoFric® Elle™, is available in one length (10cm) with a Nelaton (straight) tip and diameters of 10 Fr, 12 Fr and 14 Fr, to accommodate individual anatomy of female users.
The provided text describes the regulatory clearance of the LoFric® Elle™ urological catheter and does not contain detailed information about a clinical study with acceptance criteria and device performance metrics in the format requested. The document explicitly states: "No data from human clinical studies has been included to support the substantial equivalence of the LoFric Elle."
Instead, the submission relied on non-clinical performance data and comparisons to a predicate device (LoFric® Sense™) to demonstrate substantial equivalence.
Therefore, I cannot provide a detailed answer to your request based on the provided text, as the specific information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance is not present.
However, I can extract information about the non-clinical testing and verification performed:
Non-Clinical Performance Data & Verification (Not a Clinical Study):
| Acceptance Criteria (What was measured/verified) | Reported Device Performance (Passed/Met Criteria) |
|---|---|
| Biocompatibility (according to ISO 10993-1:2018) | All tests passed. |
| Strength (per Annex A of ISO 20696) | Verified. |
| Flow rate (per Annex E of ISO 20696) | Verified. |
| Peak tensile force (per Annex H of ISO 20696) | Verified. |
| Kink stability (per ISO 20696) | Verified. |
| Coating appearance (per ISO 20696) | Verified. |
| Diameter sizes (per ISO 20696) | Verified by design. |
| Water retention (internal method) | Verified. |
| Coefficient of friction (internal method) | Verified. |
| Osmolality (internal method) | Verified. |
| Packaging sterile integrity (internal method) | Verified. |
| Flexural Strength (internal method) | Verified. |
| Beam Bending stiffness (internal method) | Verified. |
| pH level (internal method) | Verified. |
| Sterilization validation (according to AAMI/ANSI/ISO 11137-1:2015 and ISO 11137-2) | All tests passed. |
| Requirements for materials, sterile barrier systems, and packaging systems (according to ISO 11607-1:2006/(R)2010) | All tests met the pre-determined acceptance criteria. |
| Validation requirements for forming, sealing, and assembly processes (according to ISO 11607-2:2006/(R)2010) | All tests met the pre-determined acceptance criteria. |
| Environmental conditioning and simulated shipping distribution (according to ASTM D4332-14 and ASTM D4169-16) | All tests met the pre-determined acceptance criteria. |
| Real time and accelerated aging shelf life testing (according to ASTM F1980-16) | All tests met the pre-determined acceptance criteria. |
Missing Information (as per your request, because no human clinical study was conducted for this submission):
- Sample size used for the test set and the data provenance: Not applicable as no human test set was used for clinical performance. Non-clinical tests were conducted on device samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable (this device is a urological catheter, not an AI-assisted diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, "ground truth" would be the established standards (e.g., ISO, ASTM) and internal specifications.
- The sample size for the training set: Not applicable (no machine learning model was involved).
- How the ground truth for the training set was established: Not applicable.
§ 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.