(184 days)
Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & Sleeved IC 2 Plus Pocket (16" and 8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.
The Sleeved IC 2 (not finalized) catheters are:
- E-beam sterilized.
- Hydrophilic-coated, single use catheter.
- Have two drainage eyelets that is used to manage urinary incontinence.
- The Sleeved IC is inserted into the urethra to drain urine from the bladder.
- Available in 16 inch and 8 inch lengths.
- Available in various Fr sizes ranging from Fr 08 through Fr 16.
- Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
- Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
- Lubricated by direct contact with the hydration fluid.
- Available with and without integrated urine collection bag.
- Available in pocket and straight packaging configurations.
- Environment of use: hospital, home setting, public places.
The provided document describes the FDA clearance for the "Sleeved IC 2 Family" of intermittent catheters (K233524). It details the device's characteristics, indications for use, and a comparison to a predicate device ("Sleeved IC" K220667). It also summarizes the non-clinical testing conducted to support the substantial equivalence claim.
However, the document does not contain the specific information required to complete a table of acceptance criteria with reported device performance from a clinical study, nor does it detail a study that demonstrates the device meets specific acceptance criteria in the way described in the prompt.
Here's an explanation of why the requested information cannot be fully provided based on the input:
- Type of Submission: This is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device. For many moderate-risk devices (Class II), clinical studies are not always required if non-clinical performance testing can demonstrate substantial equivalence.
- Focus of the Document: The document focuses primarily on the technical characteristics and non-clinical testing (e.g., physical performance, biocompatibility, sterilization, packaging) to show that the new device performs as safely and effectively as the predicate device. It explicitly states, "Brief Description of Non-Clinical Testing".
Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes for test sets (as no clinical test set is described), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for a clinical study because this information is not present in the provided text.
The document does include details on the non-clinical testing performed, which serves as the "study" demonstrating the device meets the requirements for clearance.
Below is a partial response based on the information available, noting where specific requested details are absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical performance testing against recognized standards rather than specific acceptance criteria from a clinical study. The "reported device performance" is that the device "met all applicable requirements" of these standards.
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Result) |
|---|---|
| BS EN ISO 20696:2018 (Sterile urethral catheters for single use): | Met all applicable requirements |
| Size designation | Equivalence to predicate |
| Lubricity | Equivalence to predicate |
| Strength of the catheter | Equivalence to predicate |
| Security of fit of the drainage funnel | Equivalence to predicate |
| Flow rate through catheter | Equivalence to predicate |
| Catheter kink stability | Equivalence to predicate |
| Peak tensile force | Equivalence to predicate |
| Urine collection bag flowrate (~1 min) | Sufficient flow within 1 minute |
| Biocompatibility (ISO 10993 series) | Met all requirements |
| Sterilization (ISO 11137 series, ANSI/AAMI/ISO 11737 series) | Met all requirements |
| Shelf life (by package integrity & bench performance) | Supported shelf life |
| Packaging (ISO 11607 series, ASTM F2096, ASTM F88/F88M) | Met all requirements |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the non-clinical tests. Non-clinical bench testing often uses small, representative samples.
- Data Provenance: Not specified, but generally, such testing is conducted in controlled laboratory environments by the manufacturer or contract labs. It is non-clinical (i.e., not from human subjects).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The testing described is non-clinical and does not involve expert review or "ground truth" establishment in the context of clinical expert consensus. Performance is measured against engineering and biological standards.
4. Adjudication method for the test set
- Not applicable. This is not a clinical study involving human interpretation or adjudication.
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
- Not applicable. This device is a urological catheter, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not incorporate an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For non-clinical performance, the "ground truth" is established by the specifications and measurable parameters defined in the referenced international and national standards (e.g., ISO 20696 for physical properties, ISO 10993 for biocompatibility).
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. (See #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.