(309 days)
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.
The provided text describes a 510(k) premarket notification for two medical devices: the Universa® Loop Drainage Catheter Set and the Universa® Malecot Drainage Catheter Set. It does not describe an AI/ML device or a study involving such a device. Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.
However, I can extract the information related to acceptance criteria and the studies performed for these physical medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Predetermined Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Integrity | Tensile Strength Testing | Not explicitly stated but implied to ensure catheter materials/bonds do not fracture during proper clinical use. | The predetermined acceptance criteria were met. |
| Functional Retention | Loop and Malecot Retention Testing | Not explicitly stated but implied to ensure retention features resist dislodgement/removal. | The predetermined acceptance criterion was met. |
| Fluid Dynamics | Gravity Flow Rate, Lumen Blockage, and Leakage Testing | Not explicitly stated but implied to ensure consistent water flow without blockage or leakage. | The predetermined acceptance criteria were met. |
| Biocompatibility | Biocompatibility Testing | Conformance with ISO 10993-1. | The predetermined acceptance criteria were met. |
| Usability/Performance | Simulated Use Testing | Not explicitly stated but implied to ensure compatibility and performance according to instructions for use. | The results of the study are acceptable for clinical practice. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided document.
- Data provenance: Not applicable. These are physical device tests, not data-driven studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for these physical device tests is established through engineering and biological standards, not expert consensus on data interpretation.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. Performance is measured against physical test standards.
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
- MRMC study: No. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This is not an AI/ML device.
7. The type of ground truth used
- The "ground truth" for these physical device tests is based on:
- Engineering specifications and material properties (for tensile strength, flow rates).
- Functional design requirements (for retention).
- International standards (ISO 10993-1 for biocompatibility).
- Instructions for use for simulated clinical performance.
8. The sample size for the training set
- Sample size: Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable. No training set for an AI/ML context.
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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.