(255 days)
The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.
The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.
The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.
The provided text describes the regulatory clearance of the Optilume Basic Urological Balloon Dilation Catheter (K191061) as substantially equivalent to a predicate device. It includes performance data for various engineering and biocompatibility tests, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which would typically involve human readers and assessment of performance metrics like sensitivity, specificity, or AUC.
The document focuses on the physical and biological performance of the device itself, rather than evaluating an AI algorithm's diagnostic performance. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.
Here's a breakdown of what can and cannot be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests but does not provide explicit acceptance criteria values (e.g., "burst pressure > X atm") alongside the reported results. It only states that the device "underwent extensive testing" and "performed as intended."
| Acceptance Criteria (Not explicitly stated in terms of values) | Reported Device Performance |
|---|---|
| Dimensional: (Implied to meet design specifications) | Tested |
| Balloon Burst: (Implied to meet pressure requirements) | Tested |
| Leakage Testing: (Implied to not leak) | Tested |
| Kink Resistance: (Implied to resist kinking) | Tested |
| Guidewire, Luer, and Cystoscope Compatibility: (Implied to be compatible) | Compatible |
| Trackability: (Implied to track correctly) | Tested |
| Tensile Testing: (Implied to endure tensile forces) | Tested |
| Fatigue Testing: (Implied to withstand fatigue) | Tested |
| Balloon Compliance Testing: (Implied to meet compliance specifications) | Tested |
| Biocompatibility Testing: (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity - Implied to be biocompatible with ISO 10993-1 for mucosal tissue) | Compliant |
| Packaging Testing: (Seal strength, bubble leak, distribution - Implied to meet packaging integrity) | Tested |
| Accelerated aging: (Implied to meet shelf life requirements) | Tested |
| GLP Animal Study (Safety and Use): (Implied to be safe and function as intended) | Performed as intended; no device-related adverse events occurred. |
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: Not applicable in the context of diagnostic "test set" as this is a medical device for dilation, not a diagnostic algorithm. For the GLP animal study, the sample size is not specified beyond "canines."
- Data Provenance: The GLP animal study was performed in "canines." No country of origin is mentioned for the animal study.
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 performance data relates to the physical and biological characteristics of the device, not the interpretation of diagnostic images requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the engineering tests (e.g., balloon burst, tensile testing), the "ground truth" would be the established engineering specifications and physical properties of the materials. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards. For the animal study, the "ground truth" refers to observation of device performance and absence of adverse events in living subjects.
8. The sample size for the training set:
Not applicable. This is not a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning algorithm.
§ 876.5520 Urethral dilator.
(a)
Identification. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.(b)
Classification. (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. 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.