(183 days)
The OPTION-vf is intended to provide drainage of the urinary bladder.
The OPTION-yf is indicated for use only for urinary bladder drainage in female patients: 1) who have acute conditions that require short-term (14 days or less) urinary management; 2) who are capable of operating the device in accordance with its instructions for use; and 3) for whom normal bladder cycling is not contraindicated.
The OPTION-vf is an indwelling catheter that provides controlled drainage of the urinary bladder. It is a sterile, single-use, disposable device that is to be prescribed by a physician and inserted and removed by an appropriate health care professional. The device is composed of biocompatible silicone elastomers, and consists of a flexible shaft with two opposing eyelets in the proximal tip for urine entry, one internal lumen for urine drainage and a second lumen for balloon inflation; a retention balloon; an adjustable retainer ring; a self-sealing balloon inflation microvalve port; and a urine discharge bulb with integral valve.
The device is inserted through the urethra to position the proximal tip and balloon into the urinary bladder. Once the catheter is properly inserted, the teardrop-shaped balloon is inflated with 5 to 10 cc of sterile water through the microvalve port via a standard syringe and a blunt cannula. The retainer ring is then adjusted to the urinary meatus, thus gently anchoring the device in place. Removal of the OPTION-vf follows aspiration of the fluid from the balloon.
The patient-operated discharge valve within the OPTION-vf is housed within the discharge bulb. When the bulb is squeezed, the valve opens allowing urine to pass. When the bulb is released, the valve closes, providing the patient with direct control over urinary drainage. The OPTION-vf thus allows the patient to mimic normal voiding and permits patient mobility and comfort by eliminating the need for urine collection bags and tubing.
The OPTION-vf™ Urinary Catheter is a medical device, and the provided documentation describes its performance based on engineering and clinical testing. This is not a study of a device using AI, but rather a traditional medical device submission. Therefore, some of the requested information regarding AI-specific criteria (like sample sizes for test/training sets for AI, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) is not applicable.
Here's an analysis of the provided text based on your request, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantified, measurable table format typical for a vision-based AI device. Instead, it discusses the device's conformance to a standard and clinical trial outcomes that demonstrate safety and effectiveness.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Engineering Performance: Conformance to ASTM F 623-99 Standard | The device conforms to all applicable elements of the ASTM Foley catheter standard. |
| Engineering Performance: Proper valve function | Demonstrates proper performance in all valve-related testing. |
| Clinical Performance: No significant difference in significant bacteriuria incidence compared to standard Foley catheter | There was no significant difference between groups (OPTION-vf vs. standard Foley) with respect to the incidence of significant bacteriuria following catheter removal. |
| Clinical Performance: Comparable mean residual bladder volume | The mean residual bladder volume at the time of catheter removal was comparable between groups. |
| Clinical Performance: Adverse event rates comparable to standard Foley catheter | Adverse event rates were similar between the groups. Adverse events associated with the Opticon catheter were of mild severity and resolved quickly with appropriate patient counseling or catheter removal. |
| Clinical Performance: Effective urinary bladder drainage | In all instances, the OPTION-vf functioned to provide drainage of the urinary bladder and the device performance was as expected. |
| Patient Benefits/Satisfaction: Improved mobility, reduced pain/discomfort, reduced self-consciousness, less sleep disruption, improved ability to shower/dress | Patient questionnaire revealed significant benefits of the Opticon catheter compared to the Foley catheter in these areas due to the elimination of bulky collection bags/tubing, mimicry of normal voiding, and patient control over drainage. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "In a multi-center randomized clinical trial, female patients requiring short-term urinary catheterization were treated with either a standard Foley indwelling catheter or the experimental Opticon-vf™ catheter." It does not specify the exact number of female patients included in this clinical trial.
- Data Provenance: The study was a "multi-center randomized clinical trial." The country of origin is not explicitly stated, but the submission is to the FDA (USA), implying that at least one of the centers could be in the USA. The data is prospective, gathered during a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable for this device. For a traditional medical device like a catheter, "ground truth" is typically established through physiological measurements (e.g., bacteriuria culture results, residual bladder volume measurements) and reported clinical observations by healthcare professionals during the trial, rather than expert consensus on image interpretation or diagnostic judgments.
4. Adjudication Method for the Test Set
This is not applicable as there's no mention of an adjudication process for diagnostic or interpretative outcomes. Clinical trial outcomes are typically assessed based on pre-defined endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. MRMC studies are typically for diagnostic imaging devices where multiple readers evaluate the same cases. This is a functional medical device (urinary catheter). The clinical trial compared the OPTION-vf to a standard Foley catheter in a patient population, not comparing human readers' performance with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the OPTION-vf is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the clinical trial was based on:
- Clinical Measurements: Incidence of significant bacteriuria (likely via urine culture), mean residual bladder volume (likely via ultrasound or post-void catheterization).
- Adverse Event Reporting: Documented by healthcare professionals.
- Patient Reported Outcomes: Data from patient questionnaires regarding aspects like mobility, pain/discomfort, self-consciousness, sleep disruption, and ability to shower/dress.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI device requiring a training set. Engineering tests and clinical trials were performed.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI algorithm.
§ 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.