(30 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-yf is an indwelling catheter that provides 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 catheter may be used with the Continuous Drainage Adaptor accessory to provide continuous urinary drainage.
The provided text describes the OPTION-vf™ Urinary Catheter with Adaptor and its 510(k) summary for clearance. However, it does not contain the detailed acceptance criteria, the study design, or the specific performance metrics typically associated with proving a device meets acceptance criteria in the way a diagnostic AI/ML device would.
The document primarily focuses on establishing substantial equivalence to predicate devices based on device description, intended use, and materials. The "Supporting Information" section briefly mentions "verification test results" but does not elaborate on what these tests were, their acceptance criteria, or the results.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be generated. The document does not specify quantitative acceptance criteria or reported performance metrics for the device. It states, "A risk analysis for the OPTION-yf with adaptor and the verification test results reported in this 510(k) application substantiate equivalence to the predicate devices." This is a general statement, not a detailed report of criteria and results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The text does not describe a clinical study in the typical sense with a "test set" of patients or data for performance evaluation. The "verification test results" mentioned are likely engineering or bench tests, not clinical performance studies with patient data.
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 / Not provided. No "test set" and thus no ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No "test set" is described.
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 / Not provided. This device is a urinary catheter, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth for clinical performance is mentioned. The "equivalence" is based on device design, materials, and intended use compared to predicates.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, there is no ground truth for it.
Summary based on the provided text:
The document describes the OPTION-vf™ Urinary Catheter with Adaptor and its submission for 510(k) clearance by Opticon Medical. The primary method for proving the device meets regulatory requirements is through substantial equivalence to existing predicate devices (K023090 OPTION-vf™ Urinary Catheter, K760093 Bardex® Silicone Foley Catheter, and BARD® Adaptor and Tubing).
The claim of substantial equivalence is supported by:
- Device Description: The OPTION-vf™ is an indwelling, sterile, single-use, disposable silicone catheter with a flexible shaft, eyelets, lumens, a retention balloon, an adjustable retainer ring, a self-sealing balloon inflation microvalve port, and a urine discharge bulb with an integral valve. The adaptor allows for continuous drainage by holding the valve open.
- Intended Use: Drainage of the urinary bladder in female patients for acute, short-term (≤14 days) conditions, who can operate the device, and for whom normal bladder cycling is not contraindicated.
- Comparison to Predicate Device: The OPTION-vf™ with the adaptor functions similarly to typical continuous drainage Foley catheters (like the Bardex® Silicone Foley Catheter) by providing continuous drainage when the adaptor holds the discharge valve open.
- Supporting Information: A risk analysis and "verification test results" are stated to "substantiate equivalence." However, the details of these tests, their specific acceptance criteria, and the reported results are not provided in this summary.
Conclusion stated: The OPTION-vf™ urinary catheter with adaptor is substantially equivalent to the predicate devices and does not raise any new questions of safety or efficacy.
§ 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.