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.

Device Description

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.

AI/ML Overview

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.

Summary

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K023C090
Page 1 of 3

510(k) SUMMARY

OPTICON MEDICAL, INC.

OPTION-vf™ Urinary Catheter

Submitter's Name and Contact Information

Opticon Medical, Inc. 7001 Post Road, Suite 100 Dublin, OH 43016

Primary Contact: Glenn D. Brunner, President Phone Number: (614) 366-2000 Fax Number: (614) 336-2059

Date Prepared: September 13, 2002

Device Name

Trade / Proprietary Name: OPTION-vfTM Urinary Catheter Common / Usual Name: urinary catheter or Foley catheter Classification Name: catheter, retention type, balloon (product code EZL; 21 CFR 876.5130)

Predicate Devices

K961697, Medical Device International, Inc. Opticon Female Urinary Catheter for Continuous Drainage ("Opticon Direct").
K760093, C.R. Bard, Inc. Bardex® Silicone Foley Catheter ("Bardex"). ●

Intended Use

The OPTION-vf is intended to provide drainage of the urinary bladder.

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Technological Characteristics and Substantial Equivalence

Device Description:

Substantial Equivalence Comparison:

The OPTION-vf and the predicate devices are all indwelling urinary catheters, which are used in the same anatomic location for the same purpose. The OPTION-vf is similar in design, materials of construction, physical dimensions, methods of insertion, maintenance, and removal, etc. to the predicate catheters. It also follows equivalent principles of operation, with the exception that the predicate catheters continuously drain into a urine collection bag, whereas the OPTION-yf has an integral valve that allows the user to control bladder drainage.

The OPTION-vf is substantially equivalent to the other legally marketed catheters referenced above. The OPTION-yf and the predicate devices are all indwelling urinary catheters used to drain the urinary bladder, thus the OPTION-vf raises no new issues of safety or effectiveness.

Device Performance

The company has completed both the engineering testing typically required for clearance of a standard Foley catheter, and sufficient laboratory and clinical performance testing to demonstrate the comparative safety and effectiveness of the OPTION-vf.

Engineering Testing:

Engineering verification testing confirms that results obtained from bench testing according to the recognized Foley standard; ASTM F 623-99, Standard Performance Specification for Foley Catheter, as well as additional verification testing demonstrate conformance of the OPTION-vf device with clinical and design requirements. The device conforms to all

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KU23090
page 3 of 3

applicable elements of the ASTM Foley catheter standard, and demonstrates proper performance in all valve-related testing.

Clinical Testing:

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.

There was no significant difference between groups with respect to the incidence of significant bacteriuria following catheter removal. The mean residual bladder volume at the time of catheter removal was also comparable between groups.

A review of adverse events by treatment group showed that adverse event rates were similar between the groups. In general, adverse events associated with the Opticon catheter were of mild severity and were resolved quickly either with appropriate patient counseling or catheter removal.

Results from the patient questionnaire revealed significant benefits of the Opticon catheter as compared to the Foley catheter with respect to mobility, pain/discomfort, self-consciousness, sleep disruption, and ability to shower or get dressed. These benefits follow directly from the design of the Opticon catheter in which bulky urine collection bags and connecting tubes are eliminated, as is the need to periodically empty the urine collection bag. Moreover, patients are able to maintain a more normal urinary function, with normal bladder cycling as compared to a continuously contracted bladder with constant drainage, and with the ability to discretely drain the bladder when desired.

In all instances, the OPTION-vf functioned to provide drainage of the urinary bladder and the device performance was as expected.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2003

Mr. Glenn D. Brunner President Opticon Medical, Inc. 7001 Post Road Suite 100 DUBLIN OH 43016

Re: K023090

Trade/Device Name: OPTION-vf™ Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: December 23, 2002 Received: December 24, 2002

Dear Mr. Brunner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indication for Use

510(k) Number:	K023090
Device Name:	OPTION-vf TM Urinary Catheter
Indication for use:	The OPTION-vf 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.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use
------------------	---------------------------------------------	----------------------

(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K023090
---------------	---------

Regulation Number and Section

§ 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.