(117 days)
No
The device description and intended use describe a standard indwelling urinary catheter with mechanical components, and there is no mention of AI or ML in the provided text.
No.
The device is used for drainage, which is a supportive function rather than a direct therapeutic intervention.
No.
The device is described as an indwelling catheter intended to provide drainage of the urinary bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an indwelling catheter made of silicone elastomers with physical components like a flexible shaft, eyelets, lumens, a balloon, a microvalve port, and a urine discharge bulb. This is a hardware device.
Based on the provided information, the OPTION-vm is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to provide drainage of the urinary bladder." This is a therapeutic or management function, not a diagnostic one.
- Device Description: The device is described as an "indwelling catheter" for draining urine. This is a physical device used for a physiological process.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like urine) to provide information about a patient's health status, disease, or condition. IVD devices are specifically designed for testing samples taken from the human body.
The OPTION-vm is a medical device used for managing a physical condition (urinary retention), not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The OPTION-vm is intended to provide drainage of the urinary bladder.
The OPTION-vm is indicated for use only for urinary bladder drainage in male 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.
Product codes
EZL
Device Description
The OPTION-vm 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; 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribed by a physician and inserted and removed by an appropriate health care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Verification test results reported in this 510(k) application substantiate equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 1 7 2004
K04/1983
page 1 of 2
510(k) SUMMARY
OPTICON MEDICAL
OPTION-vm™ Urinary Catheter
Submitter Information
Opticon Medical 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: July 21, 2004
Device Name
Trade / Proprietary Name: OPTION-vm™ Urinary Catheter
OPTION-vm™ Urinary Catheter with Adaptor
Common / Usual Name: urinary catheter or Foley catheter
Classification Name: Catheter, Retention type, Balloon (product code EZL; 21 CFR 876.5130)
Predicate Device
- K023090, OPTION-vf" Urinary Catheter .
- K033830, OPTION-vf" Urinary Catheter with Adaptor .
- K760093, Bardex® Silicone Foley Catheter .
Intended Use
The OPTION-vm is intended to provide drainage of the urinary bladder.
The OPTION-vm is indicated for use only for urinary bladder drainage in male 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.
1
Page 2 of 2
Device Description
The OPTION-vm 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; 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.
Comparison to Predicate Devices
The OPTION-vm and the predicate devices are all indwelling urinary catheters, which are used in the same anatomic location for the same purpose. The OPTION-vm 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 as the OPTION-vf; it uses the exact same components to form the identical integral valve assembly that allows the user to control bladder drainage, thus it can be initially used with the same Continuous Drainage Adaptor to provide continuous passive drainage of the urinary bladder into a standard urine drainage bag.
Supporting Information
Verification test results reported in this 510(k) application substantiate equivalence to the predicate devices. Thus, the OPTION-vm does not raise any new questions of safety or efficacy.
Conclusion
The OPTION-vm Urinary Catheter is substantially equivalent to the predicate devices.
9-003
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2004
Mr. Glenn D. Brunner President Opticon Medical 7001 Post Road, Suite 100 DUBLIN OH 43016
Re: K041983
Trade/Device Name: OPTION-vm™ Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: October 6, 2004 Received: October 7, 2004
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 do ice, 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 (Premarket Approval), it may be subject to such 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.
3
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/dsmaldsmamain.html
Sincerely yours,
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
4
510(k) Number (if known): K041983
Device Name: OPTION-vm™ Urinary Catheter
The OPTION-vm is indicated for use only for urinary bladder drainage in male Indications for Use: 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 DONOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Daniel h. Syprom
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
4-002
(Optional Format 1-2-96)