OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000

K033830 · Opticon Medical, Inc. · EZL · Jan 9, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033830
• Device Name: OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
• Applicant: Opticon Medical, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jan 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Indwelling urinary catheter for female bladder drainage; sterile, single-use, disposable. Composed of silicone elastomers; features flexible shaft with two proximal eyelets, internal drainage lumen, balloon inflation lumen, retention balloon, adjustable retainer ring, self-sealing balloon inflation microvalve, and urine discharge bulb with integral valve. Operated by healthcare professional for insertion/removal; patient operates discharge bulb for intermittent drainage. Optional Continuous Drainage Adaptor accessory holds discharge valve open for continuous drainage. Device facilitates bladder management; enables patient-controlled drainage or continuous drainage when used with adaptor.

Clinical Evidence

No clinical data. Substantial equivalence supported by risk analysis and bench verification testing.

Technological Characteristics

Materials: Biocompatible silicone elastomers. Design: Indwelling catheter with retention balloon, dual-lumen shaft, and integrated discharge bulb with valve. Connectivity: Mechanical accessory (Continuous Drainage Adaptor). Sterilization: Sterile, single-use.

Indications for Use

Indicated for female patients requiring short-term (≤14 days) urinary bladder drainage for acute conditions, who are capable of self-operating the device and for whom normal bladder cycling is not contraindicated.

Regulatory Classification

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).

Predicate Devices

• OPTION-vf™ Urinary Catheter (K023090)
• Bardex® Silicone Foley Catheter (K760093)
• BARD® Adaptor and Tubing

Submission Summary (Full Text)

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K033830 PG- / or 2.

#### 510(k) SUMMARY

#### OPTICON MEDICAL

#### OPTION-vftM Urinary Catheter with Adaptor

#### Submitter's Name and Contact Information

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

Primary Contact: Glenn D. Brunner, President Phone Number: [phone] Fax Number: [phone]

Date Prepared: December 08, 2002

#### Device Name

Trade / Proprietary Name: OPTION-vf™ 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 .
- K760093, Bardex® Silicone Foley Catheter .
- · BARD® Adaptor and Tubing

#### Intended Use

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.

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## Device Description

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.

## Comparison to Predicate Device

The OPTION-vf catheter incorporates a normally closed discharge valve housed within the discharge bulb (see Figure 1 of the IFU). When used without the Continuous Drainage Adaptor as previously cleared (OPTION-yf™ Urinary catheter), urine drainage occurs upon manual actuation of the discharge bulb, thus opening the valve. When the OPTION-yf catheter is used in conjunction with the Continuous Drainage Adaptor accessory according to the Instructions for Use, the adaptor simply holds the valve open for continuous drainage, making the catheter substantially equivalent to typical continuous drainage Foley catheters including its original predicate device (C.R. Bard, Inc. Bardex® Silicone Foley Catheter).

### Supporting Information

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. Thus, the OPTION-yf and Continuous Drainage Adaptor do not raise any new questions of safety or efficacy.

# Conclusion

The OPTION-vf urinary catheter with adaptor is substantially equivalent to the predicate devices.

PG- 2 UF 2

Kos3830

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing the department's mission to promote health, well-being, and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2004

Opticon Medical c/o Gerard J. Prud'homme, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. WASHINGTON DC 20004

Re: K033830

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 Regulation Number: 21 CFR §876.5250 Regulation Name: Urine collector and accessories Regulatory Class: Class II Exempt Product Code: 78 KNX Datod: December 9, 2003 Received: December 10, 2003

Dear Mr. Prud'homme:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becerement the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosury to regally the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, ac secordance with the provisions of the Federal Food. Drug, devices that have boon roomsticul require approval of a premarket approval application (PMA). and Cosmetic Act (710c) that do novice, subject to the general controls provisions of the Act. The I ou may, uteretore, mance and act include requirements for annual registration, listing of general Controls provisions of the tice, 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 your device is classified (500 above) and controls. Existing major regulations affecting your TRA increase It may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of reactir resgueerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 losumos over device complies with other requirements of the Act that I DA has made a dolorimistered by other Federal agencies. You must of any Federal statutes and regulations including, but not limited to: registration and listing comply with an the Fee I requirement 801); good manufacturing practice requirements as set (21 CFR Fall 807), laocimig (21 OF R Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if any 1980-1960 10thi in the quality 355toms (QD) rog (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA miding or substantial Province 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 If you desire specific advice for your device on our last ling of your bers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note them of their seconsel Office of Compliance at [phone]. Fabs, production of Piction of Since by reference to prematical notification (21 Of 11 amay be obtained from the Division of Small information on your responsionities under the researce at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-democracy ht Manufacturers, International and Octoberter of School.cdrh/dsma/dsmamain.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

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# Indications for Use

510(k) Number (if known): K 033830

Device Name: OPTION-vfM Urinary Catheter with Adaptor

Indications 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tand B. Sagn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number,

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