WIJAY EZ-VOID EXTERNAL CATHETER VALVE

K140562 · Leomed, LLC · KNY · Jun 16, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140562
• Device Name: WIJAY EZ-VOID EXTERNAL CATHETER VALVE
• Applicant: Leomed, LLC
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Wijay EZ-Void™ External Catheter Valve is indicated for use, to aid in emptying the urinary bladder, for short-term (7 days or less) in adult patients with indwelling urethral or Suprapubic catheters and (1) who are capable of operating the device in accordance with its instructions for use, and (2) for whom normal bladder cycling is not contraindicated.

Device Story

Wijay EZ-Void External Catheter Valve is a manual flow-control device for indwelling urinary catheters. It allows patients to manage bladder emptying by manually opening/closing the valve, facilitating normal bladder cycling. Used by adult patients in home or clinical settings. Device attaches to the distal end of a catheter; patient operates the valve mechanism to initiate or stop urine flow. Benefits include improved patient autonomy and maintenance of bladder tone by allowing periodic emptying rather than continuous drainage. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual external catheter valve for flow control. Designed for short-term use (7 days or less). Mechanical operation; no energy source or software components.

Indications for Use

Indicated for adult patients with indwelling urethral or suprapubic catheters requiring bladder emptying assistance. Contraindicated for patients where normal bladder cycling is not advised or who cannot operate the device per instructions.

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).

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2014

LeoMed, LLC Dr. Bandula Wijay President 9001 Airport Boulevard, Suite 503 Houston, TX 77061

Re: K140562

Trade/Device Name: Wijay EZ-Void External Catheter Valve Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: April 23, 2014 Received: May 05, 2014

Dear Dr. Bandula Wijay,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Dr. Bandula Wijay

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

:、

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a signature or a nameplate.

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for LeoMed, LLC. The logo consists of two parts: a square with a black triangle in the upper left corner and the letters 'lm' in white in the lower right corner, and the text 'LeoMed, LLC' above the text 'Innovations in Medicine'. The text is in black and is to the right of the square.

9001 Airport Blvd, Suite 503 Houston, Texas 77061 [phone]

## INDICATIONS FOR USE IV.

Applicant:

LeoMed, LLC. 9001 Airport Blvd., Suite 503 Houston, TX 77061 Phone: [phone]

510(k) Number (if Known): K 140562

Device Name:

Wijay EZ-Void™ External Catheter Valve

Indications for Use:

The Wijay EZ-Void™ External Catheter Valve is indicated for use, to aid in emptying the urinary bladder, for short-term (7 days or less) in adult patients with indwelling urethral or Suprapubic catheters and (1) who are capable of operating the device in accordance with its instructions for use, and (2) for whom normal bladder cycling is not contraindicated.

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Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert P. Lerner -S 2014.06.16 12:39:50 -04'00'