(103 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical valve for a catheter and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device aids in emptying the urinary bladder, which is a functional purpose, not directly therapeutic in the sense of treating or curing a disease or condition. It manages a symptom or function rather than providing therapy.
No
The device is used to aid in emptying the urinary bladder, not to diagnose a condition.
No
The 510(k) summary describes an "External Catheter Valve," which is a physical device, not software.
Based on the provided information, the Wijay EZ-Void™ External Catheter Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "External Catheter Valve" used to "aid in emptying the urinary bladder" for patients with indwelling catheters. This is a mechanical device that interacts with the body externally to manage urine flow, not a test performed on a sample.
- Lack of IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or substances in samples.
- Providing diagnostic information based on sample analysis.
Therefore, the Wijay EZ-Void™ External Catheter Valve is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
KNY
Device Description
Not Found
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
adult patients
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
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.
1
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 (800) 638-2041 or (301) 796-7100 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
2
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 (832) 818 0889
INDICATIONS FOR USE IV.
Applicant:
LeoMed, LLC. 9001 Airport Blvd., Suite 503 Houston, TX 77061 Phone: (832) 818-0889
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.
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)