(51 days)
Not Found
No
The device description and performance studies focus on the physical components, materials, and sterilization of a urinary catheter kit, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as being used to drain urine from a patient's bladder, which is a medical intervention intended to maintain or restore health, classifying it as a therapeutic device.
No
The device is described as a "urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag," which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical medical device (catheter, collection bag, introducer sheath) and its materials and manufacturing process. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "drain urine from the patient's bladder into a collection bag." This is a physical intervention for managing urine drainage, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device (catheter, collection bag, introducer sheath) designed for the mechanical process of urine drainage. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (like urine itself for diagnostic markers).
- Providing information for diagnosis, monitoring, or screening.
- Reagents, calibrators, or controls.
- Laboratory testing or analysis.
The device is clearly a medical device used for a therapeutic or management purpose (draining urine), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.
Product codes
KOD
Device Description
The United Urologics Closed System Catheter is a pre-lubricated sterile, single use, disposable, urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter is provided with a funnel bonded to the end of the catheter tube opposite the tipped end. The catheter is prelubricated with a water soluble lubricant and sealed in a urine collection bag. It is designed with a molded silicone tip at the top of the bag which acts as an introducer sheath for the tip of the catheter. This introducer and holding mechanism on the inside of the bag, provide a mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facility to facilitate drainage of urine from the bladder.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functionality: There are no FDA recognized performance standards for urethral catheters under product code KOD that are not Foley catheters. The following International standards were utilized in designing and testing the United Urologics Intermittent Catheters: BS EN 1616:1997 (plus A1:1999)- Sterile urethral catheters for single use BS EN 1618:1997 – Catheters other than intravascular catheters – test methods for common properties.
Biocompatibility: The United Urologics Closed System Catheter is characterized as a mucosal membrane contacting for a period of less than 24 hours. Therefore, the fully assembled, sterile device was tested required by Annex A of ISO 10993-1:2003, Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process. Testing for cytotoxicity, sensitization and irritation was completed.
Sterilization: The United Urologics Closed System Catheter is an Ethylene oxide sterilized device. Sterilization validation complies with ANSI/AAMI/ISO 11135-1: 2007 - Sterilization of heath care products -- Ethylene oxide -- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Robling Medical, Inc. Diane Peper Director of Quality and Regulatory Affairs 90 Weathers Street Youngsville, NC 27596
Re: K160877 Trade/Device Name: United Urologics Closed System Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: KOD Dated: May 4, 2016 Received: Mav 5. 2016
Dear Diane Peper,
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Herbert P. Lerner -S
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
Indications for Use
510(k) Number (if known)
Device Name United Urologics Closed System Catheter
Indications for Use (Describe)
United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K160877 United Urologics Closed System Catheter
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| 1.0 SUBMITTER: | Robling Medical, Inc.
90 Weathers Street
Youngsville NC 27596
Telephone: 919-570-9605
Fax: 919-570-9611
Contact: Diane N. Peper, Director RA/QA
Date Prepared: March 31, 2016 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.0 DEVICE NAME: | Trade Name: United Urologics Closed System Catheter |
| | Common Name: Urological Catheter |
| | Classification: Class II, 21 CFR Part 876.5130, Product Code KOD |
| 3.0 PREDICATE DEVICE: | Hollister Inc.
Apogee Closed System Intermittent Catheterization Kit (K032710)
Classification: Class II, 21 CFR Part 876.5130, Product Code KOD |
4.0 DEVICE DESCRIPTION
The United Urologics Closed System Catheter is a pre-lubricated sterile, single use, disposable, urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter is provided with a funnel bonded to the end of the catheter tube opposite the tipped end. The catheter is prelubricated with a water soluble lubricant and sealed in a urine collection bag. It is designed with a molded silicone tip at the top of the bag which acts as an introducer sheath for the tip of the catheter. This introducer and holding mechanism on the inside of the bag, provide a mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter.
The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facility to facilitate drainage of urine from the bladder.
INDICATIONS FOR USE 5.0
The United Urologics Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.
TECHNOLOGICAL CHARACTERISTICS 6.0
Both the subject device and the predicate device are pre-lubricated, sterile, single use, disposable catheterization systems and have been designed and tested in accordance with BS
4
EN 1616:1997 (plus A1:1999)- Sterile urethral catheters for single use and BS EN 1618:1997 – Catheters other than intravascular catheters – test methods for common properties.
Both the subject device and the predicate device use the same materials and processes to manufacture, package and sterilize the product.
Both the subject device and the predicate device have the same technological characteristics.
- · Both latex free catheters use Polyvinylchloride tubing for the catheter shaft.
- · For the Non-PVC catheters, both use natural rubber latex
- · Both catheters have smooth, atraumatic closed tips
- · Both have drainage holes in the side to allow for urine drainage
- · The PVC catheters have polyvinylchloride funnels/connectors bonded on the end of the catheter
- · The Non-PVC catheters have a flared end
- · Both devices contain a silicone introducer tip that acts as a sheath over the tip of the catheter as it is introduced into the urethra.
- Both devices are pre-lubricated with a water-soluble lubricant
- · Both devices are sealed in a sterile urine collection bag
- · Both devices have a holding mechanism built inside the bag which facilitates advancement of the catheter during insertion.
- · Both are provided sterile
PERFORMANCE CHARACTERISTICS 7.0
Functionality
There are no FDA recognized performance standards for urethral catheters under product code KOD that are not Foley catheters.
The following International standards were utilized in designing and testing the United Urologics Intermittent Catheters:
BS EN 1616:1997 (plus A1:1999)- Sterile urethral catheters for single use BS EN 1618:1997 – Catheters other than intravascular catheters – test methods for common properties.
Biocompatibility
The United Urologics Closed System Catheter is characterized as a mucosal membrane contacting for a period of less than 24 hours. Therefore, the fully assembled, sterile device was tested required by Annex A of ISO 10993-1:2003, Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process. Testing for cytotoxicity, sensitization and irritation was completed.
Sterilization
The United Urologics Closed System Catheter is an Ethylene oxide sterilized device. Sterilization validation complies with ANSI/AAMI/ISO 11135-1: 2007 - Sterilization of heath care products -- Ethylene oxide -- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.