(266 days)
No
The device description and performance studies focus on the physical properties and functionality of a traditional catheter, with no mention of AI/ML capabilities or data processing.
Yes
The device is intended for bladder management, including urine drainage, collection, measurement, and bladder fluid instillation or irrigation, which are primarily therapeutic functions aimed at managing a patient's medical condition.
No
This device is a catheter intended for bladder management, including urine drainage, collection, measurement, and fluid instillation or irrigation. It is not described as providing diagnostic information or assisting in the identification of a disease or condition.
No
The device description clearly outlines physical components such as a silicone tube, balloon, valve, and guidewire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bladder management including urine drainage, collection and measurement and / or bladder fluid instillation or irrigation." This describes a device used in vivo (within the body) for therapeutic and management purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical catheter designed to be inserted into the urethra and bladder. It describes lumens for drainage, balloon inflation, and a guidewire for insertion. This is consistent with a medical device used for direct patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample analysis, or any other components or processes typically associated with in vitro diagnostics.
In summary, the Urethrotech Urethral Catheterization Device is a medical device used for managing the urinary system, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Urethrotech Urethral Catheterization Device is intended for use for bladder management including urine drainage, collection and measurement and / or bladder fluid instillation or irrigation.
Product codes
EZL
Device Description
The Urethrotech UCD® (Urethral Catheterization Device) 3-way Silicone Foley Balloon Catheter is composed of a silicone tube with an embedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve and an integrated introducer guidewire. The tube has three lumen for urinary drainage which is to be connected to a urine collection container, one lumen with two-way valve for inflation/deflation of a Foley balloon and one lumen for the integrated removable guidewire made of Nitinol with hydrophilic coating for the introduction of the catheter through the urethra into the bladder to negotiate any prostatic curve or tight external urethral sphincter, and also for irrigation of the bladder after guidewire removal. The UCD® is intended to be used to provide safe urinary tract access through the urethra and into the bladder and to pass fluids to and from the urinary bladder and to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. The device is provided sterile and is intended for short-term use (
§ 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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October 4, 2019
Urethrotech Ltd. % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave. Crofton, MD 21114
Re: K190060
Trade/Device Name: Urethrotech UCD® Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: August 27, 2019 Received: August 28, 2019
Dear Yolanda Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Angel A. Soler-García, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Urethrotech UCD
Indications for Use (Describe)
The Urethrotech Urethral Catheterization Device is intended for use for bladder management including urine drainage, collection and measurement and / or bladder fluid instillation or irrigation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
SPONSOR
| Company Name: | Urethrotech |
|---|---|
| Company Address: | 24 Garth Road |
| Kingston upon Thames | |
| Surrey KT2 5NY United Kingdom | |
| Telephone: | +447730886705 |
| Contact Person: | Daniela Andrich Summary |
| Preparation Date: | October 4, 2019 |
DEVICE INFORMATION
| Trade Name: | Urethrotech UCD |
|---|---|
| Common/Usual Name: | Urologic catheter |
| Classification Name: | Urological catheters & accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZL |
| Device Class: | II |
| Reviewing Panel: | Gastroenterology/Urology |
PREDICATE DEVICE
All Silicone 3-way Foley Balloon Catheter (K980919)
REFERENCE DEVICE
3-Way Silicone Balloon Catheter (K091767)
DEVICE DESCRIPTION
The Urethrotech UCD® (Urethral Catheterization Device) 3-way Silicone Foley Balloon Catheter is composed of a silicone tube with an embedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve and an integrated introducer guidewire. The tube has three lumen for urinary drainage which is to be connected to a urine collection container, one lumen with two-way valve for inflation/deflation of a Foley balloon and one lumen for the integrated removable guidewire made of Nitinol with hydrophilic coating for the introduction of the catheter through the urethra into the bladder to negotiate any prostatic curve or tight external urethral sphincter, and also for irrigation of the bladder after guidewire removal. The UCD® is intended to be used to provide safe urinary tract access through the urethra and into the bladder and to pass fluids to and from the urinary bladder and to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. The device is provided sterile and is intended for short-term use (