Urethrotech UCD

K190060 · Urethrotech · EZL · Oct 4, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190060
• Device Name: Urethrotech UCD
• Applicant: Urethrotech
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Oct 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Urethrotech UCD is a 3-way silicone Foley balloon catheter featuring an integrated, removable Nitinol guidewire with a hydrophilic coating. The device is used in hospitals and sub-acute settings by clinicians to provide urinary tract access, negotiate prostatic curves or tight urethral sphincters, and facilitate bladder irrigation and urine drainage. The guidewire, which protrudes 50cm from the catheter tip, is inserted into the bladder first to guide the catheter safely into position. A female Luer lock at the proximal end of the guidewire allows for lubrication and prevents the wire from advancing too far or dislodging. Once the catheter is positioned, the guidewire is removed. The device benefits patients by providing a safer, guided method for urethral catheterization, reducing the risk of trauma during insertion. Output is the physical drainage of urine or the delivery of irrigation fluids, which the clinician monitors to manage bladder health.

Clinical Evidence

No clinical data. Bench testing only, including flow rate, balloon integrity, pullout response, volume maintenance, and deflation reliability per ASTM F623-19. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, systemic toxicity, sensitization, irritation, pyrogenicity).

Technological Characteristics

Silicone tube with embedded radiopaque stripe, silicone balloon, PVC check valves, ABS sleeve, and Nitinol guidewire with hydrophilic coating (PE/PVP). Dimensions: 16 French, 42cm length. Connectivity: None. Sterilization: Sterile. Standards: ASTM F623-19 (Foley catheter performance), ISO 10993-1 (biocompatibility), ISO 11070 (guidewires), ASTM F1980 (accelerated aging).

Indications for Use

Indicated for adult patients requiring bladder management, including urine drainage, collection, measurement, and bladder fluid instillation or irrigation.

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

• All Silicone 3-way Foley Balloon Catheter (K980919)

Reference Devices

• 3-Way Silicone Balloon Catheter (K091767)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.

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 ([e-mail]) or phone [phone] 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)

K190060

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<br>Kingston upon Thames<br>Surrey KT2 5NY United Kingdom |
| Telephone: | [phone] |
| 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 (<=30 days).

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The guidewire has a Female Luer Lock bonded to the proximal end using Medical Grade Cyanoacrylate adhesive. The Female Luer lock facilitates lubrication of the guidewire using a syringe filled with sterile water or saline and also prevents the guidewire from being advanced too far or from falling out of the catheter, as the female luer lock fits snugly into the end of the irrigation channel of the catheter which is also used as the guidewire channel.

The guidewire protrudes from the tip of the catheter by 50cm and is inserted into the bladder first, automatically feeding the urethral catheter behind so that the urethral catheter is guided safely into the bladder.

# DEVICE 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.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

| Features | Subject Device | Primary<br>Predicate Device | Similarities and<br>Differences |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Sponsor | Urethrotech Ltd | Fortune Medical<br>Instrument Corp. | |
| Brand Name | Urethrotech UCD | All Silicone 2-Way Foley<br>Balloon Catheter<br>All Silicone 3-Way Foley<br>Balloon Catheter<br>All Silicone Nelaton<br>Catheter | |
| K number | N/A | K980919 | |
| Classification<br>Name | Catheter, Retention Type,<br>Balloon | Catheter, Retention Type,<br>Balloon | |
| Product Code | EZL | EZL | |
| Regulation<br>Number | 876.5130 | 876.5130 | |
| Class | II | II | |
| Indications for Use | The Urethrotech UCD® is<br>intended for use for bladder<br>management including urine<br>drainage, collection and<br>measurement and/or bladder<br>fluid instillation | The Silicone Foley Balloon<br>Catheter and Nelaton<br>Catheter are intended for<br>use as urinary catheters to<br>pass fluids to and from the<br>urinary bladder | Same |
| Patient Population | ADULT | ADULT | Same |
| Use Environment | Hospitals, sub-acute settings | Hospitals, sub-acute<br>settings | |
| Features | Subject Device | Primary<br>Predicate Device | Similarities and<br>Differences |
| Principle of<br>Operation | Bladder management is<br>achieved by the manual<br>introduction of a silicone tube<br>to provide a means for urine<br>drainage, collection, and<br>measurement.<br>The main principle of operation<br>and mechanism to achieve the<br>intended effect is the purpose-<br>built integration of a non-<br>traumatic introducer guidewire<br>into the urethral catheter<br>design. | Bladder management is<br>achieved by the manual<br>introduction of a silicone<br>tube to provide a means<br>for urine drainage,<br>collection, and<br>measurement. | Same |
| Description | 3 way Silicone Foley Balloon<br>catheter | 3 way Silicone Foley<br>Balloon catheter | Same |
| Device Design | | | |
| Main lumen | Urine drainage | Urine drainage | Same |
| Second lumen | Inflation and deflation of<br>balloon | Inflation and deflation of<br>balloon | Same |
| Third lumen –<br>open end | Guidewire/irrigation | irrigation | Same |
| Open tip | Guidewire is integrated | No integrated guidewire | Different |
| Balloon | Yes | Yes | Same |
| Tip shape | Rounded | Rounded | Same |
| French Size range | 16 | 14. 16. 18. 20. 22. 24.<br>26 | Similar |
| Device Specifications | | | |
| Working Length | 42cm +- 10mm | 40 cm | Different |
| Balloon cuff | 4.9 x 5.3 x 365 | 4.9 x 5.3 x 365 | Same |
| Balloon Inflation<br>volume mL | 5-10 mL | 5-10 mL | Same |
| Check valves | 9.2 x 25.1 | 9.2 x 25.1 | Same |
| Guidewire | 0.35" | N/A | Different |
| Guidewire - length | 90 cm | N/A | Different |
| Device Material Specifications | | | |
| Tubing | silicone | silicone | Same |
| Balloon Cuff | silicone | silicone | Same |
| Check valves | Polyvinylchloride | Polyvinylchloride | Same |
| Sleeve | ABS | ABS | Same |
| Female Luer Lock | Terlux HD 2802 | N/A | Different |
| Guidewire | Nitinol hydrophilic / PE/ PVP | N/A | Predicate does<br>not offer a<br>guidewire with<br>the device |
| Features | Subject Device | Primary<br>Predicate Device | Similarities and<br>Differences |
| Sterile | Yes | Yes | Same |
| Indwell Time | Maximum indwell time of 30 days | Maximum indwell time of 30 days | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | According to ISO 10993-1 | According to ISO 10993-1 | Same |

## COMPARISON OF TECHNICAL CHARACTERISTICS

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# PERFORMANCE TESTING

The following performance data were provided in support of the substantial equivalence determination. The tests were conducted on devices subjected to an accelerated aging process equivalent to 5 years shelf-life.

Safety testing

| Standard | Test Description | Test Article | Acceptance Criteria | Results |
|-------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| ASTM F 623-19, Section 4.1<br>Standard Performance<br>Specification for Foley<br>Catheter | Flow Rate through<br>Drainage Lumen | 16 French<br>Silicone 3-way<br>Foley catheter<br>with<br>integrated<br>guide wire | Label French size catheters 14<br>through 24 inclusive shall have a<br>minimum average flow rate of<br>100 cm3/min, and a label French<br>size 12 catheter shall have a<br>flow rate of 70 cm3/min. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.2<br>Standard Performance<br>Specification for Foley<br>Catheter | Balloon Integrity | 16 French<br>Silicone 3-way<br>Foley catheter<br>with<br>integrated<br>guide wire | The inflation balloon must be<br>inflated easily with distilled or<br>deionized water to labeled volume<br>without showing any evidence<br>of breakage throughout the<br>test period. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.3<br>Standard Performance<br>Specification for Foley<br>Catheter | Inflated Balloon<br>Response to<br>Pullout | 16 French<br>Silicone 3-way<br>Foley catheter<br>with<br>integrated<br>guide wire | The entire balloon of catheters<br>label French size 14 through 26<br>shall not pass into or through<br>the funnel barrel. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.4<br>Standard Performance<br>Specification for Foley | Balloon Volume<br>Maintenance | 16 French<br>Silicone 3-way<br>Foley catheter<br>with | Catheter maintains its volume<br>throughout the test | 4 Pass/ 0 Fail |

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| ASTM F 623-19, Section<br>4.5<br>Standard Performance<br>Specification for Foley<br>Catheter | Balloon Size<br>and Shaft<br>Size | integrated<br>guide wire<br>16 French<br>Silicone 3-way<br>Foley catheter<br>with<br>integrated<br>guide wire | The base dimension for the<br>requirement on sizes and tolerances<br>on the diameter of the catheter tip,<br>the size of the balloon, and the<br>diameter of the shaft is the “label<br>French size.” The proximal catheter<br>tip, the balloon, and the shaft, for 10<br>in. distal to the balloon, shall meet the<br>requirements on size and tolerances<br>on diameter shown in Table 1 of<br>ASTM F623. | 4 Pass/ 0 Fail |
|----------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| ASTM F 623-19, Section<br>4.6<br>Standard Performance<br>Specification for Foley<br>Catheter | Deflation<br>Reliability | 16 French<br>Silicone 3-way<br>Foley catheter<br>with<br>integrated<br>guide wire | Balloon deflates to within four<br>French sizes of the label French<br>size within 15 minutes or be<br>otherwise manipulated to effect<br>drainage within this time period | 4 Pass/ 0 Fail |

## Biocompatibility

The Urethrotech UCD® is designed to be a surface device in contact with the mucosal membrane with contact duration of up to 30 days.

Based on the device categorization outlined above, the naterial contact and the guidance given in ISO 10993-1, the tests deemed appropriate for the device materials were selected as shown in the table below.

| Biological Effect | Test | Compliance<br>Standard |
|-------------------------------------|--------------------------------------|------------------------|
| Cytotoxicity | Mem Elution | ISO10993-5 |
| Systemic Toxicity | Systemic Injection Test | ISO10993-11 |
| Systemic Toxicity | Subchronic Toxicity Study in<br>Rats | ISO10993-11 |
| Sensitization | Magnusson-Kligman test | ISO10993-10 |
| Irritation, Intracutaneous Toxicity | Intracutaneous Injection Test | ISO10993-10 |
| Pyrogenicity | Pyrogenicity Test | ISO10993-11 |

# Additional Testing Standards

- EN 556-1:2001 Sterilization of medical devices
- . BS EN ISO 15223-1:2012- Medical Devices Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
- . BS EN 1041:2008 Information supplied by the manufacturer with medical devices
- . BS EN 1174-1:1996: Sterilization of medical devices - Estimation of the population of micro- organisms on product - Part 1: requirements

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K190060 Page 6 of 6

- ISO 11070 Sterile single-use intravascular introducers, dilators and guidewires ●
- ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ●
- ASTM F/88/F88M-15/BS EN 868-5 Standard Test Method for Seal Strength of Flexible Barrier Materials

Clinical testing was not performed with this device.

#### Substantial Equivalence Conclusion:

Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance we believe we have demonstrated that the Urethrotech UCD® is substantially equivalent and as effective as the predicate device. Furthermore, the differences versus the predicate device do not impact safety and effectiveness.