(266 days)
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.
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).
The provided text is a 510(k) summary for the Urethrotech UCD®, a urethral catheterization device. It details the device description, indications for use, comparison to a predicate device, and performance testing. However, it does not describe a study involving an AI or algorithm-based device, human readers, or the establishment of ground truth by expert consensus.
Therefore, many of the requested items related to AI/algorithm performance, human reader studies, and ground truth establishment cannot be extracted from this document. The document describes traditional medical device performance testing, not AI/ML model validation.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Standard | Test Description | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F 623-19, Section 4.1 | Flow Rate through Drainage Lumen | Label French size catheters 14 through 24 inclusive shall have a minimum average flow rate of 100 cm3/min, and a label French size 12 catheter shall have a flow rate of 70 cm3/min. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.2 | Balloon Integrity | The inflation balloon must be inflated easily with distilled or deionized water to labeled volume without showing any evidence of breakage throughout the test period. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.3 | Inflated Balloon Response to Pullout | The entire balloon of catheters label French size 14 through 26 shall not pass into or through the funnel barrel. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.4 | Balloon Volume Maintenance | Catheter maintains its volume throughout the test | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.5 | Balloon Size and Shaft Size | The base dimension for the requirement on sizes and tolerances on the diameter of the catheter tip, the size of the balloon, and the diameter of the shaft is the “label French size.” The proximal catheter tip, the balloon, and the shaft, for 10 in. distal to the balloon, shall meet the requirements on size and tolerances on diameter shown in Table 1 of ASTM F623. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.6 | Deflation Reliability | Balloon deflates to within four French sizes of the label French size within 15 minutes or be otherwise manipulated to effect drainage within this time period | 4 Pass/ 0 Fail |
Biocompatibility Testing:
| Biological Effect | Test | Compliance Standard |
|---|---|---|
| Cytotoxicity | Mem Elution | ISO10993-5 |
| Systemic Toxicity | Systemic Injection Test | ISO10993-11 |
| Systemic Toxicity | Subchronic Toxicity Study in Rats | ISO10993-11 |
| Sensitization | Magnusson-Kligman test | ISO10993-10 |
| Irritation, Intracutaneous Toxicity | Intracutaneous Injection Test | ISO10993-10 |
| Pyrogenicity | Pyrogenicity Test | ISO10993-11 |
| (Note: Results for biocompatibility tests are not explicitly stated as 'Pass/Fail' in the provided text, just that these tests were deemed appropriate and likely conducted.) |
2. Sample sizes used for the test set and the data provenance
For the physical performance tests (ASTM F 623-19 sections), the sample size was 4 for each test (indicated by "4 Pass/ 0 Fail," meaning 4 samples were tested and all passed).
The provenance of the data (e.g., country of origin, retrospective/prospective) is not specified. These are typical in-vitro/bench tests, not clinical studies involving patient data. The device sponsor is Urethrotech Ltd., based in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes physical performance testing of a medical device, not a study evaluating an AI algorithm's performance against human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This describes physical performance testing, not a clinical study requiring adjudication of diagnoses or findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "Clinical testing was not performed with this device." This is not an AI-assisted device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests derived from established engineering and material science standards (ASTM, ISO) for medical devices, defining acceptable physical properties and performance characteristics (e.g., flow rate, balloon integrity, material biocompatibility). It is based on objective measurements against these standards, not medical diagnoses.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/ML model.
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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 RoadKingston upon ThamesSurrey 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 (<=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 | PrimaryPredicate Device | Similarities andDifferences |
|---|---|---|---|
| Sponsor | Urethrotech Ltd | Fortune MedicalInstrument Corp. | |
| Brand Name | Urethrotech UCD | All Silicone 2-Way FoleyBalloon CatheterAll Silicone 3-Way FoleyBalloon CatheterAll Silicone NelatonCatheter | |
| K number | N/A | K980919 | |
| ClassificationName | Catheter, Retention Type,Balloon | Catheter, Retention Type,Balloon | |
| Product Code | EZL | EZL | |
| RegulationNumber | 876.5130 | 876.5130 | |
| Class | II | II | |
| Indications for Use | The Urethrotech UCD® isintended for use for bladdermanagement including urinedrainage, collection andmeasurement and/or bladderfluid instillation | The Silicone Foley BalloonCatheter and NelatonCatheter are intended foruse as urinary catheters topass fluids to and from theurinary bladder | Same |
| Patient Population | ADULT | ADULT | Same |
| Use Environment | Hospitals, sub-acute settings | Hospitals, sub-acutesettings | |
| Features | Subject Device | PrimaryPredicate Device | Similarities andDifferences |
| Principle ofOperation | Bladder management isachieved by the manualintroduction of a silicone tubeto provide a means for urinedrainage, collection, andmeasurement.The main principle of operationand mechanism to achieve theintended effect is the purpose-built integration of a non-traumatic introducer guidewireinto the urethral catheterdesign. | Bladder management isachieved by the manualintroduction of a siliconetube to provide a meansfor urine drainage,collection, andmeasurement. | Same |
| Description | 3 way Silicone Foley Ballooncatheter | 3 way Silicone FoleyBalloon catheter | Same |
| Device Design | |||
| Main lumen | Urine drainage | Urine drainage | Same |
| Second lumen | Inflation and deflation ofballoon | Inflation and deflation ofballoon | Same |
| Third lumen –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. 24.26 | 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 Inflationvolume 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 doesnot offer aguidewire withthe device |
| Features | Subject Device | PrimaryPredicate Device | Similarities andDifferences |
| 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 4.1Standard PerformanceSpecification for FoleyCatheter | Flow Rate throughDrainage Lumen | 16 FrenchSilicone 3-wayFoley catheterwithintegratedguide wire | Label French size catheters 14through 24 inclusive shall have aminimum average flow rate of100 cm3/min, and a label Frenchsize 12 catheter shall have aflow rate of 70 cm3/min. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.2Standard PerformanceSpecification for FoleyCatheter | Balloon Integrity | 16 FrenchSilicone 3-wayFoley catheterwithintegratedguide wire | The inflation balloon must beinflated easily with distilled ordeionized water to labeled volumewithout showing any evidenceof breakage throughout thetest period. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.3Standard PerformanceSpecification for FoleyCatheter | Inflated BalloonResponse toPullout | 16 FrenchSilicone 3-wayFoley catheterwithintegratedguide wire | The entire balloon of catheterslabel French size 14 through 26shall not pass into or throughthe funnel barrel. | 4 Pass/ 0 Fail |
| ASTM F 623-19, Section 4.4Standard PerformanceSpecification for Foley | Balloon VolumeMaintenance | 16 FrenchSilicone 3-wayFoley catheterwith | Catheter maintains its volumethroughout the test | 4 Pass/ 0 Fail |
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| ASTM F 623-19, Section4.5Standard PerformanceSpecification for FoleyCatheter | Balloon Sizeand ShaftSize | integratedguide wire16 FrenchSilicone 3-wayFoley catheterwithintegratedguide wire | The base dimension for therequirement on sizes and toleranceson the diameter of the catheter tip,the size of the balloon, and thediameter of the shaft is the “labelFrench size.” The proximal cathetertip, the balloon, and the shaft, for 10in. distal to the balloon, shall meet therequirements on size and toleranceson diameter shown in Table 1 ofASTM F623. | 4 Pass/ 0 Fail |
|---|---|---|---|---|
| ASTM F 623-19, Section4.6Standard PerformanceSpecification for FoleyCatheter | DeflationReliability | 16 FrenchSilicone 3-wayFoley catheterwithintegratedguide wire | Balloon deflates to within fourFrench sizes of the label Frenchsize within 15 minutes or beotherwise manipulated to effectdrainage 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 | ComplianceStandard |
|---|---|---|
| Cytotoxicity | Mem Elution | ISO10993-5 |
| Systemic Toxicity | Systemic Injection Test | ISO10993-11 |
| Systemic Toxicity | Subchronic Toxicity Study inRats | 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.
§ 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.