(226 days)
No
The description details a physical catheter and its materials, with no mention of software, algorithms, or AI/ML capabilities. The "Not Applicable" sections for training/test sets and key metrics further confirm this.
No
The device is used to facilitate access and delivery of gels or fluids, not to directly treat a condition. While it aids in a medical procedure, its primary function is access, not therapy itself.
No
The device is described as a Urinary Catheter used to "facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract," and "to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids." Its function is for delivery and access, not for diagnosing a condition. Furthermore, the "Key Metrics" section explicitly states "Not Applicable (This is a physical device, not a diagnostic device)."
No
The device description clearly outlines a physical medical device made of PVC and Polycarbonate, intended for insertion into the body. 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:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a Urinary Catheter used to "facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract." It's a physical tool for accessing and delivering substances to the urinary tract.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely procedural (access and delivery).
- Performance Studies: The performance studies listed (Biocompatibility, Sterilization, Bench Testing) focus on the physical properties and safety of the device itself, not on its ability to perform a diagnostic test.
- Key Metrics: The "Not Applicable" for Key Metrics like Sensitivity, Specificity, etc., further indicates it's not a diagnostic device. These metrics are crucial for evaluating the performance of diagnostic tests.
In summary, the Urinary Catheter described is a medical device used for a therapeutic or procedural purpose, not for performing in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
KOD
Device Description
The Urinary Catheter is a single use 12 Fr or 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long. The catheter tube is made of Polyvinylchloride (PVC) and the Luer lock hub is made of Polycarbonate. The catheter is uncoated.
The device is designed to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids. The catheter is indicated for use by healthcare professionals for facilitating access to the urinary tract through a retrograde route, for the delivery of gels or fluids into the urinary tract.
The catheter is supplied sterile in a Tyvek pouch. The catheter is inserted into the body for a typical duration of less than 1 hour.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, urinary bladder
Indicated Patient Age Range
Adult
Intended User / Care Setting
healthcare professionals, Health Care centers
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)
Biocompatibility:
Testing was performed in accordance with FDA guidance: Use of International Standard ISO 10993-1:2018. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The Catheter underwent the following GLP biocompatibility testing per ISO 10993: Cytotoxicity, Sensitization, and Irritation. Results showed that the Urinary Catheter materials meet the requirements.
Sterilization:
The Urinary Catheter is supplied sterile and is intended for single use only. Testing was performed according to ISO 11135:2014. "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of asterilization process for medical devices. The results showed that the Urinary Catheter meet the requirements.
Bench Testing:
The following Bench tests were performed using the Urinary Catheter which demonstrated that the device performs per its device specifications:
- Flow rate
- Kink test
- Peak Tensile Force
- Luer Hub performance
- High Viscosity Flow
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 19, 2021
UroGen Pharma Ltd % James G. Otinger. R.Ph. Executive Vice President, Regulatory and Quality UroGen Pharma Inc. 400 Alexander Park Drive Princeton, NJ 08540
K211032 Re: Trade/Device Name: Urinary Catheter 12 Fr Urinary Catheter 16 Fr Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: October 18, 2021 Received: October 20, 2021
Dear James G. Otinger:
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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,
for Jessica K. Nguyen, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K211032
Device Name Urinary Catheter 12 Fr Urinary Catheter 16 Fr
Indications for Use (Describe)
The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for UroGen Pharma, with the company name in blue text. Below the logo, the text "510(k) Summary Urinary Catheter" is displayed in a simple font. The text indicates that the document is a summary related to a urinary catheter, likely for regulatory purposes.
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER INFORMATION: 1.
| Applicant's Name: | UroGen Pharma Ltd.
9 HaTaasiya Street
Ra'anana, Israel. 4365007
Tel: +972-9-770-7600
Fax: +972-77-4171410 |
| ------------------- | ------------------------------------------------------------------------------------------------------------------------- |
|---|
| Primary Contact Person: | James G. Ottinger, R.Ph.
Executive Vice President,
Regulatory and Quality UroGen Pharma, Inc.
Telephone: +1-646-768-9780
Mobile: +1-610-745-1230
Fax: +1-646-918-1262 |
| ------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Date Prepared: | November 17, 2021 |
|---|---|
| ---------------- | ------------------- |
2. DEVICE INFORMATION
| Trade Name: | Urinary Catheter 12 Fr
Urinary Catheter 16 Fr |
|----------------------|--------------------------------------------------|
| Common Name: | Urinary Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Regulatory Class: | II |
| Product Code: | KOD |
| Review Panel: | Gastroenterology/Urology |
4
Image /page/4/Picture/0 description: The image shows the logo for UroGen Pharma, followed by the text "510(k) Summary Urinary Catheter". The UroGen logo is a blue graphic of a branching structure, possibly representing cells or a network. The text is in a simple, clear font, with "UroGen" in a larger, bolder font than "Pharma".
3. PREDICATE AND REFERENCE DEVICES:
Predicate device: UroGen Ureteral Catheter, by UroGen Pharma Ltd., Product code KOD; cleared under K180354.
Reference devices: Rüsch®- Intermittent Urethral Catheters; by Teleflex Medical; Product code: EZC, EZD; cleared under K173596.
Both predicate and the reference devices have not been subject to a design-related recall.
DEVICE DESCRIPTION 4.
The Urinary Catheter is a single use 12 Fr or 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long. The catheter tube is made of Polyvinylchloride (PVC) and the Luer lock hub is made of Polycarbonate. The catheter is uncoated.
The device is designed to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids. The catheter is indicated for use by healthcare professionals for facilitating access to the urinary tract through a retrograde route, for the delivery of gels or fluids into the urinary tract.
The catheter is supplied sterile in a Tyvek pouch. The catheter is inserted into the body for a typical duration of less than 1 hour.
ર. INDICATIONS FOR USE
The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.
5
Image /page/5/Picture/0 description: The image is a logo for UroGen Pharma. The logo features a blue abstract design on the left, resembling a cell or branching structure within a circular arc. To the right of the design, the text "UroGen" is written in a bold, blue sans-serif font, with a trademark symbol (™) next to it. Below "UroGen", the word "Pharma" is written in a lighter blue, also in a sans-serif font.
510(k) Summary Urinary Catheter
6. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE AND REFERENCE DEVICES:
| Comparison
Parameter | Urinary
Catheter
(Subject
device) | UroGen Ureteral Catheter
(Primary Predicate Device) | Rüsch® Intermittent
Urethral Catheters
(Reference Predicate
Device) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class | II | II | II |
| Regulation | 876.5130 | 876.5130 | 876.5130 |
| Product Code | KOD | KOD | KOD |
| Indication for Use | The Urinary Catheter is
indicated for facilitating
access to the urinary
tract through a
retrograde route for the
delivery of gels or fluids
into the urinary tract. | The UroGen Ureteral Catheter is
indicated for use by physicians for
facilitating access to the urinary tract
through a retrograde route and may be
used in conjunction with a guidewire
or for the injection of gels or fluids
into the urinary tract. | The Intermittent Urethral
Catheters are indicated for
routine drainage of fluids
from the bladder. These
catheters are not intended
or designed for indwelling
use |
| Target population | Adult | Adult | Not stated |
| Catheter Type | Urethral catheter | Ureteral Catheter | Urethral Catheter |
| Where used | Health Care centers | Hospital | Not stated (routine
practice)
Home Use |
| Disposable | Yes | Yes | Yes |
| Duration of use | Limited | Limited | Limited |
| Supplied sterile | Yes (Single Use) | Yes (Single Use) | Yes (single Use) |
| Prescription/over- the-
counter use | Rx only | Rx only | Rx only |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Materials | Tube: PVC Luer hub:
Polycarbonate | Tube: Polyurethane Luer hub:
Polycarbonate | Tube: PVC
(phthalates free) |
| Hydrophilic Coating | Uncoated | Uncoated | Uncoated |
| Connector | Luer lock hub | Luer lock hub | Funnel |
| Length | 40 cm | 70 cm | 40 cm |
| Size Range | 12 Fr, 16 Fr | 7 Fr | 10-24 Fr |
| Catheter Tip
Configuration | Tiemann tip | Open tip | Tiemann tip |
| 2 Drainage eyelets | Yes | No | Yes |
| Shelf life | 3 years | 3 years | 5 years |
6
Image /page/6/Picture/0 description: The image shows the logo for UroGen Pharma. The logo features a blue abstract symbol resembling a molecule or cell structure on the left. To the right of the symbol is the company name, "UroGen," in a bold, blue sans-serif font, with a trademark symbol next to it. Below "UroGen" is the word "Pharma" in a smaller, lighter blue font.
510(k) Summarv Urinary Catheter
The subject and predicate device have the same intended use. As evidenced by the above table, the subject and predicate device have different technological characteristics. The subject device is a urethral catheter whereas the predicate is a ureteral catheter and due to this difference, there are some design differences (Fr size, length, etc.) between the subject and the predicate device. However, a reference device of a urethral catheter, which has similar device design as that of the subject catheter, is included to support the catheter design. In addition, performance testing was conducted on the subject catheter, and it was established that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness.
7. PERFORMANCE DATA
Below is a list of the tests that have been performed and successfully completed for the Urinary Catheter.
Biocompatibility:
Testing was performed in accordance with FDA guidance: Use of International Standard ISO 10993-1:2018. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The Catheter underwent the following GLP biocompatibility testing per ISO 10993: Cytotoxicity, Sensitization, and Irritation. Results showed that the Urinary Catheter materials meet the requirements.
Sterilization:
The Urinary Catheter is supplied sterile and is intended for single use only. Testing was performed according to ISO 11135:2014. "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of asterilization process for medical devices. The results showed that the Urinary Catheter meet the requirements.
Bench Testing:
The following Bench tests were performed using the Urinary Catheter which demonstrated that the device performs per its device specifications:
- 트 Flow rate
- 트 Kink test
- 트 Peak Tensile Force
- Luer Hub performance ■
- I High Viscosity Flow
8. CONCLUSION:
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate