(77 days)
Not Found
No
The document describes a physical medical device (catheter) and mentions no components or functionalities related to AI, DNN, or ML.
Yes
The device is indicated for patients with urine retention and post void residual volume due to voiding dysfunction, allowing urine to drain from the bladder. This directly treats a medical condition, qualifying it as a therapeutic device.
No.
The device description clearly states that the Luja Coude is a catheter allowing urine to drain from the bladder, indicating its role in treatment rather than diagnosis.
No
The device is a physical, invasive medical device (a catheter) with a flexible tip and micro holes, designed for draining urine from the bladder. It is described with physical dimensions, materials, sterilization methods, and undergoes biocompatibility and bench performance testing characteristic of hardware rather than software. There is no mention of software components, algorithms, or digital processing.
No
The device is a urinary catheter, used to drain urine from the bladder, which is an in-vivo diagnostic or therapeutic procedure, not an in-vitro diagnostic. It does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The product is for male patients only (adults and pediatric above the age of 1 years).
Product codes
EZD
Device Description
The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.
The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.
The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra to reach the bladder
Indicated Patient Age Range
adults and pediatric above the age of 1 years
Intended User / Care Setting
Not Found
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)
Non-clinical test summary: Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices.
Biocompatibility: ISO 10993-1 :2018, Biological evaluation of medical devices – Part 1: Evaluation of testing within a risk management process
ISO 10993-5 :2009, Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity
ISO 10993-10 :2021, Biological evaluation of medical devices, Part 10: Test for irritation and skin sensitization
ISO 10993-11 :2017, Biological evaluation of medical devices, Part 11: Tests for systemic toxicity
ISO 10993-12 :2021, Biological evaluation of medical devices, Part 12: Sample preparation and reference materials
ISO 10993-23 :2021, Biological evaluation of medical devices, Part 23: Tests for irritation
USP Pyrogen Test
The following biological endpoints were addressed: cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity.
Catheter performance: ISO 20696: 2018, Sterile urethral catheters for single use
Coloplast Test Method TM6030 Friction at T=0 minutes
Coloplast Test Method TM6058 Friction after 5 minutes
Coloplast Test Method TM6129 Kink of catheter tubes
Coloplast Test Method for pH and Osmolality TM0507 and TM6032
Bench performance testing was conducted to verify the subject devices met the pre-determined acceptance criteria per specified performance requirements.
Simulated shipping distribution: ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
Aging: ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices
Transportation testing was conducted to verify that there is no impact to the subject device performance due to the hazards associated with the transportation environment. The stability study investigated whether there were changes in product properties over the shelf-life of the device. The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements.
Conclusion: The biocompatibility and performance testing demonstrated that the subject device is as safe and effective as the predicate device.
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.
FDA 510(k) Clearance Letter - Luja Coudé
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 27, 2025
Coloplast Corp.
Troy Thome
Sr. Regulatory Affairs Specialist
1601 West River Road North
Minneapolis, Minnesota 55411
Re: K251116
Trade/Device Name: Luja Coudé
Regulation Number: 21 CFR 876.5130
Regulation Name: Urological Catheter and accessories
Regulatory Class: II
Product Code: EZD
Dated: April 11, 2025
Received: April 11, 2025
Dear Troy Thome:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K251116 - Troy Thome
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
Page 3
K251116 - Troy Thome
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Jessica K. Nguyen -S
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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251116
Device Name: Luja Coudé
Indications for Use (Describe)
Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The product is for male patients only (adults and pediatric above the age of 1 years).
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)
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
Luja Coudé Traditional 510(k) notification
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
TRADITIONAL 510(K) SUMMARY
Submitted by: Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark
Contact Person: Troy Thome
Sr. Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis MN 55411
Phone: +1 (612)-356-9917
Email: ustbthome@coloplast.com
Date of Summary: June 27, 2025
Subject Device:
| Trade or Proprietary Name: | Luja Coude |
|---|---|
| Item/Model Numbers: | 20118, 20111, 20112, 20114, 20101, 20102, 20104, 20106, 20108 |
| Common Name: | Urological catheter and accessories |
| Regulation/Classification Name: | Catheter, straight |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZD |
K251116
Page 1 of 4
Page 6
K251116
Luja Coudé
Page 2 of 4
Traditional 510(k) notification
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
Review Panel: Gastroenterology/Urology
Predicate Device: K241210, Luja Coude
The predicate device has not been subject of a design-related recall.
Device Description: The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.
The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.
The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.
Indications for Use: Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for male patients only (adults and pediatric above the age of 1 years).
Technological Characteristics Comparison
The table below summarizes the technological characteristics of the subject device Luja Coude as compared to the predicate device, Luja Coude.
| Parameter | Subject device | Predicate device |
|---|---|---|
| Luja Coude | Luja Coude | |
| 510(k) Number | K251116 | K241210 |
| Regulation Name | Urological catheter and accessories | Same |
| Regulation Number | 21 CFR 876.5130 | Same |
| Product Code | EZD | Same |
| Classification | II | Same |
| Prescription Device | Yes | Same |
| Intended Use | Intermittent catheterization through the urethra | Same |
Page 7
K251116
Luja Coudé
Page 3 of 4
Traditional 510(k) notification
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
| Parameter | Subject device | Predicate device |
|---|---|---|
| Luja Coude | Luja Coude | |
| Condition of Use | Intermittent use and single-use | Same |
| Drainage | Micro holes | Same |
| Device Categorization per ISO 10993 | Surface contacting device in contact with mucosal membrane for a prolonged duration of time (24 h ˂ t˂ 30 days) | Same |
| Sterility | SAL 10⁻⁶ | Same |
| Sterilization Method | e-beam | Same |
| Shelf Life | 2 years | Same |
| Available Sizes | Male, FR 8 / CH 8 | |
| Male, FR 10 / CH 10 | ||
| Male, FR 12 / CH 12 | ||
| Male, FR 14 / CH 14 | ||
| Male, FR 16 / CH 16 | ||
| Male, FR18 / CH 18 | Same | |
| Catheter Materials | Polyurethane | Same |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) based | Similar (modified PVP based formulation) |
| Swelling media (Wetting Agent) | Saline solution with PEG | Same |
| Tip Configuration | Flexible curved tip (bended) | Same |
| Protective Sleeve Material | - Copoly (ethylene/octane) |
- Copoly (isobutylene/styrene) | Same |
| Inner Connector | Polyurethane White | Same |
| Outer Connector material | Thermoplastic Polypropylene | Same |
| Handle material | Thermoplastic Polypropylene | Same |
| Primary Packaging Description | Single and double-loop pouch packages, dark grey | Same |
| Packaging Materials | Inner layer: PE-peel Outer layer: Printed PETP | Same |
| Effective Catheter Length | Effective length (according to ISO 20696:2018):
33cm (13 inches) | Same |
Summary of Non-Clinical Performance Testing
Non-clinical test summary: Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices.
Biocompatibility: ISO 10993-1 :2018, Biological evaluation of medical devices – Part 1: Evaluation of testing within a risk management process
ISO 10993-5 :2009, Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity
Page 8
K251116
Luja Coudé
Page 4 of 4
Traditional 510(k) notification
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
ISO 10993-10 :2021, Biological evaluation of medical devices, Part 10: Test for irritation and skin sensitization
ISO 10993-11 :2017, Biological evaluation of medical devices, Part 11: Tests for systemic toxicity
ISO 10993-12 :2021, Biological evaluation of medical devices, Part 12: Sample preparation and reference materials
ISO 10993-23 :2021, Biological evaluation of medical devices, Part 23: Tests for irritation
USP Pyrogen Test
The following biological endpoints were addressed: cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity.
Catheter performance: ISO 20696: 2018, Sterile urethral catheters for single use
Coloplast Test Method TM6030 Friction at T=0 minutes
Coloplast Test Method TM6058 Friction after 5 minutes
Coloplast Test Method TM6129 Kink of catheter tubes
Coloplast Test Method for pH and Osmolality TM0507 and TM6032
Bench performance testing was conducted to verify the subject devices met the pre-determined acceptance criteria per specified performance requirements.
Simulated shipping distribution: ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
Aging: ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices
Transportation testing was conducted to verify that there is no impact to the subject device performance due to the hazards associated with the transportation environment. The stability study investigated whether there were changes in product properties over the shelf-life of the device. The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements.
Conclusion
The biocompatibility and performance testing demonstrated that the subject device is as safe and effective as the predicate device.