Luja Coude

K241210 · Coloplast Corp. · EZD · Nov 21, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241210
• Device Name: Luja Coude
• Applicant: Coloplast Corp.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Nov 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Luja Coudé is a single-use, sterile, hydrophilic-coated intermittent urinary catheter; designed for male patients to manage urine retention and PVR. Device features a flexible curved tip with multiple micro-holes forming a drainage zone; allows urine flow from bladder through catheter to an external collection bag. Catheter is constructed from polyurethane with a PVP-based hydrophilic coating; sterilized via e-beam. Used by patients for self-catheterization; facilitates bladder drainage. Clinical benefit includes effective urine evacuation for patients with voiding dysfunction.

Clinical Evidence

Bench testing only. Performance verified via ISO 20696, ASTM F623-19, and internal Coloplast test methods (friction, torque, sleeve collapse, kink/coude measurement). Biocompatibility addressed per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity). Packaging integrity and shelf-life stability validated per ISO 11607, ASTM F2096, ASTM F88, and ASTM F1980.

Technological Characteristics

Materials: Polyurethane catheter, PVP-based hydrophilic coating, thermoplastic polypropylene connectors/handle, copoly protective sleeve. Dimensions: 33cm length, 8-18 Fr diameters. Flexible curved tip with micro-hole drainage. Sterilization: E-beam (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for male patients (adults and pediatric >1 year) with urine retention and post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction.

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

• Luja Coude (K230165)

Submission Summary (Full Text)

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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2024

Coloplast Corp Troy Thome Sr. Regulatory Affairs Specialist 1601 West River Road North Plymouth, Minnesota 55411

Re: K241210

Trade/Device Name: Luja Coude Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Received: October 25, 2024

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" (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).

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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 OS 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 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-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 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-device-advicecomprehensive-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-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

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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-garcia -S

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

Enclosure

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## Indications for Use

Submission Number (if known)

#### K241210

Device Name

Luja Coude

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 indicated 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)

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Image /page/4/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue text. Below the logo, the text "K241210" is displayed, followed by "Page 1 of 4". The text indicates that this is the first page of a four-page document.

# TRADITIONAL 510(K) SUMMARY

| Submitted by: | Coloplast A/S<br>Holtedam1<br>3050 Humlebaek<br>Denmark |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Troy Thome<br>Sr. Regulatory Affairs Specialist<br>Coloplast<br>1601 West River Road North<br>Minneapolis MN 55411<br>Phone: [phone]<br>Email: [e-mail] |
| Date of Summary: | November 20, 2024 |
| Subject Device: | |
| Trade or Proprietary<br>Name: | Luja Coude |
| Item/Model Numbers: | 20118, 20111, 20112, 20114, 20101, 20102, 20104, 20106,<br>20108 |
| Common Name: | Urological catheter and accessories |
| Regulation/Classification<br>Name: | Catheter, Straight |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZD |

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Image /page/5/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in a bold, sans-serif font. Below the logo is the text "K241210" and "Page 2 of 4". The text appears to be part of a document or label.

| Review Panel: | Gastroenterology/Urology | Page 2 of 4 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Predicate Device: | K230165, Luja Coude (sizes CH8 – CH16)<br>The predicate device has not been subject of a design-related<br>recall. | |
| Device Description: | Luja Coude is a single-use, sterile, hydrophilic coated catheter for<br>intermittent urinary catheterization. The catheter has a flexible tip<br>which contains several small holes (micro holes) by the tip creating<br>a drainage zone which allows the urine to flow from the bladder<br>through the catheter. The drainage end of the device has an outlet<br>to which a urine bag with a suitable connector can be connected.<br>The catheter also contains a hydrophilic-coating and is sterilized by<br>irradiation. | |
| | The primary packaging provides the sterile barrier and contains a<br>proof of seal for identification of opened products. | |
| | Luja Coude is available in one length (33cm) with a flexible tip and<br>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<br>patients with post void residual volume (PVR) due to neurogenic<br>and non-neurogenic voiding dysfunction. The catheter is inserted<br>into the urethra to reach the bladder allowing urine to drain. The<br>product is indicated for male patients only (adult and pediatric<br>above the age of 1 years). | |

## Technological Characteristics Comparison

The table below summarizes the technological characteristics of Luja Coude as compared to the predicate device.

| Parameter | Subject device | Predicate device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Luja Coude | Luja Coude |
| 510(k) Number | Unassigned | K230165 |
| Indications for Use | Luja Coude is indicated for use by patients<br>with urine retention and patients with post<br>void residual volume (PVR) due to<br>neurogenic and non-neurogenic voiding<br>dysfunction. The catheter is inserted into the<br>urethra to reach the bladder allowing urine to<br>drain. The product is indicated for male<br>patients only (adult and pediatric above the<br>age of 1 years). | Luja Coude is indicated for use by<br>patients with urine retention and<br>patients with post void residual<br>volume (PVR) due to neurogenic<br>and non-neurogenic voiding<br>dysfunction. The catheter is<br>inserted into the urethra to reach<br>the bladder allowing urine to drain.<br>The product is indicated for male<br>patients only. |

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Image /page/6/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue globe-like symbol on the left and the word "Coloplast" in blue on the right. The globe symbol is made up of several horizontal lines, with the bottom half being a solid blue color.

K241210

| Regulation Name | Urological catheter and accessories | K241210<br>Page 3 of 4 | 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 | |
| Condition of Use | Intermittent and single use | Same | |
| Drainage | Micro holes | Same | |
| Device Categorization per ISO<br>10993 | Surface contacting device in contact with<br>mucosal membrane for a prolonged duration of<br>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<br>Male, FR 10 / CH 10<br>Male, FR 12 / CH 12<br>Male, FR 14 / CH 14<br>Male, FR 16 / CH 16<br>Male, FR 18 / CH 18 | Same | |
| Catheter Materials | Polyurethane | Same | |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) based | Same | |
| Swelling media (Wetting<br>Agent) | Saline solution with PEG | Same | |
| Tip Configuration | Flexible curved tip (bended) | Same | |
| Protective Sleeve Material | Copoly (ethylene/octane)<br>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<br>grey | Same | |
| Packaging Materials | Inner layer: PE-peel Outer layer: Printed PETP | Same | |
| Effective Catheter Length | Effective length (according to ISO 20696:2018):<br>33cm (13 inches) | Same | |

# Summary of Non-Clinical Performance Testing

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Image /page/7/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue circle on the left and the word "Coloplast" in blue on the right. The circle has several horizontal lines across it, and the word "Coloplast" is in a sans-serif font.

K241210

| | K2 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical test<br>summary: | Bench performance testing and usability testing were conducted to verify the<br>proposed subject devices met the pre-determined acceptance criteria per specified<br>requirements. Testing was performed on final, finished, and sterilized devices as<br>described in the applicable submission sessions. |
| Biocompatibility: | ISO 10993-1 :2020, Biological evaluation of medical devices – Part 1: Evaluation of<br>testing within a risk management process |
| | ISO 10993-5 :2009, Biological evaluation of medical devices – Part 5: Test for in<br>vitro cytotoxicity |
| | ISO 10993-10 :2023, Biological evaluation of medical devices, Part 10: Test for<br>irritation and skin sensitization |
| | ISO 10993-11 :2018, Biological evaluation of medical devices, Part 11: Tests for<br>systemic toxicity |
| | ISO 10993-18 :2020, Biological evaluation of medical devices, Part 18: Chemical<br>characterization of medical device materials within a risk management process |
| | ISO 10993-23 :2021, Biological evaluation of medical devices, Part 23: Tests for<br>irritation |
| | The following biological endpoints were addressed: cytotoxicity, irritation or intracutaneous reactivity,<br>sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity. |
| Catheter performance: | ISO 20696: 2018, Sterile urethral catheters for single use |
| | ASTM F623-19, Standard performance specification for Foley Catheter |
| | ASTM D1894: 2014, Standard test method for static and kinetic coefficients of<br>friction of plastic film and sheeting |
| | Coloplast Test Method TM 6058 Friction after 5 minutes |
| | Coloplast Test Method TM 6059 opening torque |
| | Coloplast Test Method TM 6100 sleeve collapse force |
| | Coloplast Test Method TM6129: Kink and Coude measurement |
| | EN/IEC 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability<br>engineering to medical devices |
| | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the<br>pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and<br>sterilized devices as described in the applicable submission sessions. |
| Packaging: | ISO 11607-1 :2019, Packaging for terminally sterilized medical devices – Part 1:<br>Requirements for materials, sterile barrier systems and packaging systems |
| | ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by<br>Internal Pressurization (Bubble Test) |
| | EN 868-5 Packaging for terminally sterilized medical devices Sealable pouches and<br>reels of porous materials and plastic film construction. Requirements and test<br>methods |
| | ASTM F88/FM88 Standard Test Method for Seal Strength of Flexible Barrier<br>Materials. |
| | ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers<br>and Systems |
| | Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life.<br>Transportation testing was conducted to verify that there is no impact to the device safety or efficacy of the<br>catheter performance due to the hazards associated with the transportation environment. |
| Aging: | ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and<br>medical devices |
| | The stability study investigated whether there were unexpected (significant) changes in product properties over the<br>shelf-life of the device. The properties meet the acceptance criteria after the aging cycle, the device is therefore<br>deemed to be stable for the defined shelf life |

## Conclusion

The performance testing demonstrates the subject device is as safe and effective as the predicate device.