Luja Set

K250270 · Coloplast Corp. · EZD · Apr 17, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K250270
• Device Name: Luja Set
• Applicant: Coloplast Corp.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Apr 17, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Luja Set 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 Set is a sterile, intermittent, hydrophilic-coated catheter with an integrated urine bag for male patients. The device features a straight tip with micro-holes for urine drainage and a protective sleeve to prevent hand contact during insertion. It is used for urethral catheterization to drain the bladder in patients with voiding dysfunction. The catheter is constructed from polyurethane with a PVP-based hydrophilic coating and is activated by a saline/PEG wetting agent. The device is intended for single-use, prescription-only application. The integrated urine bag includes a tear-off section for emptying. The device is sterilized via e-beam radiation. Clinical benefit is derived from facilitating bladder drainage in patients unable to void effectively.

Clinical Evidence

Bench testing only. Performance verified against ISO 20696:2018 (sterile urethral catheters) and ASTM F623-19 (Foley catheter performance). Testing confirmed that the device meets pre-determined acceptance criteria for flow rate and kink stability.

Technological Characteristics

Materials: Polyurethane catheter, PVP-based hydrophilic coating, saline/PEG wetting agent, polypropylene/thermoplastic elastomer connectors/handle, LLDPE bag connector, LDPE/PE-PP/LDPE collection bag. Dimensions: 33cm effective length, sizes CH10-CH16. Sterilization: e-beam (SAL 10^-6). Standards: ISO 20696:2018, ASTM F623-19. Connectivity: None.

Indications for Use

Indicated for male patients (adults and pediatric >1 year) with urine retention or post void residual volume due to neurogenic or 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 Coudé (K241210)

Reference Devices

• SpeediCath Flex Set (K222059)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

April 17, 2025

Coloplast Corp
Vallabha Tantry
Sr. Regulatory Affairs Specialist
1601 West River Road North
Minneapolis, Minnesota 55411

Re: K250270
Trade/Device Name: Luja Set
Regulation Number: 21 CFR 876.5130
Regulation Name: Urological Catheter and accessories
Regulatory Class: II
Product Code: EZD
Dated: March 18, 2025
Received: March 18, 2025

Dear Vallabha Tantry:

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).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K250270 - Vallabha Tantry
Page 2

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

{2}

K250270 - Vallabha Tantry
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 ([e-mail]) or phone [phone] 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

{3}

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.

Submission Number (if known)
K250270

Device Name
Luja Set

Indications for Use (Describe)
Luja Set 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)

## 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
[e-mail]

“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.”

{4}

K250705
Page 1 of 6
Coloplast

# SPECIAL 510(K) SUMMARY

## Submitted by:
Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark

## Contact Person:
Vallabha Tantry
Sr. Regulatory Affairs Specialist
Coloplast Corp.
1601 West River Road North
Minneapolis MN 55411
Phone: [phone]
Email: [e-mail]

## Date of Summary:
April 16, 2025

## Subject Device:
## Trade or Proprietary Name:
Luja Set

## Item/Model Numbers:
20071/20072/20074/20076

## Common Name:
Urological catheter and accessories

## Regulation/Classification Name:
Gastroenterology and Urology

## Regulation Number:
21 CFR 876.5130

## Product Code:
EZD

{5}

Luja Set
Special 510(k) notification
K250705
Page 2 of 6
Coloplast

| Review Panel: | Gastroenterology/Urology |
| --- | --- |
| Predicate Device: | K241210, Luja Coudé (Sizes CH 8-CH18)
The predicate device has not been subject of a design-related recall. |
| Reference Device: | K222059, SpeediCath Flex Set
The reference device has not been subject to a design-related recall. |
| Device Description: | The medical device is an intermittent, ready-to-use, sterile, hydrophilic-coated catheter with integrated urine bag. It contains a catheter with a flexible tip that facilitates passage through the sphincter in the urethra. The catheter is shielded by a sleeve, which serves as protection from the user’s hands during insertion. Several small holes (micro-holes) by the straight tip, create a draining zone, which allow the urine to flow from the bladder out through the catheter to a urine bag. The drainage end of the catheter is attached to a urine bag with a tear off section to open the bag for emptying. The catheter is sterilized by radiation.

The Luja Set is available in sizes: CH10, CH12, CH14, and CH16. |
| Indications for Use: | Luja Set 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). |

{6}

Luja Set
Special 510(k) notification
K250705
Page 3 of 6
Coloplast

# Technological Characteristics Comparison

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

| Parameter | Subject device | Predicate device |
| --- | --- | --- |
| | Luja Set male | Luja Coudé |
| 510(k) Number | K250270 | 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 |
| Indications for Use | Luja Set 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 year). | Same |

{7}

Luja Set
Special 510(k) notification
K250705
Page 4 of 6
^{}[]
Coloplast

| Parameter | Subject device | Predicate device |
| --- | --- | --- |
| Luja Set male | Luja Coudé | Page 4 of 6 |
| 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 | CH/ FR 10
CH/ FR 12
CH/ FR 14
CH/ FR 16 | CH/ FR 8
CH/ FR 10
CH/ FR 12
CH/ FR 14
CH/ FR 16
CH/ FR 18 |
| Catheter Materials | Polyurethane | Same |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) based | Same |
| Swelling media (Wetting Agent) | Saline solution with PEG | Same |
| Tip Configuration | Straight tip | Flexible curved tip (bended) |
| Primary Packaging Description | Single pouch package, dark grey | Single and double-loop pouch packages, dark grey |
| Packaging | Inner layer: PE-peel | Same |

{8}

Luja Set
Special 510(k) notification
K250705
Page 5 of 6
^{}[]
Coloplast

| Parameter | Subject device | Predicate device |
| --- | --- | --- |
| Materials | Outer layer: Printed PETP | Same |
| Effective Catheter Length | Effective length (according to ISO 20696:2018): 33cm (13 inches) | Same |
| Inner Connector | Polyurethane White | Same |
| Outer Connector | 2 shot components: 1st shot: Polypropylene 2nd shot: Thermoplastic elastomer | Same |
| Handle | 2 shot components: 1st shot: Polypropylene 2nd shot: Thermoplastic elastomer | Same |
| Cap | 2 shot components: 1st shot: Polypropylene 2nd shot: Thermoplastic elastomer | Polypropylene |
| Bag Connector | LLDPE - Linear Low Density Polyethylene | N/A |
| Collection Bag | (LDPE) LDPE/CO-PE-PP/LDPE – Low Density Polyethylene/ Polyethylene-Polypropylene copolymer/ Low Density Polyethylene | N/A |

{9}

Luja Set
Special 510(k) notification
K250705
Page 6 of 6
Coloplast

# Summary of Non-Clinical Performance Testing

| Non-clinical test summary: | The subject device when compared to the predicate (K241210) device shares similar technological characteristics as summarized in the technological characteristics table. The subject device differs from the predicate device in the straight tip configuration and the urine bag. Testing conducted with the predicate and reference device was deemed applicable to the subject device. Risk assessment was conducted, and two performance risks were identified: flow rate and kink stability. To support the flow rate and kink stability testing, the SpeediCath Flex Set (K222059) was used as a reference device. |
| --- | --- |
| | |
| Catheter performance: | ISO 20696: 2018, Sterile urethral catheters for single use |
| | ASTM F623-19, Standard performance specification for Foley Catheter |
| Bench performance testing was conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. | |

# Conclusion

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