Luja Soft

K262045 · Coloplast A.S. · EZD · Jul 7, 2026 · Gastroenterology, Urology

Device Facts

• Record ID: K262045
• Device Name: Luja Soft
• Applicant: Coloplast A.S.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Jul 7, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Luja Soft 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 adult male patients only.

Device Story

Intermittent, ready-to-use, sterile, hydrophilic-coated catheter; used for bladder drainage in adult males with voiding dysfunction. Device features flexible straight tip and multiple micro-holes near tip to facilitate urine flow. Operated by patient for self-catheterization. Input is manual insertion into urethra; output is urine drainage from bladder. Benefits include effective bladder emptying via micro-hole drainage zone. Sterilized by e-beam radiation.

Clinical Evidence

Bench testing only. Performance verified against ISO 20696:2018 and ASTM F623-19. Evaluated flow rate, kink stability, and wetting agent pH. No clinical data presented.

Technological Characteristics

Polyurethane catheter; TPE/SEBS/LLDPE gripper; PVP-based hydrophilic coating; saline/PEG wetting agent. Flexible straight tip. Micro-hole drainage zone. Sizes: CH10, CH12, CH14, CH16. Sterilization: e-beam (SAL 10^-6). Surface-contacting device (24h < t < 30 days).

Indications for Use

Indicated for adult male patients with urine retention or post void residual volume (PVR) 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

• SpeediCath Soft (K200142)

Reference Devices

• Luja Coude (K251116)

Submission Summary (Full Text)

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[LOGO]

FDA

U.S. FOOD & DRUG

ADMINISTRATION

July 7, 2026

Coloplast A.S.

Troy Thome

Sr. Regulatory Affairs Specialist

1601 W. River Rd. N.

Minneapolis, Minnesota 55411

Re: K262045

Trade/Device Name: Luja Soft

Regulation Number: 21 CFR 876.5130

Regulation Name: Urological catheter and accessories

Regulatory Class: II

Product Code: EZD

Dated: June 17, 2026

Received: June 17, 2026

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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (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"

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K262045 - Troy Thome

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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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

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K262045 - Troy Thome

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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,

ANDREW M. FALES -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

| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K262045 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| Luja Soft | | | |
| Please provide your Indications for Use below. | | | ? |
| Luja Soft 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 adult male patients only. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |

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Luja Soft – K262045 Special 510(k)
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Coloplast

# SPECIAL 510(K) SUMMARY

| Submitted by: | Coloplast A/S Holtedam1 3050 Humlebaek Denmark |
| --- | --- |
| Contact Person: | Troy Thome Sr. Regulatory Affairs Specialist Coloplast Corp. 1601 West River Road North Minneapolis MN 55411 Phone: [phone] Email: [e-mail] |
| Date of Summary: | July 2, 2026 |
| Subject Device: | |
| Trade or Proprietary Name: | Luja Soft |
| Common Name: | Urological catheter and accessories |
| Regulation/Classification Name: | Urological catheter and accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZD |

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Luja Soft – K262045 Special 510(k)

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[LOGO]

Coloplast

| Review Panel: | Gastroenterology/Urology |
| --- | --- |
| Predicate Device: | K200142, SpeediCath Soft The predicate device has not been subject of a design- related recall. |
| Reference Device: | K251116, Luja Coude 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. It contains a catheter with a flexible tip that facilitates passage through the sphincter in the urethra. 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. The catheter is sterilized by radiation. The Luja Soft is available in sizes: CH10, CH12, CH14, and CH16. |
| Indications for Use: | Luja Soft 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 adult male patients only. |

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Luja Soft – K262045 Special 510(k)

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### Technological Characteristics Comparison

The table below summarizes the technological characteristics of Luja Soft as compared to the predicate and reference devices.

| Parameter | Subject device | Predicate device | Reference device |
| --- | --- | --- | --- |
| | Luja Soft | SpeediCath Soft | Luja Coudé |
| 510(k) Number | K262045 | K200142 | K251116 |
| Regulation Name | Urological catheter and accessories | Same | Same |
| Regulation Number | 21 CFR 876.5130 | Same | Same |
| Product Code | EZD | Same | Same |
| Classification | II | Same | Same |
| Prescription Device | Yes | Same | Same |
| Intended Use | Intermittent catheterization through the urethra. | Same | Same |
| Indications for Use | Luja Soft 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 adult male patients only. | Same | 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). |
| Condition of Use | Intermittent use and single use | Same | Same |
| Drainage | Micro holes | 2 eyelet catheter | Micro holes |
| 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 | Same |
| Sterility | SAL 10-6 | Same | Same |
| Sterilization Method | e-beam | Same | Same |
| Shelf Life | 18 months at submission (planned 2 years) | 2 years | 2 years |
| Available Sizes | Male, FR 10 / CH 10 Male, FR 12 / CH 12 Male, FR 14 / CH 14 Male, FR 16 / CH 16 | Same | 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, FR 18 / CH 18 |

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Luja Soft – K262045 Special 510(k)

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| Parameter | Subject device Luja Soft | Predicate device SpeediCath Soft | Reference device Luja Coudé |
| --- | --- | --- | --- |
| Catheter Materials | Polyurethane | Same | Same |
| Gripper Material | Material: TPE / SEBS Colorant: Grey LLDPE | Material: Same Colorant: Turquoise LLDPE | N/A |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) based | PVP with NMP | Same as subject |
| Swelling media (Wetting Agent) | Saline solution with PEG | Same | Same |
| Tip Configuration | Flexible straight tip | Same | Flexible curved tip (bended) |
| Primary Packaging Description | Top foil and bottom foil welded together | Same | Single and double-loop pouch packages, dark grey |
| Packaging Materials | Inner layer: PE Outer layer: oriented polyamide (OPA) and aluminum Exterior outer foil color: Grey | Inner/Outer layer: Same Exterior outer foil color: White | Inner layer: PE-peel Outer layer: Printed PETP |
| Effective Catheter Length | Effective length (according to ISO 20696:2018): 33cm (13 inches) | Same | Same |

### Summary of Non-Clinical Performance Testing

| Non-clinical test summary: | The subject device when compared to the predicate (K200142) device shares similar technological characteristics as summarized in the technological characteristics table. Testing conducted with the predicate and reference device was deemed applicable to the subject device. Risk assessment was conducted and three performance risks were identified: flow rate (per ISO 20696: 2018 and ASTM F623-19), kink stability (per ISO 20696: 2018) and wetting agent pH (internal test method). It was evaluated that the modification to change the eyelet configuration from 2-eyelet to multiple hole eyelets did not introduce new biological concerns. |
| --- | --- |
| 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.