Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

K241028 · Coloplast · EZD · Jul 26, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241028
• Device Name: Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
• Applicant: Coloplast
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Jul 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Luja female is indicated for use by patients with urine retention and patients with a 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 female patients only (adults and children of and above the age of 2 years).

Device Story

Single-use, sterile, hydrophilic-coated polyurethane intermittent urinary catheter; tapered conical shape with reduced thickness for handling/weight reduction. Device consists of catheter in rigid inner container with medium-soft inner handle. Features micro-holes at tip for urine drainage; outlet at handle for urine bag connection. Used by patients for intermittent catheterization to drain bladder. Operated by patient or caregiver in home or clinical settings. Benefits include effective bladder drainage for patients with voiding dysfunction.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (ISO 10993 series), catheter performance (ISO 20696, ASTM F623-19, ASTM D1894-14), packaging integrity (ISO 11607-1, ASTM D4169-22), and accelerated aging (ASTM F1980-16).

Technological Characteristics

Materials: Polyurethane catheter, PVP-based hydrophilic coating, saline/PEG wetting agent. Dimensions: 9cm length, 10-16 Fr. Energy: None (manual). Connectivity: None. Sterilization: E-beam (SAL 10^-6). Standards: ISO 10993, ISO 20696, ASTM F623-19, ASTM D1894-14, ISO 11607-1, ASTM D4169-22, ASTM F1980-16.

Indications for Use

Indicated for female patients (adults and children ≥ 2 years) 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 Compact Plus (K203637)

Reference Devices

• Luja Coude (K230165)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 26, 2024

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

Re: K241028
Trade/Device Name: Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
Regulation Number: 21 CFR 876.5130
Regulation Name: Urological Catheter and accessories
Regulatory Class: II
Product Code: EZD
Dated: June 21, 2024
Received: June 24, 2024

Dear Thome Troy:

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"

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

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K241028 - Thome Troy
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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 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.

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

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K241028 - Thome Troy
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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-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,

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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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)
K241028

Device Name
Luja female (20051), Luja female (20052), Luja female (20054), Luja female (20056)

Indications for Use (Describe)
Luja female is indicated for use by patients with urine retention and patients with a 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 female patients only (adults and children of and above the age of 2 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."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]

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Luja female
Traditional 510(k) notification
K241028
Page 1 of 5

# 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: [phone]
Email: [e-mail]

## Date of Summary:
July 24, 2024

## Subject Device:
Luja female

## Trade or Proprietary Name:

## Item/Model Numbers:
20051, 20052, 20054, 20056

## Common Name:
Urological catheter and accessories

## Regulation/Classification Name:
Catheter, Straight

## Regulation Number:
21 CFR 876.5130

## Regulatory Class:
II

## Product Code:
EZD

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Luja female
Traditional 510(k) notification
K241028
Page 2 of 5

**Review Panel:** Gastroenterology/Urology

**Predicate Device:** K203637, SpeediCath Compact Plus
The predicate device has not been subject of a design-related recall.

**Reference Device:** K230165, Luja Coude
The reference device has not been subject of a design-related recall.

**Device Description:**
Luja female is a single-use, sterile catheter for intermittent urinary catheterization. The catheter has a tapered conical shape with reduced thickness on two sides of the lower part of the product, to improve handling and reduce weight/material consumption. The device is composed of a sterile catheter inserted in a rigid inner container. The top part of the catheter, which also includes the products sterile sealings, is covered, and sealed by a medium-soft inner handle. The catheter 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 handle 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.

Luja female is available in one effective length (9cm) in the following sizes: 10 Fr., 12 Fr., 14 Fr., and 16 Fr. The reference device supports the inclusion of the 16 Fr. model.

**Indications for Use:**
Luja female is indicated for use by patients with urine retention and patients with a 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 female patients only (adult and children of and above the age of 2 years).

**Technological Characteristics Comparison**
The table below summarizes the technological characteristics of Luja female as compared to the predicate device.

| Parameter | Subject device | Predicate device | Reference device |
| --- | --- | --- | --- |
| | Luja female | SpeediCath Compact Plus | Luja Coude |
| 510(k) Number | K241028 | K203637 | K230165 |

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Luja female
Traditional 510(k) notification
K241028
Page 3 of 5

| Parameter | Subject device | Predicate device | Reference device |
| --- | --- | --- | --- |
| | Luja female | SpeediCath Compact Plus | Luja Coude |
| 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 |
| Condition of Use | Intermittent use and single use | Same | Same |
| Drainage | Micro holes | Eyelets | 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 | 2 years | 2 years | 2 years |
| Available Sizes | FR 10 / CH 10
FR 12 / CH 12
FR 14 / CH 14
FR 16 / CH 16 | FR 8 / CH 8
FR 10 / CH 10
FR 12 / CH 12
FR 14 / CH 14 | 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 |
| Catheter Materials | Polyurethane | Same | Similar |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) based | Same | Same |
| Swelling media (Wetting Agent) | Saline solution with PEG | Same | Same |
| Tip Configuration | Nelaton (Straight) tip | Same | Flexible curved tip (bended) |
| Primary Packaging Description | Packaging consists of the container, inner handle, and the unibody which are made of polypropylene and polyethylene. | Same | Single and double-loop pouch packages, dark grey |
| Effective Catheter Length | 9 cm (3.5 in) | 9 cm (Plus) (3.5 in) | 33cm (13 inches) |

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Luja female

Traditional 510(k) notification

K241028

Page 4 of 5

# Summary of Non-Clinical Performance Testing

| Non-clinical test summary: | Bench performance testing and usability testing were 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. |
| --- | --- |
| 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: Tests for in vitro cytotoxicity |
| | ISO 10993-6:2016: Biological evaluation of medical devices – Part 6: Tests for local effects after implantation – evaluated as non-implant per standard |
| | ISO 10993-10:2023: Biological evaluation of medical devices – Part 10: Tests for skin sensitization |
| | ISO 10993-11:2017: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity |
| | ISO 10993-23:2021: Biological evaluation of medical devices – Part 23: Tests for irritation |
| 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 |
| | ASTM F623-19, Standard performance specification for Foley Catheter |
| | ASTM D1894-14: Standard test method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| | Coloplast Test Method Friction at T=0 and T=5 minutes |
| | Coloplast Test Method opening torque |
| | Coloplast Test Method collapse force |
| | Coloplast Test Method catheter rigidity |
| | Coloplast Test Method connector/handle opening torque |
| | Coloplast Test Method opening force |
| | Coloplast Test Method pH and osmolality |
| | Coloplast Test Method micro-hole diameter |
| 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. | |
| Packaging: | ISO 11607-1:2020, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| | DS EN ISO 20696:2018, Sterile urethral catheters for single use |
| | ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems |
| Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment. | |
| Aging: | ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems and |

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Luja female
Traditional 510(k) notification
K241028
Page 5 of 5

| | medical devices |
| --- | --- |
| The stability study investigated whether there were unexpected (significant) changes in product properties over the shelf-life of the device. The properties meet the acceptance criteria after the aging cycle, the device is therefore deemed to be stable for the defined shelf life. | |

## Conclusion

The intended use, indications for use, and technological characteristics of the subject device are substantially equivalent to the predicate device. The non-clinical performance testing demonstrates the subject device is as safe and effective as the predicate device.