(205 days)
Not Found
No
The summary describes a physical, single-use urinary catheter with a hydrophilic coating. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies focus on physical and material properties, not algorithmic performance.
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, which defines a therapeutic purpose.
No
Explanation: The device, Luja Coudé, is described as a catheter that allows urine to drain from the bladder. Its intended use is for patients with urine retention and post void residual volume, meaning it is used for treatment/management by enabling drainage, not for diagnosing a condition.
No
The device description clearly describes a physical, sterile, hydrophilic coated catheter with a flexible tip and drainage holes, which is a hardware medical device.
Based on the provided information, the Luja Coudé device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used for draining urine from the bladder by insertion into the urethra. This is a physical intervention for managing urine retention and voiding dysfunction.
- Device Description: The description details a physical catheter with a flexible tip, drainage holes, and an outlet for a urine bag. It's a mechanical device for facilitating drainage.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatments. The Luja Coudé does not perform any such analysis or testing of specimens. It is a device used in vivo (inside the body) for a therapeutic purpose (draining urine).
Therefore, the Luja Coudé is a medical device, specifically a urinary catheter, but it does not fit the definition of an In Vitro Diagnostic.
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 indicated for male patients only (adults and pediatric above the age of 1 years).
Product codes
EZD
Device Description
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.
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 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: 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 :2020, 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 :2023, Biological evaluation of medical devices, Part 10: Test for irritation and skin sensitization; ISO 10993-11 :2018, Biological evaluation of medical devices, Part 11: Tests for systemic toxicity; ISO 10993-18 :2020, Biological evaluation of medical devices, Part 18: Chemical characterization of medical device materials within a risk management process; 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: 2014, Standard test method for static and kinetic coefficients of 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 engineering to medical devices. 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.
Packaging: ISO 11607-1 :2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems; ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test); EN 868-5 Packaging for terminally sterilized medical devices Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods; ASTM F88/FM88 Standard Test Method for Seal Strength of Flexible Barrier Materials; 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 F1980-21, Standard guide for accelerated aging of sterile barrier systems and 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 performance testing demonstrates 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.
0
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).
1
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
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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)
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."
4
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
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: | November 20, 2024 |
| 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 |
5
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) | |
| The predicate device has not been subject of a design-related | ||
| recall. | ||
| Device Description: | 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. | ||
| 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 (adult and pediatric | ||
| 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 | |
| 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 (adult and pediatric above the | ||
| age of 1 years). | 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. |
6
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.
| Regulation Name | Urological catheter and accessories | K241210
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
10993 | Surface contacting device in contact with
mucosal membrane for a prolonged duration of
time (24 h