(30 days)
No
The description focuses on the physical characteristics, materials, and performance testing of a urinary catheter, with no mention of AI or ML capabilities.
Yes
The device is used to drain urine from the bladder, which alleviates symptoms of urine retention and high post-void residual volume, thereby providing a therapeutic effect.
No
The device description indicates that Luja Coude is a catheter for draining urine from the bladder, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines a physical, single-use, sterile catheter with a flexible tip, micro holes, an outlet, and a hydrophilic coating. The performance studies focus on physical properties like aging, bench performance, biocompatibility, catheter performance, and packaging. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain urine from the bladder, which is a physical process, not a diagnostic test performed on a sample outside the body.
- Device Description: The device is a catheter, designed for insertion into the body to facilitate drainage. IVD devices are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of Diagnostic Function: There is no mention of the device analyzing urine or providing any diagnostic information based on the urine. Its sole purpose is to remove the urine.
Therefore, the Luja Coude is a medical device used for therapeutic purposes (draining urine), not an in vitro diagnostic device.
N/A
Intended Use / 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 for adult male patients only.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
Luja Coude is a single-use, sterile 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.
Luja Coudé CH/FR 18 differs from the predicate device in the catheter size variants. Luja Coudé (predicate) includes French size 8 (CH8) through French size 16 (CH16) variants compared to the subject device which is a line extension to the Luja Coudé. The reference device supports the inclusion of the 18 Fr size variant.
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
Adult
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)
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.
Non-clinical test summary:
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.
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: Test for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices, Part 10: Test for irritation and skin sensitization
ISO 10993-11:2017, 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
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 :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.
No changes to the device materials, methods of manufacture, sterility process, and packaging were proposed in this submission compared to K230165. Therefore, leveraging these prior testing was found applicable.
The methods used in this Special 510(k) were the same methods used and accepted in K230165. Therefore, the use of well-established methods to evaluate the proposed change made this submission appropriate for a Special 510(k). The performance and non-clinical testing demonstrate the subject device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below it in a smaller font.
October 26, 2023
Coloplast Corporation Troy Thome Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K233101
Trade/Device Name: Luja Coude (20108 Male CH18 - large packaging) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: September 26, 2023 Received: September 26, 2023
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
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 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.
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 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,
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
2
Indications for Use
510(k) Number (if known) K233101
Device Name
Luja Coude (20108 Male CH18 - large packaging)
Indications for Use (Describe)
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 for adult male patients only.
| 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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3
Image /page/3/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue globe-like icon on the left and the word "Coloplast" in blue font on the right. The globe icon has several horizontal lines across it, giving it a textured appearance.
SPECIAL 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: | October 25, 2023 |
| Subject Device: | |
| Trade or Proprietary
Name: | Luja Coude (20108 Male CH18 -
large packaging) |
| Item/Model Numbers: | 20108 |
| Common Name: | Urological catheter and accessories |
| Regulation/Classification
Name: | Urological catheter and accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Regulatory Class: | II |
| Product Code: | EZD |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | K230165, Luja Coude
The predicate device has not been subject of a design-related
recall. |
| Reference Device: | K180258, SpeediCath Standard
The reference device has not been subject of a design-related
recall. |
4
Image /page/4/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, and the word "Coloplast" is in a bold, sans-serif font.
| Device Description: | Luja Coude is a single-use, sterile 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. | |
| Luja Coudé CH/FR 18 differs from the predicate device in the catheter size variants. Luja Coudé (predicate) includes French size 8 (CH8) through French size 16 (CH16) variants compared to the subject device which is a line extension to the Luja Coudé. The reference device supports the inclusion of the 18 Fr size variant. | |
| 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 for adult male patients only. |
| The subject and predicate devices have the same intended use. |
Technological Characteristics Comparison
| Parameter | Subject device | Predicate device | Reference device |
|---|---|---|---|
| Luja Coudé | Luja Coudé | SpeediCath Standard | |
| (male models only) | |||
| 510(k) Number | Unassigned | K230165 | K180258 |
| Regulation Name | Urological catheter and | ||
| accessories | Same | Same | |
| Regulation | |||
| Number | 21 CFR 876.5130 | Same | Same |
| Product Code | EZD | Same | GBM |
| Classification | II | Same | Same |
| Prescription | |||
| Device | Yes | Same | Same |
| Intended Use | Intermittent catheterization | ||
| through the urethra. | Same | Same | |
| 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 for adult male | |||
| patients only. | 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 for adult male | |||
| patients only. | Urinary catheter for | ||
| intermittent use. The | |||
| catheter is intended for use | |||
| by patients with chronic | |||
| 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. | |||
| Condition of Use | Intermittent use and single | ||
| use | Same | Same | |
| Drainage | Micro holes | Same | Eyelets |
| Device | |||
| Categorization | |||
| per | |||
| ISO 10993 | Surface contacting device in | ||
| contact with mucosal | |||
| membrane for a prolonged | |||
| duration of time (24 h 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.
The following tests were leveraged from prior testing cleared under K230165. As applicable, the 18 fr size was included in analysis for all worst-case scenarios and included in testing. Test methods and protocols were reviewed and accepted as part of the review of K230165.
| Non-clinical test
summary: | 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. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: Test for in
vitro cytotoxicity |
| | ISO 10993-10:2021, Biological evaluation of medical devices, Part 10: Test for
irritation and skin sensitization |
| | ISO 10993-11:2017, 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 |
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Image /page/7/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue bold letters on the right. The circular graphic is made up of several horizontal lines that create a layered effect.
| 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 | |
| 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 :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. |
No changes to the device materials, methods of manufacture, sterility process, and packaging were proposed in this submission compared to K230165. Therefore, leveraging these prior testing was found applicable.
The methods used in this Special 510(k) were the same methods used and accepted in K230165. Therefore, the use of well-established methods to evaluate the proposed change made this submission appropriate for a Special 510(k).
Conclusion
The performance and non-clinical testing demonstrate the subject device is as safe and effective as the predicate device.