(30 days)
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.
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.
The provided text describes the non-clinical performance testing for the Luja Coude (20108 Male CH18 - large packaging) device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values for each test. Instead, it lists the types of tests conducted and generally states that the "properties meet the acceptance criteria" or "proposed subject devices met the pre-determined acceptance criteria."
Here's an inferred table based on the information provided:
| Test Category | Specific Test / Standard | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Aging/Stability | ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices | Not explicitly detailed, but implied to demonstrate stability over defined shelf life. | "The properties meet the acceptance criteria after the aging cycle, the device is therefore deemed to be stable for the defined shelf life." (Planned 2 years shelf life mentioned) |
| Biocompatibility | ISO 10993-1:2018, -5:2009, -10:2021, -11:2017, -18:2020, -23:2021 (Cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, subacute toxicity, chemical characterization) | Not explicitly detailed, but implied to ensure biological safety and compatibility with human tissue. | Testing was conducted "to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." (Leveraged from K230165, where "the 18 fr size was included in analysis for all worst-case scenarios and included in testing.") |
| Catheter Performance | ISO 20696: 2018 (Sterile urethral catheters for single use) | Not explicitly detailed, but implied to meet performance characteristics for urethral catheters (e.g., kink resistance, coude measurement, friction, opening torque, sleeve collapse force, drainage characteristics). | Bench performance testing "was conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." (Leveraged from K230165, where "the 18 fr size was included in analysis for all worst-case scenarios and included in testing.") |
| ASTM F623-19 (Standard performance specification for Foley Catheter) | Not explicitly detailed. | ||
| ASTM D1894: 2014 (Static and kinetic coefficients of friction of plastic film and sheeting) | Not explicitly detailed. | ||
| Coloplast Test Method TM 6058 (Friction after 5 minutes) | Not explicitly detailed. | ||
| Coloplast Test Method TM 6059 (Opening torque) | Not explicitly detailed. | ||
| Coloplast Test Method TM 6100 (Sleeve collapse force) | Not explicitly detailed. | ||
| Coloplast Test Method TM6129 (Kink and Coude measurement) | Not explicitly detailed. | ||
| Packaging | ISO 11607-1 :2019 (Packaging for terminally sterilized medical devices) | Not explicitly detailed, but implied to maintain sterile barrier, prevent leaks, and withstand transportation. | 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." |
| ASTM F2096 (Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)) | Not explicitly detailed. | ||
| EN 868-5 (Packaging for terminally sterilized medical devices Sealable pouches and reels) | Not explicitly detailed. | ||
| ASTM F88/FM88 (Seal Strength of Flexible Barrier Materials) | Not explicitly detailed. | ||
| ASTM D4169-22 (Performance Testing of Shipping Containers and Systems) | Not explicitly detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each test conducted. It generally states that "the 18 fr size was included in analysis for all worst-case scenarios and included in testing." This implies that a sufficient number of 18 Fr devices were tested to represent the product.
- Data Provenance: The data is from non-clinical in vitro and bench testing conducted by Coloplast A/S (Denmark), with the contact person based in Minneapolis, MN, USA. The studies are retrospective in the sense that they are internal corporate testing used for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are non-clinical bench and lab tests for a medical device (urological catheter). There are no human subjects, images, or diagnostic outputs that would require expert consensus or ground truth establishment by medical professionals like radiologists. The "ground truth" for these tests comes from established engineering and regulatory standards (e.g., ISO, ASTM, Coloplast internal methods).
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., by multiple readers).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The submission describes non-clinical performance testing for a urological catheter, not an AI or imaging diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical urological catheter, not an algorithm or software.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical tests described is based on:
- Established international and national standards (e.g., ISO, ASTM).
- Internal Coloplast test methods and specifications, which are themselves derived from engineering principles and regulatory requirements for safe and effective medical devices.
- The physical and chemical properties of the device materials and design.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The "training" for the device's design and manufacturing comes from engineering and material science principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set" in that context.
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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).
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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
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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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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/SHoltedam13050 HumlebaekDenmark |
|---|---|
| Contact Person: | Troy ThomeSr. Regulatory Affairs SpecialistColoplast1601 West River Road NorthMinneapolis MN 55411Phone: +1 (612)-356-9917Email: ustbthome@coloplast.com |
| Date of Summary: | October 25, 2023 |
| Subject Device: | |
| Trade or ProprietaryName: | Luja Coude (20108 Male CH18 -large packaging) |
| Item/Model Numbers: | 20108 |
| Common Name: | Urological catheter and accessories |
| Regulation/ClassificationName: | Urological catheter and accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Regulatory Class: | II |
| Product Code: | EZD |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | K230165, Luja CoudeThe predicate device has not been subject of a design-relatedrecall. |
| Reference Device: | K180258, SpeediCath StandardThe reference device has not been subject of a design-relatedrecall. |
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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 andaccessories | Same | Same |
| RegulationNumber | 21 CFR 876.5130 | Same | Same |
| Product Code | EZD | Same | GBM |
| Classification | II | Same | Same |
| PrescriptionDevice | Yes | Same | Same |
| Intended Use | Intermittent catheterizationthrough the urethra. | Same | Same |
| Indications forUse | Luja Coudé is indicated foruse by patients with urineretention and patients withpost void residual volume(PVR) due to neurogenicand non-neurogenic voidingdysfunction. The catheter isinserted into the urethra toreach the bladder allowingurine to drain.The product is for adult malepatients only. | Luja Coudé is indicated foruse by patients with urineretention and patients withpost void residual volume(PVR) due to neurogenicand non-neurogenic voidingdysfunction. The catheter isinserted into the urethra toreach the bladder allowingurine to drain.The product is for adult malepatients only. | Urinary catheter forintermittent use. Thecatheter is intended for useby patients with chronicurine retention and patientswith a post void residualvolume (PVR) due toneurogenic and non-neurogenic voidingdysfunction. The catheter isinserted into the urethra toreach the bladder allowingurine to drain. |
| Condition of Use | Intermittent use and singleuse | Same | Same |
| Drainage | Micro holes | Same | Eyelets |
| DeviceCategorizationperISO 10993 | Surface contacting device incontact with mucosalmembrane for a prolongedduration of time (24 h < t < 30 days) | Same | Same |
| Sterility | SAL 10-6 | Same | Same |
| SterilizationMethod | e-beam | Same | Same |
| Shelf Life | 1 years at submission(planned 2 years) | same | 2 years |
| Available Sizes | Male, FR 18 / CH 18 | Male, FR 8 / CH 8Male, FR 10 / CH 10Male, FR 12 / CH 12Male, FR 14 / CH 14Male, FR 16 / CH 16 | Male, FR 8 / CH 8Male, FR 10 / CH 10Male, FR 12 / CH 12Male, FR 14 / CH 14Male, FR 16 / CH 16Male, FR 18 / CH 18Tiemann, FR 10 / CH 10Tiemann, FR 12 / CH 12Tiemann, FR 14 / CH 14Tiemann, FR 16 / CH 16 |
| Catheter Materials | Polyurethane | Same | Similar |
| HydrophilicCoating | Hydrophilic Coating | Same | Same |
| Swellingmedia(WettingAgent) | Saline solution with PEG | Same | Same |
| TipConfiguration | Flexible curved tip(bended) | Same | Straight (Nelaton) tip andTiemann tip |
| ProtectiveSleeveMaterial | - Copoly (ethylene/octane)- Copoly(isobutylene/styrene) | Same | N/A |
| InnerConnector | Polyurethane White | Same | N/A no inner connector |
| OuterConnectormaterial | ThermoplasticPolypropylene | Same | Thermoplastic polyurethanewith masterbatches |
| Handlematerial | ThermoplasticPolypropylene | Same | |
| PrimaryPackagingDescription | Single and double-looppouch packages, dark grey | Single pouch package, darkgrey | Similar (longer and thicker),green |
| PackagingMaterials | Inner layer: PE-peelOuter layer: Printed PETP | Same | Oriented polyamide,aluminum, low-densitypolyethylene, ring-shapedopening feature |
| EffectiveCatheter Length | Effective length (accordingto ISO 20696:2018):33cm (13 inches) | Same | Effective length (accordingto ISO 20696:2018):35cm (13.9 inches) |
The table below summarizes the technological characteristics of Luja Coude 18Fr as compared to the predicate device.
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Image /page/5/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue globe-like symbol on the left and the word "Coloplast" in blue, bold letters on the right. The globe symbol is made up of several horizontal lines that curve around the shape.
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Image /page/6/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue globe-like icon on the left and the word "Coloplast" in bold, blue letters on the right. The globe icon is made up of several horizontal lines and a solid blue lower half.
Summary of Non-Clinical Performance Testing
The following test was submitted in this Special 510(k):
| 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 testsummary: | Bench performance testing was conducted to verify the proposed subject devicesmet the pre-determined acceptance criteria per specified requirements. Testing wasperformed on final, finished, and sterilized devices asdescribed in the applicable submission sessions. |
|---|---|
| Biocompatibility: | ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation oftesting within a risk management process |
| ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Test for invitro cytotoxicity | |
| ISO 10993-10:2021, Biological evaluation of medical devices, Part 10: Test forirritation and skin sensitization | |
| ISO 10993-11:2017, Biological evaluation of medical devices, Part 11: Tests forsystemic toxicity | |
| ISO 10993-18:2020, Biological evaluation of medical devices, Part 18: Chemicalcharacterization 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. | |
| Catheterperformance: | 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.
§ 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.