(217 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 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, and 16 Fr. The reference device supports the inclusion of 8 Fr models.
The provided text describes the acceptance criteria and the studies performed for the Luja Coude urological catheter. However, it does not contain information relevant to AI/ML device performance, ground truth establishment for a training set, MRMC studies, or standalone algorithm performance. The device is a traditional medical device, not an AI/ML device.
Therefore, many of the requested fields cannot be answered from the provided document.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various non-clinical performance tests and associated standards. The general reported performance is that the "proposed subject devices met the pre-determined acceptance criteria per specified requirements" and "The performance testing demonstrates the subject device is as safe and effective as the predicate device." Specific numerical acceptance criteria and performance results are not provided in this summary.
| Test Category | Study/Standard | Acceptance Criteria (General) | Reported Performance (General) |
|---|---|---|---|
| Biocompatibility | ISO 10993-1, -5, -10, -11, -18, -23 | Not explicitly stated in detail, but implied compliance with these ISO standards. | Addressed cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity, implying meeting the requirements of these standards. |
| Catheter Performance | ISO 20696:2018, ASTM F623-19, ASTM D1894:2014, Coloplast Test Methods (TM 6058, TM 6059, TM 6100, TM6129), EN/IEC 62366-1:2015/A1:2020 | Not explicitly stated in detail, but implied compliance with these standards and internal test methods. | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. These tests included friction, opening torque, sleeve collapse force, and kink/coude measurements. |
| Packaging | ISO 11607-1:2019, ASTM F2096, EN 868-5, ASTM F88/FM88, ASTM D4169-22 | Not explicitly stated in detail, but implied compliance with these standards. | Packaging integrity testing verified maintenance of the sterile barrier through shelf life. Transportation testing verified no impact to device safety or efficacy due to transportation hazards. |
| Aging/Stability | ASTM F1980-21 | Properties meet acceptance criteria after aging cycle. | The stability study investigated product properties over shelf-life. The properties met the acceptance criteria after the aging cycle, deeming the device stable for the defined shelf life (8 months at submission, planned 2 years). |
2. Sample size used for the test set and the data provenance:
Not applicable information for the provided device type. The device is a physical catheter, and the testing involves bench performance and biocompatibility rather than a "test set" of data in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method for the test set:
Not applicable. This is not an AI/ML device requiring adjudication of a test set.
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:
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
Not applicable. The "ground truth" for this device's performance is established through physical and biological testing against established international and ASTM standards, as well as Coloplast's internal test methods.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 25, 2023
Coloplast Corporation Troy Thome Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K230165
Trade/Device Name: Luja Coude Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: July 28, 2023 Received: July 28, 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 (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 located 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.
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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
Enclosure
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Indications for Use
510(k) Number (if known) K230165
Device Name Luja Coude
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 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 on the right. The globe icon has several horizontal white lines across it.
TRADITIONAL 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: | August 24, 2023 |
| Subject Device: | |
| Trade or ProprietaryName: | Luja Coude |
| Item/Model Numbers: | 20118, 20111, 20112, 20114, 20101, 20102, 20104, 20106 |
| Common Name: | Urological catheter and accessories |
| Regulation/ClassificationName: | Urological catheter and accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Regulatory Class: | II |
| Product Code: | EZD |
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Image /page/4/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 blue, sans-serif font on the right. The globe icon is made up of several horizontal lines, with the lower half filled in with solid blue.
| Review Panel: | Gastroenterology/Urology |
|---|---|
| Predicate Device: | K190620, SpeediCath Flex Coude ProThe 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. |
| Device Description: | Luja Coude is a single-use, sterile catheter for intermittent urinarycatheterization. The catheter has a flexible tip which containsseveral small holes (micro holes) by the tip creating a drainagezone which allows the urine to flow from the bladder through thecatheter. The drainage end of the device has an outlet to which aurine bag with a suitable connector can be connected. The catheteralso contains a hydrophilic-coating and is sterilized by irradiation.The primary packaging provides the sterile barrier and contains aproof of seal for identification of opened products.Luja Coude is available in one length (33cm) with a flexible tipand diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, and 16 Fr. The referencedevice supports the inclusion of 8 Fr models. |
| Indications for Use: | Luja Coude is indicated for use by patients with urine retention andpatients with post void residual volume (PVR) due to neurogenicand non-neurogenic voiding dysfunction. The catheter is insertedinto the urethra to reach the bladder allowing urine to drain. Theproduct is for adult male patients only.The subject and predicate devices have the same intended use. |
Technological Characteristics Comparison
The table below summarizes the technological characteristics of Luja Coude as compared to the predicate device.
| Parameter | Subject device | Predicate device | Reference device |
|---|---|---|---|
| Luja Coude | SpeediCath FlexCoudé Pro | SpeediCath Standard(male models only) | |
| 510(k) Number | Unassigned | K190620 | K180258 |
| Regulation Name | Urological catheter andaccessories | Same | Same |
| Regulation Number | 21 CFR 876.5130 | Same | Same |
| Product Code | EZD | GBM | GBM |
| Classification | II | Same | Same |
| Parameter | Subject device | Predicate device | Reference device |
| Luja Coude | SpeediCath FlexCoudé Pro | SpeediCath Standard(male models only) | |
| Prescription Device | Yes | Same | Same |
| Intended Use | Intermittentcatheterization through theurethra. | Same | Same |
| Condition of Use | Intermittent use and singleuse | Same | Same |
| Drainage | Micro holes | Eyelets | Eyelets |
| Device CategorizationperISO 10993 | Surface contacting devicein contact with mucosalmembrane for a prolongedduration of time (24 h < t<30 days) | Same | Same |
| Sterility | SAL 10-6 | Same | Same |
| Sterilization Method | e-beam | Same | Same |
| Shelf Life | 8 months at time ofsubmission (planned 2years) | 2 years | 2 years |
| Available Sizes | Male, FR 8 / CH 8Male, FR 10 / CH 10Male, FR 12 / CH 12Male, FR 14 / CH 14Male, FR 16 / CH 16 | FR 10 / CH 10FR 12 / CH 12FR 14 / CH 14FR 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 |
| Hydrophilic Coating | Polyvinylpyrrolidone(PVP) based | Same | Same |
| Swelling media (WettingAgent) | Saline solution with PEG | Same | Same |
| Tip Configuration | Flexible curved tip(bended) | Same | Straight (Nelaton) tip andTiemann tip |
| Protective SleeveMaterial | Copoly(ethylene/octane)Copoly(isobutylene/styrene) | Same | N/A |
| Inner Connector | PolyurethaneWhite | Same | N/A no inner connector |
| Parameter | Subject device | Predicate device | Reference device |
| Luja Coude | SpeediCath FlexCoudé Pro | SpeediCath Standard(male models only) | |
| Outer Connector material | ThermoplasticPolypropylene | Same with turquoisecolor | Thermoplasticpolyurethane withmasterbatches |
| Handle material | ThermoplasticPolypropylene | Same with turquoisecolor | N/A |
| Primary PackagingDescription | Single and double-looppouch packages, dark grey | Single and double-looppouch packages, grey | Similar (longer andthicker), green |
| Packaging Materials | Inner layer: PE-peelOuter layer: Printed PETP | Same | Oriented polyamide,aluminum, low-densitypolyethylene, ring-shapedopening feature |
| Effective Catheter Length | Effective length(according to ISO20696:2018):33cm (13 inches) | Same | Effective length(according to ISO20696:2018):35cm (13.9 inches) |
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
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Image /page/5/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, sans-serif font on the right. The globe symbol is made up of several horizontal lines that curve around to create a spherical shape.
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Image /page/6/Picture/1 description: The image shows the Coloplast logo. The logo consists of a blue globe-like symbol on the left and the word "Coloplast" in blue, sans-serif font on the right. The globe symbol is made up of several horizontal lines that curve to form a sphere shape.
Summary of Non-Clinical Performance Testing
| Non-clinical testsummary: | Bench performance testing and usability testing were conducted to verify theproposed subject devices met the pre-determined acceptance criteria per specifiedrequirements. Testing was performed 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 | |
| ISO 10993-23 :2021, Biological evaluation of medical devices, Part 23: Tests forirritation | |
| 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 offriction 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 usabilityengineering to medical devices |
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
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Image /page/7/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue text on the right. The circular graphic is divided into two halves, with the top half containing several horizontal lines.
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 byInternal Pressurization (Bubble Test) | |
| EN 868-5 Packaging for terminally sterilized medical devices Sealable pouches andreels of porous materials and plastic film construction. Requirements and testmethods | |
| ASTM F88/FM88 Standard Test Method for Seal Strength of Flexible BarrierMaterials. | |
| ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containersand 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 thecatheter performance due to the hazards associated with the transportation environment. | |
| Aging: | ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems andmedical 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.
§ 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.