Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

{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 & 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. March 5, 2025 Well Lead Medical Co., Ltd. Jimmy Chen Regulatory Affairs Specialist No.47, Guomao Avenue South, Hualong, Panyu Guangzhou, 511434 CHINA Re: K241734 > Trade/Device Name: Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Dated: January 18, 2025 Received: February 3, 2025 Dear Jimmy Chen: 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" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the 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 Rue"). 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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2}------------------------------------------------ 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241734 Device Name Wellead® Hydrophilic Intermittent Catheter Ready to Use, Wellead® Hydrophilic Intermittent Catheter Compact Indications for Use (Describe) Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying. 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. 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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 contains the word "wellead" in a large, bold, blue font. To the right of the word "wellead" is the text "K241734 Page 1 of 10" in a smaller, black font. The text appears to be a document identifier and page number. # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. # 1. Submitter Identification Submitter Name: Well Lead Medical CO., LTD. Submitter Address: No.47, Guomao Avenue South, Hualong, Panyu, Guangzhou, China 511434 Establishment Registration Number: 3010400865 Tel: 86 2084758878-8628 Contact Person (including title): Ms. Jenny Zhu (RA Supervisor); Mr. Jimmy Chen (RA Specialist); E-mail: jenny zhu@welllead.com.cn; chenjinyi@welllead.com.cn; # 2. Device Identification Type of 510(k) submission: Traditional Common Name: Urethral Catheter Trade Name: Wellead® Hydrophilic Intermittent Catheter Ready to Use Wellead® Hydrophilic Intermittent Catheter Compact Device: Catheter, urethral Regulation Name: Urological catheter and accessories Regulation Medical Specialty: Gastroenterology/Urology Review Panel: Gastroenterology/Urology Product Code: EZD Regulation Number: 21 CFR 876.5130 Regulation Class: Class II #### 3. Predicate Device Information | | Predicate Device | |-------------------|---------------------| | Sponsor | Coloplast Corp | | Device Name | SpeediCath Standard | | 510(k) Number | K180258 | | Product Code | GBM | | Regulation Number | 21 CFR 876.5130 | | Regulation Class | Class II | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "wellead" in blue, with a black line underneath. The font is rounded and sans-serif. The word is written in lowercase letters. | | Predicate Device | |-------------------|-----------------------------------------------| | Sponsor | Coloplast Corp | | Device Name | SpeediCath Compact<br>SpeediCath Compact Plus | | 510(k) Number | K203637 | | Product Code | EZD | | Regulation Number | 21 CFR 876.5130 | | Regulation Class | Class II | The predicate devices have not been subject of a design-related recall. #### 4. Device Description Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments. The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized. The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier. The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations: - Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr) ● - Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr) ● - Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) . The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr). {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "wellead" in a bold, blue font. To the right of the word, there is the text "K241734 Page 3 of 10" in a smaller, black font. The text indicates that this is page 3 of a 10-page document. #### 5. Indications for Use Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying. ## 6. Summary of Non-clinical Performance Testing Hydrophilic Intermittent Catheter has been evaluated for safety and performance by lab bench testing as follows: Non -clinical bench testing: - ISO 20696:2018, Sterile urethral catheters for single use ● - ASTM F623-19, Standard performance specification for Foley Catheter ● - pH testing - Osmolarity testing - Surface drying time of coating #### Packaging: - ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials - ASTM F1886 Standard Test Method for Determining integrity of Seals for Flexible Packaging by Visual inspection #### Aging: - ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices #### Biocompatibility: - ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process - ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for ● in vitro cytotoxicity - ISO 10993-6:2016 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects after Implantation - ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation; - ISO 10993-17:2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents; - ISO 10993-18: 2020, Biological Evaluation of Medical Devices -Part 18: Chemical characterization of medical device materials within a risk management process {7}------------------------------------------------ Subject Device: Hydrophilic Intermittent Catheter Image /page/7/Picture/2 description: The image shows the word "wellead" in a bold, sans-serif font. The color of the text is a vibrant blue. The word is presented in all lowercase letters and is horizontally oriented. # 7. Comparison of Technological Characteristics | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Device Name<br>and Model | Hydrophilic Intermittent<br>Catheter Ready to Use<br>Hydrophilic Intermittent<br>Catheter Compact | SpeediCath Standard | SpeediCath Compact<br>SpeediCath Compact Plus | N/A | | 510 (K) Number | K241734 | K180258 | K203637 | N/A | | Regulation<br>number | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | SE | | Regulation<br>description | Urological catheter and<br>accessories | Urological catheter and<br>accessories | Urological catheter and<br>accessories | SE | | Product code | EZD | GBM | EZD | SE | | Class | Class II | Class II | Class II | SE | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate<br>Device 2 | Remark | | Indication for<br>Use | Hydrophilic intermittent catheter<br>is used to empty the bladder for<br>patients with urinary retention<br>or incomplete bladder<br>emptying. | Urinary catheter for intermittent<br>use.<br>The catheter is indicated for<br>use by patients with chronic<br>urine retention and patients<br>with a post void residual<br>volume (PVR) due to<br>neurogenic and non-neurogenic<br>voiding dysfunction. The<br>catheter is inserted into the<br>urethra to reach the bladder<br>allowing the urine to drain. | SpeediCath Compact and<br>SpeediCath Compact Plus is<br>indicated for use by patients<br>with chronic urine retention and<br>patients with a post void<br>residual volume (PVR) due to<br>neurogenic and non-<br>neurogenic voiding<br>dysfunction. The catheter is<br>inserted into the urethra to<br>reach the bladder allowing<br>urine to drain. The product is<br>indicated for female patients<br>only (adults and children of and<br>above the age of 2 years).<br>Choice of model and size of<br>the catheter for the individual<br>patient is made upon<br>recommendation by the local<br>health care professional. | SE<br>Note 1 | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | Prescription use | Prescription use | Prescription use | Prescription use | SE | | Sterility | Sterilized - Single use | Sterilized – Single use | Sterilized – Single use | SE | | Sterilization<br>Method | Radiation | Radiation | Radiation | SE | | Use | The catheter is inserted into the<br>urethra to reach the bladder<br>allowing the urine to drain. | The catheter is inserted into the<br>urethra to reach the bladder<br>allowing the urine to drain. | The catheter is inserted into the<br>urethra to reach the bladder<br>allowing the urine to drain. | SE | | Catheter<br>Material | Polyurethane | Polyurethane | Polyurethane | SE | | Packaging | The Hydrophilic Intermittent<br>Catheter Ready to Use is<br>placed in a wetting liquid,<br>packed and sealed in a foil<br>pouch and sterilized.<br>The Hydrophilic Intermittent<br>Catheter Compact is placed in | The catheter is placed in a<br>swelling media, packed and<br>sealed in a foil pouch and<br>sterilized. | The catheter is hydrophilic<br>coated and placed in a sterile<br>solution (swelling medium)<br>inside the inner tube, which<br>together with a handle and plug<br>make up the primary packaging<br>and the sterile barrier. | SE<br>Note 2 | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | | a wetting liquid inside the<br>container, which together with<br>screw cap, connector and plug<br>make up the primary packaging<br>and the sterile barrier. | | | | | Catheter OD (Fr<br>Size) | Ready to use Standard: 8Fr,<br>10Fr, 12Fr, 14Fr, 16Fr, 18Fr<br>Ready to use Female: 8Fr,<br>10Fr, 12Fr, 14Fr, 16Fr, 18Fr<br>Ready to use Tiemann: 10Fr,<br>12Fr, 14Fr, 16Fr, 18Fr<br>Compact Female: 8Fr, 10Fr,<br>12Fr, 14Fr, 16Fr | Male: 8Fr, 10Fr, 12Fr, 14Fr,<br>16Fr, 18Fr<br>Female: 6Fr, 8Fr, 10Fr, 12Fr,<br>14Fr, 16Fr<br>Tiemann: 10Fr, 12Fr, 14Fr,<br>16Fr<br>Pediatric: 6Fr, 8Fr, 10Fr<br>Boys: 6Fr, 8Fr, 10Fr, 12Fr | SpeediCath Compact is<br>available in size FR/CH 8-14.<br>SpeediCath Compact Plus is<br>available in FR/CH 10-14. | SE<br>Note 3 | {8}------------------------------------------------ Subject Device: Hydrophilic Intermittent Catheter Image /page/8/Picture/2 description: The image shows the word "wellead" in a bold, sans-serif font. The word is written in a blue color. The letters are closely spaced together, giving the word a compact appearance. {9}------------------------------------------------ Subject Device: Hydrophilic Intermittent Catheter Image /page/9/Picture/2 description: The image shows the word "wellead" in a bold, blue font. The letters are closely spaced together, creating a compact and unified appearance. A thin black line is visible beneath the word, adding a subtle visual separation. {10}------------------------------------------------ Subject Device: Hydrophilic Intermittent Catheter Image /page/10/Picture/2 description: The image shows the word "wellead" in blue font. The font is bold and rounded. There is a black line underneath the word. {11}------------------------------------------------ Subject Device: Hydrophilic Intermittent Catheter Image /page/11/Picture/2 description: The image shows the word "wellead" in a bold, sans-serif font. The word is in blue color. There is a black line below the word. | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Biocompatibility | Cytotoxicity Test-ISO 10993-5;<br>Intracutaneous Reactivity Test-<br>ISO 10993-23;<br>Sensitization Test-ISO 10993-<br>10;<br>Pyrogen Test-ISO 10993-11;<br>Implantation Test-ISO 10993-6.<br>Chemical characterization-ISO<br>10993-18. | Biocompatibility testing<br>according to ISO 10993-1:2009<br>and FDA Guidance "Use of<br>International Standard ISO<br>10993-1" (2016) was<br>completed. | Biocompatibility testing<br>(cytotoxicity, irritation,<br>sensitivity, pyrogenicity and<br>chemical<br>characterization) according to<br>ISO 10993-1:2009 and FDA<br>Guidance "Use of International<br>Standard ISO 10993-1" (2016)<br>was completed. | SE<br>Note 4 | | Accelerated<br>Aged shelf life<br>Test | Complies with ASTM F1980-16. | Complies with ASTM F1980-16. | Complies with ASTM F1980-16. | SE<br>Note 5 | | Sterilization | Complies with ISO 11137-<br>11137-1 and ISO 11137-2. | Complies with ISO 11137-<br>11137-1 and ISO 11137-2. | Sterilization dose setting<br>according to ISO 11137-1:2015<br>and ISO/TS 13004:2013 | SE<br>Note 6 | | Hydrophilic<br>Coating | PVP | PVP | PVP | SE | # 8. Comparison in Detail(s): #### Note 1: Although the specific language in the indication for use statement of the ent from the predicate device, both have the same intended use applications and environment. Therefore, the subject device have the same intended use. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the word "wellead" in blue font. The letters are rounded and connected to each other. The word is written in lowercase letters. There is a black line underneath the word. # Note 2: The catheter material and packaging of the subject device are same. The second predicate device was used to justify the packaging of Compact Type of the subject device. # Note 3: The outer diameters of the subject device and the predicate device are within the same range. #### Note 4: Both the subject device and the predicate have undergone biocompatibility testing based on ISO 10993-1:2009 and FDA guidelines, showing that they are substantially equivalent. # Note 5: Accelerated aging test of subject device and predicate device are in compliance with ASTM F1980-16. # Note 6: The sterilization dose confirmation of subject equipment is completed in accordance with ISO 11137-1. {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the word "wellead" in blue font. The font is sans-serif and the letters are rounded. The word is written in lowercase letters. There is a black line underneath the word. #### 9. Final Conclusion: The technological characteristics, features, sperformance testing and indication for use of the Hydrophilic Internittent Catheter support that the subject device is substantially equivalent to the predicate devices cited above. ### 10. Date of the summary prepared: March 5, 2025.