Who is the manufacturer of SureCath Set?

Coloplast Corp. filed the 510(k) submission for SureCath Set (K242049).

What is the FDA product code for SureCath Set?

EZD. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SureCath Set?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SureCath Set?

Conveen EasiCath Set (K973090).

Who can help prepare an FDA 510(k) submission like SureCath Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SureCath Set

K242049 · Coloplast Corp. · EZD · Nov 26, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K242049
Device Name	SureCath Set
Applicant	Coloplast Corp.
Product Code	EZD · Gastroenterology, Urology
Decision Date	Nov 26, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Device Story

SureCath Set is a sterile, single-use hydrophilic-coated intermittent catheter with an integrated urine bag; includes an internal saline ampoule. Operation: user pours saline from ampoule over catheter to activate hydrophilic coating; catheter inserted through urethra for bladder drainage. Used in clinical or home settings by patients or caregivers. Output: urine collection in integrated bag. Benefits: facilitates bladder drainage for patients with urinary retention; hydrophilic coating reduces friction during insertion. Device is manual; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993), catheter performance (ISO 20696, ASTM F623), packaging integrity (ISO 11607, ASTM D4169), and accelerated aging (ASTM F1980). Usability testing conducted per EN/IEC 62366-1.

Technological Characteristics

Materials: PVC with DEHT plasticizer, PVP hydrophilic coating, PP/PE urine bag. Dimensions: various lengths (15-34cm) and French sizes (CH 8-18). Sterilization: Ethylene Oxide (EO) over-kill. Connectivity: None. Software: None.

Indications for Use

Indicated for male, female, and pediatric patients requiring bladder drainage due to inability to promote natural urine flow or presence of significant residual urine volume following voiding.

Regulatory Classification

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).

Predicate Devices

Conveen EasiCath Set (K973090)

Reference Devices

Self-Cath and Self-Cath Plus (K221401)

Related Devices

K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT · Rochester Medical Corp. · Jun 10, 2004
K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter · Convatec Limited · Jun 22, 2022
K110862 — VAPRO PLUS INTERMITTENT CATHETER · Hollister Incorporated · Apr 26, 2011
K251178 — Ready to use Nelaton Catheter · Jamjoom Fullcare Corporation · Jan 2, 2026
K192904 — SpeediCath Compact Set · Coloplast · Nov 2, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 26, 2024 Coloplast Corp Vallabha Tantry Senior Regulatory Specialist 1601 West River Road North Minneapolis, Minnesota 55441 Re: K242049 > Trade/Device Name: SureCath Set Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 12, 2024 Received: October 30, 2024 Dear Vallabha Tantry: 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. {1}------------------------------------------------ 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). Your device is also subject to, among other requirements, the Quality System (OS) 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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) #### K242049 Device Name SureCath Set ### Indications for Use (Describe) The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue text. To the right of the logo, there is the text "K242049" and "Page 1 of 7". The text indicates that this is the first page of a document that is seven pages long. # TRADITIONAL 510(K) SUMMARY | Submitted by: | Coloplast A/S Holtedam1 3050 Humlebaek Denmark | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Vallabha Tantry Sr. Regulatory Affairs Specialist Coloplast 1601 West River Road North Minneapolis MN 55411 Phone: +1 (612)-806-1798 Email: usvtan@coloplast.com | | Date of Summary: | July 12, 2024 | | Subject Device: | | | Trade or Proprietary Name: | SureCath Set | | Item/Model Numbers: | 28012, 28013, 28001, 28002, 28003, 28004, 28014, 28005 / 28005S, 28006 / 28006S, 28007 / 28007S, 28008 / 28008S, 28009 / 28009S, 28010, 28017, 28018, 28019, 28026 / 28026S, 28027 / 28027S, 28028 / 28028S, 28029 / 28029S | | Common Name: | Urological catheter and accessories | | Regulation/Classification Name: | Gastroenterology and Urology | | Regulation Number: | 21 CFR 876.5130 | | Product Code: | EZD | {5}------------------------------------------------ | Review Panel: | Gastroenterology/Urology | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device: | K973090, Conveen EasiCath Set. The predicate device has not been subject of a design-related recall. | | Reference Device: | K221401, Self-Cath and Self-Cath Plus The reference devices have not been subject to a design-related recall. | | Device Description: | SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use. | | Indications for Use: | The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. | ## Technological Characteristics Comparison ## The table below summarizes the technological characteristics of SureCath Set as compared to the predicate device. | Parameter | Subject device | Predicate device | Reference Device | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SureCath Set | Conveen EasiCath Set | Self-Cath and Self-Cath Plus | | 510(k) Number | Unassigned | K973070 | K221401 | | Regulation Name | Gastroenterology and Urology | Gastroenterology and Urology | Gastroenterology and Urology | | Regulation Number | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | | Product Code | EZD | EZD KNX | EZD (Self-Cath) EZL (Self-Cath Plus) | | Classification | II | II | II | | Parameter | Subject device | Predicate device | Reference Device | | | SureCath Set | Conveen EasiCath Set | Self-Cath and Self-Cath Plus | | Prescription Device | Yes | Yes | Yes | | Intended Use | Intermittent catheterization through the urethra. | Intermittent catheterization through the urethra. | The product is intended for intermittent catheterization through the urethra | | Indications for Use | The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode. | The Conveen EasiCath Set is indicated for use by patients for intermittent Catherization for the purpose of bladder drainage. | Self-Cath and Self- Cath Plus are intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. The devices are indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder- voiding episode. | | Condition of Use | Intermittent use and single use | Same | Same | | Device Categorization per ISO 10993 | Surface contacting device in contact with mucosal membrane for a prolonged duration of time (24 h < t< 30 days) | Same | Same | | Sterility | SAL 10-6 | Same | Same | | Sterilization Method | Ethylene Oxide (EO), Half cycle, Over-kill | Same | Same | | Shelf Life | 24 months at time of submission (planned 36 months) | 36 months | 24 months | | Parameter | Subject device | Predicate device | Reference Device | | | SureCath Set | Conveen EasiCath Set | Self-Cath and Self-Cath Plus | | Catheter Materials | Polyvinyl chloride, DEHT | Polyvinyl chloride, DEHP | Same | | Hydrophilic Coating | Polyvinylpyrrolidone (PVP) with DEHT | Polyvinylpyrrolidone (PVP) with DBP | Polyvinylpyrrolidone (PVP) (Self-Cath Plus) | | Tip Configuration | Nelaton tip and Tiemann tip | Nelaton tip | Straight tip Olive Coudé tip Tapered Coudé tip | | Urine bag material | Polypropylene (PP) (bottom film of the urine bag) Polyethylene (PE) | Same | Not applicable | | Ampoule | The product is supplied with an ampoule containing sterile water for lubrication of the catheter. The ampoule is placed inside the urine bag. | Same | None | | Connector | Polyvinyl chloride (PVC) compound containing different masterbatch colours and Bis(2-ethylhexyl) terephthalate plasticizer (DEHT) | Polyvinyl chloride (PVC) compound containing different masterbatch colours and DEHP | Polyvinyl chloride (PVC) compound containing different masterbatch colours and Bis(2-ethylhexyl) terephthalate plasticizer (DEHT) | | Primary Packaging Description | Foil pouch which provides identification of a used product | Same | Same | | Parameter | Subject device | Predicate device | Reference Device | | | SureCath Set | Conveen EasiCath Set | Self-Cath and Self-Cath Plus | | Packaging Materials | Polyethylene terephthalate (PET) / Polyethylene (PE) Uncoated medical paper | Same | Coated polyolefin Ultra-low-density polyethylene/Ethylene-vinyl acetate | | Effective Catheter Length | Male (CH 8 - 18) 34cm / 13.4in Paediatric(CH 8 – 10) 15cm / 5.8 in Female (CH 8 – 16) 15cm / 5.8 in | Same | Male: 14.9 inches (38 cm) Female: 4.8 inches (12 cm) Pediatric (CH05, CH06): 8.0 inches (20 cm) Pediatric (CH08 and CH 10): 8.1 inches (21 cm) | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Coloplast logo on the left side. On the right side, the text "K242049 Page 3 of 7" is visible. The logo consists of a blue sphere with horizontal lines on top of it, followed by the word "Coloplast" in blue. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue. To the right of the logo, there is the text "K242049" and "Page 4 of 7". The text appears to be a page number or document identifier. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic to the left of the word "Coloplast" in blue font. To the right of the logo is the text "K242049 Page 5 of 7" in black font. The text indicates that this is page 5 of a 7-page document with the identifier K242049. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the Coloplast logo on the left side. On the right side of the image, the text "K242049 Page 6 of 7" is visible. The logo consists of a blue circle with white horizontal lines inside and the word "Coloplast" in blue bold letters. # Summary of Non-Clinical Performance Testing | Non-clinical test summary: | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility: | ISO 10993-1:2018, 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: Tests for in vitro cytotoxicity ISO 10993-7: 2008: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals ISO 10993-10: 2023: Biological evaluation of medical devices - Part 10: Tests for skin sensitization ISO 10993-11: 2017: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 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 Coloplast Test Strength of connection between the catheter and the urine bag Coloplast Test Method Aseptic insertion (non-touch approach) of catheter through urine bag Coloplast Test Method for water amount of 20 ml in ampoule must activate coating on catheter Coloplast Test Method Friction of the coated catheter after 30 seconds activation time Coloplast Test Method Tearing and emptying of the urine bag Coloplast Test Method Volume of the urine bag Coloplast Test Method Strength of the urine bag EN/IEC 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices | | | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. | | Packaging: | ISO 11607-1:2020, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems DS EN ISO 20696: 2018, Sterile urethral catheters for single use ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment. | | Aging: | ASTM F1980-21 Standard guide for accelerated aging of sterile barrier systems and medical devices | | The stability study investigated whether there were unexpected (significant) changes in product properties over the shelf-life of the device. The properties meet the acceptance criteria after the aging cycle, the device is therefore deemed to be stable for the defined shelf life. | | {10}------------------------------------------------ ## Conclusion The performance testing demonstrates the subject device is as safe and effective as the predicate device.