GentleCath Intermittent Urinary Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. November 21, 2017 ConvaTec Limited Hannah Sharp Regulatory Affairs Specialist First Avenue, Deepside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom Re: K172924 > Trade/Device Name: GentleCath™ Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: September 26, 2017 Received: September 28, 2017 Dear Hannah Sharp: 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. 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. {1}------------------------------------------------ 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The name is written in black and is centered on a white background. The letters are clear and easy to read. The image is simple and straightforward, with the focus on the name. Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K172924 Device Name GentleCath™ Intermittent Urinary Catheter Indications for Use (Describe) Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra. | 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) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 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 Druq 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." {3}------------------------------------------------ K172924 Page 1 of 11 Image /page/3/Picture/1 description: The image features the ConvaTec logo, which consists of a blue circular icon with a white building symbol inside, followed by the text "ConvaTec" in a matching blue color. A light blue curved line extends from the logo, adding a subtle design element to the composition. The overall design is clean and professional, suggesting a corporate or institutional identity. ### Section 5 510(k) Summary Applicant: ConvaTec Limited. Applicant Address: ConvaTec Limited (GDC), First Avenue, Deeside Industrial Park, Deeside, Flintshire, CH5 2NU, UK The Establishment Registration number is 1000317571 Contact: Hannah Sharp Regulatory Affairs Specialist ConvaTec Limited (GDC) First Avenue, Deeside industrial Park Deeside Flintshire, CH5 2NU UK Tel: +44(0) 1244584145 Date Prepared: 20th October 2017 Device Identification: Trade Name: GentleCath™ Intermittent Urinary Catheter. Common Name: Catheter, urethral Regulation Number: 21 CFR §876.5130 Classification Panel: Gastroenterology and Urology Classification Name: Urological Catheter and accessories Regulatory Class: II Product Code: KOD {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the ConvaTec logo. The logo consists of a blue circle with a white building icon inside, followed by the word "ConvaTec" in blue sans-serif font. The building icon has three columns and a roof, resembling a classical building. ## Product Reference: 419800, 501002, 501003, 501004, 501005, 501006, 501011, 501006, 501011, 501012, 501013, 501014, 501015, 501016, 501019, 501020, 501021, 501022, 501023 ## Predicate Devices: Primarv Predicate: 510(K) number: K140953-GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter Secondary Predicate: 510(k) number: K100878-Self-Cath® Intermittent Urinary Catheter ### Device Description The GentleCath™ Intermittent Urinary Catheter is labelled as a single use, sterile device and is sterilized by Ethylene Oxide to a Sterility Assurance Level of 10°6 A urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. tip/distal end of the tube is inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. Both components of the device are made using Polyvinyl chloride (PVC) as base material and bonded with Cyclohexanone. The products are designed for transient use only and are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH16, CH18. An increasing Charrière corresponds to a larger external diameter. ### Indication for Use GentleCath™ Intermittent Urinary Catheter are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra. The Indications for Use statement for the GentleCath™ Intermittent Urinary Catheter is identical to the primary predicate, GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter but differs from the Secondary Predicate, Self-Cath® Intermittent Urinary Catheter. Self-Cath® Intermittent Urinary Catheters do not state a usage duration, however, the differences do not alter the intended therapeutic use of the devices nor do they affect the safety and effectiveness of the devices relative to the predicate. Both the subject and predicate devices have the same intended use for bladder drainage. ### Intended Use Population GentleCath™ Intermittent Urinary Catheter is intended for male, female and paediatric patients (children, adolescents and transitional adolescents). {5}------------------------------------------------ Image /page/5/Picture/1 description: The image features the logo of ConvaTec, a global medical products and technologies company. The logo consists of a blue circular icon on the left, containing a stylized image of a building with three columns. To the right of the icon is the company name, "ConvaTec," rendered in a bold, sans-serif typeface, also in blue. The overall design is clean and modern, reflecting the company's focus on innovation and healthcare solutions. # Comparison of the Technological Characteristics with the Predicate Devices. Intermittent bladder drainage is the technological principle for both the subject and predicate devices. It is based on the use of an intermittent catheter facilitating bladder drainage when required by the end user. The subject device and predicate devices are based on the following same technological elements: - All products inserted through urethra ● - Singe use products - Intended for intermittent catheterization ● - Device configuration is the same, consisting of a tube and connector with funnel - Use of Ethylene Oxide as sterilization method ● - Same colour coding of connectors . - All devices are uncoated catheters . The following technological differences exist between the subject and predicate devices. - Use of different plasticizer (DEHP) within secondary predicate device . # Performance Testing - Bench Details relating to performance testing of the subject device and the two predicate devices can be found in section 18 of this submission. The following comparison tests were performed to demonstrate equivalence: 1)Flow Rate 2)Catheter Tensile properties 3)K Dimension The laboratory testing shows the GentleCath™ Intermittent Urinary Catheter performs similarly to the predicate devices. All the results are similar or superior for the GentleCath™ Intermittent Urinary Catheter. Therefore, the testing has demonstrated substantial equivalence of the GentleCath™ intermittent Urinary Catheter to predicate devices. # Substantial Equivalence Conclusion It has been demonstrated through comparison of design features and performance testing, that the proposed device and its predicates are substantially equivalent; see following pages. The bench testing performed on the subject device and the predicate devices supports the safety of the devices, this demonstrates that the GentleCath™ Intermittent Urinary Catheter should perform as intended. This data demonstrates that the subject device performs comparably to the predicate devices that are currently marketed for the same intended use. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the ConvaTec logo. The logo consists of a blue icon on the left and the word "ConvaTec" in blue on the right. The icon appears to be a stylized building with three columns. # Substantial Equivalence Discussion ConvaTec Limited has been manufacturing intermittent urinary catheters for several decades, dating back to the clearance of K896729- Nelaton, Female or Tiemann Catheter determined substantially equivalent on 500. The catheters associated with K896729 are essentially the same product as the subject device, GentleCath™ Internittent Urinary Catheter. The key difference between the products listed in K896729 and those covered within this submission are the materials of construction, namely the use of DEHT plasticizer as opposed to DEHP. The following table compares the similarities and differences between the subject, GentleCath™ Intermittent Urinary Catheter, and the predicate devices, GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter (ref; K140553, determined substantially equivalent on 1* August 2014) and Self-Cath® Intermittent Urinary Catheter (ref; K100878, determined substantially equivalent on 26th May 2010) and outlines the product characteristics and specifications which form the basis of the substantial equivalence discussion. The intended use, technological characteristics and principles of operation of the GentleCath™ Intermittent Urinary Catheter remains the same as those of the predicate devices. | | Subject Device | Comparison | | | | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | FDA Product<br>Code | KOD | KOD | EZD | GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter are classified<br>under the product<br>code "KOD-Catheter,<br>Urological" | Self-Cath®<br>Intermittent Urinary<br>Catheter has been<br>classified under the<br>product code "EZD-<br>Catheter, Straight",<br>however Coudé tip<br>catheters are also<br>included within<br>submission<br>K100878. | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | FDA<br>Classification<br>Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are the<br>same classification<br>Regulation Number. | None. | | Regulatory<br>Class | Class II | Class II | Class II | All devices are the<br>same classification. | None. | | Intended<br>Use/<br>Indication for<br>Use | Catheters are intended for<br>routine short term<br>drainage of the bladder.<br>The catheter is inserted<br>through the urethra. | Catheters are intended for<br>routine short term drainage of<br>the bladder. The catheter is<br>inserted through the urethra. | Intended for use in patients<br>requiring bladder drainage as<br>determined by their<br>physician. | All devices are<br>intended for bladder<br>catheterization<br>through the urethra. | Self-Cath®<br>Intermittent Urinary<br>Catheters do not state<br>a usage duration. | | Cautions | For single use<br>Discard after use<br>Prescription only | For single use<br>Discard after use<br>Prescription only | For single use<br>Discard after use<br>Prescription only | All devices carry the<br>same cautions. | None. | | Method of<br>Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | All devices are<br>sterilized by Ethylene<br>Oxide. | None. | | Functional<br>configuration | A tube and connector with<br>funnel | A tube and connector with<br>funnel | A tube and connector with<br>funnel | All devices are to<br>same configuration. | None. | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | Tube | PVC material with DEHT<br>plasticizer | PVC material with DEHT<br>plasticizer | PVC material with DEHP<br>plasticizer | GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary | Materials for<br>GentleCath™ have<br>been replaced to<br>switch DEHP<br>plasticizer to DEHT.<br>The plasticizer used | | Connector | PVC material with DEHT<br>plasticizer and pigment | PVC material with DEHT<br>plasticizer and pigment | PVC material with DEHP<br>plasticizer | Catheter are<br>manufactured with the<br>same materials. | for the Self-Cath®<br>Intermittent Urinary<br>Catheter is DEHP. The<br>solvent and lubricant | | Solvent | Cyclohexanone | Cyclohexanone | Unknown | | used for the<br>manufacture of Self-<br>Cath® Intermittent<br>Urinary Catheter is<br>unknown. | | Lubricant for<br>tip end | Pluronic RPE non-ionic<br>surfactant | Pluronic RPE non-ionic<br>surfactant | Unknown | | | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | Length<br>(Inches) | Male: 16"<br>Female: 6.5" | Male: 16" | Male: 16"<br>Female: 6"<br>Pediatric: 10" | The length of the male<br>catheters available in<br>all devices is 16". The<br>length of the female<br>catheters within the<br>for GentleCath™<br>Intermittent Urological<br>Catheter range and<br>the Self-Cath®<br>Intermittent Urinary<br>Catheter range are<br>both a standard length<br>for female catheters.<br>Lengths in compliance<br>with EN<br>ISO1616:1997. | The Self-Cath®<br>Intermittent Urinary<br>Catheter is available in<br>a specific 10", CH05<br>pediatric size.<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Catheter is<br>only available as a<br>male product. | | French/<br>Charrière<br>(FR/CH)<br>Size | Devices are delivered in<br>CH/FR sizes from CH08 to<br>CH18 | Devices are delivered in<br>CH/FR sizes from CH08 to<br>CH18 | Devices are delivered in<br>CH/FR sizes from CH05 to<br>CH18 | The same FR/CH<br>range is available for<br>GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter. | | | Connector<br>color<br>differences<br>between<br>sizes | CH08 - blue<br>CH10 - black<br>CH12 - white<br>CH14 - green<br>CH16 - orange<br>CH18 - red | CH08 - blue<br>CH10 - black<br>CH12 - white<br>CH14 - green<br>CH16 - orange<br>CH18 - red | CH08 - blue<br>CH10 - black<br>CH12 - white<br>CH14 - green<br>CH16 - orange<br>CH18 - red | The same colour<br>coding for the<br>connectors is applied<br>across all products. | None. | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | Catheter<br>tube -outer<br>diameter<br>(mm) | CH08 - 2.6<br>CH10 - 3.33<br>CH12 - 4.00<br>CH14 - 4.67<br>CH16 - 5.33<br>CH18 - 6.00 | CH08 - 2.67<br>CH10 - 3.33<br>CH12 - 4.00<br>CH14 - 4.67<br>CH16 - 5.33<br>CH18 - 6.00 | CH08 - 2.66<br>CH10 - 3.29<br>CH12 - 4.16<br>CH14 - 4.65<br>CH16 - 5.37<br>CH18 - 5.99 | The diameters of<br>GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip | The diameters of the<br>Self-Cath®<br>Intermittent Urinary<br>Catheter can be<br>considered<br>substantially | | Catheter<br>tube -inner<br>diameter<br>(mm) | CH08 - 1.65<br>CH10 - 2.25<br>CH12 - 2.65<br>CH14 - 3.25<br>CH16 - 3.65<br>CH18 - 4.30 | CH08 - 1.65<br>CH10 - 2.25<br>CH12 - 2.65<br>CH14 - 3.25<br>CH16 - 3.65<br>CH18 - 4.30 | CH08 - 1.65<br>CH10 - 2.15<br>CH12 - 2.60<br>CH14 - 3.10<br>CH16 - 3.65<br>CH18 - 4.30 | Intermittent Urinary<br>Catheter are the<br>same. | equivalent to the<br>diameter of<br>GentleCath™<br>products. | | Catheter<br>Flow Rate<br>(ml/min) | 150.5 to 1403.8 ml/min | 148.7 to 1321.5 ml/min | 115.1 to 1380.7 ml/min | All products found to<br>comply with the<br>requirements of ASTM<br>F623 -99 | GentleCath™<br>Intermittent Urological<br>Catheter has<br>demonstrated a<br>slightly higher flowrate | | Catheter<br>Tensile<br>Properties<br>(N) | 67.7 to 207.1 N | 60.7 to 203.3 N | 60.1 to 152.5 N | The tensile properties<br>of the GentleCath™<br>Intermittent Urinary<br>Catheter was found to<br>be comparable to that<br>of both predicates for<br>the strength of the<br>tube and connector<br>attachment. | Slightly greater force is<br>needed for<br>disconnection of the<br>tube and connector in<br>the subject device,<br>GentleCath™<br>Intermittent Urinary<br>Catheter. | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | K Dimension<br>(mm) | 4.7 to 8.4 mm | 5 to 7.9 mm | 5 to 8.1 mm | The coudé tip angle of<br>the GentleCath™<br>Intermittent Urinary<br>Catheter was found to<br>be comparable to that<br>of predicate devices. | The K Dimension of<br>subject device and<br>predicate devices can<br>be considered<br>substantially<br>equivalent. | | Tube surface | Uncoated | Uncoated | Uncoated | All devices are<br>uncoated catheters. | None. | | Eyelets | Smooth eyelet edges | Smooth eyelet edges | Smooth eyelet edges | All devices have<br>smooth eyelet edges. | None. | | Eyelet<br>position | Placed on the right and left<br>side if angled tip of catheter<br>is oriented upwards. | Placed on the right and left<br>side if angled tip of catheter is<br>oriented upwards. | Placed on the right and left<br>side if angled tip of catheter is<br>oriented upwards. | All devices have the<br>same placement of<br>the eyelets. | None. | | Eyelet size -<br>width<br>(mm) | CH08 - 1.65<br>CH10 - 2.25<br>CH12 - 2.65<br>CH14 - 3.25<br>CH16 - 3.65<br>CH18 - 4.30 | CH08 - 1.65<br>CH10 - 2.25<br>CH12 - 2.65<br>CH14 - 3.25<br>CH16 - 3.65<br>CH18 - 4.30 | CH08 - 0.97<br>CH10 - 1.09<br>CH12 - 1.07<br>CH14 - 1.57<br>CH16 - 2.18<br>CH18 - 2.67 | The dimension of the<br>GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter eyelets are<br>the same. | The dimension of the<br>Self-Cath®<br>Intermittent Urinary<br>Catheter eyelets are<br>slightly smaller than<br>those of the<br>GentleCath™<br>products. | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | Eyelet size -<br>length<br>(mm) | CH08 - 2.50<br>CH10 - 3.40<br>CH12 - 3.70<br>CH14 - 4.35<br>CH16 - 5.40<br>CH18 - 5.90 | CH08 - 2.50<br>CH10 - 3.40<br>CH12 - 3.70<br>CH14 - 4.35<br>CH16 - 5.40<br>CH18 - 5.90 | CH08 - 2.01<br>CH10 - 2.89<br>CH12 - 3.70<br>CH14 - 4.22<br>CH16 - 4.48<br>CH18 - 5.03 | The dimension of the<br>GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter eyelets are<br>the same. | The dimension of the<br>Self-Cath®<br>Intermittent Urinary<br>Catheter eyelets are<br>slightly smaller than<br>those of the<br>GentleCath™<br>products. | | Tip end | Angled (without ball) | Angled (with ball) | Angled (without ball) | All devices include an<br>angled tip variant. | GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter is the only<br>device that has a ball<br>(Olive) at the end of<br>the catheter. | | | Straight (without ball) | N/A | Straight (without ball) | The GentleCath™<br>Intermittent Urological<br>Catheter and Self-<br>Cath® Intermittent<br>Urinary Catheter are<br>both available in a<br>straight tip variant. | The GentleCath™<br>Male Coudé Olive Tip<br>Intermittent Urinary<br>Catheter is only<br>available in an angled<br>tip. | | | Subject Device | Comparison | | | | | Parameter | GentleCath™ Intermittent<br>Urological Catheter | Primary Predicate:<br>GentleCath™ Male Coudé<br>Olive Tip Intermittent Urinary<br>Catheter (K140953) | Secondary Predicate:<br>Self-Cath® Intermittent<br>Urinary Catheter (Coloplast)<br>(K100878) | Similarities | Differences | | Coudé<br>indicator | The connector has an<br>indicator which shows the<br>orientation of the coudé tip<br>after insertion into the<br>body | The connector has an<br>indicator which shows the<br>orientation of the coudé tip<br>after insertion into the body | A blue line on the tube shows<br>the orientation of the coudé<br>tip after insertion into the<br>body | The indicator on<br>GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter is on the<br>connector component<br>of the catheter. | The indicator on the<br>Self-Cath®<br>Intermittent Urinary<br>Catheter is located on<br>the tube component of<br>the catheter. | | Packaging | Chevron package<br>comprising medical grade<br>paper and film, Corrugated<br>board inner. Corrugated<br>board outer case. | Chevron package comprising<br>medical grade paper and film,<br>Corrugated board inner.<br>Corrugated board outer case. | Peel pack comprises paper<br>and film. Corrugated board<br>inner. Corrugated board outer<br>case. | The same materials<br>are used to package<br>the GentleCath™<br>Intermittent Urological<br>Catheter and<br>GentleCath™ Male<br>Coudé Olive Tip<br>Intermittent Urinary<br>Catheter. | The Self-Cath®<br>Intermittent Urinary<br>Catheter is packaged<br>in a paper/poly peel<br>pack but the exact<br>materials are<br>unknown. | {7}------------------------------------------------ # ac 111 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image features the ConvaTec logo. The logo consists of a blue circular icon with a white stylized building with three columns inside. To the right of the icon is the company name "ConvaTec" in a bold, sans-serif blue font. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for ConvaTec. The logo consists of a blue icon resembling a building with three columns, followed by the word "ConvaTec" in a blue sans-serif font. The text is slightly blurred, suggesting the image may be a screenshot or a low-resolution version of the logo. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for ConvaTec. The logo consists of a blue circle with a white building icon inside, followed by the word "ConvaTec" in blue. The building icon appears to be a government building or a museum. {11}------------------------------------------------ Image /page/11/Picture/1 description: The image contains the logo for ConvaTec. The logo consists of a blue icon resembling a building with columns, followed by the word "ConvaTec" in a blue sans-serif font. The icon is positioned to the left of the text, creating a unified brand representation. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the ConvaTec logo. The logo consists of a blue circle with a white image of a building with three columns inside. To the right of the circle is the word "ConvaTec" in blue, with the "C" capitalized. {13}------------------------------------------------ Image /page/13/Picture/1 description: The image contains the logo for ConvaTec. The logo consists of a blue circle with a white image of a building with columns inside of it. To the right of the circle is the name "ConvaTec" in a blue, sans-serif font.