Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 17, 2019 Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404 Re: K182695 Trade/Device Name: Pigtail Ureteral Catheter Set Pigtail Ureteral Catheter Sof-Flex® AO® Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: May 9, 2019 Received: May 10, 2019 #### Dear Chelsea Woods: 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. However, you are responsible to determine that the medical devices you use as components in the kit/tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 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. for Glenn B. Bell, Ph.D. Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182695 Device Name Pigtail Ureteral Catheter Set Pigtail Ureteral Catheter Sof-Flex® AQ® Indications for Use (Describe) Indicated for drainage or irrigation in the urinary tract as well as access, advancement, or exchange of wire guides. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ K182695 Page 1 of 4 H-002-1 Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font. Below "COOK" is the word "MEDICAL" in white, sans-serif font, set against a dark red background. OOK INCORPORATED 750 DANIELS WAY OOMINGTON, IN 47404 USA 2235 TOLL FREE: 800.457,4500 WW.COOKMEDICAL.COM ### 2.0 510(k) Summary ### Pigtail Ureteral Catheter Set and Pigtail Ureteral Catheter Sof-Flex® AQ® 21 CFR §807.92 Date Prepared: May 8, 2019 #### Submitted By: Submission: Applicant: Primary Contact: Secondary Contact: Applicant Address: Primary Contact Phone: Secondary Contact Phone: Contact Fax: #### Device Information: Trade Name: Device Common Name: Regulation Name: Regulation Number: Product Code: Device Class Review Panel: Traditional 510(k) Premarket Notification Cook Incorporated Chelsea Woods Karthik Pillai Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104007 (812) 335-3575 x104929 (812) 332-0281 Pigtail Ureteral Catheter Set Pigtail Ureteral Catheter Sof-Flex® AQ® Catheter, Ureteral, Gastro-Urology Urological Catheter and accessories 21 CFR §876.5130 EYB Class II Gastroenterology/Urology #### Predicate Device: The predicate device is the AQ® Hydrophilic Urological Catheter manufactured by Cook Urological, Inc, which was cleared under K962004. #### Predicate Device: - AQ® Hydrophilic Urological Catheter (K962004) ■ #### Reference Device: - I Open-End Ureteral Catheter Sof-Flex® (K171662) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half. Below the word "COOK" is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font. The logo is simple and clean, and the red and white colors are eye-catching. COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM ## Device Description: The Pigtail Ureteral Catheter Sets consist of a catheter and wire guide. The catheters are constructed from polyurethane tubing and have a proximal female Luer lock adapter constructed from polyamide. The catheters are available in 5, 6, and 7 French (Fr) and a length of 70 centimeters (cm). The distal end of the catheter has a single pigtail loop with six sideports. The catheter has ink marks denoting depth and body orientation. The stainless steel wire guides are coated with polytetrafluoroethylene (PTFE) and available in diameters of 0.038 and 0.045 inches (in) with a length of 145 cm. The Pigtail Ureteral Catheter Sof-Flex® AO® is a catheter with a hydrophilic coating. The catheters are constructed from polyurethane tubing and have a female Luer lock adapter constructed from polyamide. The catheters are available in 8.2 and 10 Fr and have a length of 56 cm. The distal end of the catheter has a single pigtail loop with 5 evenly spaced sideports around the pigtail loop. There are also 6 sideports spaced at 1 cm intervals just proximal to the pigtail loop on the same side of the catheter. For the next 10 cm after the sideports, on the straight portion of the catheter, there are no sideports. After which, there are 9 sideports placed at 1 cm intervals spiraled around the catheter across 8 cm. The subject devices are provided sterile and are intended for one time use. ## Indications for Use: Indicated for drainage or irrigation in the urinary tract as well as access, advancement or exchange of wire guides. ## Comparison to Predicate Device: The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject devices and the predicate device include a difference in indications for use, length, and coating. Characteristics of the subject devices that differ from the predicate {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background that is shaped like a banner. COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM device are supported by testing and analysis. The substantial equivalence comparison of the subject devices to the predicate device is provided in the table below. | | Predicate Device | Subject Devices | | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | | AQ Hydrophilic Urological<br>Catheter | Pigtail Ureteral Catheter<br>Set | Pigtail Ureteral Catheter<br>Sof-Flex® AQ® | | 510(k)<br>Number | K962004 | Subject of this Submission | Subject of this Submission | | Manufacturer | Cook Urological, Inc (Merged<br>with Cook Incorporated) | Cook Incorporated | | | Regulation<br>Number | 876.5130 - Urological Catheter<br>and accessories | Identical to Predicate | | | Product Code | EYB - Catheter, Ureteral, Gastro-<br>Urology | Identical to Predicate | | | Device Class | II | Identical to Predicate | | | Indications<br>for Use | The AQ Hydrophilic Urological<br>Catheters are intended for<br>drainage, irrigation and/or<br>retrograde pyelogram. The<br>hydrophilic coating will allow the<br>catheters to become lubricious<br>which will reduce friction. | Indicated for drainage or irrigation in the urinary tract as<br>well as access, advancement or exchange of wire<br>guides. | | | Catheter<br>Diameter (Fr) | 3 - 10 | 5, 6, 7 | 8.2, 10 | | Catheter<br>Length (cm) | 70 | 70 | 56 | | Catheter<br>Material | Polyurethane, polyethylene, and<br>vinyl | Polyurethane | | | Distal End | Pigtail Coil, Straight, Flexi-Tip,<br>Whistle Tip, Round Tip,<br>Echotip®, Angled Tip, Spiral Tip,<br>Cone Tip | Pigtail Coil | | | Sideports | Sideports in coil and shaft | Identical to Predicate | | | Ink Marks | Orientation Marker | Orientation Marker,<br>Depth Marker | None | | Coating | Hydrophilic | None | Hydrophilic | | Radiopaque<br>Catheter | Yes | Identical to Predicate | | | Proximal<br>Fitting | Luer Lock Connector | Identical to Predicate | | | Wire Guide<br>Compatibility<br>(in) | 0.025, 0.038, 0.045 | 0.038 and 0.045 | 0.038 | | Set<br>Components | Catheter and Wire Guide,<br>Catheter Only | Catheter and Wire Guide | Catheter Only | | Packaging | Tyvek Pouch | Identical to Predicate | | | Sterilization | EtO | Identical to Predicate | | | SAL | 10-6 | Identical to Predicate | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The logo is simple and clean, and the red and white colors are eye-catching. COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM ## Performance Data: The following testing was performed in order to demonstrate that the subject devices, the Pigtail Ureteral Catheter Sets and Pigtail Ureteral Catheter Sof-Flex® AQ®, met applicable design and performance requirements. - I Biocompatibility - Sterilization I - Radiopacity ■ - l Visual Inspection - I Dimensional Evaluation - Wire Guide Compatibility I - Leakage ■ - Flow Rate I - Kink Radius l - l Curl Restoration - Curl Retention Strength ■ - I Tensile Strength - Dynamic Friction l ## Conclusion: The results of these tests support a conclusion that Pigtail Ureteral Catheter Sets and the Pigtail Ureteral Catheter Sof-Flex® AQ® will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device.