Instinct Plus Endoscopic Clipping Device

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March 5, 2020 Cook Endoscopy Karthik Pillai Regulatory Scientist 4900 Bethania Station Road Winston-Salem, NC 27105 Re: K192697 Trade/Device Name: Instinct Plus Endoscopic Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: January 28, 2020 Received: January 29, 2020 Dear Karthik Pillai: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 {1}------------------------------------------------ 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 Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192697 Device Name Instinct Plus Endoscopic Clipping Device Indications for Use (Describe) This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of - 1. Endoscopic marking, - 2. Hemostasis for - · Mucosal/submucosal defects less than 3 cm - · Bleeding ulcers, - · Arteries less than 2 mm, - · Polyps less than 1.5 cm in diameter, - · Diverticula in the colon, and - · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, - 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion. | 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." {3}------------------------------------------------ K192697 Page 1 of 7 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 written in white, sans-serif font, with the registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is written in white, sans-serif font, set against a black background. ### 510(k) SUMMARY COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM ### Instinct Plus Endoscopic Clipping Device 21 CFR §876.4400 Date Prepared: 4 March 2020 | Submitted By: | | |------------------------|-------------------------------------------------------| | Submission: | Traditional 510(k) Premarket Notification | | Applicant: | Cook Endoscopy (Wilson-Cook Medical, Inc) | | Applicant Address: | 4900 Bethania Station Road<br>Winston-Salem, NC 27105 | | Primary Contact: | Karthik Pillai, Ph.D., RAC | | Contact Phone Number | 812-335-3575 x104929 | | Device Information: | | | Device Name: | Instinct Plus Endoscopic Clipping Device | | Common Name: | Endoscopic Clipping Device | | Classification Number: | 21 CFR §876.4400 | | Classification Name: | Hemorrhoidal Ligator | | Product Code: | PKL | | Product Code Name: | Hemostatic Metal Clip for the Gi Tract | | Regulatory Class: | II | ### Predicate Devices: - K151802 Resolution™ 360 Clip (primary) . - K132809 Instinct Endoscopic Hemoclip (secondary) ### Device Description: The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, {4}------------------------------------------------ K192697 Page 2 of 7 or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment. The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life. ## Intended Use: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of - 1. Endoscopic marking. - 2. Hemostasis for - Mucosal/submucosal defects less than 3 cm . - Bleeding ulcers, . - Arteries less than 2 mm. . - Polyps less than 1.5 cm in diameter, . - Diverticula in the colon, and . - Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection . - 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel - 4. As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively - 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion. ### Technological Characteristics The Instinct Plus Endoscopic Clipping Device has identical or similar technological characteristics, and mode of operation compared to the predicate devices. The subject device and the predicate devices have the same Intended Use and similar Indications for Use. The comparison of technological characteristics is provided in table 1. The primary difference between the subject device and the predicates are materials, dimensions and design elements. These differences do not affect device performance as demonstrated by biological and functional testing of the subject device. {5}------------------------------------------------ K192697 Page 3 of 7 | Device<br>Characteristics | Primary Predicate<br>Resolution™ 360 Clip | Secondary Predicate<br>Instinct Endoscopic Hemoclip | Subject Device<br>Instinct Plus Endoscopic Clipping<br>Device | Comparison | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K151802 | K132809 | Subject of this submission | N/A | | Manufacturer | Boston Scientific Corporation | Wilson-Cook Medical,<br>Inc./Cook Endoscopy | Wilson-Cook Medical, Inc./Cook<br>Endoscopy | Same manufacturer as Secondary<br>Predicate | | Device Class | II | II | II | Identical | | Indications for<br>Use | The Resolution™ 360 Clip is<br>indicated for clip placement<br>within the gastrointestinal (GI)<br>tract for the purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for:<br>• Mucosal/sub-mucosal<br>defects < 3 cm<br>• Bleeding ulcers<br>• Arteries < 2 mm<br>• Polyps < 1.5 cm in<br>diameter<br>• Diverticula in the colon<br>• Prophylactic clipping to<br>reduce the risk of delayed<br>bleeding post lesion<br>resection<br>3. Anchoring to affix jejunal<br>feeding tubes to the wall of<br>the small bowel; and<br>Anchoring to affix fully<br>covered esophageal self-<br>expanding metal stents to the<br>wall of the esophagus<br>4. As a supplemental closure<br>method of luminal<br>perforations < 20 mm that<br>can be treated<br>conservatively | This device is used for<br>endoscopic clip placement<br>within the gastrointestinal tract<br>for the purpose of<br>1. Endoscopic marking,<br>2. Hemostasis for:<br>• Mucosal/submucosal<br>defects less than 3 cm in<br>the upper GI tract,<br>• Bleeding ulcers,<br>• Arteries less than 2 mm,<br>and<br>• Polyps less than 1.5 cm in<br>diameter in the GI tract.<br>This device is not intended for<br>the repair of GI tract luminal<br>perforations. | This device is used for endoscopic<br>clip placement within the<br>gastrointestinal tract for the purpose<br>of<br>1. Endoscopic marking,<br>2. Hemostasis for<br>• Mucosal/submucosal defects<br>less than 3 cm<br>• Bleeding ulcers,<br>• Arteries less than 2 mm,<br>• Polyps less than 1.5 cm in<br>diameter,<br>• Diverticula in the colon, and<br>• Prophylactic clipping to<br>reduce the risk of delayed<br>bleeding post lesion resection,<br>3. Anchoring to affix jejunal<br>feeding tubes to the wall of the<br>small bowel,<br>4. As a supplementary method for<br>closure of GI tract luminal<br>perforations less than 20mm that<br>can be treated conservatively<br>5. Anchoring to affix fully covered<br>esophageal self-expanding metal<br>stents to the wall of the<br>esophagus in patients with | Same indications for use as primary<br>predicate and added indications<br>compared to the secondary predicate.<br>The indications are identical to<br>primary predicate and do not raise<br>additional questions of safety and<br>effectiveness (S&E). | | Device | Primary Predicate | Secondary Predicate | Subject Device | Comparison | | Characteristics | Resolution™ 360 Clip | Instinct Endoscopic Hemoclip | Instinct Plus Endoscopic Clipping<br>Device | | | Packaging | Pouch | Pouch | Pouch | Identical | | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical | | Shelf Life | 3 years | 3 Years | 1 year | The subject device is supported for a<br>shelf life of one year. | | Configuration | Delivery system and clip | Delivery system and clip | Delivery system and clip | Identical | | MR Conditional | Yes | Yes | Yes | Identical | | | | Clip | | | | Number of<br>Prongs | 2 | 2 | 2 | Identical | | Jaw Width | 11 mm | 16 mm | 16 mm | The jaw width of the open clip is<br>larger than primary predicate, and<br>identical to the secondary predicate.<br>This difference does not affect S&E. | | Clip Geometry | Cylindrical housing, rounded<br>arms with serrated tip | Cylindrical housing, flat arms<br>with serrated tip | Cylindrical housing, rounded arms<br>with serrated tip | Clip geometry is identical to the<br>primary predicate, but slightly<br>different than the secondary predicate.<br>No effect on S&E. | | Number of<br>Open-Close<br>Cycles Prior to<br>Deployment | 5 | 5 | 5 | Identical | | Handle<br>Controlled Clip<br>Rotation | Yes | Yes | Yes | Identical | | Material | Stainless steel, Cobalt chrome<br>and Styrene | Stainless-steel and Nitinol | Stainless-steel, Delrin, and Nitinol | Difference in material evaluated by<br>biological and performance testing<br>and shown not to affect S&E. | | | | Introducer | | | | Working length | 155, 235 cm | 230 cm | 230 cm | Subject device only sold in one device<br>length which is similar to the larger<br>size of primary predicate and identical<br>in length to secondary predicate | | Device<br>Characteristics | Primary Predicate<br>Resolution™ 360 Clip | Secondary Predicate<br>Instinct Endoscopic Hemoclip | Subject Device<br>Instinct Plus Endoscopic Clipping<br>Device | Comparison | | Introducer<br>Diameter<br>(nominal) | 7 Fr | 7 Fr | 7 Fr | Identical | | Minimum<br>Working<br>Channel of<br>Endoscope | 2.8 mm | 2.8 mm | 2.8 mm for forward viewing<br>endoscope, and 4.2 mm for side-<br>viewing endoscope | The subject device has been evaluated<br>for compatibility with side-viewing<br>endoscopes and found to be<br>compatible with scopes with at least a<br>4.2 mm working-channel. | | Material:<br>Introducer Coil<br>Spring | Stainless steel | Stainless Steel, Polyether block<br>polyamide copolymer | Stainless steel, Polyether block<br>polyamide copolymer | | | Drive Wire | Stainless steel | Nitinol | Nitinol, polyarylamide | Difference in material evaluated by<br>biological testing and performance<br>testing and shown not to affect S&E. | | Material:<br>Handle | Thermoplastic elastomers,<br>polyethylene and polyester | Polystyrene, polypropylene and<br>polycarbonate | Polystyrene, polypropylene and<br>polycarbonate | | # Table 1. Comparison between predicates and the subject device {6}------------------------------------------------ K192697 Page 4 of 7 {7}------------------------------------------------ K192697 Page 5 of 7 #### Performance Data: Performance testing was conducted to meet the following design input requirements: - 1. Sterility - 2. Packaging - 3. Biocompatibility - 4. Advance device into the GI tract through a compatible endoscope - 5. Position and approximate target site - 6. Deploy clip onto targeted GI tissue - 7. Removal of device from the endoscope - 8. Force of clip retention at tissue - 9. Force of clip compression at tissue - 10. Strength of clip assembly - 11. Strength of clip housing - 12. MRI Testing {8}------------------------------------------------ K192697 Page 6 of 7 13. Corrosion testing 14. Force to deploy clip on tissue handle {9}------------------------------------------------ K192697 Page 7 of 7 - 15. Strength of Introducer Coil Cath - 16. Strength of Handle and Drivewire # Conclusion: The results of these tests provide reasonable assurance that the Instinct Plus Endoscopic Clipping Device met the design input requirements based on the intended use. The subject device does not raise new questions of safety or effectiveness as compared to the predicate devices.