INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Ethicon Endo-Surgery, Inc. Kimberly Shoemaker, RAC Manager, Regulatory Affairs 4545 Creek Road Cincinnati, OH 45242-2839 JUL 27 2015 Re: K051950 Trade/Device Name: InScope™ Multi-Clip Applier Regulation Number: 21 CFR § 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: MND, FHN, OCW, HBT and MCH Dated (Date on orig SE ltr): September 23, 2005 Received (Date on orig SE ltr): September 26, 2005 Dear Ms. Shoemaker, This letter corrects our substantially equivalent letter of October 7, 2005. 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 {1} 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 (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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Benjamin R. Fisher -S 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} K05/1950 # Indications for Use 510(k) Number (if known): K051950 Device Name: InScope™ Multi-Clip Applier Indications for Use: The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking, - Hemostasis for: - Mucosal and submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the colon - Anchoring to affix jejunal feeding tubes to the wall of the small bowel, - Closure of GI tract luminal perforations < 20 mm in patients where an alternative to surgery is required. Prescription Use ☑ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Sypem (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K051950 Page 1 of 1 {3} OCT 7 - 2005 K051950 Pg1 of 2 # InScope™ Multi-Clip Applier 510(k) Summary of Safety and Effectiveness ## Company INSCOPE A Division of Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242 ## Contact Kimberly Shoemaker, RAC Manager, Regulatory Affairs ## Date Prepared: July 15, 2005 ## Name of Device Trade Name: InScope™ Multi-Clip Applier Classification Name: Clip Applier/Endoscopic Clipping Device ## Predicate Devices: Trade Name: Syntheon, LLC: Endoscopic Multi-Fire Clip Applier Olympus Optical Co., Ltd.: Rotatable Clip Fixing Device HX-5/6-1 ## Device Description The InScope™ Multi-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips. {4} K051950 Pg 2 of 2 # Indications for Use The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking, - Hemostasis for: - Mucosal and submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the colon - Anchoring to affix jejunal feeding tubes to the wall of the small bowel, - Closure of GI tract luminal perforations < 20 mm in patients where an alternative to surgery is required. # Technological Characteristics The InScope™ Multi-Clip Applier does not have the identical indication statements as the predicate devices, but the differences noted do not alter the intended therapeutic/diagnostic effect. # Performance Data Results of bench and preclinical testing demonstrate that performance of the InScope Multi-Fire Clip Applier is substantially equivalent to the predicate devices in regards to hemostasis, clip retention and lack of tissue damage upon clip placement (tissue remains viable). A literature review in combination with the preclinical data demonstrates the use of the InScope Multi-Clip Applier for closure of gastrointestinal perforations, fistulas, anastomotic leaks and for control of bleeding diverticula is not likely to raise any new or increased risks to safety and effectiveness compared to risks experienced with similar marketed devices.