Single Use Electrosurgical knife

{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 & Human Services logo. To the right of that is the FDA logo, which 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 17, 2017 Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Vallev. PA 18034-0610 Re: K171158 Trade/Device Name: Single Use Electrosurgical knife Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: October 20, 2017 Received: October 23, 2017 Dear Daphney Germain-Kolawole: 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 text is black and appears to be centered on a white background. The letters are clear and easy to read, with a simple and professional appearance. 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) K171158 Device Name Single Use Electrosurgical Knife Indications for Use (Describe) These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Underneath the word is a thin, horizontal, yellow line. Below the line is the company's slogan, "Your Vision, Our Future," written in a smaller font. # 510(k) Summary April 19, 2017 ### I. General Information OLYMPUS MEDICAL SYSTEMS CORP. = Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 ■ Daphney Germain-Kolawole Official Correspondent: Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128 Email: daphney.germain-kolawole@olympus.com = Manufacturer: Aomori Olympus Co., Ltd. 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0357 Establishment Registration No.: 9614641 II. Device Identification ■ Device Trade Name: Single Use Electrosurgical knife ■ Common Name: Single Use Electrosurgical knife . Regulation Number: 876.4300 ■ Regulation Name: Endoscopic electrosurgical unit and accessories ■ Regulatory Class: II ■ Classification Panel: Gastroenterology and urology - Product Code: KNS {4}------------------------------------------------ | Single Use Electrosurgical knife | | | |-----------------------------------------------------------------|----------------------------------------|---------| | Primary Predicate Device1 | | | | Device name | Applicant | 510(k)# | | SINGLE USE<br>ELECTROSURGICAL KNIFE<br>SERIES | OLYMPUS MEDICAL<br>SYSTEMS CORPORATION | K092309 | | Additional Predicate Device2 | | | | Device name | Applicant | 510(k)# | | ERBE WaterJet Model<br>ERBEJET®2 System with<br>HybridAPC Probe | ERBE USA, INC. | K143306 | | Additional Predicate Device3 | | | | Device name | Applicant | 510(k)# | | ERBE HYBRID KNIFE | ERBE USA, INC. | K083608 | # III. Predicate Device and Reference Devices Information #### Device Description IV. The subject device is an endoscopic electrosurgical knife incorporating the saline feeding function for Endoscopic Submucosal Dissection (ESD). The indications for use of the subject device is a combination of predicate devices 1 and 2. #### V. Indications for Use These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. # VI. Comparison of Technological Characteristics Compared to the primary predicate device (KD-620LR, K092309), the subject device has a different knife shape. Additionally, the subject device incorporates the saline feeding function for ESD procedures which is an equivalent function available in both predicate device 2 (HybridAPC Probe, K143306) and predicate device 3 (ERBE HYBRID KNIFE, K083608). ## VII. Summary of non-clinical testing - Performance testing was conducted to demonstrate the essential performance of the subject device and confirmed that the subject device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the cited predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, blue font. K171158 ### <Test A> A test to evaluate the performance to cut the digestive tract mucosa and compare the result with that of the predicate device. The subject device and the primary predicate device 1 (KD-620LR, K092309) were compared for the equivalency in cutting the ex-vivo porcine digestive tract mucosa (esophagus, stomach, and colon). ### <Test B> A test to evaluate the lifting of the digestive tract mucosa and compare the size of mucosal lift with that of the predicate device. The subject device and the predicate device 3 (Hybridknife, K083608) were compared for the equivalency in lifting of the ex-vivo porcine digestive tract mucosa (esophagus, stomach, and colon). ### <Test C> A test composed of the test items "cut the mucosa" and "lift the mucosa by induction of saline to the submucosal layer" to compare the degree of thermal damage on the ex-vivo porcine digestive tract (esophagus, stomach, and colon) wall caused by the subject device and that caused by the predicate device 3 (Hybridknife, K083608). The histological study was carried out to evaluate the degree of thermal damage. <Other performance testing> - > Knife operation with the compatible endoscopes - >> Dimension of each part of the knife - > General durability - Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. - Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test. - Sterilization validation was carried out with Methods Half-cycle approach in accordance with ISO 11135:2014. - Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process' issued on June 16, 2016. - Electromagnetic compatibility, electric safety, and thermal safety had been confirmed. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a yellow line. Below the line, the words "Your Vision, Our Future" are written in a smaller font. K171158 Page 4 of 4 The following standards have been applied to the Single Use Electrosurgical knife. - > ISO 11135 - > ASTM F1980-16 - > ISO 10993-1 - > AAMI/ANSI/ISO 10993-5 - > AAMI/ANSI/ISO 10993-10 - > ISO 10993-11 - > AAMI/ANSI ES60601-1 - > IEC 60601-1-2 - > IEC 60601-1-6 - > IEC 60601-2-2 - > IEC 60601-2-18 - > ISO 14971 ### VIII. Conclusion Compared to the predicate devices, the proposed design modifications to the Single Use Electrosurgical Knife were verified and validated and do not raise any significant issues with safety and effectiveness. Therefore, the subject device is substantially equivalent to the cited predicate devices.