ClearEndoclip

{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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". October 5, 2020 Finemedix Co., Ltd. % Kyungyoon Kang CEO K-Bio Solutions 589 Oakwood Drive Santa Clara, CA 95054 Re: K200217 Trade/Device Name: ClearEndoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL, FHN, MND Dated: August 26, 2020 Received: September 1, 2020 Dear Kyungyoon Kang: 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 {1}------------------------------------------------ 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 (OS) 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200217 Device Name ClearEndoclip Indications for Use (Describe) ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for - (1) Endoscopic marking - (2) Hemostasis for - (a) Mucosal/sub-mucosal defects < 3cm - (b) Bleeding ulcers - (c) Arteries < 2 mm - (d) Polyps < 1.5 cm in diameter - (e) Diverticula in the colon - (3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively 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. 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}------------------------------------------------ ## 510(k) SUMMARY #### I. SUBMITTER Company: Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu, Daegu Postal code: 41065, Republic of Korea Tel: 82-053-741-8388 Fax: 82-053-741-8168 510(k) Correspondent: Kyungyoon Kang, CEO: K-Bio Solutions (Tel: 812-345-7485, Kyungyoon.kang@kbiotechsolutions.com) Manufacturer Contact: Heon-Sik Lee, RA Manager, Finemedix (hslee@finemedix.com) Date Prepared: September 30th , 2020 #### II. DEVICE Trade Name: ClearEndoclip Common Name: Endoscopic Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Product Code: PKL (hemostatic metal clip for the GI tract), FHN (ligator, hemorrhoidal), MND (ligator, esophageal) Regulatory Class: II #### III. PREDICATE DEVICE Predicate Device: ClearEndoclip (K183021), Manufacturer: Finemedix Co., Ltd. This predicate has not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is preloaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow {4}------------------------------------------------ for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths. ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope. | Component Name | Function | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clip | | | Clip | It is detached from the Inner Sheath and holds the tissue by physical<br>force and fixes it to perform hemispheres, indication of lesion and<br>treatment of perforation substantially for the user's intended purpose. | | Clip Ring | The clip ring moves according to the slider forward / backward. The<br>Clip is opened / closed by the Clip Ring, and when the Slider is pushed<br>all the way, the Clip is clamped. | | Delivery System/Clip Fixing Device | | | Inner Sheath (Coil) | The Clip is attached to the end of the Inner Sheath and is connected to<br>the handle to transmit the force and movement from the handle to the<br>Clip. | | Outer Sheath<br>(Polyethylene<br>Catheter Tube) | A plastic wrapping around the Inner Sheath and Clip helps protect the<br>endoscope channel. | | Tube Joint | When using the product, the outer sheath moves forward and backward<br>to expose the clip from the outer sheath, and to recover the inner sheath<br>into the outer sheath when the product is recovered. | | Stopper | It prevents the outer sheath from moving in the direction of Handle<br>when the product is moved and stored, thereby preventing the clip from<br>opening. | | Slider | It is used for open/close and detachment of clip. | | Handle | It serves to fix this device with user's hand | Functional Descriptions for Critical Components of ClearEndoclip As far as the raw material compositions are concerned, Clip of ClearEndoclip is constructed with stainless steel material and deployed from the delivery system during the clinical use. ClearEndoclip is engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. {5}------------------------------------------------ #### V. INDICATIONS FOR USE ClearEndoclip is intended to be used with FDA-cleared endoscope for endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for - (1) Endoscopic marking - (2) Hemostasis for - (a) Mucosal/sub-mucosal defects < 3cm - (b) Bleeding ulcers - (c) Arteries < 2 mm - (d) Polyps < 1.5 cm in diameter - (e) Diverticula in the colon - (3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel - (4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDI VI. CATE DEVICE Fundamental technological characteristics of the ClearEndoclip are the same as those of the predicate device, ClearEndoclip. The operation principle, clinical applications, and instructions for use of the ClearEndoclip is the same as the predicate device, as both devices are used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract by placing an endoscopic clip for the purpose of achieving hemostasis for gastrointestinal bleeding. Both the proposed and predicate devices are provided sterile with ethylene oxide sterilization and used for single use only. Both the proposed and predicate devices consist of the endoscopic clip, which gets physically deployed and placed as hemostatic purpose clip in the patient's gastrointestinal tract and the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope. The clinical application and operation principle of the proposed, ClearEndoclip are the same as the predicate device as the stainless mechanical clipping device is used in endoscopy in order to close two mucosal surfaces without the need for surgery or suturing. For both the proposed ClearEndoclip and predicate device, from the mechanical operation- point of view, the endoscopic clipping function is similar to a suture in gross surgical hemostatic applications as it is used to join together disjointed mucosal surfaces that lead to bleeding, however, ClearEndoclip can be applied through the channel of an endoscope under direct visualization, based upon the same clinical and operation principle as the predicate device. Both ClearEndoclip and predicate device consist of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope. {6}------------------------------------------------ Using the delivery system (a clip fixing device) that utilizes the same technological characteristics as the predicate device, in terms of the delivery mechanism to facilitate release of the endoscopic clip. the Delivery System is designed to control closing and re-opening of the endoscopic clip. As the same as the predicate device, a clip of ClearEndoclip is pre-loaded in its Delivery System (clip fixing device), connected with an operation wire. The manipulation mechanism of opening or closing the clip is also the same as the predicate device, as the ClearEndoclip will open when the handle slider placed in the delivery system (clip fixing device) is pushed and closed when the handle slide is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider of the delivery system is pulled further, the clip closes completely. The clip will be released when the slider is pushed. As demonstrated herein, the fundamental technological characteristics of ClearEndoclip including the device system construction and operation mechanism, which have been designed in order to meet the indications and user needs are the same as the predicate device. As for technological characteristics, the raw material constructions of ClearEndoclip are the same as the predicate device. The clinical application and operation principle of the proposed. ClearEndoclip are the same as the predicate device as the stainless mechanical clipping device is used in endoscopy in order to close two mucosal surfaces without the need for surgery or suturing. For both the proposed ClearEndoclip and predicate device, from the mechanical operation- point of view, the endoscopic clipping function is similar to a suture in gross surgical hemostatic applications as it is used to join together disjointed mucosal surfaces that lead to bleeding, however, ClearEndoclip can be applied through the channel of an endoscope under direct visualization, based upon the same clinical and operation principle as the predicate device. Additional MR Testing which demonstrates Finemedix ClearEndoclip will remain in place when exposed to worst case magnetically induced displacement force and torque in 3.0T MR system is being proposed in order to meet the FDA's requirements for "MR Conditional" This particular labeling update which is addressed by the additional MR testing verification does not raise different questions in terms of safety and effectiveness compared to the predicate device. | | ClearEndoclip | Predicate Device:<br>ClearEndoclip<br>(K183021) | |-----------------|----------------|-------------------------------------------------| | MRI Information | MR Conditional | MR Unsafe | The aforementioned raw material difference with the predicate device is not assessed to raise different questions of safety and effectiveness as ClearEndoclip also demonstrated its conformance to the FDA's same recognized consensus standards applied to both the predicate and reference devices. {7}------------------------------------------------ #### VII. PERFORMANCE DATA The following performance data for MR-related verification testing were provided in support of this substantial equivalence determination. | Testing | Test Objective/Standard | Result | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Magnetically<br>Induced,<br>Maximum<br>Displacement<br>Force | Evaluation of the magnetically induced<br>displacement force was completed in<br>accordance with standard, ASTM F2052-<br>15. | Pass,<br>Met criteria | | Magnetically<br>Induced<br>Maximum<br>Torque | Magnetically induced torque evaluation<br>was completed in accordance with<br>ASTM F2213-17. | Pass, Met<br>criteria | | MR Image<br>Artifact Test | MR image artifact test was completed in<br>accordance with ASTM F2119. | Pass, Met<br>criteria | | Radiofrequency<br>(RF) Induced<br>Heating | RF induced heating test was completed in<br>accordance with ASTM F2182. | Pass, Met<br>criteria | | MR Pull-off<br>Test | Evaluation of the force needed to pull the<br>ClearEndoclip off the attached tissue in<br>comparison to the maximum<br>magnetically induced force was<br>completed. | Pass, Met<br>criteria | MR Performance Testing of ClearEndoclip #### VIII. CONCLUSIONS The proposed, ClearEndoclip is assessed substantially equivalent to the predicate device given the fact that its indications for use/intended use are identical, and fundamental technological characteristics are the same as the predicate device. The favorable results of the aforementioned safety and performance testing demonstrate conformance to the appropriate recognized standards of FDA, and further demonstrate that no different questions in safety and effectiveness assessment are being raised compared to the predicate device.