ClearTip FNA and FNB Types

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 21, 2025 FINEMEDIX Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612 Re: K250994 Trade/Device Name: ClearTip FNA and FNB Types Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: July 21, 2025 Received: July 21, 2025 Dear Priscilla Chung: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250994 - Priscilla Chung Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K250994 - Priscilla Chung Page 3 assistance/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, SIVAKAMI VENKATACHALAM -S 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 {3} ClearTip FNA and FNB Types Page 7 of 31 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250994 | ? | | Please provide the device trade name(s). | | ? | | ClearTip FNA and FNB Types | | | | Please provide your Indications for Use below. | | ? | | The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum). | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K250994 Page 1 of 4 # 510(K) SUMMARY (K250994) July 18, 2025 ## 1. Submitted by: FINEMEDIX Co., Ltd. 140-9, Yuram-ro, Dong-gu, Daegu, 41059 Republic of Korea Tel: 82-53-741-8388, Fax: 82-53-741-8168 ## 2. US Agent/ Official Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com ## 3. Device Name: - Trade Name: ClearTip FNA and FNB Types - Classification: Class II - Classification Name: Gastroenterology-Urology Biopsy Instrument - Product Code: FCG - Regulation Number: 876.1075 - Review Panel: Gastroenterology/Urology ## 4. Predicate Devices: - Primary Predicate Device: ClearTip (K231267) by FINEMEDIX Co., Ltd. - Reference Device: Clear-Tip EUS-FNA (K180363) by FINEMEDIX Co., Ltd. Page 1 of 4 {5} K250994 Page 2 of 4 # 5 Device Description: The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract). The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. ClearTip is offered in various needle gauges for insertion and aspiration. The available needle gauge sizes of 19, 22, and 25 gauge. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the length of the coil sheath and the needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human gastrointestinal tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized. # 6 Indications for Use Statement The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum). # 7 Substantial Equivalence Discussion: ## 7.1. Comparison Chart | | Subject Device | Primary Predicate | Reference Device | | --- | --- | --- | --- | | Manufacturer | FINEMEDIX Co., Ltd. | FINEMEDIX Co., Ltd. | FINEMEDIX Co., Ltd. | | Device Name | ClearTip FNA and FNB Types | ClearTip | Clear-Tip EUS-FNA | | 510(k) Number | K250994 | K231267 | K180363 | | Device Classification Name | Gastroenterology-urology Biopsy instrument | Gastroenterology-urology Biopsy instrument | Gastroenterology-urology Biopsy instrument | | Product Code | FCG | FCG | FCG | | Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | 21 CFR 876.1075 | | Indications for Use | The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum). | The ClearTip is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum). | The Clear-Tip EUS-FNA is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. | | Needle Gauge | 19, 22, 25 Gauge | 22 Gauge | 19, 22, 25 Gauge | | Needle Material | Stainless Steel, Nitinol | Nitinol | Stainless Steel | | Needle length | 0~8 cm | 0~5 cm | 0~8cm | Page 2 of 4 {6} K250994 Page 3 of 4 | Adjustment range | | | | | --- | --- | --- | --- | | Stylet Material | Nitinol | Nitinol | Nitinol | | Sheath length | 1,510 mm | 738.5 mm | 1,507 mm | | Sheath Material | Stainless Steel | PEEK, PTFE | PEEK | | Sheath length Adjustment range | 0~5cm | 0~3cm | 0~5cm | | Accessory Channel Diameter | Minimum Accessory Channel Diameter (2.8 mm) | Minimum Accessory Channel Diameter (2.0 mm) | Minimum Accessory Channel Diameter (2.0 mm) | | Use with a Syringe and stopcock | Yes | Yes | Yes | | Principle of Operation | Manual (sampling using aspiration) | Manual (sampling using aspiration) | Manual (sampling using aspiration) | | Shelf life | 3 Years | 3 Years | 3 Years | | Sterility | Ethylene oxide(EO) | Ethylene oxide(EO) | Ethylene oxide(EO) | | Single use | Yes | Yes | Yes | ## 7.2. Substantial Equivalence Discussion The subject device is substantially equivalent to the predicate device in the indications for use and technical characteristics including endoscope compatibility, use with a syringe and stopcock, principle of operation, sterility, and single use. The differences are in needle gauge, needle length, adjustment range, and sheath length so we identified a reference device (K180363) which encompass the specifications. The sheath material is also different; however, we conducted biocompatibility and performance testing and the test results supports that these differences do not raise a question in safety and effectiveness. ## 8. Non-clinical Tests The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices. - Sterilization Validation - Shelf-Life Test - Appearance - Dimensions - Operability - Elasticity - Bending Strength - Pull-out - Tensile Force - Biocompatibility Tests Page 3 of 4 {7} K250994 Page 4 of 4 - Endoscope Compatibility Test ## 9. Conclusion: Based on the information provided herein and the test results, we conclude that the subject device is substantially equivalent to its predicate device. Page 4 of 4