Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION October 24, 2025 Olympus Medical Systems Corp. % Jillian Connery Program Manager RA Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581 Re: K252646 Trade/Device Name: Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: August 15, 2025 Received: August 21, 2025 Dear Jillian Connery: 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} K252646 - Jillian Connery 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} K252646 - Jillian Connery 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} | 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. | K252646 | ? | | Please provide the device trade name(s). | | ? | | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | | | | Please provide your Indications for Use below. | | ? | | The Single-use Fine Needle Biopsy (FNB) device NA-U210H has been designed to be used with an ultrasound endoscope for sampling of submucosal and extramural lesions within or adjacent the gastrointestinal tract. | | | | 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} OLYMPUS K252646 Page 1 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H # SINGLE-USE FINE NEEDLE BIOPSY (FNB) # 510(k) SUMMARY 510(k) Summary: K252646 ## 1. COMPANY INFORMATION - Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 Ishikawa-cho, Hachioji-shi Tokyo 192-8507, Japan FDA Establishment Registration #: 8010047 - Official Correspondent Jillian Connery c/o Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, MA 01581 Cell: 404-542-5854 Email: jillian.connery@olympus.com - Manufacturing Site AOMORI OLYMPUS CO., LTD. 2-248-1 OKKONOKI KUROISHI_SHI Aomori, Japan FDA Establishment Registration #: 3003995201 - Date Prepared: 21-Aug-2025 ## 2. PRODUCT INFORMATION - Trade Name: Single-Use Fine Needle Biopsy - Models: NA-U210H - Common Name: Fine Needle Biopsy - Classification Name: Gastroenterology-Urology Biopsy Instrument - Product Code: FCG - Regulation Number: 21 CFR 876.1075 - Regulation Name: Gastroenterology-Urology Biopsy Instrument - Device Class: II 510(k) Summary Page 1 of 10 {5} OLYMPUS K252646 Page 2 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H # 3. PREDICATE DEVICE - Trade Name: Single-use Aspiration Needle - Model: NA-U200H - 510(k) Number: K180449 # 4. DEVICE DESCRIPTION The Single-Use Fine Needle Biopsy (FNB) Device NA-U210H (SecureFlex) is a sterile, single-use fine needle biopsy device intended for use with an ultrasound endoscope to sample submucosal and extramural lesions within or adjacent to the gastrointestinal tract. It consists of: - Biopsy Needle Assembly: Handle, needle (19G, 22G, or 25G), and coiled sheath. - Aspiration System: VACLOK syringe and stopcock (FDA-cleared under K994253). The device features a bifurcated needle tip for enhanced tissue acquisition, echo-enhanced regions for ultrasound visibility, and is compatible with Olympus GF and TGF endoscopes with ≥2.8 mm channel diameter. # 5. INDICATIONS FOR USE/INTENDED USE The Single-Use Fine Needle Biopsy (FNB) Device NA-U210H has been designed to be used with an ultrasound endoscope for sampling of submucosal and extramural lesions within or adjacent to the gastrointestinal tract. # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The Single-Use Fine Needle Biopsy (FNB) Device NA-U210H 0H is substantially equivalent to the NA-U200H (K180449) in terms of: - Intended use - Technological characteristics - Materials - Sterilization method (EO) - Biocompatibility - Performance ## Differences include: - Bifurcated needle tip (vs. single tip) - No side hole (simplified design) - Minor internal handle design changes for improved assembly These differences do not raise new questions of safety or effectiveness. 510(k) Summary Page 2 of 10 {6} K252646 Page 3 of 10 OLYMPUS Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H Refer to Table 1 for Comparison of Technological Characteristics: | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Model | SINGLE-USE FINE NEEDLE BIOPSY (FNB) DEVICE NA-U210H | SINGLE-USE ASPIRATION NEEDLE NA-U200H | The model name and number are changed to identify the new device. | | Company | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. | Same | | 510(k) Number | - | K180449 | K180449 listing is for reference. | | Indications for use | The Single-use Fine Needle Biopsy (FNB) NA-U210H device has been designed to be used with an ultrasound endoscope for sampling of submucosal and extramural lesions within or adjacent the gastrointestinal tract. | This instrument has been designed to be used with Olympus ultrasound endoscope for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes) | The Subject Device Indications for Use is the same as the predicate. The examples were removed from the Subject Device Indications for Use. | | Regulation name | Gastroenterology-Urology Biopsy Instrument | Gastroenterology-Urology Biopsy Instrument | Same | | Regulation number | 876.1075 | 876.1075 | Same | | Regulatory Class | II | II | Same | | Product Code | FCG | FCG | Same | | Classification | Gastroenterology and | Gastroenterology and | Same | 510(k) Summary Page 3 of 10 {7} K252646 Page 4 of 10 OLYMPUS Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Panel | Urology | Urology | | | Compatible Ultrasound endoscope | Model & Working length: GF/ 1250mm TGF/ 1245mm Channel inner diameter: 2.8 mm or more | Model & Working length: GF/ 1244 to 1265mm TGF/ 1245mm Channel inner diameter: 2.8 mm or more | Same | | Needle Width | NA-U210H-8019: 19G NA-U210H-8022: 22G NA-U210H-8025: 25G | NA-U200H-8019, NA-U200H-8019S: 19G NA-U200H-8022, NA-U200H-8022S: 22G NA-U200H-8025: 25G | Same | | Penetration Depth | 80mm | 80mm | Same | | Maximum insertion portion diameter | NA-U210H-8019:2.6mm NA-U210H-8022:2.2mm NA-U210H-8025:2.2mm | NA-U200H-8019, NA-U200H-8019S:2.6mm NA-U200H-8022, NA-U200H-8022S:2.2mm NA-U200H-8025:2.2mm | Same | | Working length | 1400mm Working length indicates the same length as when the sheath adjuster is positioned at sheath scale 3. | 1400mm Working length indicates the same length as when the sheath adjuster is positioned at sheath scale 3. | Same | | Sheath Type | Coiled Sheath | Coiled Sheath | Same | | Inner Sheath | Equipped | Equipped | Same | | Joining of Sheath | Equipped | Equipped | Same | | Stylet diameter | NA-U210H-8019:0.75mm NA-U210H-8022:0.41mm | NA-U200H-8019, NA-U200H-8019S:0.75mm NA-U200H-8022, NA-U200H-8022S:0.41mm | Same | 510(k) Summary Page 4 of 10 {8} K252646 Page 5 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | | NA-U210H-8025:0.28mm | NA-U200H-8025:0.28mm | | | Side Hole of Needle | Not equipped | NA-U200H-8019S, NA-U200H-8022S:Equipped NA-U200H-8019, NA-U200H-8022:Not equipped NA-U200H-8025: Not equipped | The subject device does not include a side hole feature, which simplifies the product configuration. This design choice enhances needle durability and does not introduce any new concerns regarding safety or effectiveness. | | Joining of Needle | Equipped | Equipped | Same | | Tip Shape of Needle | | | Different than Predicate device The needle tip shape of the Single-Use Fine Needle Biopsy (FNB) Device NA-U210H differs from the predicate device, featuring a bifurcated design intended to enhance tissue collection by allowing larger sample volumes. Despite this design change, needle durability | 510(k) Summary Page 5 of 10 {9} OLYMPUS K252646 Page 6 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | | | | remains equivalent to the predicate, as demonstrated in performance testing (refer to K-PERB_001). This difference does not impact the device’s safety or effectiveness. | | Echo Enhanced Region | Equipped | Equipped | Same | | Elastomer on Handle | Equipped | Equipped | Same | | Needle Stopper | Equipped | Equipped | Same | | Sheath Slide Function | Equipped | Equipped | Same | | Knob Dropout Prevention | Equipped | Equipped | Same | | Syringe (for aspiration) | Equipped | Equipped | Same | | Biocompatibility | Meets requirements | Meets requirements | Same | | Sterilization Method | EO, Single-use | EO, Single-use | Same | | Shelf Life | Three years | Three years | Same | 510(k) Summary Page 6 of 10 {10} K252646 Page 7 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Handle design change | | | There is no difference in specification between the subject device and predicate device, only the content printed on the handle is changed. Changes in the printing on the subject device handle make it possible to distinguish it easily from existing products and emphasize the uniqueness of the new product. This difference does not raise any concern on safety and effectiveness. | | Dimensional changes to inner components of the handle | | | Different than Predicate device Since the needle is bifurcated for the subject device, the needle tip can easily come into contact with the parts during assembly, so the inner surface shape has been changed for the purpose of improving the ease of assembly. | 510(k) Summary Page 7 of 10 {11} K252646 Page 8 of 10 ORIGINE OLYMPUS Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | | | | The size of the C chamber will be changed from 0.1mm to 0.5mm (the weight will be slightly reduced). There is no change in the material, processing destination, and processing method (cutting) of the parts when compared to the Predicate device. Hence, the difference does not affect the safety and effectiveness of the subject device. | | Sheath | Stainless steel | Stainless steel | Same | | Needle | NA-U210H-8019, NA-U210H-8022:Nitinol & Stainless steel(SUS 304TP) * The Nitinol needle is joined to the SUS needle NA-U210H-8025: Stainless steel (SUS 304) | NA-U200H-8019S, NA-U200H-8022S, NA-U200H-8019, NA-U200H-8022:Nitinol & Stainless steel(SUS 304TP) * The Nitinol needle is joined to the SUS needle NA-U200H-8025: Stainless steel (SUS 304) | Same | | Stylet | Nitinol | Nitinol | Same | 510(k) Summary Page 8 of 10 {12} OLYMPUS K252646 Page 9 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H | Feature | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Distal tip | Stainless steel | Stainless steel | Same | | Inner Sheath | PEEK&HDPE | PEEK&HDPE | Same | ## 7. PERFORMANCE DATA Bench performance testing was conducted on all gauge sizes (19G, 22G, 25G) of the Single-Use Fine Needle Biopsy (FNB) Device NA-U210H device using 30 samples per model. The following tests were performed: - Insertion into the endoscope - Advancement of the needle - Retraction of the stylet - Visibility of the needle under ultrasound - Aspiration using the syringe - Retraction of the needle - Withdrawal from the endoscope - Specimen extraction by feeding air - Specimen extraction by advancing the stylet - Repetition test (7 cycles) - Needle durability - Animal study – tissue quantity and quality All test items met predefined acceptance criteria, confirming the device’s mechanical performance, usability, and durability under simulated worst-case conditions. ## 8. BIOCOMPATIBILITY The Single-use Fine Needle Biopsy (FNB) Device NA-U210H was evaluated for biocompatibility in accordance with ISO 10993-1:2018 and FDA guidance for external communicating devices with tissue contact for limited duration (≤24 hours). Testing was conducted using the biologically equivalent predicate device NA-U200H, which shares materials, sterilization method, and manufacturing processes. The following endpoints were assessed: cytotoxicity (initial and aged samples), sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility, and bacterial-mediated pyrogenicity. All tests met acceptance criteria, confirming the biological safety of the device for its intended use. 510(k) Summary Page 9 of 10 {13} OLYMPUS K252646 Page 10 of 10 Traditional 510(k) Single-use Fine Needle Biopsy (FNB) NA-U210H ## 9. STERILIZATION AND SHELF LIFE The Single-Use Fine Needle Biopsy (FNB) Device NA-U210H is sterilized using ethylene oxide (EO), with validation conducted to ensure appropriate sterility assurance levels for single-use medical devices. Shelf life is supported by comprehensive testing, including accelerated aging per ASTM F1980-21, ongoing real-time aging, simulated distribution testing, and packaging system stability per ISO 11607-1:2019 and ISO 11607-2:2019. Functional performance testing on aged devices confirmed that sterility, mechanical integrity, and packaging remained intact over a validated shelf life of three years. ## 10. SUBSTANTIAL EQUIVALENCE Based on the intended use, technological characteristics, performance testing, and comparison to the predicate device, the Single-Use Fine Needle Biopsy (FNB) Device NA-U210H raises no new issues of safety and effectiveness and are substantially equivalent to the predicate device. ## 11. CONCLUSION Based on the results of the comparison of the indications for use, technological characteristics, and performance testing of the Subject and Predicate devices, the Subject SINGLE-USE FINE NEEDLE BIOPSY (FNB) DEVICE NA-U210H raises no new issues of safety and effectiveness and the device is substantially equivalent to the Predicate device. 510(k) Summary Page 10 of 10