SmartClip Delivery Catheter (ADR-1715)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 14, 2026 Elucent Medical Jake Burke Regulatory Affairs Manager 6509 Flying Cloud Dr. Suite 160 Eden Prairie, Minnesota 55344 Re: K260565 Trade/Device Name: SmartClip Delivery Catheter (ADR-1715) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: February 19, 2026 Received: February 19, 2026 Dear Jake Burke: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260565 - Jake Burke Page 2 (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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-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). {2} K260565 - Jake Burke Page 3 Sincerely, John S. Bender -S for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K260565 | | | Device Name SmartClip Delivery Catheter | | | Indications for Use (Describe) SmartClip Delivery Catheter is to be utilized through a flexible bronchoscope by physicians trained in endoscopic techniques to puncture the tracheobronchial wall and to facilitate the delivery and placement of an Elucent SmartClip soft tissue marker within the lung parenchyma at a target site. The device is used in situations where the lung tissue site needs to be marked for future diagnostic or therapeutic procedures. | | | Type of Use (Select one or both, as applicable) ☑ 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." | | {4} # 510(k) Summary Applicant Name: Elucent Medical Applicant Address: 6509 Flying Cloud Drive Suite 160 Eden Prairie MN 55344 United States Applicant Contact: Mr. Jake Burke Applicant Contact Telephone: 651-210-2813 Applicant Contact Email: jake.burke@elucent.com Device Trade Name: SmartClip Delivery Catheter (ADR-1715) Common Name: Bronchoscope (Flexible or Rigid) Classification Name: Bronchoscope (flexible or rigid) and accessories Regulation Number: 21 CFR 874.4680 Product Codes: EOQ Legally Marketed Predicate Device: K142934 – CrossCountry Transbronchial Access Tool - EOQ ## Device Description Summary: The Catheter Delivery System is a single-use, terminally sterilized (EO) device used by a physician, trained in bronchoscopic techniques, to facilitate the placement of SmartClip soft tissue markers (SmartClips). The Catheter Delivery System consists of a flexible sheath, a stylet with a tapered distal tip, and a handle. The outer sheath, containing the inner stylet is traversed through a 2.0mm or greater working channel of a bronchoscope to the target tissue intended to be marked by a SmartClip. The stylet is used to puncture the tracheobronchial wall, and the outer sheath is advanced into the tissue to maintain access to the implantation site. The SmartClip is then deposited into the proximal end of the catheter and deployed to the target site by the stylet. ## Intended Use/Indications for Use: SmartClip Delivery Catheter is to be utilized through a flexible bronchoscope by physicians trained in endoscopic techniques to puncture the tracheobronchial wall and to facilitate the delivery and placement of an Elucent SmartClip soft tissue marker within the lung parenchyma at a target site. The device is used in situations where the lung tissue site needs to be marked for future diagnostic or therapeutic procedures. ## Indications for Use Comparison: The subject and predicate devices share the same intended use. While the indications for use of the subject and predicate vary slightly, the differences do not constitute a new intended use. The subject and predicate devices are both intended to traverse through an endoscope, puncture the tracheobronchial wall using a sharp tipped component, maintain access to the target lung tissue with a catheter, and facilitate placement of markers or endoscopic tools to the target site. {5} # Technological Comparison The subject device shares several technological characteristics as the predicate device including: - Design: A flexible catheter and sharp tipped component used for puncturing the tracheobronchial wall - Materials: Sterile, single-use, biocompatible materials - Principle of Operation: A catheter and sharp tipped component are traversed through an endoscope, the sharp tip punctures the tracheobronchial wall and the catheter maintains access to the within the lung parenchyma. - Energy Source: Mechanical | Description | Subject Device: SmartClip Delivery Catheter | Predicate Device: CrossCountry (K142934) | Comments | | --- | --- | --- | --- | | Intended Use | Facilitate access, via a channel, to enable placement of a SmartClip soft tissue marker | Facilitate access, via a channel, to enable placement of endoscopic tools, including fiducial markers | Directly comparable Both devices facilitate access to the lung parenchyma to enable fiducial marker placement | | Indications for Use | SmartClip Delivery Catheter is to be utilized through a flexible bronchoscope by physicians trained in endoscopic techniques to puncture the tracheobronchial wall and to facilitate the delivery and placement of an Eluent SmartClip soft tissue marker within the lung parenchyma at a target site. The device is used in situations where the lung tissue site needs to be marked for future diagnostic or therapeutic procedures. | The CrossCountry transbronchial access tool is to be utilized through a flexible endoscope with an extended working channel by physicians who are trained in endoscopic techniques to puncture the tracheobronchial wall and facilitate access of additional endobronchial tools for patients with endobronchial lesions, peripheral lung nodules, or lung masses. | Directly comparable Both devices are utilized via a flexible endoscope to puncture the tracheobronchial wall and to facilitate access to the lung parenchyma. | | Principle of Operation | The SmartClip Delivery Catheter is composed primarily of a stylet and catheter. The stylet is used to pierce a hole through the tracheobronchial wall, traversing the lung parenchyma into the targeted site. The catheter is advanced through the lung parenchyma to maintain access to the lung parenchyma. The stylet is then used to facilitate placement of a SmartClip soft tissue marker within the lung parenchyma. | The CrossCountry is composed primarily of a guidewire and catheter. The guidewire is used to pierce a hole through the tracheobronchial wall, traversing the lung parenchyma into the desired site of implantation. The dilation catheter is advanced over the guidewire and introduced into the target lesion to maintain access within the lung parenchyma. | Directly comparable Both devices utilize a sharp tipped component to puncture the tracheobronchial wall and a catheter component to maintain access within the lung parenchyma. | {6} | Patient Contacting Components | Stylet and Catheter | Wire and Catheter | Directly comparable The stylet of the subject device and wire of the predicate device share the same function: to mechanically puncture the tracheobronchial wall | | --- | --- | --- | --- | | Working Outer Diameter (OD) | Catheter OD: 1.79mm Stylet: 1.40mm | Catheter OD: 2.01mm Wire OD: 0.66mm | Directly comparable Differences in the OD of the catheter (0.22mm), and stylet and wire (0.74mm) do not impact the overall performance or clinical functionality. | | Working Length | Catheter: 115.6cm Stylet: 124.4cm | Catheter: 109.9cm Wire: 116.1cm | Directly comparable Differences in the working length of the catheter (5.7cm), stylet and wire (8.3cm) do not impact overall performance or clinical functionality. | | Working Outer Material | Outer Sheath: Pebax | Polymer - Copolyester Elastomer Braid - 304 Stainless Steel | Directly comparable Materials are biocompatible | | Stylet/Wire Material | Stylet: High-Density Polyethylene (HDPE) | Tip: Titanium Wire: Nitinol | Directly comparable Materials are biocompatible | In summary, the subject SmartClip Delivery Catheter has similar technology and principle of operation as the predicate device. {7} # Non-Clinical Tests Summary The following performance data were provided in support of the substantial equivalence determination between the subject SmartClip Delivery Catheter and the CrossCountry transbronchial access tool. Biocompatibility: Conducted in accordance with ISO 10993-1 and FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Cytotoxicity - Acute Systemic Toxicity - Material Mediated Pyrogenicity - Sensitization - Irritation Design Verification and Validation: - Functional Testing - Inspections Testing - Shelf Life Testing - Packaging Testing - Distribution Testing - Sterilization Validation - Human Factors and Usability Testing Animal Study: A preclinical study was conducted using the SmartClip Delivery Catheter. All acceptance criteria were met. This study demonstrated the SmartClip Delivery Catheter is able to meet its intended use. Clinical Testing: Clinical data were not necessary to support a determination of substantial equivalence. # Non-Clinical Tests Conclusion In summary, verification testing conducted demonstrated that the subject SmartClip Delivery Catheter meets defined specification and is substantially equivalent to the predicate CrossCountry Transbronchial Access Tool. # Conclusion (Statement of Equivalence): Elucent Medical has demonstrated that the proposed SmartClip Delivery Catheter is substantially equivalent to the CrossCountry transbronchial access tool which is legally marketed for the same intended use. The non-clinical test data and the in vivo animal study provide adequate justification to demonstrate that the SmartClip Delivery Catheter is substantially equivalent to the predicate device.