Emboliner Embolic Protection System (EPC-03)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION Emboline, Inc. Will Michul VP of Quality and Regulatory 2901 Mission St. Bldg. 2 Santa Cruz, California 95060 September 8, 2026 Re: K261715 Trade/Device Name: Emboliner Embolic Protection System (EPC-03) Regulation Number: 21 CFR 870.1251 Regulation Name: Temporary catheter for embolic protection during transcatheter intracardiac procedures Regulatory Class: Class II Product Code: PUM Dated: July 17, 2026 Received: August 11, 2026 Dear Will Michul: 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} K261715 - Will Michul 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} K261715 - Will Michul Page 3 Sincerely, FINN E. DONALDSON -S Digitally signed by FINN E. DONALDSON -S Date: 2026.09.08 15:46:29 -04'00' Finn Donaldson Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} 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) K261715 Device Name Emboliner Embolic Protection System Indications for Use (Describe) The Emboliner Embolic Protection System is indicated for use as an embolic protection device to capture and remove embolic material during transcatheter aortic valve replacement (TAVR). Anatomical requirements for aortic diameters and femoral access site to sinotubular junction (STJ) distance should meet the requirement as specified in the Instructions for Use. 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."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} Emboline K261715^{}[] Page 1 of 6 ## 510(k) Summary # **Applicant Information:** Emboline, Inc. 2901 Mission St. Building 2 Santa Cruz, CA 95060 Contact Person: Will Michul Phone: 831 900 5039 Fax: 831 900 5019 # **Submission Correspondent:** VP of Quality and Regulatory, Emboline # **Device Information:** | Trade Name: | Emboliner Embolic Protection System | | --- | --- | | Common Name: | Embolic Protection Catheter | | Classification Name: | Temporary catheter for embolic protection during transcatheter intracardiac procedures. | | Classification Regulation: | 21CFR 870.1251 | | Device Class: | II | | Product Code: | PUM | # **Primary Predicate:** Boston Scientific Corporation Sentinel Cerebral Protection System, K192460 # **Reference Device:** Medtronic SpiderFX™ Embolic Protection Device, K111010 # **Date Prepared:** May 15, 2026 {5} Emboline K261715 Page 2 of 6 # Device Description: The Emboliner® Embolic Protection System (“Emboliner”) is a sterile, short term use medical device. The Emboliner is a percutaneously delivered embolic protection filter, designed to capture and remove debris dislodged during transcatheter aortic valve replacement (TAVR). The Emboliner is comprised of the filter, its catheter, an integrated delivery sheath, and a balloon catheter. The system is also supplied with a filter loading tool. The Emboliner is delivered over a guidewire via femoral artery access. The filter is deployed via the integrated delivery sheath across the aortic arch to capture debris that would otherwise enter the cerebral branch vessels and descending aorta during transcatheter aortic valve replacement (TAVR). The Emboliner catheter and delivery sheath contain radiopaque markers to facilitate visualization during use. The filter is composed of a double-layer, heparin-coated, cylindrical nitinol mesh. The Emboliner catheter contains an integrated 6 Fr lumen to allow the introduction of procedural devices (e.g., angiography pigtail catheter, guidewire, etc.). At the completion of the procedure, the filter and debris are retrieved into the delivery sheath and removed from the patient. # Indications for Use: The Emboliner Embolic Protection System is indicated for use as an embolic protection device to capture and remove embolic material during transcatheter aortic valve replacement (TAVR). Anatomical requirements for aortic diameters and femoral access site to sinotubular junction (STJ) distance should meet the requirement as specified in the Instructions for Use. # Comparison of Intended Use and Technological Characteristics with the Predicate Device: The Subject Device (Emboliner Embolic Protection System) is the same as the Primary Predicate (Boston Scientific Sentinel CPS) in that: - Both devices are embolic protection catheters, Class II, Special controls (Product Code PUM) - Both devices have the same intended user - Both devices have the same type of patient contact/duration – Circulating blood, limited duration (<24 hour) Both devices are nonpyrogenic, biocompatible, and sterilized via e-Beam sterilization - Both devices are delivered percutaneously via a guidewire The Subject Device (Emboliner Embolic Protection System) is different than the Primary Predicate (Boston Scientific Sentinel CPS) in that: - Both devices have similar intended use / indications for use with only slight differences in wording. Both are indicated as embolic protection devices that capture and remove embolic debris/material during transcatheter valve interventions (Subject) or procedures (Predicate). The Subject Device includes specification for use by the given intended user, while the Predicate Device includes specification on compatible arterial diameters. - The Subject Device is delivered via contralateral femoral artery access, unlike the Predicate Device which requires an additional brachioradial access site. {6} Emboline K261715 Page 3 of 6 - The Subject Device and the Predicate Device have differing vessel sizing guides due to the difference in device delivery methods and access route. - The Subject Device and the Predicate Device have different technological characteristics, methods of operation, and specific materials of construction. The Subject Device includes a non-active heparin coating as an ancillary substance. ### Comparison of Subject Device and Reference Device: The Subject Device (Emboliner Embolic Protection System) is the same as the Reference Device (Medtronic SpiderFX™ Embolic Protection Device) in that: - Both devices have a heparin coating on the nitinol wire filters - Both devices are embolic protection devices, Class II - Both devices have the same type of patient contact/duration – Circulating blood, limited duration (<24 hour) - Both devices are nonpyrogenic, biocompatible, and provided in a sterile condition - Both devices are delivered percutaneously The Subject Device (Emboliner Embolic Protection System) is different than the Reference Device (Medtronic SpiderFX™ Embolic Protection Device) in that: - Both devices have similar intended users, but differ based on the associated procedures the users are trained on. - Both devices have similar intended use / indications for use as embolic protection devices that capture and remove embolic debris/material during interventional procedures but differ based on associated procedures and anatomical sites in which they are used. - Both devices are used in the cardiovascular system. The Subject device is used in the aortic arch whereas the Reference Device is used in extremities, carotid arteries, or saphenous vessels. - The subject device and the predicate device have different technological characteristics, methods of operation, and specific materials of construction ### Performance Data: The following performance data were provided in support of substantial equivalence determination: - Biocompatibility testing for the finished device was completed in accordance with ISO 10993 per the following: - Part 4: Hemocompatibility - Part 5: Cytotoxicity - Part 10: Sensitization - Part 11: Systemic Toxicity - Part 11: Material mediated pyrogenicity - Part 23: Irritation or intracutaneous reactivity The test results demonstrate that the device is biocompatible for the intended use. {7} Emboline K261715 Page 4 of 6 - Design verification and validation and process validation testing was completed, demonstrating that the manufacturing process and finished device meet product requirement specifications. Testing included the following: ○ Joint Strength (ISO 10555-1:2023 and ISO 11070:2014+A1:2018) ○ Fluid Tight Testing (ISO 10555-1:2023 and ISO 11070:2014+A1:2018) ○ Luer Compliance (ISO 80369-7:2021) ○ Particulate Generation Characterization (AAMI TIR42:2021. and USP <788>) ○ Heparin Coating Durability ○ Balloon Catheter Performance (ISO 10555-4:2023) ○ Corrosion (ISO 10555-1:2023) ○ System Dimensions ○ System Kink and Flexibility Characterization ○ Benchtop Clinical Simulation ○ Characterization of Peak Deployment and Retrieval Forces ○ Characterization of the Nitinol filter (percent open area, pore size, transformation temperature, mechanical properties, and foreshortening) ○ Filter Particle Capture Characterization ○ Characterization of the Effect of the Filter on Aortic Blood Flow ○ Filter Radial Outward Force Characterization (ASTM F3067-14(2021)) ○ Balloon Catheter Puncture Characterization - Design validation animal testing was conducted to demonstrate that the finished device meets user needs and intended use performance requirements. ○ An acute non-GLP study was performed using the porcine animal model as part of the design validation activities. ○ A chronic GLP animal study was conducted to further validate the functionality of the Emboliner EPC-03 System. The study was a single center, chronic GLP study designed to evaluate the tissue response and changes in cerebral blood flow following deployment and use of the Test Article in the porcine animal model. The study was intended to demonstrate the following requirements: ■ Device Delivery ■ Device retrieval ■ Cerebral flow dynamics ■ Device tissue response ■ Potential for downstream embolization ○ A non-GLP animal study was performed to evaluate tissue response including gross and histopathology assessment after deployment and retrieval of the Emboliner EPC-03 at an appropriate physiological distance from the aortic valve. - User validation testing was completed, demonstrating that the device conforms to the user needs and intended use. {8} Emboline K261715 Page 5 of 6 - Packaging verification and shelf-life testing was completed, supporting the labeled shelf life of the device, including the following: ○ Exposure to extreme environmental conditioning per ASTM D4332-22, and exposure to simulated distribution testing per ASTM D4169-22. ○ Following transit testing, device pouches were evaluated for package integrity via the following: ■ Visual inspection ■ Gross leak testing per ASTM F2096-11 ■ Seal strength testing per ASTM F88/F88M-23 ○ Artificial aging per ASTM F1980-21, after which the listed Design Verification and Validation and packaging testing was repeated. - A clinical investigation was completed, supporting non-inferiority of the Subject Device for safety and efficacy. The study details are summarized below. | Study Title | Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner® Embolic Protection Device, referred to as Protect H2H Study | | --- | --- | | Sponsor: | Emboline, Inc. | | ClinicalTrials.gov ID | NCT05684146 | | Investigation Device | Emboliner® Embolic Protection Catheter (EPC-03), referred to as Emboliner | | Study Phase | Pivotal (Safety and Efficacy) | | Study Design | Prospective, randomized, multicenter, 2-arm, safety and efficacy study | | Study Centers | 18 centers: 11 in the United States, 2 in Brazil, 5 in Germany | | Study Initiation Date | 04 May 2023 (first subject treated) | | Study Completion Date | 12 December 2025 (last subject completed) | | Population: | Subjects with symptomatic severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with an FDA-approved valve in conjunction with the use of embolic protection | | Total Subjects Enrolled | The study was planned to enroll up to 540 randomized subjects and up to 40 roll-in subjects (total: up to 580 enrolled subjects) A total of 557 subjects were enrolled (522 randomized + 35 roll-in) | | Primary Analysis Population (mITT) | The study was powered to include a minimum of 236 evaluable subjects in the modified intent-to-treat (mITT) population in each treatment arm The final mITT population includes 485 subjects (Emboliner n=244; Sentinel n=241) | | Study Objective | The primary objective of Protect The Head To Head study was to evaluate the safety and efficacy of Emboliner by demonstrating non-inferiority to the control device (Sentinel CPS) with respect to the incidence of 30-day (±7 days) composite major adverse cardiac and cerebrovascular events (MACCE) following the TAVR procedure | | Primary Endpoint | Combined safety and efficacy: 30-day composite of MACCE, defined as all-cause death, stroke, and stage 3 acute kidney injury (AKI) | | Non-inferiority Margin | 7% absolute difference; one-sided alpha = 2.3% (after alpha spending at | {9} Emboline K261715 Page 6 of 6 | | interim analysis) | | --- | --- | | Primary Endpoint Result | Emboliner 4.5% (11/244) vs. Sentinel 5.0% (12/241); 95% CI upper bound 3.51% <7%; P(NI) = 0.0004 | | MACCE Components | 23 total MACCE events: Emboliner 11 (4.5%) vs. Sentinel 12 (5.0%), comprisingAll-cause death: Emboliner 5 (2.0%) vs. Sentinel 5 (2.1%),Stroke: Emboliner 5 (2.0%) vs. Sentinel 5 (2.1%), andStage 3 AKI Emboliner 1 (0.4%) vs. Sentinel 3 (1.2%) | | Timing of Endpoint Events | Cardiovascular deaths: Emboliner 4 (1.6%) vs. Sentinel 3 (1.2%) occurred earlier in the follow-up period in both arms (POD 0-17, median POD 2).Non-cardiovascular deaths: Emboliner 1 (0.4%) vs. Sentinel 2 (0.8%) occurred later in the follow-up period in both arms (POD 18-26, median POD 22).Stroke timing presented below.Stage 3 AKI occurred early (2–3 days) in both arms. | | Stroke (Secondary Endpoint #1) | Incidence of all stroke events (VARC-2 defined) occurring within 30 days following the procedure, adjudicated by the independent DMC/CEC (Emboliner 2.0% [5/244] vs. Sentinel 2.1% [5/241]; 95% CI upper bound 2.88% <7%; P[NI] = 0.0001) | | Stroke Severity and Timing | Disabling stroke: Emboliner 4 (1.6%) vs. Sentinel 1 (0.4%)Non-disabling stroke: Emboliner 1 (0.4%); vs. Sentinel 4 (1.7%)Onset ≤72 hours: Emboliner 3 (1.2%) vs. Sentinel 4 (1.7%)Onset >72 hours: Emboliner 2 (0.8%) vs. Sentinel 1 (0.4%)All events ischemic except one hemorrhagic stroke (Emboliner, POD 17) | | Debris Capture (Secondary Endpoint #2) | Total count of embolic debris particles >150 μm captured in the first 100 consecutive, evaluable filters - 50 Emboliner + 50 Sentinel) - analyzed by CVPath Institute histopathology core laboratory (Emboliner median 93 particles ≥150 μm vs. Sentinel 31 [p<0.0001]; 3-fold superior capture) | | Conclusion | Non-inferiority of the Emboliner vs. Sentinel demonstrated for both MACCE and stroke. | ## Conclusion: The Emboliner Embolic Protection System has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the Emboliner Embolic Protection System is substantially equivalent to the cleared predicate device.