Extroducer Infusion Catheter System

{0}  September 11, 2026 SmartWise Sweden AB Kamran Kaviani Head of Quality and Regulatory Affairs Alfred Nobels Allé 150 Tullinge, 146 48 Sweden Re: K254051 Trade/Device Name: Extroducer® Infusion Catheter System (200200) Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: August 12, 2026 Received: August 12, 2026 Dear Kamran Kaviani: 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" (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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254051 - Kamran Kaviani Page 2 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} K254051 - Kamran Kaviani Page 3 Sincerely, Brian D. Pullin -S for Lydia Glaw 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) K254051 Device Name Extroducer Infusion Catheter System Indications for Use (Describe) The Extroducer® Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the extravascular area of the peripheral vasculature or intraluminally. The Extroducer® Infusion Catheter System is not intended for use in the coronary or neurovasculature. 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} SmartWise Traditional 510(k) Premarket submission # 510(k) Summary - K254051 Date prepared: August 11 2026 Applicant: Kamran Kaviani Head of Quality Assurance and Regulatory Affairs SmartWise Sweden AB Alfred Nobels Allé 150 SE-146 48 Tullinge SWEDEN Phone: +46 70 354 17 53 E-mail: kamran.kaviani@smartcella.com # 1 Device Information Trade Name: Extroducer® Infusion Catheter System Regulation number: 21 CFR 870.1210 Regulation name: Continuous flush catheter Product code: KRA Class: II Submission number: K254051 # 1.1 Predicate Device Extroducer Infusion Catheter System, manufactured by SmartWise Sweden AB, (K213442) # 2 Device Description The Extroducer® Infusion Catheter System is a minimally invasive device for administering diagnostic or therapeutic solutions through the vascular wall directly to the extravascular area of the peripheral vasculature of adult patients. The device is sterile and designed for single patient use and is intended for use in hospital operating theatres and catheterization laboratories under normal clinical conditions, by healthcare professionals trained in relevant medical procedures. The duration of use is approximately 1 hour. The device has two main components: an Infusion Needle used to penetrate the vessel wall that allows for infusion of diagnostic or therapeutic solutions, and an Outer Protective Sheath which enables flushing and protects the Infusion Needle tip during positioning and/or repositioning. Page 1 of 5 {5} SmartWise Traditional 510(k) Premarket submission The package also includes the following accessories, which are optional to use: - A 0.25 mL syringe with a male Luer lock - A dispensing tip to aid in the flush of the outer protective sheath Additional accessories, not covered by this submission, includes: - Guide catheters with a minimum ID of 0.022" - Additional syringes 0.25-1.0 mL, male Luer lock (one syringe included in package) During use, the device (the Infusion Needle positioned within the Outer Protective Sheath) is fed through a guide catheter already pre-positioned within the patient's vasculature. At the site of treatment, the device exits the guide catheter directly into the blood vessel. The most distal part of the device's Infusion Needle is then advanced out of the Outer Protective Sheath and pushed through the vessel wall into the perivascular or extravascular area. Additionally, the device can deliver solutions intraluminally, without exiting the blood vessel. ### 2.1 Models The Extroducer® Infusion Catheter system is available in six models, see Table 1, The device exists in two lengths, and each length has a radiopaque marker band positioned at different lengths from the infusion needle distal tip: 5mm, 10mm and 15mm. Aside from the overall device length and position of the radiopaque marker band, the models are identical. Table 1 Available models of the Extroducer® Infusion Catheter System | Marker band position from tip | Device effective length* | | | --- | --- | --- | | | 161 cm | 142 cm | | | Effective Infusion Needle length | | | | 177 cm | 158 cm | | 5 mm | 200201-5 | 200202-5 | | 10 mm | 200201-10 | 200202-10 | | 15 mm | 200201-15 | 200202-15 | *Device effective length is the same as effective length of Outer Protective Sheath ### 2.2 Indications for Use The Extroducer® Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the extravascular area of the peripheral vasculature or intraluminally. The Extroducer® Infusion Catheter System is not intended for use in the coronary or neurovasculature. Page 2 of 5 {6} SmartWise Traditional 510(k) Premarket submission # 2.1 Technological Characteristics | Item | Subject Device – Extroducer® Infusion Catheter System | Predicate device – Extroducer Infusion Catheter System (K213442) | Differences | | --- | --- | --- | --- | | Intended Use / Indications for Use | The Extroducer® Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the extravascular area of the peripheral vasculature or intraluminally. The Extroducer® Infusion Catheter System is not intended for use in the coronary or neurovasculature | The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally. | The differences in wording do not alter the intended use and indications for use of the device since both statements address the same anatomy and clinical use. | | Intended clinical environment | Hospital operating theaters and catheterization labs under normal clinical conditions | Hospital operating theaters and catheterization labs under normal clinical conditions | None. | | Intended patient population | Adult patients requiring treatment or therapy through administrations of compatible solutions directly into the extravascular space/area, including direct delivery to organs. | Adult populations who do not meet contraindications, regardless of gender. | None. | | Conditions of use | Sterile, single-use | Sterile, single-use | None. | | Design | Infusion Needle with a radiopaque marker and Luer lock connector, placed inside Outer Protective Sheath with a radiopaque marker and Luer lock connector | Infusion Needle with a radiopaque marker and Luer lock connector, placed inside Outer Protective Sheath and Luer lock connector | The overall design characteristics are the same. The design differences do not have a negative impact on safety and effectiveness. | | Infusion Needle length (Catheter length) | 177 cm (from needle hub to distal tip) 158 cm (from needle hub to distal tip) | 179 cm (from needle hub to distal tip) | The length difference of the catheters does not have a negative impact on safety and effectiveness. | | Infusion Needle outer diameter (OD) | 33G | 33G | None. | | Infusion Needle radiopaque marker positions | 5, 10, 15 mm from the distal tip | 5, 10, 15 mm from the distal tip | None. | Page 3 of 5 {7} SmartWise Traditional 510(k) Premarket submission | Outer Protective Sheath length | 161 cm (from Outer Protective Sheath hub to distal tip) 142 cm (from Outer Protective Sheath hub to distal tip) | 161 mm (from Outer Protective Sheath hub to distal tip) | The length difference of the catheters does not have a negative impact on safety and effectiveness. | | --- | --- | --- | --- | | Outer Protective Sheath outer diameter (OD) (Catheter OD) | 0.53 mm | 0.50 mm | The difference in the catheter outer diameter do not impact safety and effectiveness. | | Outer Protective Sheath radiopaque marker positions | 5, 10, 15 mm from the distal tip | None | The Predicate device does not have radiopaque marker band on the Outer Protective Sheath. The change improves safety and effectiveness. | | Materials in direct contact with tissue/blood | PTFE/Pebax Nitinol Platinum iridium Epoxy glue | PTFE/Pebax Nitinol Platinum iridium | Only difference in materials is the glue. The difference does not impact safety and effectiveness. | | Needle deployment method | Manual deployment by physician | Manual deployment by physician | None. | | Sterilization Method | Ethylene oxide | Ethylene oxide | None. | | Contact duration | Limited (≤ 24 hours) tissue/blood contact | Limited (≤ 24 hours) tissue/blood contact | None. | | Biocompatibility | Tested according to ISO 10993 | Tested according to ISO 10993 | None. | | Shelf Life | 1 year | 1 year | None. | ### 3 Performance Data The following performance data were provided in support of the substantial equivalence determination. ### 3.1 Non-clinical performance data The following tests have been conducted in order to verify the safety and effectiveness of the device: - Dimensional verification of catheter - Dimensional and functional tests of hubs - Catheter tensile tests (Catheter bond tests) - Simulated use evaluation through Tortuous Path - Flexibility and kinking - Torque strength - Radiopacity - Particulate evaluation - Force and pressure measurements through fluid injections o Infuse payload o Operators' infusion force o Infusion flow rate Page 4 of 5 {8} SmartWise Traditional 510(k) Premarket submission ○ Catheter burst pressure ○ Freedom of leakage - Visual inspection ○ Freedom of extraneous matter ○ Surface - Needle tensile strength - Needle tip testing - Functional testing of Thumb wheel/haemostatic valve - Magnetic properties - Distal tip of Outer Protective Sheath - Corrosion testing - Biocompatibility (according to ISO 10993): ○ Cytotoxicity ○ Sensitization ○ Intracutaneous Reactivity ○ Systemic Toxicity, including Acute Systemic Toxicity and Material Mediated Pyrogenicity ○ Hemocompatibility, including Direct and indirect hemolysis, Complement activation assay, Partial Thromboplastin Time Assay, Heparinized Blood Platelet and Leukocyte Count Assay, and comparative surface assessment - Sterilization validation - Transport testing - Package testing (sterile barrier) - Stability studies (selected bench tests and package tests) ### 3.2 Animal testing No animal testing has been performed since the differences between the Subject Device and the Predicate Device are minor and raise no different questions of safety and effectiveness. ### 3.3 Clinical data No clinical testing data was required for this 510(k) submission. ## 4 Conclusions The results of the testing described above demonstrate that the Extroducer® Infusion Catheter System is as safe and effective as the predicate device and supports a determination of substantial equivalence. 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