Aristotle 65 Macrowire

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 Scientia Vascular, Inc. Bailey Johannsen Regulatory Affairs Specialist 2460 South 3270 West West Valley City, Utah 84119 Re: K254181 Trade/Device Name: Aristotle 65 Macrowire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: August 13, 2026 Received: August 14, 2026 Dear Bailey Johannsen: 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} K254181 - Bailey Johannsen 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 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- {2} K254181 - Bailey Johannsen 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, NAIRA MURADYAN -S Naira Muradyan, PhD Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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. | K254181 | ? | | Please provide the device trade name(s). | | ? | | Aristotle 65 Macrowire | | | | Please provide your Indications for Use below. | | ? | | The Aristotle 65 Macrowire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. | | | | 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} Scientia Vascular, Inc. K254181  ## K254181 510(k) SUMMARY 510(k) Sponsor: Scientia Vascular, Inc. 2460 South 3270 West West Valley City, UT 84119 Tel (888) 385-9016 Contact Person(s): Bailey Johannsen Regulatory Affairs Specialist Tel: (888) 385-9016 E-mail: regulatory@scientiavascular.com Date Prepared: September 14, 2026 Pg. 1 {5} Scientia Vascular, Inc. K254181 Table 1. Subject Device Information | Trade Name: | Aristotle 65 Macrowire | | --- | --- | | Common Name: | Guidewire | | Classification Name: | Catheter Guide Wire per 21 CFR 870.1330 | | Primary Product Code: | MOF | | Subsequent Product Code: | DQX | | Predicate Device: | Aristotle Colossus Guidewire (K222437) | ## DEVICE DESCRIPTION Scientia Vascular's Aristotle 65 Macrowire is a 0.063" steerable guidewire with a pre-shaped tip to aid in accessing the neuro and peripheral vasculatures. The device is supplied sterile, for single use only, in 200 cm and 300 cm lengths. The distal portion of the device's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The device has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The device is provided with two (2) accessories consisting of a guidewire introducer (to aid with the insertion of the device into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion of the device to facilitate gripping and manipulation of the guidewire during use). These accessories are included to facilitate use of the device and are not intended to contact the patient's body. ## INDICATIONS FOR USE The Aristotle 65 Macrowire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. ## INTENDED USE The subject device is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The subject device is substantially equivalent to the predicate device and has the same or similar - Indications for use - Materials - Technological characteristics - Packaging and sterilization of devices Pg. 2 {6} Scientia Vascular, Inc. K254181 Table 2 provides details on the technological characteristics of the subject device compared to the predicate device. Table 2. Technological Characteristics Comparison | Characteristic | Subject Device Aristotle 65 Macrowire (K254181) | Predicate Device Aristotle Colossus Guidewire (K222437) | | --- | --- | --- | | Indications for Use | The Aristotle 65 Macrowire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. | The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. | | Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | | Dimensions | Diameter: 0.063" (1.60mm) | Diameter: 0.035" (0.88mm) | | | Length: 200cm - 300cm | Length: 150cm - 300cm | | Core Wire | Stainless-steel | Stainless-steel | | Distal Tip | Length: 35cm Material: Nitinol | Length: 35cm Material: Nitinol | | Tip Shape | Pre-shaped Tip | Straight, Shapeable | | Stiffness Profiles | Standard | Standard | | Distal Coating | Hydrophilic | Hydrophilic | | Proximal Coating | PTFE | PTFE | | Radiopaque Marker | 1 radiopaque marker at distal tip | 1 radiopaque marker at distal tip | | Centering Coil(s) | Stainless-steel | Stainless-steel | | Centering Washer | Stainless-steel | Stainless-steel | | Introducer (Accessory) | Provided with each guidewire | Provided with each guidewire | Pg. 3 {7} Scientia Vascular, Inc. K254181 | Characteristic | Subject Device Aristotle 65 Macrowire (K254181) | Predicate Device Aristotle Colossus Guidewire (K222437) | | --- | --- | --- | | Torque Device (Accessory) | Provided with each guidewire | Provided with each guidewire | | Sterilization Method | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) | | Shelf Life | 1 year | 1 year | When compared with the predicate device, the subject device has the technological characteristic differences shown in the table above. These differences do not raise new questions of safety and effectiveness for the subject device. To evaluate the effects of these differences, performance testing was conducted to demonstrate the subject device performs as intended. ## NON-CLINICAL PERFORMANCE TESTS ### Biocompatibility The subject device is considered externally communicating device with circulating blood contact for a limited duration (≤ 24 hours) and the following tests were performed: Table 3. Summary of Biocompatibility Testing | Test | Test Method Summary | Conclusion | | --- | --- | --- | | Cytotoxicity | MEM elution cell culture observed for cytotoxic reactivity. | Pass | | Pyrogenicity | Study animals were observed for individual temperature rise. | Pass | | Sensitization | Study animals with subject device were observed for dermal sensitization. | Pass | | Irritation | Study animals with subject device were observed for dermal reaction. | Pass | | Acute Systemic Toxicity | Study animals with the subject device were observed for abnormal clinical signs indicative of toxicity. | Pass | | ASTM Hemolysis | The difference between the hemolytic indexes of the subject device and the negative control was evaluated (direct contact and extract). | Pass | | Complement Activation of SC5b-9 | Comparison of the subject device SC5b-9 value to the predicate device for all exposure times was performed. | Pass | | Partial Thromboplastin Time | The clotting time was observed for both the subject device and the predicate. | Pass | | In Vitro Thrombogenicity | Device is placed in an in vitro blood loop for three runs. The thrombus score for the subject and predicate device is observed. | Pass | | Platelet and Leukocyte Count Assay | Comparison of the subject device platelet and leukocyte count to the predicate device. | Pass | Pg. 4 {8} Scientia Vascular, Inc. K254181 ## Sterilization The subject device was adopted into an existing validated sterilization cycle that uses 100% EO to achieve a sterilization assurance level (SAL) of 10⁻⁶, and testing for EO and ethylene chlorohydrin (ECH) residuals and bacterial endotoxin levels was performed. The subject device followed the requirements of AAMI TIR 28:2016 “Product adoption and process equivalence for ethylene oxide sterilization” to ensure it meets the requirements of the following standards: - ISO 11135:2014/A1:2018, “Sterilization of Health Care Products - Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices” - ANSI/AAMI/ISO 10993-7:2008, “Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals” ## Bench Performance Testing Following review of the risk assessments conducted in accordance with ISO 14971:2019, performance testing was performed on the subject devices. Additional performance tests to evaluate continued compliance with ISO 11070:2014, “Sterile single-use intravascular introducers, dilators and guidewires,” and per recommendations of the FDA guidance document, “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019), were also performed. Table 4 summarizes these tests and their results below. Table 4. Summary of Bench Performance Tests | Test | Test Method Summary | Results | | --- | --- | --- | | Visual Inspection and Dimensional Verification | Performed visual inspection and verified key dimensions of the guidewire per specifications. | Acceptance criteria met | | Tensile Testing | Test per FDA guidance document, “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019) | Acceptance criteria met | | Kink Resistance | Test per FDA guidance document, “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019) | Acceptance criteria met | | Torqueability | Test per FDA guidance document, “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019) | Acceptance criteria met | | Torque Strength | Test per FDA guidance document, “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019) | Acceptance criteria met | | Tip Flexibility | Test per FDA guidance document, “Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling” (2019) | Acceptance criteria met | Pg. 5 {9} Scientia Vascular, Inc. K254181 | Test | Test Method Summary | Results | | --- | --- | --- | | Pre-Shape and Tip Shape Retention | The tip shape angle was measured before and after use in a simulated pathway model. | Acceptance criteria met | | Coating, Lubricity, Durability, and Integrity | Test per FDA guidance document, “*Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling*” (2019) | Acceptance criteria met | | Particulate | Particulate measured and counted after use in a simulated pathway model. | Acceptance criteria met | | Corrosion Resistance | Test per FDA guidance document, “*Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling*” (2019) | Acceptance criteria met | | Compatibility with Agents | Guidewires were tested for compatibility with IsoVue 300, IsoVue 370, DMSO, and heparinized saline. | Acceptance criteria met | | Simulated Use and Device Compatibility | Conducted simulated use in anatomical model designed to simulate the tortuous anatomy of the neurovasculature. | Acceptance criteria met | | Flex and Fracture | Subjected the guidewire to multiple flexure cycles around cylindrical pins. | Acceptance criteria met | | Usability Validation | Physicians evaluated the subject and comparator devices in clinically relevant anatomical model. | Acceptance criteria met | | Radiopacity Testing | Test per FDA guidance document, “*Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling*” (2019). Subject and predicate devices evaluated under fluoroscopy. | Acceptance criteria met | | Packaging Testing | Test per ISO 11607-1 | Acceptance criteria met | ## Animal Testing The safety and performance of the Aristotle 65 Macrowire was evaluated in two (2) comparative porcine studies conducted under Good Laboratory Practices (GLP) (21 CFR Part 58) against the predicate and cleared control devices, respectively. The two studies evaluated at subacute (3 day) and chronic (30 day) time points, with three (3) animals evaluated at each time point. Study 1 evaluation included the delivery of the subject and predicate guidewires to the target location. Target vessels evaluated included renal arteries, brachial arteries, and external carotid artery branches (internal maxillary, ascending pharyngeal, and lingual). Study 2 evaluated delivery to target locations utilizing (1) subject device with an access catheter and (2) predicate device with intermediate catheter and an access catheter, reflective of clinical use. Vessels evaluated included renal arteries, brachial arteries, and branch vessels of the carotid arteries (ascending pharyngeal, lingual). The studies performed assessments for usability, trackability, thrombogenicity, and catheter delivery (Study 2 only). Angiographic and histopathology evaluations were also conducted. There were no significant gross or histological findings suggestive of significant vascular injury in the subject, predicate or control treated vessels in either study at either time point. Additionally, there were no gross or histological findings in nontarget organs which were attributable to the subject, predicate, or control articles in either study at either time point. Therefore, the study endpoints support equivalent safety and performance of the Aristotle 65 Macrowire when compared Pg. 6 {10} Scientia Vascular, Inc. K254181 with the predicate. ### **Clinical Testing** No clinical testing was deemed necessary to support the substantial equivalence of the subject device. ### **CONCLUSION** The subject device has the same intended use and indications for use statement as the predicate device. The identified technological difference does not raise new questions of safety or effectiveness regarding the use of the subject devices. The testing demonstrates the subject device performs as intended and is substantially equivalent to the predicate device. Pg. 7