X-Wire Guidewire

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION August 26, 2025 Imperative Care, Inc. Shivani Patel Principal Regulatory Affairs Specialist 1359 Dell Avenue Campbell, California 95008 Re: K244061 Trade/Device Name: X-Wire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: July 23, 2025 Received: July 24, 2025 Dear Shivani Patel: 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 &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K244061 - Shivani Patel 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} K244061 - Shivani Patel 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, Ph.D. 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} 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) K244061 | | | Device Name X-Wire Guidewire | | | Indications for Use (Describe) The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. | | | 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} K244061 # 510(k) Summary K244061 ## A. Submitter Information: Submitter's Name: Imperative Care, Inc. Address: 1359 Dell Avenue Campbell, CA 95008 Contact Person: Shivani Patel Telephone: 510-468-8862 Email: spatel@imperativecare.com Date of Preparation: August 21, 2025 ## B. Subject Device: Proprietary Name: X-Wire Guidewire Common/Usual Name: Guidewire Classification Name: Catheter guide wire Product Codes: MOF, DQX Regulation: 21 CFR 870.1330 Manufacturer: Imperative Care, Inc. ## C. Predicate Devices: Proprietary Names: Aristotle 18 Guidewire; Aristotle 24 Guidewire (K231954) Aristotle 14 Guidewire (K220398) Common/Usual Name: Guidewire Classification Name: Catheter guide wire Product Codes: MOF, DQX Regulation: 21 CFR. 870.1330 Manufacturer: Scientia Vascular, Inc. ## D. Device Description: The Imperative Care’s X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014”, 0.018” and 0.024” diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device. Page 1 of 8 {5} K244061 # E. Indications for Use: The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. # F. Comparison with the Predicate Devices: The predicate devices are the Aristotle 18, 24, and 14 Guidewires cleared under K231954 and K220398. The predicate and subject devices share the same intended use and basic technological characteristics as shown in Table 1, below. Table 1: Comparison of Subject and Predicate Devices | | Predicate Aristotle 18 and 24 Guidewires (K231954) | Predicate Aristotle 14 Guidewire (K220398) | Subject Device X-Wire Guidewire (K244061) | | --- | --- | --- | --- | | Regulation Number | 21 CFR 870.1330 | Same | Same | | Regulation Name | Catheter Guide Wire | Same | Same | | Regulatory Class | Class II | Same | Same | | Product Code | MOF, DQX | Same | Same | | Manufacturer | Scientia Vascular, Inc. | Scientia Vascular, Inc. | Imperative Care., Inc | | Anatomical Location | Peripheral and Neuro Vasculature | Same | Same | | Indications for Use | The Aristotle 18 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. The Aristotle 24 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. | The Aristotle 14 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. | The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. | {6} K244061 | | Predicate Aristotle 18 and 24 Guidewires (K231954) | Predicate Aristotle 14 Guidewire (K220398) | Subject Device X-Wire Guidewire (K244061) | | --- | --- | --- | --- | | | in the coronary vasculature. | | | | **Condition Supplied** | Sterile, single-use | Same | Same | | **Accessory Devices** | Shaping Mandrel, Introducer, Torque Device | Same | Same | | **Wire Outer Diameter** | 0.018” (0.46mm) 0.024” (0.61mm) | 0.014” (0.36mm) | 0.014” (0.36mm) 0.018” (0.46mm) 0.024” (0.61mm) | | **Device Length** | 200 cm, 300 cm | 200cm, 300cm | X-Wire 14: Same as Aristotle 14 X-Wire 18: 200cm, 260cm, 300cm X-Wire 24: Same as Aristotle 24 | | **Tip Length (Hypotube)** | 35cm | 35cm | X-Wire 14S: 29cm X-Wire 14T: 19cm X-Wire 18S: 35cm X-Wire 18T: 25cm X-Wire 24S: 43.5cm X-Wire 24T: 50cm | | **Tip Type and Shape** | Core-to-tip Shapeable | Same | Same | | **Flexible Tip Material (Distal Tip)** | Nitinol | Same | Same | | **Core Wire Material** | Stainless Steel | Same | Same | | **Stiffness Profile** | Support, Standard, Soft | Soft, Standard | Support, Standard | | **Coatings** | Distal End: Hydrophilic Proximal End: PTFE | Same | Same | | **Hydrophilic Coating Length** | 46cm | 46cm | X-Wire 14S: 41cm X-Wire 14T: 27.5cm X-Wire 18S: 50cm X-Wire 18T: 41cm X-Wire 24S: 60cm X-Wire 24T: 60cm | Page 3 of 8 {7} K244061 | | Predicate Aristotle 18 and 24 Guidewires (K231954) | Predicate Aristotle 14 Guidewire (K220398) | Subject Device X-Wire Guidewire (K244061) | | --- | --- | --- | --- | | Radiopaque Marker | 1 radiopaque marker at distal tip | Same | Same | | Radiopaque Length | 10cm | 10cm | 85mm (8.5cm) | | Bushing | Aristotle 24: Nitinol Bushing Aristotle 18: None | None | None | | Centering Coil | Aristotle 18: 1 centering coil Aristotle 24: 2 centering coils | 1 centering coil | X-Wire 14S: 1 centering coil X-Wire 14T: 1 centering coil X-Wire 18S: 2 centering coils X-Wire 18T: 1 centering coil X-Wire 24S: 3 centering coils X-Wire 24T: 2 centering coils | | Sterilization Method | EO | Same | Same | | Sterility Assurance Level | SAL of 10^{-6} | Same | Same | | Shelf Life | 36 months | 4 months | 8 months | G. Performance Data - Bench: Bench testing was completed to evaluate the differences between the subject devices and predicate devices and to ensure the subject device meets the specifications and performs as intended. The test methods were based primarily on the FDA Guidance, "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, Guidance for Industry and Food and Drug Administration Staff," issued in October 2019. A summary of the evaluated performance specifications is presented in Table 2. The test results demonstrated that any differences between the subject devices and predicate devices do not significantly impact performance parameters that would negatively affect the safety or effectiveness of the subject devices. Page 4 of 8 {8} K244061 Table 2: Summary of Bench Tests and Performance Specifications | Test Attribute | Specification | Results | | --- | --- | --- | | Dimensional Verification | All defined guidewire dimensions are within the specified tolerances. | Pass | | Visual Inspection | The guidewire shall be free of visual defects when removed from packaging. | Pass | | Torqueability | The guidewire shall transmit rotation from the proximal end to the distal tip to allow users to select branches of the vasculature and reach the target location. | Pass | | Torque Strength | In the event where the distal end of the guidewire is unable to move/rotate during the procedure, the device shall not fail under expected torsional input. | Pass | | Tip Flexibility | The tip of the guidewire shall not cause vessel damage. Tip flexibility is defined by the ability of the tip to buckle when contacting vessel walls. In doing so it reduces the contact pressure to prevent vessel perforation. | Pass | | Tensile Strength and Tip Pull | The guidewire shall withstand tensile forces expected in clinical use without breaking. | Pass | | Kink Resistance | The guidewire shall be able to traverse through clinically relevant bends without kinking. | Pass | | Coating Integrity | The coating shall remain intact during clinical use. | Pass | | Coating Lubricity | The coating shall be lubricious to reduce frictional forces to allow for navigation through tortuous anatomy. | Pass | | Particulate Evaluation | The guidewire shall not generate particles at a level that is greater than the range generated by the predicate. | Pass | | Corrosion Resistance | The guidewire shall not corrode from the time of manufacture through its shelf life. | Pass | | Radiopacity | Opacity to x-ray shall allow physicians to visualize guidewire under fluoroscopy. | Pass | | Simulated Use | The guidewire must be able to reach anatomical locations and deliver catheters and other interventional devices used in common neurovascular procedures. | Pass | {9} K244061 # H. Biocompatibility Testing: Biocompatibility testing was performed on a representative final, finished guidewire to evaluate all direct patient contacting components of the device. This testing was conducted to ensure that the components and raw materials used in the subject X-Wire Guidewires and the manufacturing processes and sterilization processes result in a biocompatible product. Test results and an expert evaluation confirmed that the subject X-Wire Guidewires met biological safety requirements per ISO 10993-1 for externally communicating medical devices with direct circulating blood contact for $\leq 24$ hours. Table 3: Biocompatibility Test Summary - X-Wire Guidewire | Test | Test Method | Extraction Methods/Conditions | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Cytotoxicity | ISO 10993-5 ISO 10993-12 | Test device extracted with MEM with 5% serum at 37°C for 72 hours. | Test article extracts must yield grade 2 or lower. | Pass, Non-cytotoxic | | Sensitization | ISO 10993-10 ISO 10993-12 | Test device extracted with both SC and SO at 50°C for 72 hours. | Overall pattern, intensity, duration, character of reactions compared to control conditions. | Pass, Non-sensitizer | | Irritation or Intracutaneous Reactivity | ISO 10993-23 ISO 10993-12 | Test device extracted with both SC and SO at 50°C for 3 hours. | Difference between test extract mean score and corresponding control mean score ≤1. | Pass, Non-irritating | | Acute Systemic Toxicity | ISO 10993-11 ISO 10993-12 | Test device extracted with both SC and SO at 50°C for 72 hours. | None of the animals treated with the test article extracts must show a significantly greater biological reactivity than animals treated with the control article. | Pass, Non-toxic (acute systemic) | | Material Mediated Pyrogenicity | ISO 10993-11 USP <151> ISO 10993-12 | Test device extracted with SNPS at 50°C for 72 hours. | Test article extract must yield <0.5°C rise of | Pass, Non-pyrogenic | | | | | concentration of <0.5% increase of the amount of the material added to the test article. | reaction rate of <0.5% increase of the amount of the material added to the test article. | {10} K244061 | Test | Test Method | Extraction Methods/Conditions | Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | | | individual animal baseline temperature. | | | Hemocompatibility – Hemolysis (Direct and Indirect Contact) | ISO 10993-4 ASTM F756 ISO 10993-12 | Direct Contact: Test device incubated directly in diluted blood at 37°C for 72 hours. Indirect Contact: Test device extracted in CMF-PBS at 50°C for 72 hours and then extracts incubated with diluted blood at 37°C for 3 hours. | Test article extract must result in hemolytic index of <2%. | Pass, Non-hemolytic for both Direct and Extract Methods | | Hemocompatibility - SC5b-9 Complement Activation | ISO 10993-4 | Test device exposed to Normal Human Serum at 37°C for 60 minutes. | SC5b-9 concentration of the test article is similar to both the activated NHS and negative controls. | Pass, Hemocompatible | | Hemocompatibility – In vivo thromboresistance | ISO 10993-4 | N/A, non-anticoagulated venous implant study. | Test article performs similarly to the predicate. | Pass, Hemocompatible | I. Sterilization: The X-Wire Guidewires are sterilized using a validated EO process with a sterility assurance level of $1 \times 10^{-6}$ validated per the overkill method in accordance with ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices". J. Shelf Life and Packaging: Accelerated aging testing based on ASTM F1980 was conducted to verify device, accessory, and packaging performance. An accelerated aging equivalent of 8 months was used to support 8-month shelf life. Device performance was verified by functional and performance testing. Page 7 of 8 {11} K244061 Packaging and sterile barrier integrity through transportation challenge has been verified. Aging testing has also been performed that supports the sterile barrier integrity following 8 months of accelerated aging. **K. Animal Study:** Animal study was not deemed necessary to demonstrate substantial equivalence. **L. Clinical Study:** Clinical study was not deemed necessary to demonstrate substantial equivalence. **M. Conclusions:** The X-Wire Guidewire has the same intended use and similar technological characteristics as the predicate devices. The performance testing was conducted to ensure the subject device performs as intended, meets all design specifications, and performs consistently throughout its labeled shelf life. The differences between subject and predicate devices do not raise any new or different questions of safety and effectiveness. Therefore, the X-Wire Guidewire is substantially equivalent to the predicate devices. Page 8 of 8