35 Helix Guidewire

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION August 27, 2026 Piraeus Medical, Inc. Sarah Kabanuk COO 7351 Kirkwood Lane N, Suite 116 Maple Grove, Minnesota 55369 Re: K260751 Trade/Device Name: 35 Helix Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: July 23, 2026 Received: July 24, 2026 Dear Sarah Kabanuk: 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} K260751 - Sarah Kabanuk 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} K260751 - Sarah Kabanuk 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. | K260751 | ? | | Please provide the device trade name(s). | | ? | | 35 Helix Guidewire | | | | Please provide your Indications for Use below. | | ? | | The 35 Helix 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K260751 Page 1 # 510(k) Summary, K260751 # A. Submitter Information Submitter's Name: Address: Contact Person: Telephone: Email: Date of Preparation: Piraeus Medical, Inc. 7351 Kirkwood Lane N, Suite 116 Maple Grove, MN 55369, USA Sarah Kabanuk 507-782-0184 skabanuk@piraeusmedical.com March 6th, 2026 # B. Correspondent Information Contact Name: Telephone: Sarah Kabanuk 507-782-0184 # C. Subject Device Proprietary Name: Common/Usual Name: Classification Name: Product Codes: Regulation: 35 Helix™ Guidewire Guidewire Guide, Wire, Catheter, Neurovasculature MOF, DQX 21 CFR 870.1330 # D. Predicate Device Proprietary Name: Common/Usual Name: Classification Name: Product Codes: Regulation: Manufacturer: 510(k) #: Aristotle® Colossus® Guidewire Guidewire Guide, Wire, Catheter, Neurovasculature MOF, DQX 21 CFR 870.1330 Scientia Vascular, Inc. K222437 # E. Device Description The 35 Helix Guidewire is a 0.035" diameter guidewire designed to facilitate access to neuro and peripheral vasculatures. It is supplied sterile for single use only and is available in a standard stiffness profile with a length of 180 cm. The guidewire is offered pre-shaped with either a straight tip or a round curve distal tip. The guidewire is constructed of nitinol and features a distal radiopaque polymer jacket to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment is to reduce friction during manipulation in vessels. The guidewire is provided with an introducer, to aid with guidewire insertion into a catheter hub and/or rotating hemostasis valve (RHV), and a torque device to attach to the proximal portion of the guidewire to facilitate steering. # F. Intended Use The 35 Helix Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature. # G. Indications for Use The 35 Helix 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. # H. Comparison of Technological Characteristics Shown in the table below is the comparison of technological characteristics for the 35 Helix Guidewire to those of the predicate device, Aristotle Colossus Guidewire (K222437). {5} K260751 Page 2 Table 1: Comparison of Predicate and Subject Devices | Device Attribute | Predicate Device (K222437) | Subject Device (K260751) | | --- | --- | --- | | Regulation / Product Code | Class II, MOF, DQX, 21 CFR 870.1330 | Same | | Indications for Use | 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. | The 35 Helix 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. | | Intended Use | The Aristotle Colossus Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature. | The 35 Helix Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature. | | Wire Diameter Maximum | 0.035" (0.88 mm) | Same | | Wire Diameter Profile | 0.018"- 0.035" | 0.024" - 0.035" | | Device Length | 150 cm to 300 cm | 180 cm | | Flex (Tip) Length | 35 cm | 25 cm | | Tip Type and Shape | Straight, Shapeable | Pre-Shaped Straight Pre-Shaped Round Curve | | Flexibility (stiffness) | Standard | Same | | Wire Material | Core Wire: Stainless Steel | Core Wire: Nitinol | | Coatings | Distal End: Hydrophilic | Same | | | Distal Coated Length: 46 cm | Distal Coated Length: 80 cm | | | Proximal End: Polytetrafluoroethylene (PTFE) | Proximal End: None | | Distal Portion Radiopacity | Tip includes a radiopaque platinum wire marker coil that is 10 cm long | Tip includes a radiopaque loaded polymer section that is 13.75 cm long | | Accessories | Guidewire Introducer, Torque Device, Shaping Mandrel | Guidewire Introducer, Torque Device | | Packaging Configuration | High-Density Polyethylene (HDPE) Tube, Tyvek Pouch, Carton, Shipper Box | Same | | Sterilization Method | 100% Ethylene Oxide (EO) | Same | | Shelf Life | 1 year | 6 months | ### I. Performance Data Supporting Substantial Equivalence A summary of the supportive testing is presented in Table 2. These tests were performed per company approved protocols, test methods, and performance standards. {6} K260751 Page 3 Table 2: Test and Performance Specifications | Test | Test Method Summary [standard and/or guidance] | Result | | --- | --- | --- | | Dimensional Verification | The guidewire diameter, usable length and coating length were measured [ISO 11070, FDA guidance “Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling” (FDA-2018-D-1775)]. | Pass | | Visual Inspection | The guidewire was examined for surface defects and extraneous matter which could cause trauma to vessels during use. The distal tip was inspected to confirm the presence of smooth, rounded edges and correct tip configuration [ISO 11070, FDA-2018-D-1775]. | Pass | | Radiopacity | Radiopacity testing per ASTM F640. | Pass | | Delivery, Compatibility, and Retraction (Trackability and Simulated Use) | The guidewire can be inserted, tracked and removed per the instructions for use (IFU) within a simulated use model without damage to the guidewire [ FDA-2018-D-1775]. | Pass | | Pushability | The proximal shaft of the guidewire has sufficient stiffness that the user can push the guidewire to the target anatomy without buckling [FDA-2018-D-1775]. | Pass | | Tip Flexibility | Measure force to deflect guidewire tips at 5 mm, 10 mm, and 20 mm test lengths [FDA-2018-D-1775]. | Pass | | Torqueability/Torque Strength | Torque response (average input-to-output lag) and torque turns to failure were measured in an anatomical model [FDA-2018-D-1775]. | Pass | | Particulate | Particulates of various size ranges counted after simulated use in a tortuous path [FDA-2018-D-1775]. | Pass | | Coating Lubricity and Durability | Frictional force of coated guidewires was determined after simulated use in a tortuous path [FDA-2018-D-1775]. | Pass | | Tip Pull and Tensile Strength | Tensile strength / Tip Pull / Peak tensile force of the entire length of the guidewire [ISO 11070, FDA-2018-D-1775]. | Pass | | Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use [FDA-2018-D-1775]. | Pass | | Corrosion Resistance | Corrosion resistance evaluated the metallic components related to corrosion contacting the intended fluid path [ISO 11070]. | Pass | | Fracture and Flexing | The guidewire does not fracture, loosen, or fail during repeated, tortuous use [ISO 11070]. | Pass | | Compatibility with Other Devices | The guidewire is compatible with catheters and interventional devices up to the minimum size indicated in the device labeling [FDA-2018-D-1775]. | Pass | | Usability and Design Validation | Physicians evaluated subject and predicate guidewires for various performance characteristics in an anatomically relevant model [IEC 62366-1, FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” (FDA-2011-D-0469)]. | Pass | | Accessory Compatibility | The guidewires shall be compatible with their packaged accessories (introducer and torque device). | Pass | {7} K260751 Page 4 | Coating Integrity | Coating coverage was assessed after simulated use in a tortuous path anatomical model [ISO 11070, FDA-2018-D-1775]. | Pass | | --- | --- | --- | # J. Biocompatibility Testing The following biocompatibility testing was conducted for the 35 Helix Guidewire: Table 3: Summary of Subject Device Biocompatibility Testing Performed | Test | Test Method Summary | Conclusion of Testing | | --- | --- | --- | | Cytotoxicity (MEM Elution) | Test in accordance with ISO 10993-5 | Non-cytotoxic | | Sensitization | Test in accordance with ISO 10993-10 | Non-sensitizing | | Irritation | Tested in accordance with ISO 10993-23 | Non-irritating | | Acute Systemic Toxicity | Tested in accordance with ISO 10993-11 | Non-toxic | | Material Mediated Rabbit Pyrogen | Tested in accordance with ISO 10993-11 and USP <151> | Non-pyrogenic | | Direct Contact and Extract Method Hemolysis | Tested in accordance with ISO 10993-4 and ASTM F756 | Non-hemolytic | | Platelet and Leukocyte Count Assay | Tested in accordance with ISO 10993-4 | The subject device had similar or lesser impact on platelet and leukocyte counts when compared to the predicate. | | Sc5b-9 Complement Activation | Tested in accordance with ISO 10993-4 | The subject device had similar potential to activate the complement system when compared to the predicate. | | In vitro blood flow loop | Tested in accordance with ISO 10993-4 | The thrombus deposition on the subject device was similar to or less than that of the comparator device. | | Partial Thromboplastin Time (PTT) Test | Tested in accordance with ISO 10993-4 | No effect on the PTT. The subject device and the predicate are considered similar. | # K. Sterilization The 35 Helix Guidewire is sterilized using a validated EO process with a sterility assurance level of 1x10⁻⁶ 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”, and tested for EO and ethylene chlorohydrin (ECH) residuals and bacterial endotoxin levels. # L. Shelf Life and Packaging Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance to support a 6-month shelf-life claim. Device and package performance was verified by functional and performance testing. # M. Conclusions The subject device, 35 Helix Guidewire, has the same intended use, same indications for use, same fundamental design and similar device features as the predicate device. The differences in technological characteristics have been evaluated through testing and risk evaluation, and do not raise new or different questions of safety and effectiveness, supporting that the subject device is substantially equivalent to the predicate.