Zenith Micro Guidewire

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 16, 2026 Suzhou Zenith Vascular SciTech Limited Yexia Zhang Senior Regulatory Affair Supervisor Building 6, Block B, Phase 5, Biobay No. 21 Dongyanli Road, SIP Suzhou Suzhou, Jiangsu 215123 China Re: K252317 Trade/Device Name: Zenith Micro Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: July 15, 2025 Received: July 25, 2025 Dear Yexia Zhang: 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} K252317 - Yexia Zhang 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. {2} K252317 - Yexia Zhang Page 3 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). Sincerely, **JAIME RABEN -S** for Naira Muradyan 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) K252317 | | | Device Name Zenith Micro Guidewire | | | Indications for Use (Describe) Zenith Micro Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | | | 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} 中天医疗 Zenith Vascular Micro Guidewire K252317 # 510(k) Summary-K252317 | Applicant | Suzhou Zenith Vascular SciTech Limited Building 6, Block B, Phase 5, Biobay, No.21 Dongyanli Road, SIP Suzhou, China 215123 | | | --- | --- | --- | | Contact Person | Yexia Zhang | Xiaoyu Wang | | Email | reginfo@zenithmedtech.com | xiaoyu.wang@zenithmedtech.com | | Tel | +86-0512-66174311 | | | Date Prepared | April 16, 2026 | | | Device Trade Name | Zenith Micro Guidewire | | | Device Regulation Rule | 21CFR 870.1330 | | | Device Regulation Name | Catheter Guide Wire | | | Product Code | MOF | DQX | | Device Class | Class II | | | Predicate Device | Traxcess 14 Guidewire (K133725) | | | | Aristotle 18 Guidewire (K243938) | | # Device Description The Micro Guidewire is a non-active, surgically invasive device intended for limited duration use within the vasculature, which is manufactured by Suzhou Zenith Vascular SciTech Limited. The four series of Micro Guidewire: Zenith 12 Micro Guidewire, 13 Micro Guidewire, 16 Micro Guidewire and 18 Micro Guidewire ("the Micro Guidewires") are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only. The distal portion of each Micro Guidewire's tip includes a radiopaque platinum spring marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a hydrophobic (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. 1 / 6 {5} 中天医疗 Zenith Vascular Micro Guidewire K252317 The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body. # Indications for Use Zenith Micro Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. # Predicate Device Comparison The predicate devices for the Micro Guidewire are the Traxcess 14 Guidewire (K133725) and the Aristotle 18 Guidewire (K243938). The table below describes the technological differences between them. | Table 1. Technological Comparison to Subject Device and Predicate Devices | | | | | | --- | --- | --- | --- | --- | | Attributes | Subject Device (K252317) | Predicate Device (K133725) | Predicate Device (K243938) | Difference Analysis | | Device Name | Zenith Micro Guidewire | Traxcess 14 Guidewire | Aristotle 18 Guidewire | N.A. | | Indications for use | Zenith Micro Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | The Traxcess 14 Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature. | Same | | Regulation No. | 21CFR 870.1330 | 21CFR 870.1330 | 21CFR 870.1330 | Same | | Regulatory Class | II | II | II | Same | | Product Code | MOF, DQX | MOF, DQX | MOF, DQX | Same | | Review Panel | Neurology | Neurology | Neurology | Same | | Dimensional | | | | | | Wire Diameter | 0.012" (Proximal 0.013", Distal 0.012"); 0.013"; 0.016"; 0.018". | 0.014" (Proximal 0.014", Distal 0.012"). | 0.018". | Same | | Device Length | 110 cm -320 cm | 200 cm | 200 cm, 300 cm | Similar, and the device performance has been verified. | {6} 中天医疗 Zenith Vascular Micro Guidewire K252317 | Table 1. Technological Comparison to Subject Device and Predicate Devices | | | | | | --- | --- | --- | --- | --- | | Attributes | Subject Device (K252317) | Predicate Device (K133725) | Predicate Device (K243938) | Difference Analysis | | Radiopaque Coil Length | 30 mm; 85 mm | Coil Length 40 cm Radiopaque Length 3 cm | Undisclosed | Similar. | | Woven Jacket length | 80 mm; 335 mm | Undisclosed | Undisclosed | Similar, and the device performance has been verified. | | Shapeable Tip Length | 1 cm | 1.4 cm | 35 cm | Similar, and the device performance has been verified. | | Hydrophilic Coating Length | 10 cm, 35.5 cm | 40 cm | 46 cm | Similar, and the coating performance has been verified. | | Hydrophobic Coating Length | 95 cm - 285 cm | 160 cm | Undisclosed | Similar, and the coating performance has been verified. | | Tip shape | Straight and Shapeable | Straight and Shapeable | Straight and Shapeable | Same | | Coil Wire Type | Integrated | Undisclosed | Undisclosed | Similar | | Raw Material | | | | | | Core Wire Material | Stainless steel | Proximal: Stainless steel; Distal: Nickel titanium alloy. | Stainless steel | Same | | Jacket | Woven jacket: Nitinol Protective jacket: TPU | NA | Undisclosed | Different, but the biological safety has been validated. | | Radiopaque coil | Platinum nickel alloy | Stainless steel and platinum nickel alloy | Platinum | Similar | | Coating | Distal end: Hydrophilic Proximal end: PTFE | Distal: Hydrophilic Proximal: PTFE/Silicone | Distal end: Hydrophilic Proximal end: PTFE | Different, but the biological safety has been validated. | | Accessories | Shaping Mandrel, Guidewire Introducer and Torque Device | Shaping Mandrel, Insertion tool and Torque Device | Shaping Mandrel, Guidewire Introducer and Torque Device | Same | | Packaging Configuration | Placed into a packaging coil, Tyvek pouch, and box carton. | Placed into a dispenser hoop, Tyvek pouch, and box carton. | Placed into a dispenser hoop, Tyvek pouch, and box carton. | Same | | Sterilization Method | EO | EO | EO | Same | | Shelf Life | 2 years | 3 years | 1 year | Different, but the shelf-life period has been verified. | 3 / 6 {7} 中天医疗 Zenith Vascular Micro Guidewire K252317 # Performance Data Non-clinical tests have been conducted to support substantial equivalence of the device to the predicate devices and are summarized as follows. # Performance Testing-Bench The results of the bench testing conducted on the subject device demonstrate that it performs as intended and meets design specifications. Bench performance testing included the following: | Test | Test Method Summary | Conclusion | | --- | --- | --- | | Dimensional and Visual Inspection | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Verified key dimensions and surface of the Guidewire. | Acceptance criteria were met. | | Corrosion Resistance | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Measured the force required to break at each bond, including the distal tip. | Acceptance criteria were met. | | Tensile Strength | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Measured the force required to break at each bond, including the distal tip. | Acceptance criteria were met. | | Simulated Use | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Guidewires were tested for use with a micro catheter, the Guidewire Introducer, and Torque Device while navigating to target locations in the vascular model. | Acceptance criteria were met. | | Tip Shaping | Shaped the Guidewire tip for a total of 5 times per labeling. | Acceptance criteria were met. | | Tip Shape Retention | Measured the tip shape retention rate after tip shaping and simulated use in the vascular model. | Acceptance criteria were met. | | Coating Integrity | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Coating integrity was inspected before and after simulated use tracking with comparison to predicate. | Coating integrity was reported and considered acceptable. | | Coating Lubricity (Friction Force, Durability) | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). The coating lubricity and durability of the Guidewire was evaluated for frictional forces on a universal testing machine after multiple pull cycles. | Acceptance criteria were met. | | Kink Resistance | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Wrapped the | Acceptance criteria were met. | 4 / 6 {8} 中天医疗 Zenith Vascular Micro Guidewire K252317 | | Guidewire around a test fixture with a clinically relevant radius. | | | --- | --- | --- | | Torque Strength | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Recorded the number of times the distal end of the Guidewire can be rotated until it exceeds its maximum rotations and fails after tip shaping and simulated use. | Acceptance criteria were met. | | Torqueability | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). After tip shaping, the Guidewire was tracked in the vascular model during simulated use and evaluated the steerability and torque response. | Acceptance criteria were met. | | Tip Flexibility/Stiffness | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). Measured the force required to deflect the Guidewire tip when held at 5 mm, 10 mm and 20 mm gauge lengths. Forces were compared to the predicate device. | Acceptance criteria were met. | | Flexing Test | Testing completed per ISO 11070:2014 "Sterile single-use intravascular introducers, dilators and guidewires". | Acceptance criteria were met. | | Fracture Test | Testing completed per ISO 11070:2014 "Sterile single-use intravascular introducers, dilators and guidewires". | Acceptance criteria were met. | | Particulate Evaluation | Testing completed per FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019). | Particulate counts were reported and considered acceptable. | | Compatibility tests | After tip shaping, the Guidewires were inserted into compatible micro catheters and subjected to simulated use. | Acceptance criteria were met. | | Radiopacity | Subject and predicate guidewires were evaluated under fluoroscopy. | Zenith Micro Guidewire demonstrated acceptable radiopacity. The radiopacity of the subject device was comparable to that of the predicate device. | The performance data demonstrate that the subject device is substantially equivalent to the Predicate devices. ## Biocompatibility Test Biocompatibility tests were conducted with the Zenith Micro Guidewire in accordance with ISO 10993-1:2018, Biological evaluation of medical devices-Evaluation and testing within a risk management process, and the FDA biological evaluation guidance. The tests performed are listed in Table 3. | Table 3 Biocompatibility Testing | | | | --- | --- | --- | | Test | Standards | Conclusion | | Cytotoxicity- MEM Elution | ISO 10993-5 | Pass: Non-cytotoxic | | Sensitization | ISO 10993-10 | Pass: Non-sensitizing | 5 / 6 {9} 中天医疗 Zenith Vascular Micro Guidewire K252317 | Intracutaneous Reactivity | ISO 10993-23 | Pass: Non-reactive | | --- | --- | --- | | Acute Systemic Toxicity | ISO 10993-11 | Pass: No evidence of acute systemic toxicity | | Pyrogenicity | ISO 10993-11 | Pass: Non-pyrogenic | | Hemolysis (direct and indirect) | ISO 10993-4 | Pass: Non-hemolytic | | Complement Activation | ISO 10993-4 | Pass: Not an activator | | In Vivo Thrombogenicity | ISO 10993-4 | Pass: Non-thrombogenic | ## Sterilization and Shelf Life The Zenith Micro Guidewire is sterilized using the ethylene oxide (EO) method. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of $10^{-6}$ 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. Aging studies for subject device have been conducted and demonstrated for 2 year shelf-life. Packaging aging tests were also conducted and the results met all acceptance criteria. ## Packaging Each package consists of SBS (Sterile Barrier System) and protective packaging. SBS type is a flexible peel pouch, materials are UF 1250 and Tyvek Paper 1073B. All of the materials are subjected to EO sterilization with good compatibility, and the sterilization validation proves this. Shipping container is a logistic unit. Corrugated case is used as packaging material for transportation. ## Animal Study An animal study was not deemed necessary to support the substantial equivalence of the subject device to the predicate device. Bench testing was determined sufficient to support substantial equivalence ## Clinical Studies This pre-market submission did not rely on the assessment of clinical data to demonstrate device performance and equivalence. Non-clinical testing described above was determined to be sufficient to support substantial equivalence. ## Conclusion The conclusions of the performance data demonstrate that the subject device - Zenith Micro Guidewire performs substantially equivalent to the predicate devices and does not raise new questions of safety and effectiveness. 6 / 6