Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire

Q: Who is the manufacturer of Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Scientia Vascular, LLC filed the 510(k) submission for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire (K220398).

Q: What is the FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

MOF. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire (K173235); Aristotle 18 Guidewire (K183608); Aristotle 24 Guidewire (K192783); Volo 14 Guidewire (K181828); Zoom 14 Guidewire (K201760).

Q: Who can help prepare an FDA 510(k) submission like Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K220398 · Scientia Vascular, LLC · MOF · Mar 10, 2023 · Cardiovascular

Device Facts

Record ID	K220398
Device Name	Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
Applicant	Scientia Vascular, LLC
Product Code	MOF · Cardiovascular
Decision Date	Mar 10, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The guidewires are intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature.

Device Story

Steerable guidewires with shapeable tips; used by physicians to access neuro and peripheral vasculatures. Input: manual manipulation by physician. Transformation: guidewire provides trackability and support for catheter placement; distal platinum marker coil allows fluoroscopic visualization; hydrophilic distal coating and PTFE proximal coating reduce friction. Output: physical positioning of interventional devices. Used in clinical settings (e.g., neuro/peripheral interventions). Benefits: facilitates navigation through tortuous anatomy to deliver therapeutic devices. Accessories include introducer, torque device, and shaping mandrel.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench performance testing and biocompatibility assessment.

Technological Characteristics

Materials: Stainless steel core, Nitinol distal tip, hydrophilic distal coating, PTFE proximal coating, platinum marker coil. Dimensions: 0.014"-0.024" O.D., 200-300 cm lengths. Sterilization: 100% Ethylene Oxide (EO). Compliance: ISO 11070:2014, ISO 10993, ISO 14971:2019.

Indications for Use

Indicated for general vascular use within neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. Not intended for coronary vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

Aristotle 14 Guidewire (K173235)
Aristotle 18 Guidewire (K183608)
Aristotle 24 Guidewire (K192783)
Volo 14 Guidewire (K181828)
Zoom 14 Guidewire (K201760)

Related Devices

K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire · Scientia Vascular, Inc. · Apr 1, 2025
K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire · Scientia Vascular, Inc. · Aug 1, 2023
K153053 — Traxcess Pro 14 Guidewire · MicroVention, Inc. · Dec 29, 2015
K252011 — CHIKAI Nexus petit · Asahi Intecc Co., Ltd. · Feb 2, 2026
K260130 — Willow 18 Guidewire · Arbor Endovascular, LLC · Feb 13, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ March 10, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Scientia Vascular, Inc. Thomas Lippert Regulatory Affairs Associate 3487 West 2100 South Suite 100 West Valley City, Utah 84119 Re: K220398 Trade/Device Name: Aristotle 14 Guidewire: Aristotle 18 Guidewire: Aristotle 24 Guidewire: Volo 14 Guidewire; Zoom Wire 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX, Dated: February 10, 2023 Received: February 10, 2023 Dear Thomas Lippert: 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 (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 located 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K220398 Device Name Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; 20om Wire 14 Guidewire Indications for Use (Describe) 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 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 Volo 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 Zoom Wire 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block;"> <img alt="Checked" src="checkbox_checked.png" style="width:15px;height:15px;"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;"> <img alt="Unchecked" src="checkbox_unchecked.png" style="width:15px;height:15px;"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized, blue, intertwined "S" shape above the word "SCIENTIA" in a futuristic-looking font. The background is a plain, light color, which makes the blue logo and text stand out. # K220398 510(k) SUMMARY | 510(k) Sponsor: | Scientia Vascular, Inc. | |--------------------|-----------------------------------------| | | 3487 West 2100 South Suite 100 | | | West Valley City, UT 84119 | | | Tel (888) 385-9016 | | Contact Person(s): | Thomas Lippert | | | Bailey Johannsen | | | Regulatory Affairs Specialist | | | Tel: (888) 385-9016 | | | E-mail: regulatory@scientiavascular.com | | Date Prepared: | March 9, 2023 | {4}------------------------------------------------ #### Table 1. Subject Device Information | Aristotle 14 Guidewire | | |-------------------------|-----------------------------------------| | Trade Name: | Aristotle 14 Guidewire | | Common Name: | Guidewire | | Classification Name | Catheter Guide Wire per 21 CFR 870.1330 | | Primary Product Code: | MOF | | Subsequent Product Code | DQX | | Predicate Device: | Aristotle 14 Guidewire (K173235) | | Aristotle 18 Guidewire | | | Trade Name: | Aristotle 18 Guidewire | | Common Name: | Guidewire | | Classification Name | Catheter Guide Wire per 21 CFR 870.1330 | | Primary Product Code: | MOF | | Subsequent Product Code | DQX | | Predicate Device: | Aristotle 18 Guidewire (K183608) | | Aristotle 24 Guidewire | | | Trade Name: | Aristotle 24 Guidewire | | Common Name: | Guidewire | | Classification Name | Catheter Guide Wire per 21 CFR 870.1330 | | Primary Product Code: | MOF | | Subsequent Product Code | DQX | | Predicate Device: | Aristotle 24 Guidewire (K192783) | | Volo 14 Guidewire | | | Trade Name: | Volo 14 Guidewire | | Common Name: | Guidewire | | Classification Name | Catheter Guide Wire per 21 CFR 870.1330 | | Primary Product Code: | MOF | | Subsequent Product Code | DQX | | Predicate Device: | Volo 14 Guidewire (K181828) | | Zoom Wire 14 Guidewire | | | Trade Name: | Zoom Wire 14 Guidewire | | Common Name: | Guidewire | | Classification Name | Catheter Guide Wire per 21 CFR 870.1330 | | Primary Product Code: | MOF | | Subsequent Product Code | DQX | | Predicate Device: | Zoom 14 Guidewire (K201760) | {5}------------------------------------------------ ## DEVICE DESCRIPTION The Scientia Vascular's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 Guidewires ("the 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, in the following diameters, stiffness profiles, and lengths: | Aristotle 14 Guidewire | | |---------------------------|-------------------------| | Diameter | 0.014" | | Stiffness Profiles | Soft, Standard | | Lengths | 200 cm, 300 cm | | Aristotle 18 Guidewire | | | Diameter | 0.018" | | Stiffness Profiles | Soft, Standard, Support | | Length | 200 cm | | Aristotle 24 Guidewire | | | Diameter | 0.024" | | Stiffness Profiles | Soft, Standard, Support | | Length | 200 cm | | Volo 14 Guidewire | | | Diameter | 0.014" | | Stiffness Profiles | Soft, Standard | | Lengths | 200 cm, 300 cm | | Zoom Wire 14 Guidewire | | | Diameter | 0.014" | | Stiffness Profiles | Support, Extra Support | | Lengths | 200 cm, 300 cm | The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have 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 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. {6}------------------------------------------------ ## INDICATIONS FOR USE #### Aristotle 14 Guidewire 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. #### Aristotle 18 Guidewire 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. ### Aristotle 24 Guidewire 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. #### Volo 14 Guidewire The Volo 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. #### Zoom Wire 14 Guidewire The Zoom Wire 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. {7}------------------------------------------------ Scientia Vascular, Inc. Special 510(k) ## INTENDED USE The guidewires are 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 devices have the following similarities to the previously cleared predicate devices: - The same indications for use. - The same intended use, - The same operating principle, - The same basic guidewire design, ● - The similar materials, and ● - The same packaging materials and sterilization processes. The tables (Table 2 - Table 6) below provide additional details on the technological characteristics of the subject devices compared to their respective predicate devices. | Characteristic | Subject Device Aristotle 14 Guidewire (K220398) | Predicate Aristotle 14 Guidewire (K173235) | Comparison | |------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------| | Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same | | Dimensions | O.D. : 0.014" (0.36 mm) Length : 200 cm, 300 cm | O.D. : 0.014" (0.36 mm) Length : 200 cm, 300 cm range | Same | | Core Wire | Stainless Steel | Stainless Steel | Same | | Distal Tip | Shapeable Length : 35 cm Material : Nitinol | Shapeable Length : 35 cm Material : Nitinol | Same | | Stiffness Profiles | Soft, standard | Soft, standard | Same | | Coatings | Distal End : Hydrophilic Proximal End : Proposed PTFE | Distal End : Hydrophilic Proximal End : Current PTFE | Different | | Table 2. Aristotle 14 Guidewire Technological Characteristics Comparison | |--------------------------------------------------------------------------| |--------------------------------------------------------------------------| {8}------------------------------------------------ | Characteristic | Subject Device Aristotle 14 Guidewire (K220398) | Predicate Aristotle 14 Guidewire (K173235) | Comparison | |----------------------------------------|-------------------------------------------------------|--------------------------------------------------|------------| | Radiopaque Marker | 1 radiopaque marker at distal tip | 1 radiopaque marker at distal tip | Same | | Centering Coil | 1 centering coil | 1 centering coil | Same | | Shaping Mandrel (Accessory) | Provided with each guidewire | NA | Different | | Guidewire Introducer (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Torque Device (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Sterilization Method | 100% Ethylene Oxide (EO) | 100% EO | Same | | Shelf Life | 4 month | 3 year | Different | ### Table 3. Aristotle 18 Guidewire Technological Characteristics Comparison | Characteristic | Subject Device Aristotle 18 Guidewire (K220398) | Predicate Aristotle 18 Guidewire (K183608) | Comparison | |------------------------|-------------------------------------------------------|--------------------------------------------------|------------| | Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same | | Dimensions | O.D.: 0.018" (0.46 mm) Length: 200 cm | O.D.: 0.018" (0.46 mm) Length: 200 cm | Same | | Core Wire | Stainless Steel | Stainless Steel | Same | | Distal Tip | Shapeable Length: 35 cm Material: Nitinol | Shapeable Length: 35 cm Material: Nitinol | Same | | Stiffness Profiles | Support, standard, soft | Support, standard, soft | Same | | Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same | | | Proximal End: Proposed PTFE | Proximal End: Current PTFE | Different | {9}------------------------------------------------ | Characteristic | Subject Device Aristotle 18 Guidewire (K220398) | Predicate Aristotle 18 Guidewire (K183608) | Comparison | |----------------------------------------|-------------------------------------------------------|--------------------------------------------------|------------| | Radiopaque Marker | 1 radiopaque marker at distal tip | 1 radiopaque marker at distal tip | Same | | Centering Coil | 1 centering coil | 1 centering coil | Same | | Shaping Mandrel (Accessory) | Provided with each guidewire | NA | Different | | Guidewire Introducer (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Torque Device (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Sterilization Method | 100% EO | 100% EO | Same | | Shelf Life | 4 month | 3 year | Different | ## Table 4. Aristotle 24 Guidewire Technological Characteristics Comparison | Characteristic | Subject Device Aristotle 24 Guidewire (K220398) | Predicate Aristotle 24 Guidewire (K192783) | Comparison | |------------------------|-------------------------------------------------------|--------------------------------------------------|------------| | Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same | | Dimensions | O.D.: 0.024" (0.61 mm) Length: 200 cm | O.D.: 0.024" (0.61 mm) Length: 200 cm | Same | | Core Wire | Stainless steel | Stainless steel | Same | | Distal Tip | Shapeable Length: 35 cm Material: Nitinol | Shapeable Length: 35 cm Material: Nitinol | Same | | Stiffness Profiles | Support, standard, soft | Support, standard, soft | Same | | Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same | | | Proximal End: Proposed PTFE | Proximal End: Current PTFE | Different | {10}------------------------------------------------ | Characteristic | Subject Device Aristotle 24 Guidewire (K220398) | Predicate Aristotle 24 Guidewire (K192783) | Comparison | |----------------------------------------|-------------------------------------------------------|--------------------------------------------------|------------| | Radiopaque Marker | 1 radiopaque marker at distal tip | 1 radiopaque marker at distal tip | Same | | Centering Coil | 2 centering coils | 2 centering coils | Same | | Bushing | 1 bushing | 1 bushing | Same | | Shaping Mandrel (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Guidewire Introducer (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Torque Device (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Sterilization Method | 100% EO | 100% EO | Same | | Shelf Life | 4 month | 3 year | Different | ### Table 5. Volo 14 Guidewire Technological Characteristics Comparison | Characteristic | Subject Device Volo 14 Guidewire (K220398) | Predicate Volo 14 Guidewire (K181828) | Comparison | |------------------------|--------------------------------------------------|--------------------------------------------------|------------| | Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same | | Dimensions | O.D.: 0.014" (0.36 mm) Length: 200 cm, 300 cm | O.D.: 0.014" (0.36 mm) Length: 200 cm, 300 cm | Same | | Core Wire | Stainless Steel | Stainless Steel | Same | | Distal Tip | Shapeable Length: 35 cm Material: Nitinol | Shapeable Length: 35 cm Material: Nitinol | Same | | Stiffness Profiles | Soft, standard | Soft, standard | Same | | Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same | | | Proximal End: Proposed | Proximal End: Current PTFE | Different | {11}------------------------------------------------ | Characteristic | Subject Device Volo 14 Guidewire (K220398) | Predicate Volo 14 Guidewire (K181828) | Comparison | |----------------------------------------|--------------------------------------------------|---------------------------------------------|------------| | | PTFE | | | | Radiopaque Marker | 1 radiopaque marker at distal tip | 1 radiopaque marker at distal tip | Same | | Centering Coil | 1 centering coil | 1 centering coil | Same | | Shaping Mandrel (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Guidewire Introducer (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Torque Device (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Sterilization Method | 100% EO | 100% EO | Same | | Shelf Life | 4 month | 3 year | Different | #### Table 6. Zoom Wire 14 Guidewire Technological Characteristics Comparison | Characteristic | Subject Device Zoom Wire 14 Guidewire (K220398) | Predicate Zoom 14 Guidewire (K201760) | Comparison | |------------------------|-------------------------------------------------------|------------------------------------------------------|------------| | Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same | | Dimensions | Max O.D.: 0.014" (0.36 mm) Length: 200 cm, 300 cm | Max O.D.: 0.014" (0.36 mm) Length: 200 cm, 300 cm | Same | | Core Wire | Stainless Steel | Stainless Steel | Same | | Distal Tip | Shapeable Length: 35 cm Material: Nitinol | Shapeable Length: 35 cm Material: Nitinol | Same | | Stiffness Profiles | Support, extra support | Support, extra support | Same | | Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same | {12}------------------------------------------------ | Characteristic | Subject Device Zoom Wire 14 Guidewire (K220398) | Predicate Zoom 14 Guidewire (K201760) | Comparison | |----------------------------------------|-------------------------------------------------------|---------------------------------------------|------------| | Proximal End | Proximal End: Proposed PTFE | Proximal End: Current PTFE | Different | | Radiopaque Marker | Radiopaque marker at distal tip | Radiopaque marker at distal tip | Same | | Centering Coil | 1 centering coil | 1 centering coil | Same | | Bushing | None | None | Same | | Shaping Mandrel (Accessory) | Provided with each guidewire | NA | Different | | Guidewire Introducer (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Torque Device (Accessory) | Provided with each guidewire | Provided with each guidewire | Same | | Sterilization Method | 100% EO | 100% EO | Same | | Shelf Life | 4 month | 3 year | Different | The subject devices have a different PTFE coating on the proximal end of the guidewire. This difference does not raise new questions of safety and effectiveness, nor does it result in new risks for the subject devices. Testing and evaluation (see below) of the subject devices has been performed with regards to this characteristic and demonstrated the safety and effectiveness of the subject devices. ## NON-CLINICAL PERFORMANCE TESTS ## Biocompatibility A biological risk assessment was performed in accordance with recommendations in the ISO 10993 series and ISO 14971:2019 and concluded that the alternative PTFE coating does not impact biocompatibility of the subject devices. The subject devices are considered externally communicating devices with circulating blood contact for a limited duration (< 24 hours) and the following tests were performed: | Test | Test Method Summary | Conclusion | |--------------|-----------------------------------------------------------------|----------------------| | Cytotoxicity | MEM elution cell culture observed for cytotoxic reactivity. | Pass: Non-cytotoxic. | | Pyrogenicity | Study animals were observed for individual temperature rise. | Pass: Non-pyrogenic. | #### Table 7. Summary of Biocompatibility Testing {13}------------------------------------------------ | Test | Test Method Summary | Conclusion | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Sensitization | Study animals with subject device were observed for dermal sensitization. | Pass: Non-sensitizing. | | Irritation | Study animals with subject device were observed for dermal reaction. | Pass: Non-irritant. | | Acute Systemic Toxicity | Study animals with the subject device were observed for abnormal clinical signs indicative of toxicity. | Pass: No evidence of acute systemic toxicity. | | Hemocompatibility | The difference between the hemolytic indexes of the subject device and the negative control was evaluated (direct contact and extract). | Pass: Non-hemolytic. | | Complement Activation of SC5b-9 | Comparison of the subject device SC5b-9 value to the predicate device for all exposure times was performed. | Pass: The test article complement activation was similar to the comparator device. | | Partial Thromboplastin Time | The clotting time was observed for both the subject device and the predicate. | Pass: The test article clotting time was similar to the comparator device. | | 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: Thromboresistant. | | Latex Detection | ELISA Inhibition Assay used for the quantitation of extractable latex proteins. | Pass: Latex was not detected. | ## Sterilization The existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10- , and testing for EO and ethylene chlorohydrin (ECH) residuals and bacterial endotoxin levels were performed. ## Bench Performance Testing Following review of the risk assessments conducted in accordance with ISO 14971:2012, 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 the FDA guidance document, Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019), were also performed. Table 8 summarizes these tests and their results below. #### Table 8. Summary of Bench Performance Tests | Test | Test Method Summary | Results | |---------------------------------------------------|---------------------|-------------------------| | Visual Inspection and Dimensional Verification | Test per ISO 11070 | Acceptance criteria met | {14}------------------------------------------------ | Test | Test Method Summary | Results | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Coating Integrity Assessment | Test per ISO 11070 and FDA guidance document "Coronary, Peripheral and Neurovascular Guidewires - Performance Tests and Recommended Labeling" (2019) | Acceptance criteria met | | Corrosion Resistance | Test per ISO 11070 | Acceptance criteria met | | Agent Compatibility | Test per ISO 11070 | Acceptance criteria met | | Simulated Use | Anatomical model designed to simulate the tortuous anatomy of the neurovasculature used for simulated use testing. | Acceptance criteria met | | Particulate | Particulate measured and counted after use in a simulated pathway model. | Acceptance criteria met | ## Animal Testing No animal testing was deemed necessary to support the substantial equivalence of the subject devices. ## Clinical Testing No clinical testing was deemed necessary to support the substantial equivalence of the subject devices. ## CONCLUSION The Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Volo 14 Guidewire, and Zoom Wire 14 Guidewire have the same intended use and indications for use statement as their respective predicate device. The identified technological difference does not raise new questions of safety or effectiveness regarding the use of the subject devices. Risk evaluation along with testing, bench and biological, was completed for the subject devices. The testing and risk evaluation demonstrate that the subject devices are substantially equivalent to their respective predicate device.