(102 days)
Not Found
No
The document describes a medical guidewire and its physical properties, use, and testing. It does not mention any software, algorithms, or computational models that would suggest the presence of an AI model.
No
This device is a guidewire, intended to introduce and position other interventional devices, primarily for diagnostic or facilitative purposes rather than directly treating a condition.
No
This device is a guidewire, intended to introduce and position catheters and other interventional devices within blood vessels, not to diagnose medical conditions.
No
The device is a physical guidewire and accessory kit used for interventional procedures, not a software application. The description details physical attributes, materials, and mechanical testing.
No.
The device is a guidewire intended to introduce and position catheters and other interventional devices within the neuro and peripheral vasculatures. It is an invasive surgical tool and does not perform in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
Device Description
The Scientia Vascular's Aristotle 14, Aristotle 18, Aristotle 24, Zoom Wire 14, and Aristotle Colossus 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, 300cm
Aristotle 24 Guidewire
Diameter: 0.024"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300cm
Aristotle Colossus Guidewire
Diameter: 0.035"
Stiffness Profiles: Standard
Lengths: 150 cm to 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculatures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
- Cytotoxicity: MEM elution cell culture observed for cytotoxic reactivity. Conclusion: Pass: Non-cytotoxic.
- Pyrogenicity: Study animals were observed for individual temperature rise. Conclusion: Pass: Non-pyrogenic.
- Sensitization: Study animals with subject device were observed for dermal sensitization. Conclusion: Pass: Non-sensitizing.
- Irritation: Study animals with subject device were observed for dermal reaction. Conclusion: Pass: Non-irritant.
- Acute Systemic Toxicity: Study animals with the subject device were observed for abnormal clinical signs indicative of toxicity. Conclusion: Pass: No evidence of acute systemic toxicity.
- Hemocompatibility: The difference between the hemolytic indexes of the subject device and the negative control was evaluated (extract). Conclusion: Pass: Non-hemolytic.
Sterilization:
- The existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10-6. Testing for EO and ethylene chlorohydrin (ECH) residuals and bacterial endotoxin levels were performed.
Bench Performance Testing:
- Visual Inspection and Dimensional Verification: Test per ISO 11070. Results: Acceptance criteria met.
- Coating Integrity Assessment: Test per ISO 11070 and FDA guidance document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Results: Acceptance criteria met.
- Corrosion Resistance: Test per ISO 11070. Results: Acceptance criteria met.
- Agent Compatibility: Guidewires were tested for compatibility with dimethyl sulfoxide (DMSO), heparinized saline, IsoVue 300 contrast, and IsoVue 370 contrast. Results: Acceptance criteria met.
- Simulated Use: Guidewires were tested for use with a microcatheter, the guidewire introducer, and torque device while navigating to target locations in a simulated use model. Results: Acceptance criteria met.
- Particulate: Particulate measured and counted after guidewire use in a simulated pathway model with a microcatheter and the guidewire introducer. Results: Acceptance criteria met.
Animal Testing: No animal testing was deemed necessary.
Clinical Testing: No clinical testing was deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aristotle 14 Guidewire (K173235), Aristotle 18 Guidewire (K231954), Aristotle 24 Guidewire (K231954), Zoom 14 Guidewire (K201760), Aristotle Colossus Guidewire (K222437)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1330 Catheter guide wire.
(a)
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.(b)
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.
FDA 510(k) Clearance Letter - K243938
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 1, 2025
Scientia Vascular, Inc.
Bret Draper
Regulatory Affairs Specialist
2460 South 3270 West
West Valley City, Utah 84119
Re: K243938
Trade/Device Name: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: MOF, DQX
Dated: March 7, 2025
Received: March 7, 2025
Dear Bret Draper:
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.
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K243938 - Bret Draper 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-
Page 3
K243938 - Bret Draper 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
Page 4
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): K243938
Device Name: Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus 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 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.
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.
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."
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Scientia Vascular, Inc.
Special 510(k)
K243938
Pg. 1
510(k) SUMMARY
510(k) Sponsor: Scientia Vascular, Inc.
2460 South 3270 West
West Valley City, UT 84119
Tel (888) 385-9016
Contact Person(s): Bret Draper
Regulatory Affairs Specialist
Tel: (888) 385-9016
E-mail: regulatory@scientiavascular.com
Date Prepared: March 31, 2025
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Table 1. Subject Device Information
| 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 (K231954) |
| 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 (K231954) |
| 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) |
| Aristotle Colossus Guidewire | |
| Trade Name: | Aristotle Colossus 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 Colossus Guidewire (K222437) |
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Pg. 3
DEVICE DESCRIPTION
The Scientia Vascular's Aristotle 14, Aristotle 18, Aristotle 24, Zoom Wire 14, and Aristotle Colossus 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:
| Guidewire | Specifications |
|---|---|
| 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, 300cm |
| Aristotle 24 Guidewire | |
| Diameter | 0.024" |
| Stiffness Profiles | Soft, Standard, Support |
| Length | 200 cm, 300cm |
| Aristotle Colossus Guidewire | |
| Diameter | 0.035" |
| Stiffness Profiles | Standard |
| Lengths | 150 cm to 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.
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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.
Aristotle Colossus Guidewire
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.
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.
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INTENDED USE
The subject 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,
- 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.
Table 2. Aristotle 14 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device Aristotle 14 Guidewire (K243938) | 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 | 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:PTFE | Different |
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| Characteristic | Subject Device Aristotle 14 Guidewire (K243938) | 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 | Cleared in K220398 |
| 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 | 1 year | 3 year | Different |
Table 3. Aristotle 18 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device Aristotle 18 Guidewire (K243938) | Predicate Aristotle 18 Guidewire (K231954) | Comparison |
|---|---|---|---|
| Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same |
| Dimensions | O.D.: 0.018" (0.46 mm) Length: 200 cm, 300 cm | O.D.: 0.018" (0.46 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, standard, soft | Support, standard, soft | Same |
| Coatings | Distal End: Hydrophilic Proximal End:Proposed PTFE | Distal End: Hydrophilic Proximal End: PTFE | Different |
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| Characteristic | Subject Device Aristotle 18 Guidewire (K243938) | Predicate Aristotle 18 Guidewire (K231954) | 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 | 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 | 1 year | 3 year | Different |
Table 4. Aristotle 24 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device Aristotle 24 Guidewire (K243938) | Predicate Aristotle 24 Guidewire (K231954) | Comparison |
|---|---|---|---|
| Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same |
| Dimensions | O.D.: 0.024" (0.61 mm) Length: 200 cm, 300 cm | O.D.: 0.024" (0.61 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, standard, soft | Support, standard, soft | Same |
| Coatings | Distal End: Hydrophilic Proximal End:Proposed PTFE | Distal End: Hydrophilic Proximal End: PTFE | Different |
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| Characteristic | Subject Device Aristotle 24 Guidewire (K243938) | Predicate Aristotle 24 Guidewire (K231954) | 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 | 1 year | 3 year | Different |
Table 5. Zoom Wire 14 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device Zoom Wire 14 Guidewire (K243938) | 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 |
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| Characteristic | Subject Device Zoom Wire 14 Guidewire (K243938) | Predicate Zoom 14 Guidewire (K201760) | Comparison |
|---|---|---|---|
| Coatings (cont.) | Proximal End:Proposed PTFE | Proximal End: 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 | 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 | 1 year | 3 year | Different |
Table 6. Aristotle Colossus Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device Aristotle Colossus Guidewire (K243938) | Predicate Aristotle Colossus Guidewire (K222437) | Comparison |
|---|---|---|---|
| Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same |
| Dimensions | O.D.: 0.035" (0.88 mm) Length: 150 cm to 300 cm | O.D.: 0.035" (0.88 mm) Length: 150 cm to 300 cm | Same |
| Core Wire | Stainlesssteel | Stainlesssteel | Same |
| Distal Tip | Shapeable Length: 35 cm Material: Nitinol | Shapeable Length: 35 cm Material: Nitinol | Same |
| Stiffness Profiles | Standard | Standard | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
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| Characteristic | Subject Device Aristotle Colossus Guidewire (K243938) | Predicate Aristotle Colossus Guidewire (K222437) | Comparison |
|---|---|---|---|
| Coatings (cont.) | Proximal End:Proposed PTFE | Proximal End: PTFE | Different |
| 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 |
| Centering Washer | 1 washer | 1 washer | 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 | 1 year | 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 have been performed with regards to this characteristic and demonstrated the subject devices perform as intended.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
A biological risk assessment was performed in accordance with recommendations in the ISO 10993 series and ISO 14971:2019 to assess the impact of the alternative PTFE coating on the biocompatibility profile 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 to assess the modification made to the indirect blood contacting region of the guidewires:
Table 7. Summary of Biocompatibility Testing
| 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. |
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| 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 (extract). | Pass: Non-hemolytic. |
Sterilization
The existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10-6. 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 14971:2019 performance testing was performed on the subject devices. Additional performance tests to evaluate continued compliance with ISO 11070:2014, "Sterile single-use intravascular introducers, dilators and guidewires," and 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 |
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| 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 | Guidewires were tested for compatibility with dimethyl sulfoxide (DMSO), heparinized saline, IsoVue 300 contrast, and IsoVue 370 contrast. | Acceptance criteria met |
| Simulated Use | Guidewires were tested for use with a microcatheter, the guidewire introducer, and torque device while navigating to target locations in a simulated use model. | Acceptance criteria met |
| Particulate | Particulate measured and counted after guidewire use in a simulated pathway model with a microcatheter and the guidewire introducer. | 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, Zoom Wire 14 Guidewire, and Aristotle Colossus 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 bench and biocompatibility testing, was completed for the subject devices. The testing and risk evaluation demonstrate that the subject devices are substantially equivalent to their respective predicate device.