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.

Device Description

The Aristotle 18 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.018" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has 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 guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

AI/ML Overview

This document describes the safety and performance testing for a medical device called the "Aristotle 18 Guidewire" to demonstrate its substantial equivalence to a predicate device, the "Aristotle 14 Guidewire." This is a 510(k) premarket notification, not a clinical study of an AI/ML device, therefore many of the requested criteria are not applicable.

Here's an analysis of the provided text in relation to your request:

Key Takeaway: The provided document is a 510(k) summary for a guidewire, which is a physical medical device, not an AI/ML diagnostic or treatment device. Therefore, many of the questions related to AI/ML device performance (such as MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods) are not applicable to this submission. The "study" described herein refers to non-clinical performance and biocompatibility testing of a physical product.

1. A table of acceptance criteria and the reported device performance

The document provides a table summarizing functional tests and their results. The "acceptance criteria" are implied by the "Results" column, indicating that the device "met," "demonstrated acceptable," or "showed acceptable" performance according to relevant standards (ISO 11070, AAMI TIR 28:2016, ASTM D 4169:16) and internal specifications.

Test	Test Method Summary	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	In vitro blood flow loop thrombogenicity, MEM elution, toxicological risk assessment, ASTM hemolysis (direct/extract), PTT, complement activation	Equivalent to predicate device	Established that the biocompatibility profile of the subject device is equivalent to the predicate device due to identical materials and no increased thrombogenic potential from increased surface area. New testing was conducted to specifically address the increased diameter.
Sterilization	100% Ethylene Oxide (EO) to achieve SAL of at least 10^-6, evaluated per AAMI TIR 28:2016	SAL of at least 10^-6	The device was adopted into an EO sterilization processing group, and review indicates similarity between Aristotle 18 and Aristotle 14 regarding characteristics affecting sterilization.
Functional Testing	Per ISO 11070:2014 & FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (Jan 1995)
Visual Inspection	For extraneous matter, process/surface defects, trauma-causing defects.	No defects observed	No extraneous matter, surface defects or visible droplets of coating are present on the Aristotle 18 Guidewires.
Dimensional Verification	Per engineering drawings.	Met dimensional specifications	All Aristotle 18 guidewires met dimensional specifications.
Tensile Strength	Per ISO 11070.	Met minimum force breakage	All Aristotle 18 guidewires meet minimum force breakage requirements specified in ISO 11070.
Flexing Test	Inspection for defects, damage, or flaking of coating after flexing.	No defects or damage	No defects or damage / flaking of the coating were observed after flexing.
Fracture	Inspection for fracture, loosening, or failure after wrapping around mandrel.	No fracture, loosening, or failure	No Aristotle 18 guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
Torqueability	Measurement of torque response (avg input to output lag) in anatomical model.	Acceptable, comparable to predicate	All Aristotle 18 guidewires demonstrated acceptable torque responses. The torque response of the subject device was comparable to that of the predicate device.
Torque Strength	Torque turns to failure in anatomical model.	Acceptable, comparable to predicate	All Aristotle 18 guidewires demonstrated acceptable torque strength. The torque strength of the subject device was comparable to that of the predicate device.
Tip Flexibility	Measure force to deflect guidewire tips to 45 & 90 deg at 5mm, 10mm, 20mm.	Acceptable, comparable to predicate	The forces required to deflect the Aristotle 18 guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire.
Tip Shape, Retention	Must be shapeable and retain shaped angle after simulated use.	Met requirements	All tips met shaping and shape retention requirements after simulated use.
Particulate	Particulates of various size ranges counted after simulated use in tortuous path.	Comparable to predicate	A comparable number of particulates was recovered from subject and predicate device following simulated use.
Coating Lubricity & Durability	Frictional force determined after simulated use in tortuous path.	Met specified requirements	All Aristotle 18 guidewires met specified frictional force requirements.
Coating Integrity	Uniformity/integrity visually examined on dyed samples after simulated use in tortuous path.	Acceptable coverage	All Aristotle 18 guidewires showed acceptable coating coverage after simulated use.
Simulated Use Model Testing & Product Compatibility	Anatomical model (neurovasculature) for simulated use testing.	Acceptable performance	Aristotle 18 Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter.
Usability Evaluation	Physicians evaluated subject/predicate guidewires for various characteristics in human cadaver.	Acceptable performance	Subject and predicate guidewires both exhibited acceptable performance.
Radiopacity	Physicians evaluated during simulated use in human cadaver.	Acceptable radiopacity	Both subject and predicate guidewires exhibited acceptable radiopacity.
Corrosion Resistance	Per ISO 11070, after soaking in typical end-use solutions.	No signs of corrosion	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
Compatibility with Agents	Exposed to saline, contrast agents, DMSO, then examined for degradation.	No degradation, corrosion, decomp.	All Aristotle 18 guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
Packaging	Simulated transportation test per ASTM D 4169:16.	Product secured, labeling legible	Following exposure to typical storage and transportation conditions, product remained secured and labeling remained affixed and legible.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact number of guidewires tested for each functional test. It refers to "All Aristotle 18 guidewires" (e.g., for tensile strength, torqueability, flexibility), implying that the entire batch or lot tested passed. For biocompatibility, it states "new biocompatibility testing was conducted" but does not give sample sizes.
Data Provenance: The tests are non-clinical, laboratory-based functional and material tests. There is no "country of origin" for patient data as no patient data was used. These tests are prospective, meaning they were performed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a physical device testing summary. "Ground truth" in the context of AI/ML diagnostic studies (where experts typically label images) is not relevant here.
However, for usability and radiopacity evaluations, "physicians" were used in a simulated use (cadaver) model. The number and qualifications of these physicians are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This concept is for resolving discrepancies in expert labeling or diagnoses in AI/ML performance studies. It is not relevant to the functional testing of a physical guidewire.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is specific to AI/ML software. The submission describes a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is specific to AI/ML software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth (for this type of device): The "ground truth" for a physical medical device like a guidewire is established by adherence to engineering specifications, validated test methods (e.g., ISO, ASTM standards), and risk assessments. For biocompatibility, the "ground truth" is that the materials are safe for human contact and do not induce adverse biological responses, often confirmed through standardized in vitro and in vivo tests. For functional performance, the "ground truth" is that the device performs reliably according to its design parameters and intended use.
For the usability and radiopacity assessments, the "ground truth" was physician evaluation in a simulated (cadaver) environment, where they determined "acceptable performance" and "acceptable radiopacity."

8. The sample size for the training set

Not Applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. As above, no training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 22, 2019

Scientia Vascular LLC David Sabodski Director of Quality Assurance 3487 West 2100 South. Suite 100 West Valley City, Utah 84119

Re: K183608

Device Name: Aristotle 18 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 20, 2018 Received: December 26, 2018

Dear David Sabodski:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Lin Zheng

Digitally signed by
Xiaolin Zheng -S
Date: 2019.03.22
10:44:47 -04'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183608

Device Name Aristotle 18 Guidewire

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Scientia Vascular LLC Traditional 510(k) Aristotle 18 Guidewire

Image /page/3/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized, interconnected blue symbol above the word "SCIENTIA" in a futuristic-looking font. The symbol is composed of two curved lines that appear to be intertwined, creating a sense of connection or flow. The word "SCIENTIA" is written in capital letters with a font that has sharp angles and a modern aesthetic.

510(K) SUMMARY (Per 21 CFR 807.92)

SCIENTIA VASCULAR LLC

Aristotle 18 Guidewire

510(k) Sponsor:	Scientia Vascular LLC3487 West 2100 South Suite 100West Valley City, UT 84119Tel: (775) 657-6330
Contact Person:	David Sabodski, Director of Quality AssuranceTel: 801.573.5897E-mail: dsabodski@scientiavascular.com
Date Prepared:	March 11, 2019
Prepared by:	Ryan O'Callaghan, MS, RACPhil Triolo and Associates LCTel: 801.699.9846Fax: 801.328.2399E-mail: ryano@philt.com
Trade Name:	Aristotle 18 Guidewire
Common Name:	Guidewire
Classification Name	Catheter Guide Wire per 21 CFR 870.1330
Primary Product Code:	MOF
Secondary Product Code:	DQX
Predicate Device:	Aristotle 14 Guidewire (K173235)

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Scientia Vascular LLC Traditional 510(k) Aristotle 18 Guidewire

DEVICE DESCRIPTION

The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has 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 guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The Aristotle 18 Guidewire is substantially equivalent with respect to technological characteristics, indications for use, design and materials to the previously cleared Aristotle 14 Guidewire.

INTENDED USE/INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The Aristotle 18 Guidewire has the following similarities to the previously cleared Aristotle 14 Guidewire:

Both devices have the same indicated use,
Both devices use the same operating principle, ●
Both devices incorporate the same basic guidewire design, ●
Both devices incorporate the same materials, and ●
Both devices are packaged and sterilized using the same materials and processes. .

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Comparison between Subject & Predicate Device Technological Characteristics
Characteristic	Subject DeviceAristotle 18 Guidewire	PredicateAristotle 14 Guidewire(K173235)	Comparison
AnatomicalLocation	Neuro and peripheralvasculature	Neuro and peripheralvasculature	Same
Dimensions	O.D.: 0.018" (0.46mm)Length: 200cm	O.D.: 0.014" (0.36mm)Length: 200cm to 300cmrange	The diameter of thesubject device islarger than thediameter of thepredicate device
Core Wire	Stainless Steel	Stainless Steel	Same
Distal Tip	ShapeableLength: 35cmMaterial: Nitinol	ShapeableLength: 35cmMaterial: Nitinol	Same
Stiffness Profiles	Range from support (stiff),standard (middle) to soft(flex)	Range from support (stiff)to soft (flex)	Equivalent
Coatings	Distal End: HydrophilicProximal End: PTFE	Distal End: HydrophilicProximal End: PTFE	Equivalent
RadiopaqueMarker	1 radiopaque marker atdistal tip	1 radiopaque marker atdistal tip	Same
Centering Coil	1 stainless steel centeringcoil	None	The subject deviceincludes a centeringcoil component thatis not included inthe predicatedevice.

Comparison between Subject & Predicate Device Technological Characteristics
Characteristic	Subject DeviceAristotle 18 Guidewire	PredicateAristotle 14 Guidewire(K173235)	Comparison
Introducer(Accessory)	Provided with eachguidewire	Provided with eachguidewire	Equivalent
Torque Device(Accessory)	Provided with eachguidewire	Provided with eachguidewire	Same
SterilizationMethod	100% Ethylene Oxide(EO)	100% Ethylene Oxide(EO)	Same

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The two differences between Aristotle 18 Guidewire and Aristotle 14 Guidewire is in the outer dimensions and the addition of a centering coil. The outer dimension of the Aristotle 18 Guidewire is 0.018" whereas the outer dimension of the Aristotle 14 Guidewires is 0.014". A centering coil made of stainless steel is added to the Aristotle 18 Guidewire whereas the Aristotle 14 Guidewire does not have a centering coil. However, the core wire and the centering coil are made from the same stainless steel material. Thus, no new materials were added to the Aristotle 18 Guidewire that were not present in the Aristotle 14.

NON-CLINICAL PERFORMANCE TESTS

Biocompatibility

The materials used in the manufacture of the subject Aristotle 18 Guidewire are identical to those used in the manufacture of the Aristotle 14 Guidewire also manufactured by Scientia Vascular LLC, cleared January 22, 2018 after review of K173235; in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).

Due to the increased diameter of the subject device compared to the predicate device and the risk assessment of these design differences, new biocompatibility testing was conducted including an in vitro blood flow loop thrombogenicity study, MEM elution, toxicological risk assessment, ASTM hemolysis (direct contact), ASTM hemolysis (extract), partial thromboplastin time (PTT), and complement activation to establish that the increased surface area of the Aristotle 18 Guidewire would not result in an increased thrombogenic potential compared to the Aristotle 14 Guidewire predicate device. and further demonstrate the biocompatibility profile of the subject device is equivalent to the predicate device.

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Scientia Vascular LLC Traditional 510(k) Aristotle 18 Guidewire

Sterilization

100% EO is used to sterilize the device to achieve a SAL of at least 10-9. The device was adopted into an EO sterilization processing group in accordance with AAMI TIR 28:2016. Completion of the review performed to the requirements of AAMI TIR 28:2016 indicate the Aristotle 18 and the Aristotle 14 are similar with regards to all device and packaging characteristics that could affect the ability to sterilize the devices.

Functional Testing

Performance testing on the subject device was performed after conducting a risk assessment in accordance with EN ISO 14971:2012 Medical Devices – Risk Management. Functional testing was performed in accordance with ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires and the FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (January 1995). The following table summarizes the functional tests performed and test results obtained to demonstrate substantial equivalence to the predicate device:

Summaries of Functional Tests Conducted to Support this Premarket Notificationfor the Modified (Subject) Device, Aristotle 18 Guidewire
Test	Test Method Summary	Results
VisualInspection	Tests per ISO 11070:Visual inspection for extraneousmatter, process and surface defectsor defects that may cause traumato vessels during use.	No extraneous matter, surfacedefects or visible droplets of coatingare present on the Aristotle 18Guidewires
DimensionalVerification	Tests per ISO 11070:Dimensional inspection perengineering drawings.	All Aristotle 18 guidewires metdimensional specifications.
TensileStrength	Tensile testing per ISO 11070.	All Aristotle 18 guidewires meetminimum force breakagerequirements specified in ISO11070.
Flexing Test	Tests per ISO 11070:Inspection for defects and damageor flaking of the coating afterflexing.	No defects or damage / flaking ofthe coating were observed afterflexing.
Fracture	Tests per ISO 11070:Inspection for fracture, loosening,or failure after wrapping aroundmandrel.	No Aristotle 18 guidewires showedsigns of fracture, loosening, orfailure after wrapping them 8 timesaround a mandrel.
Summaries of Functional Tests Conducted to Support this Premarket Notificationfor the Modified (Subject) Device, Aristotle 18 Guidewire
Test	Test Method Summary	Results
Torqueability	Measurement of torque response(average input to output lag) in ananatomical model.	All Aristotle 18 guidewiresdemonstrated acceptable torqueresponses. The torque response ofthe subject device was comparableto that of the predicate device.
TorqueStrength	Torque turns to failure in ananatomical model.	All Aristotle 18 guidewiresdemonstrated acceptable torquestrength. The torque strength of thesubject device was comparable tothat of the predicate device.
TipFlexibility	Measure force to deflect guidewiretips to 45 and 90 degrees at 5mm,10mm, and 20mm test lengths.	The forces required to deflect theAristotle 18 guidewire tips wereacceptable. The flexibility of thetips of all subject devices wascomparable to the tip flexibility ofthe predicate guidewire.
Tip Shape,Retention	Guidewires must be shapeable andmust retain shaped angle aftersimulated use.	All tips met shaping and shaperetention requirements aftersimulated use.
Particulate	Particulates of various size rangescounted after simulated use in atortuous path.	A comparable number ofparticulates was recovered fromsubject and predicate devicefollowing simulated use.
CoatingLubricity andDurability	Frictional force of coatedguidewires was determined aftersimulated use in a tortuous path.	All Aristotle 18 guidewires metspecified frictional forcerequirements.
Summaries of Functional Tests Conducted to Support this Premarket Notificationfor the Modified (Subject) Device, Aristotle 18 Guidewire
Test	Test Method Summary	Results
CoatingIntegrity	Coating uniformity and integrityvisually examined on dyedsamples after simulated use in atortuous path.	All Aristotle 18 guidewires showedacceptable coating coverage aftersimulated use.
SimulatedUse ModelTesting andProductCompatibility	Anatomical model designed tosimulate the tortuous anatomy ofthe neurovasculature used forsimulated use testing.	Aristotle 18 Guidewires andpredicate devices were found toperform acceptably in evaluationsof: Torqueability in tortuousvasculature, Lubricity,Microcatheter Support & Tracking,Compatibility with Introducer,Compatibility with Torque Device,and Compatibility withMicrocatheter.
UsabilityEvaluation	Physicians evaluated subject andpredicate guidewires for variousperformance characteristics in ahuman cadaver.	Subject and predicate guidewiresboth exhibited acceptableperformance.
Radiopacity	Subject and predicate guidewiresevaluated by physicians duringsimulated use in a human cadaver.	Both subject and predicateguidewires exhibited acceptableradiopacity.
Summaries of Functional Tests Conducted to Support this Premarket Notificationfor the Modified (Subject) Device, Aristotle 18 Guidewire
Test	Test Method Summary	Results
CorrosionResistance	Test for corrosion resistance perISO 11070.	There were no signs of corrosion onguidewires after soaking in typicalend-use solutions.
Compatibilitywith Agents	Guidewires were exposed tosaline, contrast agents, and DMSOand then examined fordegradation.	All Aristotle 18 guidewires showedno signs of degradation, corrosionor physical decomposition afterexposure.
Packaging	Simulated transportation test perASTM D 4169:16.	Following exposure to typicalstorage and transportationconditions, product remainedsecured and labeling remainedaffixed and legible.

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CONCLUSION:

Scientia Vascular, LLC has presented information in this premarket notification supporting its contention that the Aristotle 18 Guidewire is substantially equivalent with respect to technological characteristics and indications for use to the predicate device.

Regulation Number and Section

§ 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.