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.

Device Description

The Scientia Vascular Aristotle 14 Guidewire is a 0.014" 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, from soft to support, The product is provided in 200cm and 300cm lengths. 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

The provided text is a 510(k) summary for the "Aristotle 14 Guidewire". This document summarizes non-clinical performance tests to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, many of the requested elements for an AI algorithm study (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the Non-Clinical Performance Tests section, focusing on the functional and biocompatibility tests.

Acceptance Criteria and Reported Device Performance for the Aristotle 14 Guidewire

The provided document details non-clinical performance tests for the Aristotle 14 Guidewire to demonstrate substantial equivalence to a predicate device (PVS 1300 Synchro® 0.014" Guidewire, K032146). The study is based on a series of laboratory and simulated use tests rather than a clinical trial with human subjects or an AI algorithm performance evaluation.

Here's a summary of the acceptance criteria (implied by the test objective and relevant standards) and the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Tests

Test	Acceptance Criteria (Implied)	Reported Device Performance
Cytotoxicity (L-929 MEM Elution)	No reactivity (Grade 0)	Cell culture treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic.
Sensitization (Magnusson-Kligman)	No erythema or edema (Grade 0) at challenge sites	Challenge sites treated with test sample exhibited no erythema or edema (Grade 0). Conclusion: Negative for dermal sensitization.
Irritation (Intracutaneous Toxicity)	Low mean test score (e.g., ≤1 for 0.9% Normal Saline and Sesame Oil extracts)	The mean test score in 0.9% Normal Saline extract was 0, and in Sesame Oil was 0.1. Conclusion: Non-irritating.
Systemic Toxicity (Acute)	No abnormal clinical signs indicative of toxicity during the 72-hour test period	No study animals were observed with abnormal clinical signs indicative of toxicity during the 72-hour test period. Conclusion: Non-toxic.
Material Mediated Pyrogenicity (Rabbit)	Temperature increases for all test animals not exceeding acceptable test limit for maximum individual temperature rise	Temperature increases for all test animals did not exceed the acceptable test limit for maximum individual temperature rise. Conclusion: Non-pyrogenic.
Hemolysis (Direct Contact and Extract)	Difference between hemolytic indices of test article and negative control within acceptable limits (e.g., ≤2% for non-hemolytic)	The difference between the hemolytic indices of the test article and the negative control was 0.00% for both direct and indirect hemolysis. Conclusion: Non-hemolytic.
Partial Thromboplastin Time (PTT)	Same thrombogenicity category as predicate device (minimal activator)	Both the subject device and predicate device fell within the same thrombogenicity category (minimal activator). Conclusion: Subject and predicate devices showed similar thrombogenicity.
Complement Activation (SC5b-9)	Amounts of SC5b-9 generated comparable to predicate device	Amounts of SC5b-9 generated by the test article and predicate device after exposure times of 30 and 60 minutes were not statistically different. The amount of SC5b-9 generated by the test article was statistically lower than that released by the predicate after 90 minutes exposure. Conclusion: Subject and predicate devices showed similar complement system activation.
Thrombogenicity (Dog Model)	Average thrombus score comparable to predicate device	The average thrombus score was the same for both the subject and predicate device. Conclusion: Subject and predicate devices showed similar thrombogenic potential.
Latex Antigenic Protein Content (LEAP)	No detectable Latex Antigenic Proteins	No Latex Antigenic Proteins were detected. Conclusion: Contains no detectable traces of latex.

Functional Testing

Test	Test Method & Acceptance Criteria (Implied / Explicit)	Reported Device Performance
Visual Inspection	ISO 11070: Absence of extraneous matter, process/surface defects, or defects that may cause trauma to vessels.	No extraneous matter, surface defects, or visible droplets of coating were present on the Aristotle 14 Guidewires.
Dimensional Verification	ISO 11070: All guidewires meet dimensional specifications per engineering drawings.	All guidewires met dimensional specifications.
Flexing Test	ISO 11070: No defects or damage / flaking of the coating after flexing.	No defects or damage / flaking of the coating were observed after flexing.
Tensile Strength	ISO 11070: All guidewires meet minimum force breakage requirements.	All guidewires met minimum force breakage requirements specified in ISO 11070.
Tip Shape, Retention	Guidewires must be shapeable and must retain shaped angle after simulated use.	All tips met shaping and shape retention requirements after simulated use.
Torqueability	Measurement of torque response (average input to output lag) in an anatomical model; acceptable torque responses, comparable to predicate device.	All 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 an anatomical model; acceptable torque strength, comparable to predicate device.	All 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 and 90 degrees at 5mm, 10mm, and 20mm test lengths; acceptable forces & comparable flexibility to predicate.	The forces required to deflect the guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire.
Fracture	ISO 11070: No signs of fracture, loosening, or failure after wrapping around mandrel.	No guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
Coating Lubricity and Durability	Frictional force of coated guidewires determined after simulated use in a tortuous path; meet specified frictional force requirements.	All guidewires met specified frictional force requirements.
Coating Integrity	Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path; acceptable coating coverage.	All samples showed acceptable coating coverage after simulated use.
Particulates	Particulates of various size ranges counted after simulated use in a tortuous path; comparable number of particulates to predicate.	A comparable number of particulates was recovered from subject and predicate devices following simulated use.
Torque Device - Introducer Testing	ISO 11070: Acceptance criteria for biocompatibility, visual inspection, corrosion resistance, tensile testing, luer taper dimensions, pouch seal strength.	Acceptance criteria of all tests were met.
Simulated Use Model Testing & Product Compatibility	Anatomical model to simulate neurovasculature; acceptable performance in evaluations of: Torqueability, Lubricity, Microcatheter Support & Tracking, Compatibility with accessories.	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.
Cadaver Testing	Physician evaluation of subject and predicate guidewires for performance characteristics; acceptable performance.	Subject and predicate guidewires both exhibited acceptable performance.
Radiopacity	Physician evaluation in human cadaver; acceptable radiopacity.	Both subject and predicate guidewires exhibited acceptable radiopacity.
Corrosion Resistance	ISO 11070: No signs of corrosion on guidewires after soaking in typical end-use solutions.	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
Chemical Compatibility	No degradation, corrosion, or physical decomposition after exposure to saline and contrast agent/saline solutions.	All guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
MRI Compatibility	(N/A, indicated as "MRI Unsafe")	No testing performed. Aristotle Guidewires are labeled “MRI Unsafe.”
Latex	ASTM D6499-07: No detectable traces of latex proteins.	No detectable traces of latex were found.
Package Integrity	ASTM D 4169:16, ASTM F 88-15, ASTM F 2096-11: Maintenance of integrity, affixation/legibility of labeling after transport simulation.	Following exposure to typical storage and transportation conditions, all sterile barrier pouches maintained their integrity and labeling remained affixed and legible.
Shelf Life	ASTM F1980: All device performance acceptance criteria met after accelerated aging conditions simulating 6 months real-time storage.	After exposure to accelerated aging conditions simulating real-time storage under ambient conditions for 6 months, all device performance acceptance criteria were met, justifying labeling the devices with a 6-month shelf life.
Sterilization Validation	AAMI TIR 28:2009, ISO11135:2007 Annex B: Justification for adoption into EO sterilization processing group, PCDs more difficult to sterilize than devices, bioburden enumeration performed, bacteriostasis/fungistasis tests demonstrate no inhibition of growth.	Results justified adoption into the EO sterilization processing group: Comparative and Bioburden Resistance study results demonstrated that PCDs are more difficult to sterilize than devices; Bioburden Enumeration and Extraction Efficiency tests were used to enumerate the CFUs present on devices; and Bacteriostasis/Fungistasis test results demonstrated that the product does not inhibit the growth of organisms.
Sterilization Validation: EO and ECH Residuals	AAMI/ANSI/ISO 10993-7: Residual traces of EO and ECH well below limits.	The residual traces of EO and ECH remaining in the Aristotle 14 Guidewire after exposure to the EO sterilization process are well below the limits specified in ISO 10993-7.
Sterilization Validation: Bacterial Endotoxin Levels	ANSI/AAMI ST72:2011/(R)2016, USP <161>, and USP <85>: LAL testing; Endotoxin levels below specified limit (e.g., < 2.15 EU/device).	< 2.15 EU/device.

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

The document does not explicitly state a single "test set" sample size in the context of an AI algorithm, or detailed provenance for each test (e.g., country of origin, retrospective/prospective). Instead, it describes various non-clinical tests.

Sample Size: For each functional and biocompatibility test, "All guidewires" or "All samples" or "All test animals" met the criteria, suggesting that a sufficient number of devices/samples were tested according to relevant standards (e.g., ISO 11070, ISO 10993-1). Specific sample numbers for each test are not provided but are implied to be adequate for conformity to the referenced standards.
Data Provenance: This is not applicable in the context of an AI evaluation. The tests are laboratory-based, simulating use conditions or evaluating material properties. The cadaver testing involved "human cadaver" generally, without specifying origin.

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)

Number of Experts: For the "Cadaver Testing" and "Radiopacity" tests, "Physicians" evaluated the guidewires. The specific number of physicians is not stated.
Qualifications of Experts: The specific qualifications (e.g., specialty, years of experience) of the "Physicians" involved in cadaver testing are not provided.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert-driven evaluations where there's a need to resolve discrepancies in independent assessments. This is not applicable to the non-clinical, objective laboratory tests described in this 510(k) summary. For the cadaver studies, the method of aggregation or adjudication among physicians, if more than one, is not described.

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 document describes non-clinical performance and substantial equivalence tests for a medical device (guidewire), not an AI algorithm. Therefore, an MRMC study related to AI assistance was not performed.

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

Not applicable. As stated above, this document concerns a medical device, not an AI algorithm.

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

For the non-clinical tests, "ground truth" is established by:
- Referenced Standards: Adherence to international and FDA-recognized standards (e.g., ISO 10993-1, ISO 11070) for material properties and functional performance.
- Laboratory Measurements: Objective measurements (e.g., dimensions, force, torque, particulate counts, chemical analysis).
- Qualitative Assessments by Trained Personnel: Visual inspections, qualitative assessments in simulated use.
- Physician Evaluation: For cadaver testing and radiopacity, physician opinion served as the "ground truth" for acceptable performance.
- Comparison to Predicate Device: Many tests establish equivalence by showing comparable performance to the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document is for a physical medical device and does not involve an AI algorithm training set.

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

Not applicable. This document is for a physical medical device and does not involve an AI algorithm training set.

Summary

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January 22, 2018

Scientia Vascular LLC % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K173235

Trade/Device Name: Aristotle 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 13, 2017 Received: December 14, 2017

Dear Mark Job:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Carlos L. Pena -S

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)

K173235

Device Name

Aristotle 14 Guidewire

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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 14 Guidewire

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510(K) SUMMARY (Per 21 CFR 807.92)

SCIENTIA VASCULAR LLC ARISTOTLE 14 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:	December 8, 2017
Prepared by:	Ryan O'Callaghan, MS, RACPhil Triolo and Associates LCTel: 801.699.9846Fax: 801.328.2399E-mail: ryano@philt.com
Trade Name:	Aristotle 14 Guidewire
Common Name:	Guidewire
Classification Name	Catheter Guide Wire per 21 CFR 870.1330
Product Code:	DQX
Predicate Device:	PVS 1300 Synchro® 0.014" Guidewire (K032146)

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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 14 guidewire is substantially equivalent with respect to technological characteristics, design and materials to Boston Scientific - Precision Vascular's currently marketed PVS 1300 Synchro® 0.014" Guidewire cleared under K032146. Both devices are provided with a torque device and introducer.

INDICATIONS FOR USE

The indications for use statement is equivalent to that of the predicate device and the differences in wording are not critical to the intended therapeutic, diagnostic, prosthetic, surgical or other use of the device. The differences do not affect the safety and effectiveness of the device when used as labeled, as the same intent is documented for the predicate and new devices.

TECHNOLOGICAL CHARACTERISTICS

As shown in the table below, the technological characteristics of the Aristotle 14 Guidewire are equivalent to those of the predicate device, the PVS 1300 Synchro® 0.014" Guidewire.

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Comparison between Subject & Predicate Device Technological Characteristics
Characteristic	Subject DeviceAristotle 14 Guidewire	PVS 1300 Synchro®0.014" Guidewire(K032146)	Comparison
AnatomicalLocation	Neuro and peripheralvasculature	Neuro and peripheralvasculature	Same
Dimensions	0.D.: 0.014" (0.36mm)Length: 200cm to 300cmrange	0.D.: 0.014" (0.36mm)Length: 180cm to 300cmrange, with 200cm beingtypical	Equivalent
Core Wire	Stainless Steel	Stainless Steel	Same
Distal Tip	ShapeableLength: 35cmMaterial: Nitinol	ShapeableLength: 25cm to 65cmrange, with 35 to 45cmbeing typicalMaterial: Nitinol	Equivalent
Stiffness Profiles	Range from support (stiff)to flex (soft)	Range from support (stiff)to flex (soft)	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
Introducer(Accessory)	Provided with eachguidewire	Provided with eachguidewire	Equivalent
Torque Device(Accessory)	Provided with eachguidewire	Provided with eachguidewire	Same
SterilizationMethod	100% Ethylene Oxide(EO)	Currently radiationsterilization [devicesoriginally cleared weresterilized with100%Ethylene Oxide (EO)]	Same

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Scientia Vascular LLC Traditional 510(k) Aristotle 14 Guidewire

Results of tests performed on the new Aristotle 14 Guidewire demonstrate that the new guidewire performs as well as the predicate device and/or meets requirements of relevant standards. Further, any differences in technological characteristics of the Aristotle Guidewires when compared with predicate device characteristics do not raise different questions of safety and effectiveness.

NON-CLINICAL PERFORMANCE TESTS

Biocompatibilitv

Biocompatibility of the Aristotle 14 Guidewire and accessory materials has been verified in accordance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA's Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016.

The results of the following biological and toxicological safety evaluations verified the biocompatibility of the subject device when tested as an external communicating, blood contact, limited duration (<24 hours) device:

. Cytotoxicity;
. Sensitization;
Irritation/Intracutaneous Reactivity:
Acute Systemic Toxicity;
Materials-Mediated Pyrogenicity:
. Hemocompatibility
- Hemolysis by Direct Contact and Extract: o
- Partial Thromboplastin Time (PTT); о
- Complement Activation of C3a and SC5b-9; O
- Thrombogenicity in a Dog Model; and O
Latex Antigenic Protein Content

Results of these tests are summarized in the following table.

Summaries of Biocompatibility Tests Conducted to Support this PremarketNotification
Test	Results	Conclusions
Cytotoxicity[L-929 MEM Elution]	Cell culture treated withtest sample exhibited noreactivity (Grade 0).	Non-cytotoxic
Summaries of Biocompatibility Tests Conducted to Support this PremarketNotification
Test	Results	Conclusions
Sensitization[Maximization(Magnusson-Kligman)]	Challenge sites treatedwith test sample exhibitedno erythema or edema(Grade 0).	Negative for dermalsensitization
Irritation[Intracutaneous Toxicity(ISO)]	The mean test score in0.9% Normal Salineextract was 0, and inSesame Oil was 0.1.	Non-irritating
Systemic Toxicity(Acute)[Systemic Injection(ISO)]	No study animals wereobserved with abnormalclinical signs indicative oftoxicity during the 72-hourtest period.	Non-toxic
Systemic Toxicity(Acute)[Material MediatedPyrogen in a RabbitModel]	Temperature increases forthe all test animals did notexceed the acceptable testlimit for maximumindividual temperaturerise.	Non-pyrogenic
Hemocompatibility[Hemolysis, directcontact - device/material(human blood)]	The difference betweenthe hemolytic indices ofthe test article and thenegative control was0.00%.	Non-hemolytic
Hemocompatibility[Hemolysis, indirect -device/material (humanblood)]	The difference betweenthe hemolytic indices ofthe test article and thenegative control was0.00%.	Non-hemolytic
Summaries of Biocompatibility Tests Conducted to Support this PremarketNotification
Test	Results	Conclusions
Hemocompatibility[Partial ThromboplastinTime (PTT test) - Humanplasma]	Both the subject deviceand predicate device fellwithin the samethrombogenicity category(minimal activator)	Subject and predicate devicesshowed similarthrombogenicity.
Hemocompatibility[Complement Activation- SC5b-9]	Amounts of SC5b-9generated by the testarticle and predicatedevice after exposuretimes of 30 and 60minutes were notstatistically different. Theamount of SC5b-9generated by the testarticle was statisticallylower than that released bythe predicate after 90minutes exposure.	Subject and predicate devicesshowed similar complementsystem activation.
Hemocompatibility[Thrombogenicity in aDog Model]	Both test animals had asubject device (Aristotle14 Guidewire) andpredicate device (Synchro-14 Guidewire) inserted.The average thrombusscore was the same forboth the subject andpredicate device.	Subject and predicate devicesshowed similar thrombogenicpotential.
Latex[LEAP test]	No Latex AntigenicProteins were detected.	Contains no detectable traces oflatex

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Scientia Vascular LLC Traditional 510(k) Aristotle 14 Guidewire

Functional Testing

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 Notification
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 coatingwere present on the Aristotle 14Guidewires.
DimensionalVerification	Tests per ISO 11070:Dimensional inspection perengineering drawings	All guidewires met dimensionalspecifications.
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.
TensileStrength	Tensile testing per ISO 11070	All guidewires met minimum forcebreakage requirements specified inISO 11070.
Tip Shape,Retention	Guidewires must be shapeable andmust retain shaped angle aftersimulated use	All tips met shaping and shaperetention requirements aftersimulated use.
Torqueability	Measurement of torque response(average input to output lag) in ananatomical model	All guidewires demonstratedacceptable torque responses. Thetorque response of the subjectdevice was comparable to that of thepredicate device.
TorqueStrength	Torque turns to failure in ananatomical model	All guidewires demonstratedacceptable torque strength. Thetorque strength of the subject devicewas comparable to that of thepredicate device.

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Summaries of Functional Tests Conducted to Support this Premarket Notification
Test	Test Method Summary	Results
TipFlexibility	Measure force to deflect guidewire tips to 45 and 90 degrees at 5mm, 10mm, and 20mm test lengths	The forces required to deflect the guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire.
Fracture	Tests per ISO 11070:Inspection for fracture, loosening, or failure after wrapping around mandrel	No guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
CoatingLubricity andDurability	Frictional force of coated guidewires was determined after simulated use in a tortuous path	All guidewires met specified frictional force requirements.
CoatingIntegrity	Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path	All samples showed acceptable coating coverage after simulated use.
Particulates	Particulates of various size ranges counted after simulated use in a tortuous path	A comparable number of particulates was recovered from subject and predicate devices following simulated use.
TorqueDevice -IntroducerTesting	Various tests on guidewire accessories per ISO 11070: biocompatibility, visual inspection, corrosion resistance, tensile testing, luer taper dimensions, pouch seal strength	Acceptance criteria of all tests were met.
SimulatedUse ModelTesting andProductCompatibility	Anatomical model designed to simulate the tortuous anatomy of the neurovasculature used for simulated use testing	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
Summaries of Functional Tests Conducted to Support this Premarket Notification
Test	Test Method Summary	Results
CadaverTesting	Physicians evaluated subject and predicate guidewires for variousperformance characteristics in a human cadaver	Subject and predicate guidewiresboth exhibited acceptableperformance.
Radiopacity	Subject and predicate guidewires evaluated by physicians in humancadaver	Both subject and predicateguidewires exhibited acceptableradiopacity.
CorrosionResistance	Test for corrosion resistance perISO 11070	There were no signs of corrosion onguidewires after soaking in typicalend-use solutions.
ChemicalCompatibility	Guidewires were exposed to salineand contrast agent/saline solutionsand examined for degradation.	All guidewires showed no signs ofdegradation, corrosion or physicaldecomposition after exposure.
MRICompatibility	Guidewires are constructed ofmetallic materials and should notbe exposed to MRI procedures.	No testing performed. AristotleGuidewires are labeled “MRIUnsafe.”
Latex	Tested for trace latex proteins perASTM D6499-07	No detectable traces of latex werefound.
PackageIntegrity	Simulated transportation test perASTM D 4169:16. Pouchevaluated for seal strength perASTM F 88-15 and leak tests(bubble test) per ASTM F 2096-11	Following exposure to typicalstorage and transportationconditions, all sterile barrierpouches maintained their integrityand labeling remained affixed andlegible.
Shelf Life	Device performance attributes thatcan be affected by storageconditions were evaluated afterexposure to accelerated agingconditions per ASTM F1980.	After exposure to accelerated agingconditions simulating real-timestorage under ambient conditionsfor 6 months, all deviceperformance acceptance criteriawere met, justifying labeling thedevices with a 6-month shelf life.
Summaries of Functional Tests Conducted to Support this Premarket Notification
Test	Test Method Summary	Results
SterilizationValidation	100% EO is used to sterilize thedevice to achieve a SAL of at least10-6. The device was adopted intoan EO sterilization processinggroup in accordance with AAMITIR 28:2009. Validation of the EOsterilization cycle was performedusing the Half-cycle, overkillapproach described in SectionB.1.2 of ISO11135:2007 Annex B.	Results justified adoption into theEO sterilization processing group:Comparative and BioburdenResistance study resultsdemonstrated that PCDs are moredifficult to sterilize than devices;Bioburden Enumeration andExtraction Efficiency tests wereused to enumerate the CFUs presenton devices; and Bacteriostasis/Fungistasis test results demonstratedthat the product does not inhibit thegrowth of organisms.
SterilizationValidation:EO and ECHResiduals	Measured EO and ECH residualsper AAMI/ANSI/ISO 10993-7	The residual traces of EO and ECHremaining in the Aristotle 14Guidewire after exposure to the EOsterilization process are well belowthe limits specified in ISO 10993-7.
SterilizationValidation:BacterialEndotoxinLevels	LAL testing was conducted inaccordance with ANSI/AAMIST72:2011/(R)2016, USP <161>,and USP <85>, using the kineticchromogenic method.	< 2.15 EU/device

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CONCLUSION:

Scientia Vascular, LLC has presented information in this premarket notification supporting its contention that the Aristotle 14 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.