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.

Device Description

The Aristotle 24 Guidewire is a modification of Scientia Vascular's Aristotle 18 Guidewire. It is a 0.024" 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 a shaping mandrel, 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 mandrel, 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 describes the 510(k) premarket notification for the Aristotle 24 Guidewire. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Aristotle 18 Guidewire) rather than acting as a traditional clinical study report with detailed acceptance criteria and performance data for a novel AI/software device.

Therefore, many of the requested details, such as those related to AI algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details), are not applicable to this document as it pertains to a physical medical device (guidewire) and its mechanical/biocompatibility testing, not an AI/ML algorithm.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (functional and non-clinical performance tests) that prove the device meets these criteria as described in the provided text for this specific medical device.

Here's an interpretation based on the provided document, addressing the applicable points and noting where information is not relevant to this specific clearance:

Acceptance Criteria and Device Performance for Aristotle 24 Guidewire (Based on 510(k) K192783)

The Aristotle 24 Guidewire is a physical medical device, and its "acceptance criteria" are demonstrated through non-clinical performance and design characteristic comparisons to a predicate device. The goal is to show substantial equivalence, not to prove clinical efficacy through a comparative effectiveness study involving human readers or AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like a guidewire, the "acceptance criteria" are implicitly met when the device successfully passes a battery of functional, dimensional, and biocompatibility tests, demonstrating performance consistent with its intended use and safety profile, and comparable to a predicate device. The tables below outline the tests conducted and their general "results" as stated in the document.

Acceptance Criteria Category	Specific Test/Characteristic	Test Method Summary (as described)	Reported Device Performance (as described)
Biocompatibility	In-vitro Blood Flow Thrombogenicity Study	Not detailed	Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate.
	MEM elution	Not detailed	Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate.
	Toxicological risk assessment	Not detailed	Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate.
	ASTM Hemolysis (direct contact and extract)	Not detailed	Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate.
	Partial Thromboplasting Time	Not detailed	Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate.
	Compliment Activation	Not detailed	Not explicitly stated "met," but implied satisfactory as no concerns raised. Materials are identical to predicate.
Sterilization	Sterility Assurance Level (SAL)	100% Ethylene Oxide (EO) to achieve SAL of at least 10^-6, adopted into EO sterilization processing group in accordance with AAMI TIR 28:2016.	Aristotle 24 and Aristotle 18 are similar regarding device and packaging characteristics affecting sterilization ability. Implied successful sterilization to SAL 10^-6.
Functional Testing	Dimensional Verification	Tests per ISO 11070; Dimensional inspection per engineering drawings.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Tensile Strength	Tensile testing per ISO 11070.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Flexing Test	Tests per ISO 11070; Inspection for defects and damage or flaking of the coating after flexing.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Fracture	Tests per ISO 11070; Inspection for fracture, loosening, or failure after wrapping around mandrel.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Torqueability	Measurement of torque response (average input to output lag) in an anatomical model.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Torque Strength	Torque turns to failure in an anatomical model.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Tip Flexibility	Measure force to deflect guidewire tips to 45 and 90 degrees at 5mm, 10mm, and 20mm test lengths.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Tip Shape, Retention	Guidewires must be shapeable and must retain shaped angle after simulated use.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Particulate	Particulates of various size ranges counted after simulated use in a tortuous path.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Coating Lubricity and Durability	Frictional force of coated guidewires was determined after simulated use in a tortuous path.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Coating Integrity	Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Simulated Use Model Testing and Product Compatibility	Anatomical model designed to simulate the tortuous anatomy of the neurovasculature used for simulated use testing.	The Aristotle 24 Guidewires met testing acceptance criteria.
	Usability Evaluation	Physicians evaluated subject and predicate guidewires for various performance characteristics in a human cadaver.	The Aristotle 24 Guidewires met testing acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

For the functional testing of the guidewire, specific sample sizes are not explicitly stated in the document. The testing involves physical samples of the Aristotle 24 Guidewire. The provenance of this "data" is the non-clinical bench testing conducted by Scientia Vascular LLC. This is not a retrospective or prospective clinical study, but rather laboratory testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The concept of "experts establishing ground truth" in the context of an AI algorithm is not applicable here. For a physical device like a guidewire, "ground truth" is established by adherence to engineering specifications, national/international standards (e.g., ISO 11070), and validated test methods.

However, for the "Usability Evaluation," it states "Physicians evaluated subject and predicate guidewires."

Number of experts: Not specified (plural "Physicians" indicates more than one).
Qualifications of experts: Explicitly stated as "Physicians." No further details on their years of experience or specialization are provided within this document.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1) is typically relevant for expert review of images or data in AI/diagnostic studies to establish a consensus ground truth. It is not applicable to the functional and mechanical testing of a physical medical device. The "adjudication" for mechanical tests is whether the device passes or fails predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance, which is not relevant for the clearance of a guidewire.

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

Not applicable. This device is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

For the functional and biocompatibility testing, the "ground truth" is defined by:

Adherence to internal engineering specifications and design parameters.
Compliance with recognized industry standards (e.g., ISO 11070:2014 for guidewires, EN ISO 14971:2012 for risk management, AAMI TIR 28:2016 for sterilization).
Equivalence to the performance characteristics of the predicate device (Aristotle 18 Guidewire) as established by its clearance and prior testing.

For the "Usability Evaluation," the "ground truth" was likely subjective feedback and performance metrics collected from the evaluating physicians using the device in a cadaver model.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

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

Summary of the Study Proving Acceptance Criteria:

The "study" conducted for the Aristotle 24 Guidewire was a series of comprehensive non-clinical performance tests, including:

Biocompatibility Testing: Confirmed the safety of the device's materials by assessing blood compatibility and cytotoxicity. This was supported by the fact that the materials are identical to those used in the cleared predicate device.
Sterilization Validation: Demonstrated the effectiveness of the Ethylene Oxide (EO) sterilization process to achieve a required sterility assurance level (SAL).
Functional Testing: Evaluated various mechanical and physical properties of the guidewire (e.g., dimensional accuracy, tensile strength, flexibility, torqueability, tip retention, particulate generation, coating lubricity/integrity) in accordance with ISO 11070:2014 and FDA guidance. These tests were stated to "meet testing acceptance criteria," implying successful performance against pre-defined engineering and performance specifications.
Simulated Use Model Testing: Used an anatomical model to simulate tortuous neurovasculature for assessing device performance and compatibility during simulated use.
Usability Evaluation: Involved physicians evaluating the device in a human cadaver model for performance characteristics.

The overarching goal of these tests was to demonstrate that the Aristotle 24 Guidewire is substantially equivalent to the predicate Aristotle 18 Guidewire, despite minor technological differences (larger O.D., two centering coils, one bushing). The document explicitly states that these differences "do not result in new materials used or new questions of safety or effectiveness, nor do they result in new risks for the subject device," and that "testing of the subject device has been performed, demonstrating the safety and effectiveness of the device."

Summary

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October 30, 2019

Scientia Vascular LLC Amy McManus Regulatory Affairs Manager 3487 West 2100 South, Suite 100 West Valley City, Utah 84119

Re: K192783

Device Name: Aristotle 24 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: September 24, 2019 Received: September 30, 2019

Dear Amy McManus:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Director (Acting) 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

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Indications for Use

510(k) Number (if known) K192783

Device Name Aristotle 24 Guidewire

Indications for Use (Describe)

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)

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Image /page/3/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized blue symbol above the word "SCIENTIA" in a sans-serif font. The symbol is made up of two curved lines that are parallel to each other and form an S shape. The word "SCIENTIA" is in all caps and is in a light gray color.

510(K) SUMMARY

(PER 21 CFR 807.92)

SCIENTIA VASCULAR LLC

Special 510(K): Device Modification Aristotle 24 Guidewire

510(k) Sponsor:	Scientia Vascular LLC3487 West 2100 South Suite 100West Valley City, UT 84119Tel: (888) 385.9016
Contact Person:	Amy McManus,Regulatory Affairs ManagerTel: (888) 385.9016E-mail: amcmanus@scientiavascular.com
Date Prepared:	September 13, 2019

Subject Device Information:

Trade Name:	Aristotle 24 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 18 Guidewire (K183608)

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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 a shaping mandrel, 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 mandrel, 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 24 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to the previously cleared Aristotle 18 Guidewire.

INDICATION FOR USE

This is the same indication for use as previously cleared for the Aristotle 18 Guidewire, K183608.

INTENDED USE

The Aristotle 24 Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature.

TECHNOLOGICAL CHARACTERISTICS

The Aristotle 24 Guidewire has the following similarities to the previously cleared Aristotle 18 Guidewire:

Both devices have the same indicated use, .
Both devices have the same intended use ●
Both devices use the same operating principle,
Both devices incorporate the same basic guidewire design, ●
Both devices incorporate the same materials, and ●

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Both devices are packaged and sterilized using the same materials and processes.
The technological characteristic comparison of the subject and predicate device is summarized in Table 1 below.

Table 1:Comparison between Subject & Predicate Device Technological Characteristics:Note: Areas of difference will be indicated in RED
Characteristic	Subject DeviceAristotle 24 Guidewire	PredicateAristotle 18 Guidewire (K183608)
Anatomical Location	Neuro and peripheral vasculature	Neuro and peripheral vasculature
Dimensions	Max O.D.: 0.024" (0.61mm)Length: 200cm	Max O.D.: 0.018" (0.46mm)Length: 200cm
Core Wire	Stainless Steel	Stainless Steel
Distal Tip	ShapeableLength: 35cmMaterial: Nitinol	ShapeableLength: 35cmMaterial: Nitinol
Stiffness Profiles	Range from support (stiff), standard(middle) to soft (flex)	Range from support (stiff), standard(middle) to soft (flex)
Coatings	Distal End: HydrophilicProximal End: PTFE	Distal End: HydrophilicProximal End: PTFE
Radiopaque Marker	Radiopaque marker at distal tip	Radiopaque marker at distal tip
Centering Coil	Two (2) Centering coil	One (1) Centering coil
Bushing	One	None
Shaping Mandrel(Accessory)	Provided with each guidewire	Provided with each guidewire
Guidewire Introducer(Accessory)	Provided with each guidewire	Provided with each guidewire
Torque Device(Accessory)	Provided with each guidewire	Provided with each guidewire
Sterilization Method	100% Ethylene Oxide (EO)	100% Ethylene Oxide (EO)

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The subject device, Aristotle 24, has three technological characteristic differences when compared to the predicate device. The changes in technological characterists do not result in new materials used or new questions of safety or effectiveness, nor do they result in new risks for the subject device. Testing of the subject device has been performed, demonstrating the safety and effectiveness of the device.

NON-CLINICAL PERFORMANCE TESTS

Biocompatibility

The materials used in the manufacture of the subject device Aristotle 24 Guidewire are identical to those used in the manufacturing of the predicate device Aristotle 18 Guidewire also manufactured by Scientia Vascular LLC, cleared March 22, 2019 after review of K183608. Biocompatibility testing was completed for the Aristotle 24 and consisted of the following tests:

In-vitro Blood Flow Thrombogenicity Study
MEM elution ●
Toxicological risk assessment
ASTM Hemolysis (direct contact and extract) ●
Partial Thromboplasting Time, and .
Compliment Activation

Sterilization

100% EO is used to sterilize the device to achieve a SAL of at least 10-6. 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 24 and the Aristotle 18 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). Table 2 summarizes the functional tests performed and test results obtained to demonstrate substantial equivalence to the predicate device:

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Table 2:Summaries of Functional Tests Conducted to Support this Premarket Notification
for the Modified (Subject) Device, Aristotle 24 Guidewire
Test	Test Method Summary	Results
DimensionalVerification	Tests per ISO 11070:Dimensional inspection per engineeringdrawings.	The Aristotle 24 Guidewires mettesting acceptance criteria.
Tensile Strength	Tensile testing per ISO 11070.	The Aristotle 24 Guidewires mettesting acceptance criteria
Flexing Test	Tests per ISO 11070:Inspection for defects and damage or flakingof the coating after flexing.	The Aristotle 24 Guidewires mettesting acceptance criteria
Fracture	Tests per ISO 11070:Inspection for fracture, loosening, or failureafter wrapping around mandrel.	The Aristotle 24 Guidewires mettesting acceptance criteria
Torqueability	Measurement of torque response (averageinput to output lag) in an anatomical model.	The Aristotle 24 Guidewires mettesting acceptance criteria
Torque Strength	Torque turns to failure in an anatomicalmodel.	The Aristotle 24 Guidewires mettesting acceptance criteria
Tip Flexibility	Measure force to deflect guidewire tips to45 and 90 degrees at 5mm, 10mm, and20mm test lengths.	The Aristotle 24 Guidewires mettesting acceptance criteria
Tip Shape,Retention	Guidewires must be shapeable and mustretain shaped angle after simulated use.	The Aristotle 24 Guidewires mettesting acceptance criteria
Particulate	Particulates of various size ranges countedafter simulated use in a tortuous path.	The Aristotle 24 Guidewires mettesting acceptance criteria
Coating Lubricityand Durability	Frictional force of coated guidewires wasdetermined after simulated use in a tortuouspath.	The Aristotle 24 Guidewires mettesting acceptance criteria
Coating Integrity	Coating uniformity and integrity visuallyexamined on dyed samples after simulateduse in a tortuous path.	The Aristotle 24 Guidewires mettesting acceptance criteria
Simulated UseModel Testingand ProductCompatibility	Anatomical model designed to simulate thetortuous anatomy of the neurovasculatureused for simulated use testing	The Aristotle 24 Guidewires mettesting acceptance criteria
UsabilityEvaluation	Physicians evaluated subject and predicateguidewires for various performancecharacteristics in a human cadaver.	The Aristotle 24 Guidewires mettesting acceptance criteria

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CONCLUSION:

Scientia Vascular, LLC has presented information in this premarket notification supporting the Aristotle 24 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.