The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.

Device Description

Scientia Cardio Access's CrossTorg™ 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 with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 300cm.

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 (to shape the flexible tip of the guidewire), 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 shaping 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 a 510(k) premarket notification for the "CrossTorq 14 Guidewire". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the acceptance criteria and study described are geared towards demonstrating this equivalence through non-clinical performance and functional testing.

Here's a breakdown based on your requested information:

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

The document lists various tests with associated "Results." For substantial equivalence, the "acceptance criteria" are implicitly that the new device performs "as well as the predicate devices and/or meets requirements of relevant standards" or that any differences "do not raise different questions of safety and effectiveness."

Test Category	Specific Test	Acceptance Criteria (Implicit from context)	Reported Device Performance/Results
Biocompatibility	General Biocompatibility	Identical materials and processing to reference devices (Aristotle 18 Guidewire K183608, Aristotle 14 Guidewire K173235) such that dimensional change does not alter chemical/physical properties or involve new biological interactions. Low and acceptable biological and toxicological risk.	The materials and processing are identical to the reference Aristotle 18 Guidewire (K183608) in formulation, processing, sterilization, and geometry, with only a smaller outer diameter. This dimensional change does not alter chemical/physical properties, allowing results from the Aristotle 18 Guidewire to be applied. No additional biological evaluations were deemed necessary as the design presents a low and acceptable biological risk.
	Radiopacity	Acceptable radiopacity for physician visualization in human cadaver.	Guidewires exhibited acceptable radiopacity.
	Corrosion Resistance	No signs of corrosion after soaking in typical end-use solutions (per ISO 11070).	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
	Chemical Compatibility	No signs of 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.
	Latex	No detectable traces of latex proteins (per ASTM D6499-07).	No detectable traces of latex were found.
	Accessories Testing	Acceptance criteria of all tests (biocompatibility, visual inspection, corrosion resistance, tensile testing, luer taper dimensions) for torque device and shaping mandrel were met.	Acceptance criteria of all tests were met.
	Package Integrity	All sterile barrier pouches maintained integrity and labeling remained affixed and legible after simulated transportation (per ASTM D 4169:16). Seal strength (ASTM F 88-15) and leak tests (ASTM F 2096-11) criteria met.	Following exposure to typical storage and transportation conditions, all sterile barrier pouches maintained their integrity and labeling remained affixed and legible.
	Sterilization Validation	SAL of at least 10^-6, results justified adoption into EO sterilization processing group. PCDs more difficult to sterilize than devices. Bioburden Enumeration and Extraction Efficiency, and Bacteriostasis/Fungistasis test results demonstrated.	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	Residual traces of EO and ECH well below limits specified in ISO 10993-7.	The residual traces of EO and ECH remaining in the CrossTorq 14 Guidewire after exposure to the EO sterilization process are well below the limits specified in ISO 10993-7.
	Sterilization Validation: Bacterial Endotoxin Levels	< 2.15 EU/device (per ANSI/AAMI ST72:2011/(R)2016, USP <161>, and USP <85>).	< 2.15 EU/device.
Functional Testing	Visual Inspection	No extraneous matter, process and surface defects, or defects that may cause trauma to vessels (per ISO 11070).	No extraneous matter, surface defects or visible droplets of coating were present on the CrossTorq 14 Guidewires.
	Dimensional Verification	All guidewires met dimensional specifications (per engineering drawings).	All guidewires met dimensional specifications.
	Flexing Test	No defects or damage/flaking of coating after flexing (per ISO 11070).	No defects or damage / flaking of the coating were observed after flexing.
	Tensile Strength	All guidewires met minimum clinically relevant force breakage requirements (per ISO 11070).	All guidewires met minimum clinically relevant force breakage requirements when tested according to ISO 11070.
	Tip Shape, Retention	All tips were shapeable and retained shaped angle after simulated use.	All tips met shaping and shape retention requirements after simulated use.
	Torqueability	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	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	Forces required to deflect softer CrossTorq 14 tips comparable to Kinetix; stiffer tips comparable to Boston Scientific Hornet 14.	The forces required to deflect the guidewire tips of the softer CrossTorq 14 tip profiles were comparable to the forces required to deflect the Kinetix, while the forces required to deflect the tips of the stiffer CrossTorq 14 tip profiles were comparable to the forces required for the Boston Scientific Hornet 14 guidewire tips.
	Fracture	No signs of fracture, loosening, or failure after wrapping around mandrel (per ISO 11070).	No guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
	Coating Lubricity and Durability	All guidewires met specified frictional force requirements after simulated use.	All guidewires met specified frictional force requirements.
	Coating Integrity	Acceptable coating coverage after simulated use.	All samples showed acceptable coating coverage after simulated use.
	Particulates	All guidewires met specified number/size recovered particulate requirements after simulated use.	All guidewires met specified number/size recovered particulate requirements.
	Simulated Use Model Testing and Product Compatibility	Acceptably performed in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter and Balloon Catheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter and Balloon Catheter.	Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter and Balloon Catheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter and Balloon Catheter.
	Column Buckling	Forces required to buckle softer CrossTorq 14 tips comparable to Kinetix; stiffer tips comparable to Boston Scientific Hornet 14.	The forces required to buckle the guidewire tips of the softer CrossTorq 14 tip profiles were comparable to the forces required to deflect the Kinetix, while the forces required to buckle the tips of the stiffer CrossTorq 14 tip profiles were comparable to the forces required for the Boston Scientific Hornet 14 guidewire tips.
	MRI Compatibility	Device must be labeled "MRI Unsafe" as it contains metallic materials and should not be exposed to MRI procedures.	No testing performed. CrossTorq 14 Guidewires are labeled "MRI Unsafe."
	Shelf Life	All device performance acceptance criteria met after exposure to accelerated aging conditions simulating real-time storage for 13 months.	After exposure to accelerated aging conditions simulating real-time storage under ambient conditions for 13 months, all device performance acceptance criteria were met, justifying labeling the devices with a 1-year shelf life.

2. Sample sized 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 explicitly state the numerical sample size (n-value) for each specific test, nor does it detail multiple test sets. The functional and biocompatibility tests generally refer to "Guidewires" or "All guidewires" or "All samples" in the results, implying that a sufficient number were tested to satisfy the testing standards (e.g., ISO 11070). For "Radiopacity," it mentions "Guidewires evaluated by physicians in human cadaver" without specifying the number of guidewires or cadavers.
Data Provenance: The document states that "Results for following tests, performed on the reference Aristotle 14 Guidewires and reference Aristotle 18 Guidewires, were included in Scientia Vascular LLC's premarket notifications K173235 and K183608..." This indicates some data was leveraged from previous submissions for reference devices. For the CrossTorq 14 Guidewire, the tests performed appear to be prospective (i.e., new tests done for this submission), although the location where they were performed is not specified. There is no information about country of 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)

The only mention of "experts" is for the "Radiopacity" test, stating "Guidewires evaluated by physicians in human cadaver." No specific number or qualifications of these physicians are provided.
For other functional tests (e.g., simulated use, torqueability), the methods describe objective measurements or observations ("acceptable torque responses," "no defects or damage"), implying expert judgment primarily in setting the testing parameters and interpreting compliance with established standards, but not necessarily in adjudicating a "ground truth" for classification purposes.

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

No formal adjudication method (like 2+1 or 3+1 consensus) is described. The tests are primarily objective measurements or evaluations against defined standards (ISO 11070, ASTM standards). The "Radiopacity" test mentions physician evaluation, but the decision process is not detailed as an adjudication.

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

No MRMC comparative effectiveness study was done.
This device (a guidewire) is a physical medical device, not an AI-assisted diagnostic tool or software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The CrossTorq 14 Guidewire is a physical interventional medical device, not an algorithm or AI system.

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

For this type of device and submission (510(k) for a guidewire), "ground truth" is established through adherence to recognized performance standards (e.g., ISO 11070), engineering specifications, and comparative non-clinical testing against predicate devices. It relies on objective physical measurements and empirical demonstrations of performance characteristics like tensile strength, torqueability, flexibility, and biocompatibility, rather than clinical outcomes or diagnostic classifications requiring expert consensus.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML model that requires a "training set." The development of the guidewire involves design, materials selection, and manufacturing processes, supported by engineering principles and testing.

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

This question is not applicable, as there is no "training set" for this physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the next line. To the left of the FDA logo is the Department of Health & Human Services logo. The Department of Health & Human Services logo is a symbol of a stylized human figure.

September 16, 2020

Scientia Cardio Access LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k, Saint Paul, Minnesota 55114

Re: K193194

Trade/Device Name: CrossTorq 14 Guidewire Regulation Number: 21 CFR 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX

Dear Prithul Bom:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 13, 2019. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lydia Glaw, OHT2: Office of Cardiovascular Devices, 301-796-1456, Lydia.glaw@fda.hhs.gov.

Sincerely,
Lydia S.Glaw -S	Digitally signed byLydia S. Glaw -SDate: 2020.09.1610:45:14 -04'00'
Lydia GlawAssistant Director
DHT2C: Division of Coronaryand Peripheral Interventional Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and QualityCenter for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.

December 13, 2019

Scientia Cardio Access LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k, Saint Paul, Minnesota 55114

Re: K193194

Trade/Device Name: CrossTorq 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 18, 2019 Received: November 19, 2019

Dear Prithul Bom:

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. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/ training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-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,

Image /page/2/Picture/6 description: The image shows the name "Lydia S. Glaw -S" in large, bold font on the left side of the image. On the right side, it says "Digitally signed by Lydia S. Glaw -S" followed by the date "Date: 2019.12.13" and the time "09:46:48 -05'00'". The text on the right side is smaller and less bold than the name on the left.

Lydia Glaw, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular 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) K193194

Device Name CrossTorq 14 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/4/Picture/2 description: The image shows the logo for Scientia. The logo consists of a stylized blue "S" shape above the word "SCIENTIA" in a futuristic-looking font. The "S" shape is made up of three parallel lines that curve around each other.

510(K) SUMMARY (Per 21 CFR 807.92)

SCIENTIA CARDIO ACCESS LLC

510(k) Sponsor:	Scientia Cardio Access LLC3487 West 2100 South Suite 100West Valley City, UT 84119Tel: (775) 657-6330
Contact Person:	Amy McManus, Regulatory Affairs ManagerPhone: 1 (888) 385-9016Email: amcmanus@scientiavascular.com)
Date Prepared:	December 6, 2019
Prepared by:	Ryan O'Callaghan, MS, RACPhil Triolo and Associates LCTel: 801.573.2651Fax: 801.328.2399E-mail: ryano@philt.com
Trade Name:	CrossTorqTM 14 Guidewire
Common Name:	Guidewire
Classification Name	Catheter Guide Wire per 21 CFR 870.1330
Product Code:	DQX
Predicate Devices:	KinetixTM Guidewire (K081021)
	HornetTM Guidewire, HornetTM 10 Guidewire, and HornetTM 14 Guidewire(K152231)
Reference Devices:	Aristotle 14 Guidewire (K173235)
	Aristotle 18 Guidewire (K183608)

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DEVICE DESCRIPTION

The CrossTorg 14 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to Boston Scientific's currently marketed Kinetix™ Guidewire cleared under K081021 and Boston Scientific's Hornet™ Guidewire, Hornet™ 10 Guidewire, and Hornet™ 14 Guidewire (also referred to as the Hornet Guidewire Series in this summary) cleared under K152231.

INDICATIONS FOR USE

The CrossTorq™ 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorg™ 14 Guidewire is not intended for use in the neurovasculature.

TECHNOLOGICAL CHARACTERISTICS

As shown in the table below, the technological characteristics of the CrossTorg 14 Guidewire are equivalent to those of the predicate devices, the Kinetix Guidewire and Boston Scientific Hornet Guidewire Series. Both of the predicate devices have intended use; however, the Kinetix Guidewire is only offered in soft tip stiffness profiles, while the Hornet Guidewire Series and the CrossTorq 14 Guidewire are offered in a wider range of stiffness profiles. The CrossTorq 14 Guidewire combines the stiffness profiles offered by the Kinetix and Hornet Guidewire Series guidewires.

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Comparison of Technological Characteristics between Subject Device and Predicate Devices
Characteristic	Subject DeviceCrossTorqTM 14Guidewire	Primary PredicateDeviceKinetixTM Guidewire(K081021)	Predicate DeviceBoston Scientific HornetGuidewire Series(K152231)	Comparison
AnatomicalLocation	Coronary andperipheral vasculature	Coronary andperipheral vasculature	Coronary and peripheralvasculature	Same
Dimensions	O.D. : 0.014"(0.36mm)Length : 200cm or300cm	O.D. : 0.014"(0.36mm)Length : 180cm or300cm	O.D. : 0.014" (0.36mm)Length : 190cm or300cm	Equivalent
Core Wire	Stainless Steel	Nitinol	Stainless Steel	Equivalent
Distal Tip	Shapeable straight tipLength : 35 cmMaterial : Nitinol	Shapeable straight tipor preshaped "J" tipLength : 18 cmMaterial : Nitinol	Shapeable straight tipLength : 15 cmMaterial : Stainless Steel	Equivalent
StiffnessProfiles	Range fromSoft(1gram) to ExtraSupport (15gram)	Range from ModerateSupport(0.8 gram) toPlus(1.3gram)	Range from 1gram to 14gram tip stiffness	Equivalent
Coatings	Distal End :HydrophilicProximal End :PTFE	Distal End :HydrophilicProximal End : PTFE	Distal End : HydrophilicProximal End : PTFE	Same
RadiopaqueMarker	Radiopaque marker atdistal tip	Radiopaque marker atdistal tip	Radiopaque marker atdistal tip	Same
Accessories	The followingaccessories areprovided with theguidewire:• Shaping Mandrel• Torque Device• Plastic Introducer	No accessories areprovided with thepredicate device.The predicate device'sIFU references use ofthe guidewire with thefollowing accessories:• Shaping instrument• Torque device• Insertion tool	No accessories areprovided with thepredicate device.The predicate device'sIFU references use of theguidewire with thefollowing accessories:• Shaping instrument• Torque device• Insertion tool	Equivalent
Comparison of Technological Characteristics between Subject Device and Predicate Devices
Characteristic	Subject DeviceCrossTorqTM 14Guidewire	Primary PredicateDeviceKinetixTM Guidewire(K081021)	Predicate DeviceBoston Scientific HornetGuidewire Series(K152231)	Comparison
SterilizationMethod	100% Ethylene Oxide(EO)	100% Ethylene Oxide(EO)	100% Ethylene Oxide(EO)	Same

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As shown in the Table above, the CrossTorq 14 Guidewire differs from the predicate guidewire in the following ways:

The CrossTorq 14 core wire is constructed of stainless steel, while the Kinetix core wire is constructed of Nitinol. The Hornet Guidewire Series guidewires are all built using the same stainless steel material as the CrossTorq 14. Stainless steel is a commonly used core wire material and the functionality and performance characteristics of the stainless steel core wire are similar to those of the Nitinol core wire used in the construction of the Kinetix Guidewire.

An accessory kit (consisting of a shaping mandrel, a torque device, and an introducer) is provided as part of the subject device, whereas the predicate devices do not provide an accessory kit as part of their finished product. Although the accessories are not provided in the packaging, the Kinetix and Hornet Guidewire Instructions For Use mentions the use of a shaping instrument, insertion tool, and torque device, which are equivalent to the accessories provided with the CrossTorq 14.

The tip stiffness profiles available for the CrossTorq 14 Guidewire are: 1gram, 6 gram, and 15 gram. These tip stiffnesses are referred to in reports and this document as Soft. Standard, Support, and Extra Support, respectively. The predicate Kinetix Guidewire is only available in 0.8 gram and 1.3 gram tips, however, the predicate Hornet Guidewire series is available in 1 gram, 10 gram, and 14 gram tips, and thus can be used to determine values for comparative testing of Tip Stiffness and Column Buckling.

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

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Scientia Cardio Access LLC Traditional_510(k) CrossTorq™ 14 Guidewire

Additionally, the indications for use statement of the subject device is equivalent to that of the predicate devices 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 devices and the new device.

NON-CLINICAL PERFORMANCE TESTS

Biocompatibility

The materials and processing of the CrossTorq 14 Guidewires are identical to those of the reference Aristotle 18 Guidewire (manufactured by Scientia Cardio Access LLC's sister company, Scientia Vascular LLC, and cleared under K183608); in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents) with the exception that the outer diameter of the CrossTorg 14 Guidewire is smaller than that of the Aristotle 18 Guidewire. The dimensional change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the Aristotle 18 Guidewire can be applied to the medical device in its final finished form.

There are no additional biologic interactions that need to be considered in order to use the cleared guidewires in the coronary vasculature. Consequently, no additional evaluations are needed to determine that the subject guidewires present a low and acceptable biological and toxicological risk when used in accordance with their intended and indicated uses, and no additional biological safety information is provided in this 510(k).

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Test Results Leveraged from Premarket Notifications K173235 (Aristotle 14 Guidewire) and K183608 (Aristotle 18 Guidewire)

Results for following tests, performed on the reference Aristotle 14 Guidewires and reference Aristotle 18 Guidewires, were included in Scientia Vascular LLC's premarket notifications K173235 and K183608 for the Aristotle 14 Guidewire and Aristotle 18 Guidewire, respectively. The results from these tests are also applicable to CrossTorq 14 Guidewire, as the materials and processing of the CrossTorq 14 Guidewires are identical to those of the Aristotle 14 and Aristotle 18 Guidewires.

Summaries of Leveraged Functional Tests Conducted to Support this PremarketNotification
Test	Test Method Summary	Results
Radiopacity	Guidewires evaluated byphysicians in human cadaver	Guidewires 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.
Latex	Tested for trace latex proteins perASTM D6499-07	No detectable traces of latex werefound.
AccessoriesTesting	Compatibility of Torque Deviceand Shaping Mandrel withAristotle Guidewires wasevaluated in cadaver testing andsimulated use evaluations.Various tests on Shaping Mandrelper ISO 11070: biocompatibility,visual inspection, corrosionresistance, tensile testing, luertaper dimensions	Acceptance criteria of all tests weremet
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.
Summaries of Leveraged Functional Tests Conducted to Support this PremarketNotification
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 CrossTorq 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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Functional Testing performed on CrossTorq 14 Guidewires

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 CrossTorq 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 minimumclinically relevant force breakagerequirements when tested accordingto ISO 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.
Summaries of Functional Tests Conducted to Support this Premarket Notification
Test	Test Method Summary	Results
TipFlexibility	Measure force to deflect guidewiretips to 45 and 90 degrees at 5mm,10mm, and 20mm test lengths	The forces required to deflect theguidewire tips of the softerCrossTorq 14 tip profiles werecomparable to the forces required todeflect the Kinetix, while the forcesrequired to deflect the tips of thestiffer CrossTorq 14 tip profileswere comparable to the forcesrequired for the Boston ScientificHornet 14 guidewire tips.
Fracture	Tests per ISO 11070:Inspection for fracture, loosening,or failure after wrapping aroundmandrel	No guidewires showed signs offracture, loosening, or failure afterwrapping them 8 times around amandrel.
CoatingLubricity andDurability	Frictional force of coatedguidewires was determined aftersimulated use in a tortuous path	All guidewires met specifiedfrictional force requirements.
CoatingIntegrity	Coating uniformity and integrityvisually examined on dyedsamples after simulated use in atortuous path	All samples showed acceptablecoating coverage after simulateduse.
Particulates	Particulates of various size rangescounted after simulated use in atortuous path	All guidewires met specifiednumber/size recovered particulaterequirements.
SimulatedUse ModelTesting andProductCompatibility	Tortuous path model defined byASTM F2394 Figure X2.4 usedfor simulated use testingCompatibility of the accessorieswith the CrossTorq 14 Guidewirewas evaluated in the simulatedtortuous path model evaluation.	Guidewires and predicate deviceswere found to perform acceptably inevaluations of: Torqueability intortuous vasculature, Lubricity,Microcatheter and Balloon CatheterSupport & Tracking, Compatibilitywith Introducer, Compatibility withTorque Device, and Compatibilitywith Microcatheter and BalloonCatheter.
Summaries of Functional Tests Conducted to Support this Premarket Notification
Test	Test Method Summary	Results
ColumnBuckling	Measure force to buckle theguidewire 1cm from the distal tip.	The forces required to buckle theguidewire tips of the softerCrossTorq 14 tip profiles werecomparable to the forces required todeflect the Kinetix, while the forcesrequired to buckle the tips of thestiffer CrossTorq 14 tip profileswere comparable to the forcesrequired for the Boston ScientificHornet 14 guidewire tips.
MRICompatibility	Guidewires are constructed ofmetallic materials and should notbe exposed to MRI procedures.	No testing performed. CrossTorq 14Guidewires are labeled "MRIUnsafe."
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 13 months, all deviceperformance acceptance criteriawere met, justifying labeling thedevices with a 1-year shelf life.

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CONCLUSION

Scientia Cardio Access, LLC has presented information in this premarket notification supporting its contention that the CrossTorq 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.