Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile

K173235 · Scientia Vascular, LLC · DQX · Jan 22, 2018 · Cardiovascular

Device Facts

• Record ID: K173235
• Device Name: Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
• Applicant: Scientia Vascular, LLC
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

Aristotle 14 Guidewire is a 0.014" diameter steerable guidewire with shapeable Nitinol distal tip; stainless steel core; hydrophilic distal coating; PTFE proximal coating; radiopaque marker coil. Supplied sterile for single use. Includes introducer and torque device accessories. Used in neuro and peripheral vasculature to navigate and position catheters/interventional devices. Operated by physicians in clinical settings. Provides tactile feedback and steerability during navigation; radiopaque tip allows fluoroscopic visualization. Benefits include facilitating access to complex vascular anatomy for interventional procedures.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, latex content), functional testing (visual inspection, dimensional verification, flexing, tensile strength, tip shape retention, torqueability, torque strength, tip flexibility, fracture, coating lubricity/durability/integrity, particulates, accessory testing), and simulated use/cadaver testing. All tests met acceptance criteria.

Technological Characteristics

0.014" (0.36mm) diameter; 200-300cm length. Stainless steel core; Nitinol distal tip. Hydrophilic distal coating; PTFE proximal coating. Radiopaque marker at distal tip. Sterilized via 100% Ethylene Oxide (EO) per ISO 11135. Accessories: introducer and torque device. MRI Unsafe.

Indications for Use

Indicated for general vascular use in neuro and peripheral vasculatures to introduce and position catheters and interventional devices. Not for use in coronary vasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PVS 1300 Synchro® 0.014" Guidewire (K032146)

Submission Summary (Full Text)

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

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">X</span> 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

Image /page/3/Picture/2 description: The image shows the logo for Scientia. The logo consists of a stylized blue symbol above the word "SCIENTIA" in a futuristic-looking font. The symbol is made up of two curved lines that are parallel to each other.

# 510(K) SUMMARY (Per 21 CFR 807.92)

## SCIENTIA VASCULAR LLC ARISTOTLE 14 GUIDEWIRE

| 510(k) Sponsor: | Scientia Vascular LLC<br>3487 West 2100 South Suite 100<br>West Valley City, UT 84119<br>Tel: [phone] | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | David Sabodski, Director of Quality Assurance<br>Tel: [phone]<br>E-mail: [e-mail] | |
| Date Prepared: | December 8, 2017 | |
| Prepared by: | Ryan O'Callaghan, MS, RAC<br>Phil Triolo and Associates LC<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| 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 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.

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

The 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 Device<br>Aristotle 14 Guidewire | PVS 1300 Synchro®<br>0.014" Guidewire<br>(K032146) | Comparison |
| Anatomical<br>Location | Neuro and peripheral<br>vasculature | Neuro and peripheral<br>vasculature | Same |
| Dimensions | 0.D.: 0.014" (0.36mm)<br>Length: 200cm to 300cm<br>range | 0.D.: 0.014" (0.36mm)<br>Length: 180cm to 300cm<br>range, with 200cm being<br>typical | Equivalent |
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | Shapeable<br>Length: 35cm<br>Material: Nitinol | Shapeable<br>Length: 25cm to 65cm<br>range, with 35 to 45cm<br>being typical<br>Material: Nitinol | Equivalent |
| Stiffness Profiles | Range from support (stiff)<br>to flex (soft) | Range from support (stiff)<br>to flex (soft) | Equivalent |
| Coatings | Distal End: Hydrophilic<br>Proximal End: PTFE | Distal End: Hydrophilic<br>Proximal End: PTFE | Equivalent |
| Radiopaque<br>Marker | 1 radiopaque marker at<br>distal tip | 1 radiopaque marker at<br>distal tip | Same |
| Introducer<br>(Accessory) | Provided with each<br>guidewire | Provided with each<br>guidewire | Equivalent |
| Torque Device<br>(Accessory) | Provided with each<br>guidewire | Provided with each<br>guidewire | Same |
| Sterilization<br>Method | 100% Ethylene Oxide<br>(EO) | Currently radiation<br>sterilization [devices<br>originally cleared were<br>sterilized with100%<br>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 Premarket<br>Notification | | | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| Test | Results | Conclusions | |
| Cytotoxicity<br>[L-929 MEM Elution] | Cell culture treated with<br>test sample exhibited no<br>reactivity (Grade 0). | Non-cytotoxic | |
| Summaries of Biocompatibility Tests Conducted to Support this Premarket<br>Notification | | | |
| Test | Results | Conclusions | |
| Sensitization<br>[Maximization<br>(Magnusson-Kligman)] | Challenge sites treated<br>with test sample exhibited<br>no erythema or edema<br>(Grade 0). | Negative for dermal<br>sensitization | |
| Irritation<br>[Intracutaneous Toxicity<br>(ISO)] | The mean test score in<br>0.9% Normal Saline<br>extract was 0, and in<br>Sesame Oil was 0.1. | Non-irritating | |
| Systemic Toxicity<br>(Acute)<br>[Systemic Injection<br>(ISO)] | No study animals were<br>observed with abnormal<br>clinical signs indicative of<br>toxicity during the 72-hour<br>test period. | Non-toxic | |
| Systemic Toxicity<br>(Acute)<br>[Material Mediated<br>Pyrogen in a Rabbit<br>Model] | Temperature increases for<br>the all test animals did not<br>exceed the acceptable test<br>limit for maximum<br>individual temperature<br>rise. | Non-pyrogenic | |
| Hemocompatibility<br>[Hemolysis, direct<br>contact - device/material<br>(human blood)] | The difference between<br>the hemolytic indices of<br>the test article and the<br>negative control was<br>0.00%. | Non-hemolytic | |
| Hemocompatibility<br>[Hemolysis, indirect -<br>device/material (human<br>blood)] | The difference between<br>the hemolytic indices of<br>the test article and the<br>negative control was<br>0.00%. | Non-hemolytic | |
| Summaries of Biocompatibility Tests Conducted to Support this Premarket<br>Notification | | | |
| Test | Results | Conclusions | |
| Hemocompatibility<br>[Partial Thromboplastin<br>Time (PTT test) - Human<br>plasma] | Both the subject device<br>and predicate device fell<br>within the same<br>thrombogenicity category<br>(minimal activator) | Subject and predicate devices<br>showed similar<br>thrombogenicity. | |
| Hemocompatibility<br>[Complement Activation<br>- SC5b-9] | Amounts of SC5b-9<br>generated by the test<br>article and predicate<br>device after exposure<br>times of 30 and 60<br>minutes were not<br>statistically different. The<br>amount of SC5b-9<br>generated by the test<br>article was statistically<br>lower than that released by<br>the predicate after 90<br>minutes exposure. | Subject and predicate devices<br>showed similar complement<br>system activation. | |
| Hemocompatibility<br>[Thrombogenicity in a<br>Dog Model] | Both test animals had a<br>subject device (Aristotle<br>14 Guidewire) and<br>predicate device (Synchro-<br>14 Guidewire) inserted.<br>The average thrombus<br>score was the same for<br>both the subject and<br>predicate device. | Subject and predicate devices<br>showed similar thrombogenic<br>potential. | |
| Latex<br>[LEAP test] | No Latex Antigenic<br>Proteins were detected. | Contains no detectable traces of<br>latex | |

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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 | | |
| Visual<br>Inspection | Tests per ISO 11070:<br>Visual inspection for extraneous<br>matter, process and surface defects<br>or defects that may cause trauma<br>to vessels during use | No extraneous matter, surface<br>defects or visible droplets of coating<br>were present on the Aristotle 14<br>Guidewires. | | |
| Dimensional<br>Verification | Tests per ISO 11070:<br>Dimensional inspection per<br>engineering drawings | All guidewires met dimensional<br>specifications. | | |
| Flexing Test | Tests per ISO 11070:<br>Inspection for defects and damage<br>or flaking of the coating after<br>flexing | No defects or damage / flaking of<br>the coating were observed after<br>flexing. | | |
| Tensile<br>Strength | Tensile testing per ISO 11070 | All guidewires met minimum force<br>breakage requirements specified in<br>ISO 11070. | | |
| Tip Shape,<br>Retention | Guidewires must be shapeable and<br>must retain shaped angle after<br>simulated use | All tips met shaping and shape<br>retention requirements after<br>simulated use. | | |
| Torqueability | Measurement of torque response<br>(average input to output lag) in an<br>anatomical model | All guidewires demonstrated<br>acceptable torque responses. The<br>torque response of the subject<br>device was comparable to that of the<br>predicate device. | | |
| Torque<br>Strength | Torque turns to failure in an<br>anatomical model | All guidewires demonstrated<br>acceptable torque strength. The<br>torque strength of the subject device<br>was comparable to that of the<br>predicate device. | | |

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| Summaries of Functional Tests Conducted to Support this Premarket Notification | | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Test Method Summary | Results |
| Tip<br>Flexibility | 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:<br>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. |
| Coating<br>Lubricity and<br>Durability | Frictional force of coated guidewires was determined after simulated use in a tortuous path | All guidewires met specified frictional force requirements. |
| Coating<br>Integrity | 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. |
| Torque<br>Device -<br>Introducer<br>Testing | 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. |
| Simulated<br>Use Model<br>Testing and<br>Product<br>Compatibility | 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 |
| Cadaver<br>Testing | Physicians evaluated subject and predicate guidewires for various<br>performance characteristics in a human cadaver | Subject and predicate guidewires<br>both exhibited acceptable<br>performance. |
| Radiopacity | Subject and predicate guidewires evaluated by physicians in human<br>cadaver | Both subject and predicate<br>guidewires exhibited acceptable<br>radiopacity. |
| Corrosion<br>Resistance | Test for corrosion resistance per<br>ISO 11070 | There were no signs of corrosion on<br>guidewires after soaking in typical<br>end-use solutions. |
| Chemical<br>Compatibility | Guidewires were exposed to saline<br>and contrast agent/saline solutions<br>and examined for degradation. | All guidewires showed no signs of<br>degradation, corrosion or physical<br>decomposition after exposure. |
| MRI<br>Compatibility | Guidewires are constructed of<br>metallic materials and should not<br>be exposed to MRI procedures. | No testing performed. Aristotle<br>Guidewires are labeled “MRI<br>Unsafe.” |
| Latex | Tested for trace latex proteins per<br>ASTM D6499-07 | No detectable traces of latex were<br>found. |
| Package<br>Integrity | Simulated transportation test per<br>ASTM D 4169:16. Pouch<br>evaluated for seal strength per<br>ASTM F 88-15 and leak tests<br>(bubble test) per ASTM F 2096-11 | Following exposure to typical<br>storage and transportation<br>conditions, all sterile barrier<br>pouches maintained their integrity<br>and labeling remained affixed and<br>legible. |
| Shelf Life | Device performance attributes that<br>can be affected by storage<br>conditions were evaluated after<br>exposure to accelerated aging<br>conditions per ASTM F1980. | After exposure to accelerated aging<br>conditions simulating real-time<br>storage under ambient conditions<br>for 6 months, all device<br>performance acceptance criteria<br>were met, justifying labeling the<br>devices with a 6-month shelf life. |
| Summaries of Functional Tests Conducted to Support this Premarket Notification | | |
| Test | Test Method Summary | Results |
| Sterilization<br>Validation | 100% EO is used to sterilize the<br>device to achieve a SAL of at least<br>10-6. The device was adopted into<br>an EO sterilization processing<br>group in accordance with AAMI<br>TIR 28:2009. Validation of the EO<br>sterilization cycle was performed<br>using the Half-cycle, overkill<br>approach described in Section<br>B.1.2 of ISO11135:2007 Annex B. | Results justified adoption into the<br>EO sterilization processing group:<br>Comparative and Bioburden<br>Resistance study results<br>demonstrated that PCDs are more<br>difficult to sterilize than devices;<br>Bioburden Enumeration and<br>Extraction Efficiency tests were<br>used to enumerate the CFUs present<br>on devices; and Bacteriostasis/<br>Fungistasis test results demonstrated<br>that the product does not inhibit the<br>growth of organisms. |
| Sterilization<br>Validation:<br>EO and ECH<br>Residuals | Measured EO and ECH residuals<br>per AAMI/ANSI/ISO 10993-7 | The residual traces of EO and ECH<br>remaining in the Aristotle 14<br>Guidewire after exposure to the EO<br>sterilization process are well below<br>the limits specified in ISO 10993-7. |
| Sterilization<br>Validation:<br>Bacterial<br>Endotoxin<br>Levels | LAL testing was conducted in<br>accordance with ANSI/AAMI<br>ST72:2011/(R)2016, USP <161>,<br>and USP <85>, using the kinetic<br>chromogenic 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.