(86 days)
No
The description focuses on the physical characteristics and functional performance of a guidewire, with no mention of AI or ML capabilities.
No
The device, a guidewire, is intended to introduce and position other interventional devices, not to provide therapy itself.
No
The device description clearly states it is a guidewire intended to introduce and position other interventional devices, and its description focuses on physical characteristics and mechanical performance, not on providing diagnostic information.
No
The device is a physical guidewire with various material components, coatings, and accessories, clearly indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Aristotle 18 Guidewire is a medical device used within the body (in the neuro and peripheral vasculatures) to introduce and position other devices. It does not analyze samples like blood, urine, or tissue.
- The intended use clearly describes a procedural function. The purpose is to facilitate the delivery of other interventional devices, not to diagnose a condition based on in vitro analysis.
- The device description focuses on physical characteristics and function within the vascular system. It talks about diameter, steerability, coatings, and accessories for manipulation, all related to its use as a guide within blood vessels.
The Aristotle 18 Guidewire is a Class II medical device used in interventional procedures.
N/A
Intended Use / Indications for Use
The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Product codes
MOF, DQX
Device Description
The Aristotle 18 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.018" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The Aristotle 18 Guidewire is substantially equivalent with respect to technological characteristics, indications for use, design and materials to the previously cleared Aristotle 14 Guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculatures. The guidewire is not intended for use in the coronary vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional Testing:
- Visual Inspection: No extraneous matter, surface defects or visible droplets of coating are present on the Aristotle 18 Guidewires.
- Dimensional Verification: All Aristotle 18 guidewires met dimensional specifications.
- Tensile Strength: All Aristotle 18 guidewires meet minimum force breakage requirements specified in ISO 11070.
- Flexing Test: No defects or damage / flaking of the coating were observed after flexing.
- Fracture: No Aristotle 18 guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
- Torqueability: All Aristotle 18 guidewires demonstrated acceptable torque responses. The torque response of the subject device was comparable to that of the predicate device.
- Torque Strength: All Aristotle 18 guidewires demonstrated acceptable torque strength. The torque strength of the subject device was comparable to that of the predicate device.
- Tip Flexibility: The forces required to deflect the Aristotle 18 guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire.
- Tip Shape, Retention: All tips met shaping and shape retention requirements after simulated use.
- Particulate: A comparable number of particulates was recovered from subject and predicate device following simulated use.
- Coating Lubricity and Durability: All Aristotle 18 guidewires met specified frictional force requirements.
- Coating Integrity: All Aristotle 18 guidewires showed acceptable coating coverage after simulated use.
- Simulated Use Model Testing and Product Compatibility: Aristotle 18 Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter.
- Usability Evaluation: Subject and predicate guidewires both exhibited acceptable performance.
- Radiopacity: Both subject and predicate guidewires exhibited acceptable radiopacity.
- Corrosion Resistance: There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
- Compatibility with Agents: All Aristotle 18 guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
- Packaging: Following exposure to typical storage and transportation conditions, product remained secured and labeling remained affixed and legible.
Key Metrics
Not Found
Predicate Device(s)
Aristotle 14 Guidewire (K173235)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 22, 2019
Scientia Vascular LLC David Sabodski Director of Quality Assurance 3487 West 2100 South. Suite 100 West Valley City, Utah 84119
Re: K183608
Device Name: Aristotle 18 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: December 20, 2018 Received: December 26, 2018
Dear David Sabodski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Lin Zheng
Digitally signed by
Xiaolin Zheng -S
Date: 2019.03.22
10:44:47 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183608
Device Name Aristotle 18 Guidewire
Indications for Use (Describe)
The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Scientia Vascular LLC Traditional 510(k) Aristotle 18 Guidewire
Image /page/3/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized, interconnected blue symbol above the word "SCIENTIA" in a futuristic-looking font. The symbol is composed of two curved lines that appear to be intertwined, creating a sense of connection or flow. The word "SCIENTIA" is written in capital letters with a font that has sharp angles and a modern aesthetic.
510(K) SUMMARY (Per 21 CFR 807.92)
SCIENTIA VASCULAR LLC
Aristotle 18 Guidewire
| 510(k) Sponsor: | Scientia Vascular LLC
3487 West 2100 South Suite 100
West Valley City, UT 84119
Tel: (775) 657-6330 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Sabodski, Director of Quality Assurance
Tel: 801.573.5897
E-mail: dsabodski@scientiavascular.com |
| Date Prepared: | March 11, 2019 |
| Prepared by: | Ryan O'Callaghan, MS, RAC
Phil Triolo and Associates LC
Tel: 801.699.9846
Fax: 801.328.2399
E-mail: ryano@philt.com |
| Trade Name: | Aristotle 18 Guidewire |
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Primary Product Code: | MOF |
| Secondary Product Code: | DQX |
| Predicate Device: | Aristotle 14 Guidewire (K173235) |
4
Scientia Vascular LLC Traditional 510(k) Aristotle 18 Guidewire
DEVICE DESCRIPTION
The Aristotle 18 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.018" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The Aristotle 18 Guidewire is substantially equivalent with respect to technological characteristics, indications for use, design and materials to the previously cleared Aristotle 14 Guidewire.
INTENDED USE/INDICATIONS FOR USE
The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
TECHNOLOGICAL CHARACTERISTICS
The Aristotle 18 Guidewire has the following similarities to the previously cleared Aristotle 14 Guidewire:
- Both devices have the same indicated use,
- Both devices use the same operating principle, ●
- Both devices incorporate the same basic guidewire design, ●
- Both devices incorporate the same materials, and ●
- Both devices are packaged and sterilized using the same materials and processes. .
5
| Comparison between Subject & Predicate Device Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Subject Device | ||
| Aristotle 18 Guidewire | Predicate | ||
| Aristotle 14 Guidewire | |||
| (K173235) | Comparison | ||
| Anatomical | |||
| Location | Neuro and peripheral | ||
| vasculature | Neuro and peripheral | ||
| vasculature | Same | ||
| Dimensions | O.D.: 0.018" (0.46mm) | ||
| Length: 200cm | O.D.: 0.014" (0.36mm) | ||
| Length: 200cm to 300cm | |||
| range | The diameter of the | ||
| subject device is | |||
| larger than the | |||
| diameter of the | |||
| predicate device | |||
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | Shapeable | ||
| Length: 35cm | |||
| Material: Nitinol | Shapeable | ||
| Length: 35cm | |||
| Material: Nitinol | Same | ||
| Stiffness Profiles | Range from support (stiff), | ||
| standard (middle) to soft | |||
| (flex) | Range from support (stiff) | ||
| to soft (flex) | Equivalent | ||
| Coatings | Distal End: Hydrophilic | ||
| Proximal End: PTFE | Distal End: Hydrophilic | ||
| Proximal End: PTFE | Equivalent | ||
| Radiopaque | |||
| Marker | 1 radiopaque marker at | ||
| distal tip | 1 radiopaque marker at | ||
| distal tip | Same | ||
| Centering Coil | 1 stainless steel centering | ||
| coil | None | The subject device | |
| includes a centering | |||
| coil component that | |||
| is not included in | |||
| the predicate | |||
| device. | |||
| Comparison between Subject & Predicate Device Technological Characteristics | |||
| Characteristic | Subject Device | ||
| Aristotle 18 Guidewire | Predicate | ||
| Aristotle 14 Guidewire | |||
| (K173235) | Comparison | ||
| Introducer | |||
| (Accessory) | Provided with each | ||
| guidewire | Provided with each | ||
| guidewire | Equivalent | ||
| Torque Device | |||
| (Accessory) | Provided with each | ||
| guidewire | Provided with each | ||
| guidewire | Same | ||
| Sterilization | |||
| Method | 100% Ethylene Oxide | ||
| (EO) | 100% Ethylene Oxide | ||
| (EO) | Same |
6
The two differences between Aristotle 18 Guidewire and Aristotle 14 Guidewire is in the outer dimensions and the addition of a centering coil. The outer dimension of the Aristotle 18 Guidewire is 0.018" whereas the outer dimension of the Aristotle 14 Guidewires is 0.014". A centering coil made of stainless steel is added to the Aristotle 18 Guidewire whereas the Aristotle 14 Guidewire does not have a centering coil. However, the core wire and the centering coil are made from the same stainless steel material. Thus, no new materials were added to the Aristotle 18 Guidewire that were not present in the Aristotle 14.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
The materials used in the manufacture of the subject Aristotle 18 Guidewire are identical to those used in the manufacture of the Aristotle 14 Guidewire also manufactured by Scientia Vascular LLC, cleared January 22, 2018 after review of K173235; in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).
Due to the increased diameter of the subject device compared to the predicate device and the risk assessment of these design differences, new biocompatibility testing was conducted including an in vitro blood flow loop thrombogenicity study, MEM elution, toxicological risk assessment, ASTM hemolysis (direct contact), ASTM hemolysis (extract), partial thromboplastin time (PTT), and complement activation to establish that the increased surface area of the Aristotle 18 Guidewire would not result in an increased thrombogenic potential compared to the Aristotle 14 Guidewire predicate device. and further demonstrate the biocompatibility profile of the subject device is equivalent to the predicate device.
7
Scientia Vascular LLC Traditional 510(k) Aristotle 18 Guidewire
Sterilization
100% EO is used to sterilize the device to achieve a SAL of at least 10-9. The device was adopted into an EO sterilization processing group in accordance with AAMI TIR 28:2016. Completion of the review performed to the requirements of AAMI TIR 28:2016 indicate the Aristotle 18 and the Aristotle 14 are similar with regards to all device and packaging characteristics that could affect the ability to sterilize the devices.
Functional Testing
Performance testing on the subject device was performed after conducting a risk assessment in accordance with EN ISO 14971:2012 Medical Devices – Risk Management. Functional testing was performed in accordance with ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires and the FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (January 1995). The following table summarizes the functional tests performed and test results obtained to demonstrate substantial equivalence to the predicate device:
| Summaries of Functional Tests Conducted to Support this Premarket Notification
| for the Modified (Subject) Device, Aristotle 18 Guidewire | |||
|---|---|---|---|
| Test | Test Method Summary | Results | |
| Visual | |||
| Inspection | Tests per ISO 11070: | ||
| Visual inspection for extraneous | |||
| matter, process and surface defects | |||
| or defects that may cause trauma | |||
| to vessels during use. | No extraneous matter, surface | ||
| defects or visible droplets of coating | |||
| are present on the Aristotle 18 | |||
| Guidewires | |||
| Dimensional | |||
| Verification | Tests per ISO 11070: | ||
| Dimensional inspection per | |||
| engineering drawings. | All Aristotle 18 guidewires met | ||
| dimensional specifications. | |||
| Tensile | |||
| Strength | Tensile testing per ISO 11070. | All Aristotle 18 guidewires meet | |
| minimum force breakage | |||
| requirements specified in ISO |
-
| |
| Flexing Test | Tests per ISO 11070:
Inspection for defects and damage
or flaking of the coating after
flexing. | No defects or damage / flaking of
the coating were observed after
flexing. | |
| Fracture | Tests per ISO 11070:
Inspection for fracture, loosening,
or failure after wrapping around
mandrel. | No Aristotle 18 guidewires showed
signs of fracture, loosening, or
failure after wrapping them 8 times
around a mandrel. | |
| Summaries of Functional Tests Conducted to Support this Premarket Notification
for the Modified (Subject) Device, Aristotle 18 Guidewire | | | |
| Test | Test Method Summary | Results | |
| Torqueability | Measurement of torque response
(average input to output lag) in an
anatomical model. | All Aristotle 18 guidewires
demonstrated acceptable torque
responses. The torque response of
the subject device was comparable
to that of the predicate device. | |
| Torque
Strength | Torque turns to failure in an
anatomical model. | All Aristotle 18 guidewires
demonstrated acceptable torque
strength. The torque strength of the
subject device was comparable to
that of the predicate device. | |
| Tip
Flexibility | Measure force to deflect guidewire
tips to 45 and 90 degrees at 5mm,
10mm, and 20mm test lengths. | The forces required to deflect the
Aristotle 18 guidewire tips were
acceptable. The flexibility of the
tips of all subject devices was
comparable to the tip flexibility of
the predicate guidewire. | |
| Tip Shape,
Retention | Guidewires must be shapeable and
must retain shaped angle after
simulated use. | All tips met shaping and shape
retention requirements after
simulated use. | |
| Particulate | Particulates of various size ranges
counted after simulated use in a
tortuous path. | A comparable number of
particulates was recovered from
subject and predicate device
following simulated use. | |
| Coating
Lubricity and
Durability | Frictional force of coated
guidewires was determined after
simulated use in a tortuous path. | All Aristotle 18 guidewires met
specified frictional force
requirements. | |
| Summaries of Functional Tests Conducted to Support this Premarket Notification
for the Modified (Subject) Device, Aristotle 18 Guidewire | | | |
| Test | Test Method Summary | Results | |
| Coating
Integrity | Coating uniformity and integrity
visually examined on dyed
samples after simulated use in a
tortuous path. | All Aristotle 18 guidewires showed
acceptable coating coverage after
simulated use. | |
| Simulated
Use Model
Testing and
Product
Compatibility | Anatomical model designed to
simulate the tortuous anatomy of
the neurovasculature used for
simulated use testing. | Aristotle 18 Guidewires and
predicate devices were found to
perform acceptably in evaluations
of: Torqueability in tortuous
vasculature, Lubricity,
Microcatheter Support & Tracking,
Compatibility with Introducer,
Compatibility with Torque Device,
and Compatibility with
Microcatheter. | |
| Usability
Evaluation | Physicians evaluated subject and
predicate guidewires for various
performance characteristics in a
human cadaver. | Subject and predicate guidewires
both exhibited acceptable
performance. | |
| Radiopacity | Subject and predicate guidewires
evaluated by physicians during
simulated use in a human cadaver. | Both subject and predicate
guidewires exhibited acceptable
radiopacity. | |
| Summaries of Functional Tests Conducted to Support this Premarket Notification
for the Modified (Subject) Device, Aristotle 18 Guidewire | | | |
| Test | Test Method Summary | Results | |
| Corrosion
Resistance | Test for corrosion resistance per
ISO 11070. | There were no signs of corrosion on
guidewires after soaking in typical
end-use solutions. | |
| Compatibility
with Agents | Guidewires were exposed to
saline, contrast agents, and DMSO
and then examined for
degradation. | All Aristotle 18 guidewires showed
no signs of degradation, corrosion
or physical decomposition after
exposure. | |
| Packaging | Simulated transportation test per
ASTM D 4169:16. | Following exposure to typical
storage and transportation
conditions, product remained
secured and labeling remained
affixed and legible. | |
8
9
10
CONCLUSION:
Scientia Vascular, LLC has presented information in this premarket notification supporting its contention that the Aristotle 18 Guidewire is substantially equivalent with respect to technological characteristics and indications for use to the predicate device.