(109 days)
Not Found
No
The device description and performance studies focus on the physical properties and functional performance of a guidewire, with no mention of AI or ML capabilities.
No
The device is a guidewire, used to introduce and position other interventional devices, rather than directly treating a condition.
No
The device is a guidewire used to introduce and position other medical devices, not to diagnose a condition. Its function is interventional, not diagnostic.
No
The device description clearly outlines a physical guidewire with specific dimensions, materials, coatings, and accessories (introducer and torque device), indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Aristotle 14 Guidewire Function: The Aristotle 14 Guidewire is a physical tool used inside the body (in vivo) to facilitate the placement of other medical devices within blood vessels. It does not analyze or test any bodily fluids or tissues.
The description clearly states its purpose is to "introduce and position catheters and other interventional devices" within the neuro and peripheral vasculatures. This is a procedural tool, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro and peripheral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
Verified in accordance with ISO 10993-1:2009 and FDA's Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1. Type: External communicating, blood contact, limited duration (
§ 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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Scientia Vascular LLC Traditional 510(k) Aristotle 14 Guidewire
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510(K) SUMMARY (Per 21 CFR 807.92)
SCIENTIA VASCULAR LLC ARISTOTLE 14 GUIDEWIRE
| 510(k) Sponsor: | Scientia Vascular 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: | December 8, 2017 | |
| 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 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 | ||
| Aristotle 14 Guidewire | PVS 1300 Synchro® | ||
| 0.014" Guidewire | |||
| (K032146) | Comparison | ||
| Anatomical | |||
| Location | Neuro and peripheral | ||
| vasculature | Neuro and peripheral | ||
| vasculature | Same | ||
| Dimensions | 0.D.: 0.014" (0.36mm) | ||
| Length: 200cm to 300cm | |||
| range | 0.D.: 0.014" (0.36mm) | ||
| Length: 180cm to 300cm | |||
| range, with 200cm being | |||
| typical | Equivalent | ||
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | Shapeable | ||
| Length: 35cm | |||
| Material: Nitinol | Shapeable | ||
| Length: 25cm to 65cm | |||
| range, with 35 to 45cm | |||
| being typical | |||
| Material: Nitinol | Equivalent | ||
| Stiffness Profiles | Range from support (stiff) | ||
| to flex (soft) | Range from support (stiff) | ||
| to flex (soft) | 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 | ||
| 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) | Currently radiation | ||
| sterilization [devices | |||
| originally cleared were | |||
| sterilized with100% | |||
| Ethylene Oxide (EO)] | Same |
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Scientia Vascular LLC Traditional 510(k) Aristotle 14 Guidewire
Results of tests performed on the new Aristotle 14 Guidewire demonstrate that the new guidewire performs as well as the predicate device and/or meets requirements of relevant standards. Further, any differences in technological characteristics of the Aristotle Guidewires when compared with predicate device characteristics do not raise different questions of safety and effectiveness.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibilitv
Biocompatibility of the Aristotle 14 Guidewire and accessory materials has been verified in accordance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA's Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016.
The results of the following biological and toxicological safety evaluations verified the biocompatibility of the subject device when tested as an external communicating, blood contact, limited duration (,
and USP , using the kinetic
chromogenic method. |