(30 days)
Not Found
No
The 510(k) summary describes a physical medical device (a guidewire) and its accessories. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The description focuses on the physical characteristics, materials, and functional performance of the guidewire.
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 interventional devices, not to diagnose a condition. Its function is purely interventional according to the "Intended Use / Indications for Use" section.
No
The device description clearly details a physical guidewire with various material components, coatings, and accessories, indicating it is a hardware medical device, not software-only.
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.
- Device Description and Intended Use: The Aristotle 24 Guidewire is a physical device intended to be inserted directly into the patient's vasculature to facilitate the introduction and positioning of other devices. It is used within the body, not to test samples from the body.
The description clearly indicates it's an interventional device used during medical procedures, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MOF, DQX
Device Description
The Aristotle 24 Guidewire is a modification of Scientia Vascular's Aristotle 18 Guidewire. It is a 0.024" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The Aristotle 24 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to the previously cleared Aristotle 18 Guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral vasculatures
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)
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
The materials used in the manufacture of the subject device Aristotle 24 Guidewire are identical to those used in the manufacturing of the predicate device Aristotle 18 Guidewire also manufactured by Scientia Vascular LLC, cleared March 22, 2019 after review of K183608. Biocompatibility testing was completed for the Aristotle 24 and consisted of the following tests:
- In-vitro Blood Flow Thrombogenicity Study
- MEM elution
- Toxicological risk assessment
- ASTM Hemolysis (direct contact and extract)
- Partial Thromboplasting Time, and
- Compliment Activation
Sterilization
100% EO is used to sterilize the device to achieve a SAL of at least 10-6. The device was adopted into an EO sterilization processing group in accordance with AAMI TIR 28:2016. Completion of the review performed to the requirements of AAMI TIR 28:2016 indicate the Aristotle 24 and the Aristotle 18 are similar with regards to all device and packaging characteristics that could affect the ability to sterilize the devices.
Functional Testing
Performance testing on the subject device was performed after conducting a risk assessment in accordance with EN ISO 14971:2012 Medical Devices – Risk Management. Functional testing was performed in accordance with ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires and the FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (January 1995).
Summary of Functional Tests Conducted to Support this Premarket Notification for the Modified (Subject) Device, Aristotle 24 Guidewire:
- Dimensional Verification: Tests per ISO 11070: Dimensional inspection per engineering drawings.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Tensile Strength: Tensile testing per ISO 11070.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Flexing Test: Tests per ISO 11070: Inspection for defects and damage or flaking of the coating after flexing.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Fracture: Tests per ISO 11070: Inspection for fracture, loosening, or failure after wrapping around mandrel.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Torqueability: Measurement of torque response (average input to output lag) in an anatomical model.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Torque Strength: Torque turns to failure in an anatomical model.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Tip Flexibility: Measure force to deflect guidewire tips to 45 and 90 degrees at 5mm, 10mm, and 20mm test lengths.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Tip Shape, Retention: Guidewires must be shapeable and must retain shaped angle after simulated use.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Particulate: Particulates of various size ranges counted after simulated use in a tortuous path.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Coating Lubricity and Durability: Frictional force of coated guidewires was determined after simulated use in a tortuous path.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Coating Integrity: Coating uniformity and integrity visually examined on dyed samples after simulated use in a tortuous path.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Simulated Use Model Testing and Product Compatibility: Anatomical model designed to simulate the tortuous anatomy of the neurovasculature used for simulated use testing.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
- Usability Evaluation: Physicians evaluated subject and predicate guidewires for various performance characteristics in a human cadaver.
- Results: The Aristotle 24 Guidewires met testing acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aristotle 18 Guidewire (K183608)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2019
Scientia Vascular LLC Amy McManus Regulatory Affairs Manager 3487 West 2100 South, Suite 100 West Valley City, Utah 84119
Re: K192783
Device Name: Aristotle 24 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: September 24, 2019 Received: September 30, 2019
Dear Amy McManus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng, Ph.D. Director (Acting) DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192783
Device Name Aristotle 24 Guidewire
Indications for Use (Describe)
The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
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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3
Image /page/3/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized blue symbol above the word "SCIENTIA" in a sans-serif font. The symbol is made up of two curved lines that are parallel to each other and form an S shape. The word "SCIENTIA" is in all caps and is in a light gray color.
510(K) SUMMARY
(PER 21 CFR 807.92)
SCIENTIA VASCULAR LLC
Special 510(K): Device Modification Aristotle 24 Guidewire
| 510(k) Sponsor: | Scientia Vascular LLC
3487 West 2100 South Suite 100
West Valley City, UT 84119
Tel: (888) 385.9016 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amy McManus,
Regulatory Affairs Manager
Tel: (888) 385.9016
E-mail: amcmanus@scientiavascular.com |
| Date Prepared: | September 13, 2019 |
Subject Device Information:
| Trade Name: | Aristotle 24 Guidewire |
|---|---|
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Primary Product Code: | MOF |
| Secondary Product Code: | DQX |
| Predicate Device: | Aristotle 18 Guidewire (K183608) |
4
DEVICE DESCRIPTION
The Aristotle 24 Guidewire is a modification of Scientia Vascular's Aristotle 18 Guidewire. It is a 0.024" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The Aristotle 24 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to the previously cleared Aristotle 18 Guidewire.
INDICATION FOR USE
The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
This is the same indication for use as previously cleared for the Aristotle 18 Guidewire, K183608.
INTENDED USE
The Aristotle 24 Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature.
TECHNOLOGICAL CHARACTERISTICS
The Aristotle 24 Guidewire has the following similarities to the previously cleared Aristotle 18 Guidewire:
- Both devices have the same indicated use, .
- Both devices have the same intended use ●
- Both devices use the same operating principle,
- Both devices incorporate the same basic guidewire design, ●
- Both devices incorporate the same materials, and ●
5
- Both devices are packaged and sterilized using the same materials and processes.
The technological characteristic comparison of the subject and predicate device is summarized in Table 1 below.
| Table 1:Comparison between Subject & Predicate Device Technological Characteristics:
| Note: Areas of difference will be indicated in RED | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | |||
| Aristotle 24 Guidewire | Predicate | |||
| Aristotle 18 Guidewire (K183608) | ||||
| Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | ||
| Dimensions | Max O.D.: 0.024" (0.61mm) | |||
| Length: 200cm | Max O.D.: 0.018" (0.46mm) | |||
| Length: 200cm | ||||
| Core Wire | Stainless Steel | Stainless Steel | ||
| Distal Tip | Shapeable | |||
| Length: 35cm | ||||
| Material: Nitinol | Shapeable | |||
| Length: 35cm | ||||
| Material: Nitinol | ||||
| Stiffness Profiles | Range from support (stiff), standard | |||
| (middle) to soft (flex) | Range from support (stiff), standard | |||
| (middle) to soft (flex) | ||||
| Coatings | Distal End: Hydrophilic | |||
| Proximal End: PTFE | Distal End: Hydrophilic | |||
| Proximal End: PTFE | ||||
| Radiopaque Marker | Radiopaque marker at distal tip | Radiopaque marker at distal tip | ||
| Centering Coil | Two (2) Centering coil | One (1) Centering coil | ||
| Bushing | One | None | ||
| Shaping Mandrel | ||||
| (Accessory) | Provided with each guidewire | Provided with each guidewire | ||
| Guidewire Introducer | ||||
| (Accessory) | Provided with each guidewire | Provided with each guidewire | ||
| Torque Device | ||||
| (Accessory) | Provided with each guidewire | Provided with each guidewire | ||
| Sterilization Method | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) |
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The subject device, Aristotle 24, has three technological characteristic differences when compared to the predicate device. The changes in technological characterists do not result in new materials used or new questions of safety or effectiveness, nor do they result in new risks for the subject device. Testing of the subject device has been performed, demonstrating the safety and effectiveness of the device.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
The materials used in the manufacture of the subject device Aristotle 24 Guidewire are identical to those used in the manufacturing of the predicate device Aristotle 18 Guidewire also manufactured by Scientia Vascular LLC, cleared March 22, 2019 after review of K183608. Biocompatibility testing was completed for the Aristotle 24 and consisted of the following tests:
- In-vitro Blood Flow Thrombogenicity Study
- MEM elution ●
- Toxicological risk assessment
- ASTM Hemolysis (direct contact and extract) ●
- Partial Thromboplasting Time, and .
- Compliment Activation
Sterilization
100% EO is used to sterilize the device to achieve a SAL of at least 10-6. The device was adopted into an EO sterilization processing group in accordance with AAMI TIR 28:2016. Completion of the review performed to the requirements of AAMI TIR 28:2016 indicate the Aristotle 24 and the Aristotle 18 are similar with regards to all device and packaging characteristics that could affect the ability to sterilize the devices.
Functional Testing
Performance testing on the subject device was performed after conducting a risk assessment in accordance with EN ISO 14971:2012 Medical Devices – Risk Management. Functional testing was performed in accordance with ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires and the FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (January 1995). Table 2 summarizes the functional tests performed and test results obtained to demonstrate substantial equivalence to the predicate device:
7
| Table 2:Summaries of Functional Tests Conducted to Support this Premarket Notification | ||
|---|---|---|
| for the Modified (Subject) Device, Aristotle 24 Guidewire | ||
| Test | Test Method Summary | Results |
| Dimensional | ||
| Verification | Tests per ISO 11070: | |
| Dimensional inspection per engineering | ||
| drawings. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria. | ||
| Tensile Strength | Tensile testing per ISO 11070. | The Aristotle 24 Guidewires met |
| testing acceptance criteria | ||
| Flexing Test | Tests per ISO 11070: | |
| Inspection for defects and damage or flaking | ||
| of the coating after flexing. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Fracture | Tests per ISO 11070: | |
| Inspection for fracture, loosening, or failure | ||
| after wrapping around mandrel. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Torqueability | Measurement of torque response (average | |
| input to output lag) in an anatomical model. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Torque Strength | Torque turns to failure in an anatomical | |
| model. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Tip Flexibility | Measure force to deflect guidewire tips to | |
| 45 and 90 degrees at 5mm, 10mm, and | ||
| 20mm test lengths. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Tip Shape, | ||
| Retention | Guidewires must be shapeable and must | |
| retain shaped angle after simulated use. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Particulate | Particulates of various size ranges counted | |
| after simulated use in a tortuous path. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Coating Lubricity | ||
| and Durability | Frictional force of coated guidewires was | |
| determined after simulated use in a tortuous | ||
| path. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Coating Integrity | Coating uniformity and integrity visually | |
| examined on dyed samples after simulated | ||
| use in a tortuous path. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Simulated Use | ||
| Model Testing | ||
| and Product | ||
| Compatibility | Anatomical model designed to simulate the | |
| tortuous anatomy of the neurovasculature | ||
| used for simulated use testing | The Aristotle 24 Guidewires met | |
| testing acceptance criteria | ||
| Usability | ||
| Evaluation | Physicians evaluated subject and predicate | |
| guidewires for various performance | ||
| characteristics in a human cadaver. | The Aristotle 24 Guidewires met | |
| testing acceptance criteria |
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CONCLUSION:
Scientia Vascular, LLC has presented information in this premarket notification supporting the Aristotle 24 Guidewire is substantially equivalent with respect to technological characteristics and indications for use to the predicate device.