(29 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No.
The device is a guidewire intended to introduce and position other interventional devices, not to provide therapy itself.
No
Explanation: The Intended Use/Indications for Use states that the guidewires are "to introduce and position catheters and other interventional devices," clearly indicating an interventional or therapeutic purpose, not a diagnostic one.
No
The device description clearly outlines physical components like guidewires, radiopaque markers, coatings, and accessory kits, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guidewire is for "general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices." This describes a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire with coatings and accessories for manipulation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing procedures.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guidewire does not fit that description.
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 device is not intended for use in the coronary vasculature.
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 Scientia Vascular's Aristotle 18 Guidewire and Aristotle 24 Guidewire are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only, in the following diameters, stiffness profiles, and lengths:
Aristotle 18 Guidewire
Diameter: 0.018"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm
Aristotle 24 Guidewire
Diameter: 0.024"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm
The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have 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 guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires 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 vasculatures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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: Biocompatibility testing was conducted for the reference devices (K222347, K173235). These results support the biocompatibility of the subject devices because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices. The evaluation supports that the subject device with its accessories meets biological safety requirements per ISO 10993-1:2018 for externally communicating medical devices with circulating blood contact for a limited duration (less than 24 hours).
Sterilization: The subject devices have been adopted into a validated sterilization cycle that uses 100% EO to achieve a sterilization assurance level (SAL) of 10-6.
Bench Performance Testing: The bench performance testing conducted for the reference devices (K222347, K173235) and the predicate 200 cm long models of the subject guidewires cleared under K183608 and K192783, support the performance of the subject devices (300 cm) because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices.
Following the risk assessments conducted in accordance with ISO 14971, no additional testing was deemed necessary to support the substantial equivalence of the subject device models.
Animal Testing: No animal testing was deemed necessary to support the substantial equivalence of the subject devices.
Clinical Testing: No clinical testing was deemed necessary to support the substantial equivalence of the subject devices.
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), Aristotle 24 Guidewire (K192783)
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.
Aristotle Colossus Guidewire (K222437), Aristotle 14 Guidewire (K173235)
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
August 1, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Scientia Vascular, Inc. Bailey Johannsen Regulatory Affairs Specialist 3487 West 2100 South, Suite 100 West Valley City, Utah 84119
Re: K231954
Trade/Device Name: Aristotle 18 Guidewire: Aristotle 24 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: June 30, 2023 Received: July 3, 2023
Dear Bailey Johannsen:
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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director 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) K231954
Device Name Aristotle 18 Guidewire: Aristotle 24 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 device is not intended for use in the coronary vasculature.
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, teal-colored symbol resembling an infinity loop or a stylized "S" shape. Below the symbol, the word "SCIENTIA" is written in a futuristic, sans-serif font, with the letters having rounded edges and a slightly blocky appearance.
K231954 510(k) SUMMARY
| 510(k) Sponsor: | Scientia Vascular, Inc. |
|---|---|
| 3487 West 2100 South, Suite 100 | |
| West Valley City, UT 84119 | |
| Tel (888) 385-9016 | |
| Contact Person(s): | Bailey Johannsen |
| Regulatory Affairs Specialist | |
| Tel: (888) 385-9016 | |
| E-mail: regulatory@scientiavascular.com | |
| Date Prepared: | July 28, 2023 |
4
Table 1. Subject Device Information
| Aristotle 18 Guidewire | |
|---|---|
| Trade Name: | Aristotle 18 Guidewire |
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Primary Product Code: | MOF |
| Subsequent Product Code: | DQX |
| Predicate Device: | Aristotle 18 Guidewire (K183608) |
| Reference Device: | Aristotle Colossus Guidewire (K222437) |
| Reference Device: | Aristotle 14 Guidewire (K173235) |
| Aristotle 24 Guidewire | |
| 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 24 Guidewire (K192783) |
| Reference Device: | Aristotle Colossus Guidewire (K222437) |
5
DEVICE DESCRIPTION
The Scientia Vascular's Aristotle 18 Guidewire and Aristotle 24 Guidewire are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only, in the following diameters, stiffness profiles, and lengths:
| Aristotle 18 Guidewire | |
|---|---|
| Diameter | 0.018" |
| Stiffness Profiles | Soft, Standard, Support |
| Length | 200 cm, 300 cm |
| Aristotle 24 Guidewire | |
| Diameter | 0.024" |
| Stiffness Profiles | Soft, Standard, Support |
| Length | 200 cm, 300 cm |
The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have 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 guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.
6
INDICATIONS FOR USE
Aristotle 18 Guidewire
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.
Aristotle 24 Guidewire
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.
The indications for use of the subject Aristotle 18 Guidewire and Aristotle 24 Guidewire are the same as in prior, predicate submissions for the Aristotle 18 Guidewire (K183608) and Aristotle 24 Guidewire (K192783), respectively.
7
Scientia Vascular, Inc. Special 510(k)
INTENDED USE
The Aristotle 18 Guidewire and Aristotle 24 Guidewire are intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject devices have the following similarities to the previously cleared predicate devices:
- The same indications for use, ●
- The same intended use,
- The same operating principle,
- The same basic guidewire design,
- The same materials, and ●
- The same packaging materials and sterilization processes. ●
The tables (Table 2 and Table 3) below provide additional details on the technological characteristics of the subject devices compared to their respective predicate and reference devices.
8
| Characteristic | Subject Device
Aristotle 18
Guidewire | Predicate
Aristotle 18
Guidewire (K183608) | Reference Device
Aristotle Colossus
Guidewire (K222437) | Reference Device
Aristotle 14
Guidewire (K173235) |
|-------------------------------------|---------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------|
| Anatomical
Location | Same | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature |
| Dimensions | O.D.: 0.018" (0.46mm)
Length: 200cm,
300cm | O.D.: 0.018" (0.46mm)
Length: 200cm | O.D.: 0.035" (0.88mm)
Length: 150cm –
300cm | O.D.: 0.014" (0.36mm)
Length: 200cm,
300cm |
| Core Wire | Same | Stainless Steel | Stainless Steel | Stainless Steel |
| Distal Tip | Same | Shapeable
Length: 35cm
Material: Nitinol | Shapeable
Length: 35cm
Material: Nitinol | Shapeable
Length: 35cm
Material: Nitinol |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Standard | Soft, standard |
| Coatings | Same | Distal End: Hydrophilic
Proximal End: PTFE | Distal End: Hydrophilic
Proximal End: PTFE | Distal End: Hydrophilic
Proximal End: PTFE |
| Radiopaque Marker | Same | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip |
| Centering Coil | Same | Stainless steel | Stainless steel | Stainless steel |
| Centering Washer | Does not contain a
washer | Does not contain a
washer | Stainless steel | Does not contain a
washer |
| Bushing | Does not contain
bushing | Does not contain
bushing | Nitinol Bushing | Does not contain
bushing |
| Shaping Mandrel
(Accessory) | Same | Provided with each
guidewire | Provided with each
guidewire | Provided with each
guidewire |
| Guidewire Introducer
(Accessory) | Same | Provided with each
guidewire | Provided with each
guidewire | Provided with each
guidewire |
| Torque Device
(Accessory) | Same | Provided with each
guidewire | Provided with each
guidewire | Provided with each
guidewire |
| Sterilization Method | Same | 100% Ethylene Oxide
(EO) | 100% EO | 100% EO |
| Shelf Life | 36 Months | 36 Months | 12 Months | 12 Months |
| Characteristic | Subject Device
Aristotle 24
Guidewire | Predicate
Aristotle 24
Guidewire (K192783) | Reference Device
Aristotle Colossus
Guidewire (K222437) | Reference Device
Aristotle 14
Guidewire (K173235) |
| Anatomical
Location | Same | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature |
| Dimensions | O.D.: 0.024" (0.61mm)
Length: 200cm,
300cm | O.D.: 0.024" (0.61mm)
Length: 200cm | O.D.: 0.035" (0.88mm)
Length: 150cm –
300cm | O.D.: 0.014" (0.36mm)
Length: 200cm,
300cm |
| Core Wire | Same | Stainless Steel | Stainless Steel | Stainless Steel |
| Distal Tip | Same | Shapeable
Length: 35cm
Material: Nitinol | Shapeable
Length: 35cm
Material: Nitinol | Shapeable
Length: 35cm
Material: Nitinol |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Standard | Soft, standard |
| Coatings | Same | Distal End: Hydrophilic
Proximal End: PTFE | Distal End: Hydrophilic
Proximal End: PTFE | Distal End: Hydrophilic
Proximal End: PTFE |
| Radiopaque Marker | Same | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip |
| Centering Coil | Same | Stainless steel | Stainless steel | Stainless steel |
| Centering Washer | Does not contain a
washer | Does not contain a
washer | Stainless steel | Does not contain a
washer |
| Bushing | Nitinol bushing | Nitinol bushing | Nitinol bushing | Does not contain
bushing |
| Shaping Mandrel
(Accessory) | Same | Provided with each
guidewire | Provided with each
guidewire | Provided with each
guidewire |
| Guidewire Introducer
(Accessory) | Same | Provided with each
guidewire | Provided with each
guidewire | Provided with each
guidewire |
| Torque Device
(Accessory) | Same | Provided with each
guidewire | Provided with each
guidewire | Provided with each
guidewire |
| Sterilization Method | Same | 100% EO | 100% EO | 100% EO |
| Shelf Life | 36 Months | 36 Months | 12 Months | 12 Months |
Table 2. Aristotle 18 Guidewire Technological Characteristics Comparison (Differences are Bolded)
9
Table 3. Aristotle 24 Guidewire Technological Characteristics Comparison (Differences are Bolded)
10
The Aristotle 18 Guidewire and Aristotle 24 Guidewire have been modified to include additional models of longer length with added 100 cm of proximally PTFE coated guidewire for a total guidewire length of 300 cm. The Aristotle 24 Guidewires have been previously cleared with a total guidewire length of 200 cm in K183608 and K192783, respectively. This additional length does not impact any features or dimensions at the distal end of the guidewire and does not raise new questions of safety and effectiveness.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
Biocompatibility testing was conducted for the reference devices (K222347, K173235). These results support the biocompatibility of the subject devices because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices. The evaluation supports that the subject device with its accessories meets biological safety requirements per ISO 10993-1:2018 for externally communicating medical devices with circulating blood contact for a limited duration (less than 24 hours).
Sterilization
The subject devices have been adopted into a validated sterilization cycle that uses 100% EO to achieve a sterilization assurance level (SAL) of 10-6.
Bench Performance Testing
The bench performance testing conducted for the reference devices (K222347, K173235) and the predicate 200 cm long models of the subject guidewires cleared under K183608 and K192783, support the performance of the subject devices (300 cm) because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices.
Following the risk assessments conducted in accordance with ISO 14971, no additional testing was deemed necessary to support the substantial equivalence of the subject device models.
Animal Testing
No animal testing was deemed necessary to support the substantial equivalence of the subject devices.
Clinical Testing
No clinical testing was deemed necessary to support the substantial equivalence of the subject devices.
11
CONCLUSION
The Aristotle 18 Guidewire and Aristotle 24 Guidewire have the same intended use and indications for use statement as their respective predicate devices. The identified technological difference does not raise new questions of safety or effectiveness regarding the use of the subject devices. Risk evaluation was completed for the subject devices. The risk evaluation and testing of the predicate and reference devices demonstrate that the subject devices are substantially equivalent to their respective predicate devices.