(29 days)
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.
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.
The provided text is a 510(k) summary for the Aristotle 18 Guidewire and Aristotle 24 Guidewire. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with a defined test set and ground truth.
Therefore, many of the requested details about acceptance criteria, test set, expert adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device clearances or more complex clinical effectiveness studies) are not applicable to this 510(k) submission.
This submission relies on:
- Similarities in indications for use, intended use, operating principles, design, materials, packaging, and sterilization processes to predicate devices.
- Bench testing data from predicate/reference devices to support the performance of the new models, particularly noting that the added length (100 cm) is at the proximal end and does not impact the distal end's features or dimensions.
- Biocompatibility and sterilization data from reference devices which are deemed applicable due to material and process commonality.
- A risk assessment (ISO 14971) concluding that no new questions of safety or effectiveness are raised and no additional testing is necessary.
Since this is a guidewire, the "performance" typically refers to physical characteristics rather than diagnostic accuracy like an AI/ML product.
Here's a breakdown based on the information provided, highlighting what is and is not present:
1. Table of acceptance criteria and the reported device performance
No explicit acceptance criteria table is provided as this is a substantial equivalence claim, not a de novo or PMA where specific performance targets might be set and then measured against. The "performance" is implicitly demonstrated through the similarity to predicate devices and the lack of new safety/effectiveness concerns due to the minor modification (increased length at the proximal end).
The document states:
- "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 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."
2. Sample size used for the test set and the data provenance
- No specific "test set" in the context of an AI/ML model for diagnostic accuracy is described. The studies referenced are bench performance testing, biocompatibility, and sterilization, which are standard for guidewire manufacturing and safety.
- The provenance of data for the bench testing and biocompatibility is not explicitly stated (e.g., country of origin) but would typically be from the manufacturer's internal testing.
- The studies were retrospective in the sense that they relied on pre-existing data from predicate and reference devices (K222347, K173235, K183608, K192783) and did not generate new clinical data for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission does not involve diagnostic interpretation or human reader performance, so there's no "ground truth" establishment by experts in the sense of image annotation or disease diagnosis. The "ground truth" for guidewire performance comes from engineering specifications and bench testing.
4. Adjudication method for the test set
- Not applicable. No human adjudication of results is mentioned or required for this type of device and submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a guidewire, a physical medical instrument, not an AI/ML diagnostic or image-assisted tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a guidewire, not an algorithm.
7. The type of ground truth used
- For the performance assessment, the "ground truth" for the guidewire's characteristics (e.g., diameter, stiffness, coating, radiopacity) is based on engineering specifications, material science properties, and established bench testing methods to ensure the physical device meets its design intent and functions as expected within the vasculature. This is not a "ground truth" in terms of disease presence or absence like in diagnostic studies.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth to establish for this type of device.
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August 1, 2023
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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
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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
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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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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 |
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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) |
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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.
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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.
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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.
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| Characteristic | Subject DeviceAristotle 18Guidewire | PredicateAristotle 18Guidewire (K183608) | Reference DeviceAristotle ColossusGuidewire (K222437) | Reference DeviceAristotle 14Guidewire (K173235) |
|---|---|---|---|---|
| AnatomicalLocation | Same | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Neuro and peripheralvasculature |
| 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 | ShapeableLength: 35cmMaterial: Nitinol | ShapeableLength: 35cmMaterial: Nitinol | ShapeableLength: 35cmMaterial: Nitinol |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Standard | Soft, standard |
| Coatings | Same | Distal End: HydrophilicProximal End: PTFE | Distal End: HydrophilicProximal End: PTFE | Distal End: HydrophilicProximal End: PTFE |
| Radiopaque Marker | Same | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip |
| Centering Coil | Same | Stainless steel | Stainless steel | Stainless steel |
| Centering Washer | Does not contain awasher | Does not contain awasher | Stainless steel | Does not contain awasher |
| Bushing | Does not containbushing | Does not containbushing | Nitinol Bushing | Does not containbushing |
| Shaping Mandrel(Accessory) | Same | Provided with eachguidewire | Provided with eachguidewire | Provided with eachguidewire |
| Guidewire Introducer(Accessory) | Same | Provided with eachguidewire | Provided with eachguidewire | Provided with eachguidewire |
| Torque Device(Accessory) | Same | Provided with eachguidewire | Provided with eachguidewire | Provided with eachguidewire |
| Sterilization Method | Same | 100% Ethylene Oxide(EO) | 100% EO | 100% EO |
| Shelf Life | 36 Months | 36 Months | 12 Months | 12 Months |
| Characteristic | Subject DeviceAristotle 24Guidewire | PredicateAristotle 24Guidewire (K192783) | Reference DeviceAristotle ColossusGuidewire (K222437) | Reference DeviceAristotle 14Guidewire (K173235) |
| AnatomicalLocation | Same | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Neuro and peripheralvasculature |
| 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 | ShapeableLength: 35cmMaterial: Nitinol | ShapeableLength: 35cmMaterial: Nitinol | ShapeableLength: 35cmMaterial: Nitinol |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Standard | Soft, standard |
| Coatings | Same | Distal End: HydrophilicProximal End: PTFE | Distal End: HydrophilicProximal End: PTFE | Distal End: HydrophilicProximal End: PTFE |
| Radiopaque Marker | Same | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip |
| Centering Coil | Same | Stainless steel | Stainless steel | Stainless steel |
| Centering Washer | Does not contain awasher | Does not contain awasher | Stainless steel | Does not contain awasher |
| Bushing | Nitinol bushing | Nitinol bushing | Nitinol bushing | Does not containbushing |
| Shaping Mandrel(Accessory) | Same | Provided with eachguidewire | Provided with eachguidewire | Provided with eachguidewire |
| Guidewire Introducer(Accessory) | Same | Provided with eachguidewire | Provided with eachguidewire | Provided with eachguidewire |
| Torque Device(Accessory) | Same | Provided with eachguidewire | Provided with eachguidewire | Provided with eachguidewire |
| 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)
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Table 3. Aristotle 24 Guidewire Technological Characteristics Comparison (Differences are Bolded)
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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.
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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.
§ 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.