(392 days)
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 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.
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 Volo 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 Zoom Wire 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 Scientia Vascular's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 Guidewires ("the guidewires") 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 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Aristotle 18 Guidewire: Diameter 0.018", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Aristotle 24 Guidewire: Diameter 0.024", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Volo 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Zoom Wire 14 Guidewire: Diameter 0.014", Stiffness Profiles Support, Extra Support, Lengths 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.
This document concerns the 510(k) premarket notification for five guidewires: Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Volo 14 Guidewire, and Zoom Wire 14 Guidewire. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are not explicitly stated as numerical thresholds for performance metrics. Instead, the document indicates that the devices "met acceptance criteria" or "passed" various tests, implying successful adherence to pre-defined standards for each test. The study's focus is on demonstrating similar performance and safety to predicate devices, particularly given a change in the PTFE coating.
| Test Category | Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Pass: Non-cytotoxic |
| Pyrogenicity | Non-pyrogenic | Pass: Non-pyrogenic | |
| Sensitization | Non-sensitizing | Pass: Non-sensitizing | |
| Irritation | Non-irritant | Pass: Non-irritant | |
| Acute Systemic Toxicity | No evidence of toxicity | Pass: No evidence of acute systemic toxicity | |
| Hemocompatibility | Non-hemolytic | Pass: Non-hemolytic | |
| Complement Activation of SC5b-9 | Similar to comparator device | Pass: The test article complement activation was similar to the comparator device. | |
| Partial Thromboplastin Time | Similar to comparator device | Pass: The test article clotting time was similar to the comparator device. | |
| In Vitro Thrombogenicity | Thromboresistant | Pass: Thromboresistant | |
| Latex Detection | Latex not detected | Pass: Latex was not detected | |
| Sterilization | Sterilization Assurance Level (SAL), EO/ECH residuals, Bacterial Endotoxin Levels | SAL of 10^-6, acceptable residual levels | Achieved SAL of 10^-6, appropriate levels of residuals and endotoxins confirmed (implied from "existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10-"). |
| Bench Performance | Visual Inspection and Dimensional Verification | Met ISO 11070 requirements | Acceptance criteria met |
| Coating Integrity Assessment | Met ISO 11070 and FDA guidance | Acceptance criteria met | |
| Corrosion Resistance | Met ISO 11070 requirements | Acceptance criteria met | |
| Agent Compatibility | Met ISO 11070 requirements | Acceptance criteria met | |
| Simulated Use | Met performance in anatomical model | Acceptance criteria met | |
| Particulate | Acceptable particulate count | Acceptance criteria met |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of guidewires tested for coating integrity). It only mentions that "performance testing was performed on the subject devices" and "testing and evaluation... of the subject devices has been performed".
- Data Provenance: The data provenance is internal to the manufacturer (Scientia Vascular, Inc.) and is prospective testing conducted specifically for this 510(k) submission. There is no mention of country of origin for the data other than it being part of an FDA submission from a U.S.-based company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission pertains to a medical device's physical and biological performance, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. Therefore, these details are not applicable. The "ground truth" for the tests mentioned (biocompatibility, sterilization, bench performance) is based on established, standardized test methods (e.g., ISO standards, FDA guidance documents).
4. Adjudication method for the test set:
- Not applicable, as this is not a diagnostic AI/software study involving human interpretation that requires adjudication of expert opinions. The performance is assessed against objective technical specifications and standards.
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 is not an AI/software device that involves human readers or an AI assistance component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device (guidewire) and does not involve an algorithm or AI.
7. The type of ground truth used:
- The "ground truth" for the various tests conducted is based on:
- Standardized Test Methods: Adherence to defined protocols from ISO 10993 series, ISO 14971:2019, ISO 11070:2014, and FDA guidance documents.
- Objective Measurements: E.g., cell culture observations for cytotoxicity, temperature rise for pyrogenicity, measurement of physical dimensions, observation of material integrity.
- "Pass/Fail" Criteria: Compliance with established thresholds or qualitative assessments as defined by the standard test methods (e.g., "Non-cytotoxic," "Non-hemolytic," "Acceptance criteria met").
8. The sample size for the training set:
- Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/software algorithm.
{0}------------------------------------------------
March 10, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
Scientia Vascular, Inc. Thomas Lippert Regulatory Affairs Associate 3487 West 2100 South Suite 100 West Valley City, Utah 84119
Re: K220398
Trade/Device Name: Aristotle 14 Guidewire: Aristotle 18 Guidewire: Aristotle 24 Guidewire: Volo 14 Guidewire; Zoom Wire 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX, Dated: February 10, 2023 Received: February 10, 2023
Dear Thomas Lippert:
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
{1}------------------------------------------------
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) 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 (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 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) K220398
Device Name
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; 20om Wire 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.
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.
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 Volo 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 Zoom Wire 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) | |
|---|---|
| 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, blue, intertwined "S" shape above the word "SCIENTIA" in a futuristic-looking font. The background is a plain, light color, which makes the blue logo and text stand out.
K220398 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): | Thomas Lippert |
| Bailey Johannsen | |
| Regulatory Affairs Specialist | |
| Tel: (888) 385-9016 | |
| E-mail: regulatory@scientiavascular.com | |
| Date Prepared: | March 9, 2023 |
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Table 1. Subject Device Information
| Aristotle 14 Guidewire | |
|---|---|
| Trade Name: | Aristotle 14 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 14 Guidewire (K173235) |
| 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) |
| 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 |
| Subsequent Product Code | DQX |
| Predicate Device: | Aristotle 24 Guidewire (K192783) |
| Volo 14 Guidewire | |
| Trade Name: | Volo 14 Guidewire |
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Primary Product Code: | MOF |
| Subsequent Product Code | DQX |
| Predicate Device: | Volo 14 Guidewire (K181828) |
| Zoom Wire 14 Guidewire | |
| Trade Name: | Zoom Wire 14 Guidewire |
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Primary Product Code: | MOF |
| Subsequent Product Code | DQX |
| Predicate Device: | Zoom 14 Guidewire (K201760) |
{5}------------------------------------------------
DEVICE DESCRIPTION
The Scientia Vascular's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 Guidewires ("the guidewires") 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 14 Guidewire | |
|---|---|
| Diameter | 0.014" |
| Stiffness Profiles | Soft, Standard |
| Lengths | 200 cm, 300 cm |
| Aristotle 18 Guidewire | |
| Diameter | 0.018" |
| Stiffness Profiles | Soft, Standard, Support |
| Length | 200 cm |
| Aristotle 24 Guidewire | |
| Diameter | 0.024" |
| Stiffness Profiles | Soft, Standard, Support |
| Length | 200 cm |
| Volo 14 Guidewire | |
| Diameter | 0.014" |
| Stiffness Profiles | Soft, Standard |
| Lengths | 200 cm, 300 cm |
| Zoom Wire 14Guidewire | |
| Diameter | 0.014" |
| Stiffness Profiles | Support, Extra Support |
| Lengths | 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 14 Guidewire
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.
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.
Volo 14 Guidewire
The Volo 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.
Zoom Wire 14 Guidewire
The Zoom Wire 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.
{7}------------------------------------------------
Scientia Vascular, Inc. Special 510(k)
INTENDED USE
The guidewires 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 similar materials, and ●
- The same packaging materials and sterilization processes.
The tables (Table 2 - Table 6) below provide additional details on the technological characteristics of the subject devices compared to their respective predicate devices.
| Characteristic | Subject DeviceAristotle 14 Guidewire(K220398) | PredicateAristotle 14 Guidewire(K173235) | Comparison |
|---|---|---|---|
| AnatomicalLocation | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Same |
| Dimensions | O.D. : 0.014" (0.36 mm)Length : 200 cm, 300 cm | O.D. : 0.014" (0.36 mm)Length : 200 cm, 300 cm range | Same |
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | ShapeableLength : 35 cmMaterial : Nitinol | ShapeableLength : 35 cmMaterial : Nitinol | Same |
| Stiffness Profiles | Soft, standard | Soft, standard | Same |
| Coatings | Distal End : HydrophilicProximal End : Proposed PTFE | Distal End : HydrophilicProximal End : Current PTFE | Different |
| Table 2. Aristotle 14 Guidewire Technological Characteristics Comparison |
|---|
| -------------------------------------------------------------------------- |
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| Characteristic | Subject DeviceAristotle 14 Guidewire(K220398) | PredicateAristotle 14 Guidewire(K173235) | Comparison |
|---|---|---|---|
| RadiopaqueMarker | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip | Same |
| Centering Coil | 1 centering coil | 1 centering coil | Same |
| Shaping Mandrel(Accessory) | Provided with eachguidewire | NA | Different |
| GuidewireIntroducer(Accessory) | Provided with eachguidewire | Provided with eachguidewire | Same |
| Torque Device(Accessory) | Provided with eachguidewire | Provided with eachguidewire | Same |
| SterilizationMethod | 100% Ethylene Oxide(EO) | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 3. Aristotle 18 Guidewire Technological Characteristics Comparison
| Characteristic | Subject DeviceAristotle 18 Guidewire(K220398) | PredicateAristotle 18 Guidewire(K183608) | Comparison |
|---|---|---|---|
| AnatomicalLocation | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Same |
| Dimensions | O.D.: 0.018" (0.46 mm)Length: 200 cm | O.D.: 0.018" (0.46 mm)Length: 200 cm | Same |
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | ShapeableLength: 35 cmMaterial: Nitinol | ShapeableLength: 35 cmMaterial: Nitinol | Same |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
| Proximal End: ProposedPTFE | Proximal End: Current PTFE | Different |
{9}------------------------------------------------
| Characteristic | Subject DeviceAristotle 18 Guidewire(K220398) | PredicateAristotle 18 Guidewire(K183608) | Comparison |
|---|---|---|---|
| RadiopaqueMarker | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip | Same |
| Centering Coil | 1 centeringcoil | 1 centeringcoil | Same |
| Shaping Mandrel(Accessory) | Provided with each guidewire | NA | Different |
| GuidewireIntroducer(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| SterilizationMethod | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 4. Aristotle 24 Guidewire Technological Characteristics Comparison
| Characteristic | Subject DeviceAristotle 24 Guidewire(K220398) | PredicateAristotle 24 Guidewire(K192783) | Comparison |
|---|---|---|---|
| AnatomicalLocation | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Same |
| Dimensions | O.D.: 0.024" (0.61 mm)Length: 200 cm | O.D.: 0.024" (0.61 mm)Length: 200 cm | Same |
| Core Wire | Stainless steel | Stainless steel | Same |
| Distal Tip | ShapeableLength: 35 cmMaterial: Nitinol | ShapeableLength: 35 cmMaterial: Nitinol | Same |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
| Proximal End: ProposedPTFE | Proximal End: Current PTFE | Different |
{10}------------------------------------------------
| Characteristic | Subject DeviceAristotle 24 Guidewire(K220398) | PredicateAristotle 24 Guidewire(K192783) | Comparison |
|---|---|---|---|
| RadiopaqueMarker | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip | Same |
| Centering Coil | 2 centeringcoils | 2 centeringcoils | Same |
| Bushing | 1 bushing | 1 bushing | Same |
| Shaping Mandrel(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| GuidewireIntroducer(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| SterilizationMethod | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 5. Volo 14 Guidewire Technological Characteristics Comparison
| Characteristic | Subject DeviceVolo 14 Guidewire(K220398) | PredicateVolo 14 Guidewire(K181828) | Comparison |
|---|---|---|---|
| AnatomicalLocation | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Same |
| Dimensions | O.D.: 0.014" (0.36 mm)Length: 200 cm, 300 cm | O.D.: 0.014" (0.36 mm)Length: 200 cm, 300 cm | Same |
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | ShapeableLength: 35 cmMaterial: Nitinol | ShapeableLength: 35 cmMaterial: Nitinol | Same |
| Stiffness Profiles | Soft, standard | Soft, standard | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
| Proximal End: Proposed | Proximal End: Current PTFE | Different |
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| Characteristic | Subject DeviceVolo 14 Guidewire(K220398) | PredicateVolo 14 Guidewire(K181828) | Comparison |
|---|---|---|---|
| PTFE | |||
| RadiopaqueMarker | 1 radiopaque marker atdistal tip | 1 radiopaque marker atdistal tip | Same |
| Centering Coil | 1 centering coil | 1 centering coil | Same |
| Shaping Mandrel(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| GuidewireIntroducer(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| SterilizationMethod | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 6. Zoom Wire 14 Guidewire Technological Characteristics Comparison
| Characteristic | Subject DeviceZoom Wire 14 Guidewire(K220398) | PredicateZoom 14 Guidewire(K201760) | Comparison |
|---|---|---|---|
| AnatomicalLocation | Neuro and peripheralvasculature | Neuro and peripheralvasculature | Same |
| Dimensions | Max O.D.: 0.014" (0.36 mm)Length: 200 cm, 300 cm | Max O.D.: 0.014" (0.36 mm)Length: 200 cm, 300 cm | Same |
| Core Wire | Stainless Steel | Stainless Steel | Same |
| Distal Tip | ShapeableLength: 35 cmMaterial: Nitinol | ShapeableLength: 35 cmMaterial: Nitinol | Same |
| Stiffness Profiles | Support, extra support | Support, extra support | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
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| Characteristic | Subject DeviceZoom Wire 14 Guidewire(K220398) | PredicateZoom 14 Guidewire(K201760) | Comparison |
|---|---|---|---|
| Proximal End | Proximal End: ProposedPTFE | Proximal End: Current PTFE | Different |
| RadiopaqueMarker | Radiopaque marker at distaltip | Radiopaque marker at distaltip | Same |
| Centering Coil | 1 centering coil | 1 centering coil | Same |
| Bushing | None | None | Same |
| Shaping Mandrel(Accessory) | Provided with each guidewire | NA | Different |
| GuidewireIntroducer(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| SterilizationMethod | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
The subject devices have a different PTFE coating on the proximal end of the guidewire. This difference does not raise new questions of safety and effectiveness, nor does it result in new risks for the subject devices. Testing and evaluation (see below) of the subject devices has been performed with regards to this characteristic and demonstrated the safety and effectiveness of the subject devices.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
A biological risk assessment was performed in accordance with recommendations in the ISO 10993 series and ISO 14971:2019 and concluded that the alternative PTFE coating does not impact biocompatibility of the subject devices. The subject devices are considered externally communicating devices with circulating blood contact for a limited duration (< 24 hours) and the following tests were performed:
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Cytotoxicity | MEM elution cell culture observedfor cytotoxic reactivity. | Pass: Non-cytotoxic. |
| Pyrogenicity | Study animals were observed forindividual temperature rise. | Pass: Non-pyrogenic. |
Table 7. Summary of Biocompatibility Testing
{13}------------------------------------------------
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Sensitization | Study animals with subject device were observed for dermal sensitization. | Pass: Non-sensitizing. |
| Irritation | Study animals with subject device were observed for dermal reaction. | Pass: Non-irritant. |
| Acute Systemic Toxicity | Study animals with the subject device were observed for abnormal clinical signs indicative of toxicity. | Pass: No evidence of acute systemic toxicity. |
| Hemocompatibility | The difference between the hemolytic indexes of the subject device and the negative control was evaluated (direct contact and extract). | Pass: Non-hemolytic. |
| Complement Activation ofSC5b-9 | Comparison of the subject device SC5b-9 value to the predicate device for all exposure times was performed. | Pass: The test article complement activation was similar to the comparator device. |
| Partial Thromboplastin Time | The clotting time was observed for both the subject device and the predicate. | Pass: The test article clotting time was similar to the comparator device. |
| In Vitro Thrombogenicity | Device is placed in an in vitro blood loop for three runs. The thrombus score for the subject and predicate device is observed. | Pass: Thromboresistant. |
| Latex Detection | ELISA Inhibition Assay used for the quantitation of extractable latex proteins. | Pass: Latex was not detected. |
Sterilization
The existing validated sterilization cycle uses 100% EO to achieve a sterilization assurance level (SAL) of 10- , and testing for EO and ethylene chlorohydrin (ECH) residuals and bacterial endotoxin levels were performed.
Bench Performance Testing
Following review of the risk assessments conducted in accordance with ISO 14971:2012, performance testing was performed on the subject devices. Additional performance tests to evaluate continued compliance with ISO 11070:2014, Sterile single-use intravascular introducers, dilators and guidewires, and the FDA guidance document, Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019), were also performed. Table 8 summarizes these tests and their results below.
Table 8. Summary of Bench Performance Tests
| Test | Test Method Summary | Results |
|---|---|---|
| Visual Inspection andDimensional Verification | Test per ISO 11070 | Acceptance criteria met |
{14}------------------------------------------------
| Test | Test Method Summary | Results |
|---|---|---|
| Coating Integrity Assessment | Test per ISO 11070 and FDAguidance document "Coronary,Peripheral and NeurovascularGuidewires - Performance Testsand Recommended Labeling"(2019) | Acceptance criteria met |
| Corrosion Resistance | Test per ISO 11070 | Acceptance criteria met |
| Agent Compatibility | Test per ISO 11070 | Acceptance criteria met |
| Simulated Use | Anatomical model designed tosimulate the tortuous anatomy ofthe neurovasculature used forsimulated use testing. | Acceptance criteria met |
| Particulate | Particulate measured andcounted after use in a simulatedpathway model. | Acceptance criteria met |
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.
CONCLUSION
The Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Volo 14 Guidewire, and Zoom Wire 14 Guidewire have the same intended use and indications for use statement as their respective predicate device. The identified technological difference does not raise new questions of safety or effectiveness regarding the use of the subject devices. Risk evaluation along with testing, bench and biological, was completed for the subject devices. The testing and risk evaluation demonstrate that the subject devices are substantially equivalent to their respective predicate device.
§ 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.