(392 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the guidewires, with no mention of AI or ML. The predicate devices are also guidewires without AI/ML capabilities.
No
Explanation: The device is intended to introduce and position catheters and other interventional devices, which are diagnostic or interventional tools, not therapeutic agents themselves. Its function is to facilitate procedures, not to provide therapy directly.
No
Guidewires are interventional devices used to introduce and position other catheters and devices, facilitating procedures. They do not diagnose conditions themselves.
No
The device description clearly describes physical guidewires made of materials like platinum, with coatings and accessory hardware. It is a physical medical device, not software.
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 guidewires are 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.
- Device Description: The description details a physical device (guidewire) with coatings and accessories designed for insertion and manipulation within blood vessels. This is consistent with an interventional medical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
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.
Product codes
MOF, DQX
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 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.
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
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 (
§ 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
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
2
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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3
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 |
4
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 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.
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 Device
Aristotle 14 Guidewire
(K220398) | Predicate
Aristotle 14 Guidewire
(K173235) | Comparison |
|------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------|
| Anatomical
Location | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | 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 | Shapeable
Length : 35 cm
Material : Nitinol | Shapeable
Length : 35 cm
Material : Nitinol | Same |
| Stiffness Profiles | Soft, standard | Soft, standard | Same |
| Coatings | Distal End : Hydrophilic
Proximal End : Proposed PTFE | Distal End : Hydrophilic
Proximal End : Current PTFE | Different |
| Table 2. Aristotle 14 Guidewire Technological Characteristics Comparison |
|---|
| -------------------------------------------------------------------------- |
8
| Characteristic | Subject Device
Aristotle 14 Guidewire
(K220398) | Predicate
Aristotle 14 Guidewire
(K173235) | Comparison |
|----------------------------------------|-------------------------------------------------------|--------------------------------------------------|------------|
| Radiopaque
Marker | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip | Same |
| Centering Coil | 1 centering coil | 1 centering coil | Same |
| Shaping Mandrel
(Accessory) | Provided with each
guidewire | NA | Different |
| Guidewire
Introducer
(Accessory) | Provided with each
guidewire | Provided with each
guidewire | Same |
| Torque Device
(Accessory) | Provided with each
guidewire | Provided with each
guidewire | Same |
| Sterilization
Method | 100% Ethylene Oxide
(EO) | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 3. Aristotle 18 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device
Aristotle 18 Guidewire
(K220398) | Predicate
Aristotle 18 Guidewire
(K183608) | Comparison |
|------------------------|-------------------------------------------------------|--------------------------------------------------|------------|
| Anatomical
Location | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | 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 | Shapeable
Length: 35 cm
Material: Nitinol | Shapeable
Length: 35 cm
Material: Nitinol | Same |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
| | Proximal End: Proposed
PTFE | Proximal End: Current PTFE | Different |
9
| Characteristic | Subject Device
Aristotle 18 Guidewire
(K220398) | Predicate
Aristotle 18 Guidewire
(K183608) | Comparison |
|----------------------------------------|-------------------------------------------------------|--------------------------------------------------|------------|
| Radiopaque
Marker | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip | Same |
| Centering Coil | 1 centering
coil | 1 centering
coil | Same |
| Shaping Mandrel
(Accessory) | Provided with each guidewire | NA | Different |
| Guidewire
Introducer
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Sterilization
Method | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 4. Aristotle 24 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device
Aristotle 24 Guidewire
(K220398) | Predicate
Aristotle 24 Guidewire
(K192783) | Comparison |
|------------------------|-------------------------------------------------------|--------------------------------------------------|------------|
| Anatomical
Location | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | 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 | Shapeable
Length: 35 cm
Material: Nitinol | Shapeable
Length: 35 cm
Material: Nitinol | Same |
| Stiffness Profiles | Support, standard, soft | Support, standard, soft | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
| | Proximal End: Proposed
PTFE | Proximal End: Current PTFE | Different |
10
| Characteristic | Subject Device
Aristotle 24 Guidewire
(K220398) | Predicate
Aristotle 24 Guidewire
(K192783) | Comparison |
|----------------------------------------|-------------------------------------------------------|--------------------------------------------------|------------|
| Radiopaque
Marker | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip | Same |
| Centering Coil | 2 centering
coils | 2 centering
coils | Same |
| Bushing | 1 bushing | 1 bushing | Same |
| Shaping Mandrel
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Guidewire
Introducer
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Sterilization
Method | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 5. Volo 14 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device
Volo 14 Guidewire
(K220398) | Predicate
Volo 14 Guidewire
(K181828) | Comparison |
|------------------------|--------------------------------------------------|--------------------------------------------------|------------|
| Anatomical
Location | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | 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 | Shapeable
Length: 35 cm
Material: Nitinol | Shapeable
Length: 35 cm
Material: 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 |
11
| Characteristic | Subject Device
Volo 14 Guidewire
(K220398) | Predicate
Volo 14 Guidewire
(K181828) | Comparison |
|----------------------------------------|--------------------------------------------------|---------------------------------------------|------------|
| | PTFE | | |
| Radiopaque
Marker | 1 radiopaque marker at
distal tip | 1 radiopaque marker at
distal tip | Same |
| Centering Coil | 1 centering coil | 1 centering coil | Same |
| Shaping Mandrel
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Guidewire
Introducer
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Sterilization
Method | 100% EO | 100% EO | Same |
| Shelf Life | 4 month | 3 year | Different |
Table 6. Zoom Wire 14 Guidewire Technological Characteristics Comparison
| Characteristic | Subject Device
Zoom Wire 14 Guidewire
(K220398) | Predicate
Zoom 14 Guidewire
(K201760) | Comparison |
|------------------------|-------------------------------------------------------|------------------------------------------------------|------------|
| Anatomical
Location | Neuro and peripheral
vasculature | Neuro and peripheral
vasculature | 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 | Shapeable
Length: 35 cm
Material: Nitinol | Shapeable
Length: 35 cm
Material: Nitinol | Same |
| Stiffness Profiles | Support, extra support | Support, extra support | Same |
| Coatings | Distal End: Hydrophilic | Distal End: Hydrophilic | Same |
12
| Characteristic | Subject Device
Zoom Wire 14 Guidewire
(K220398) | Predicate
Zoom 14 Guidewire
(K201760) | Comparison |
|----------------------------------------|-------------------------------------------------------|---------------------------------------------|------------|
| Proximal End | Proximal End: Proposed
PTFE | Proximal End: Current PTFE | Different |
| Radiopaque
Marker | Radiopaque marker at distal
tip | Radiopaque marker at distal
tip | Same |
| Centering Coil | 1 centering coil | 1 centering coil | Same |
| Bushing | None | None | Same |
| Shaping Mandrel
(Accessory) | Provided with each guidewire | NA | Different |
| Guidewire
Introducer
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Torque Device
(Accessory) | Provided with each guidewire | Provided with each guidewire | Same |
| Sterilization
Method | 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 (