(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guidewire, with no mention of AI or ML technologies.
No
The device is a guidewire used to introduce and position other interventional devices, not to provide therapy itself.
No
The device description clearly states its purpose is to "introduce and position catheters and other interventional devices," which is a therapeutic or interventional function, not a diagnostic one. While it facilitates fluoroscopic visualization, this is for guiding the intervention, not for diagnosing a condition.
No
The device description clearly details a physical guidewire with various material components, coatings, and accessory devices, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Zoom 14 Guidewire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's 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 guidewire designed to be inserted into blood vessels. It mentions features like a shapeable tip, radiopaque marker, and coatings to facilitate its use within the vasculature.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Zoom 14 Guidewire does not fit this definition. It is an interventional medical device used for accessing and navigating within the vascular system.
N/A
Intended Use / Indications for Use
The Zoom 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
DQX, MOF
Device Description
The Zoom 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: support and extra support. The product is provided in lengths of 200cm or 300cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The Zoom 14 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to the previously cleared Aristotle 14 Guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro and peripheral vasculature
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
Functional Testing was performed on the subject device after conducting a risk assessment in accordance with EN ISO 14971:2012 Medical Devices - Risk Management. This testing was performed in accordance 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). Tests included Visual Inspection, Dimensional Verification, Tensile Testing, Column Buckling, Flexing, Fracture, Torqueability, Torque Strength, and Model Evaluation. For all tests, the Zoom 14 Guidewires met testing acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Aristotle 14 Guidewire (K173235)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Scientia Vascular LLC Amy McManus Regulatory Affairs Manager 3487 West 2100 South Suite 100 West Valley City, UT 84119
Re: K201760
Trade/Device Name: Zoom 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, MOF Dated: June 23, 2020 Received: June 29, 2020
Dear Amy McManus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
July 29, 2020
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 medical devices and radiation-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, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201760
Device Name Zoom 14 Guidewire
Indications for Use (Describe)
The Zoom 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
Scientia Vascular LLC Special 510(k) Zoom 14 Guidewire
Image /page/3/Picture/2 description: The image features the logo of Scientia. The logo consists of a stylized, interconnected blue symbol resembling a chain or a series of linked 'S' shapes, positioned above the company name. The word "SCIENTIA" is written in a sans-serif font, with a modern and slightly futuristic appearance, placed directly below the blue symbol.
510(K) SUMMARY
(PER 21 CFR 807.92)
SCIENTIA VASCULAR LLC
Special 510(K): Device Modification Zoom 14 Guidewire
| 510(k) Sponsor: | Scientia Vascular LLC
3487 West 2100 South Suite 100
West Valley City, UT 84119
Tel (888) 385.9016 |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amy McManus,
Regulatory Affairs Manager
Tel: (888) 385.9016
E-mail: amcmanus@scientiavascular.com |
| Date Prepared: | June 10, 2020 |
Subject Device Information:
| Trade Name: | Zoom 14 Guidewire |
|---|---|
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Primary Product Code: | DQX |
| Secondary Product Code | MOF |
| Predicate Device: | Aristotle 14 Guidewire (K173235) |
4
Scientia Vascular LLC Special 510(k) Zoom 14 Guidewire
DEVICE DESCRIPTION
The Zoom 14 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: support and extra support. The product is provided in lengths of 200cm or 300cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The Zoom 14 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to the previously cleared Aristotle 14 Guidewire.
INDICATION FOR USE
The Zoom 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.
This is the same indication for use as previously cleared for the Aristotle 14 Guidewire, K173235.
INTENDED USE
The Zoom 14 Guidewire is intended for use by a physician to help introduce and position catheters or other interventional devices within the neuro and peripheral vasculature.
TECHNOLOGICAL CHARACTERISTICS
The Zoom 14 Guidewire has the following similarities to the previously cleared Aristotle 14 Guidewire:
- . Both devices have the same indicated use,
- Both devices have the same intended use ●
- Both devices use the same operating principle,
- Both devices incorporate the same basic guidewire design, ●
- Both devices incorporate the same materials, and ●
5
- Both devices are packaged and sterilized using the same materials and processes. ●
The technological characteristic comparison of the subject and predicate device is summarized in Table 1 below.
| Table 1:Comparison between Subject & Predicate Device Technological Characteristics: | ||
|---|---|---|
| Note: Areas of difference will be indicated in RED | ||
| Characteristic | Subject Device | |
| Zoom 14 Guidewire | Predicate | |
| Aristotle 14 Guidewire (K173235) | ||
| Anatomical Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature |
| Dimensions | Max O.D.: 0.014" (0.36mm) | |
| Length: 200cm and 300 cm | Max O.D.: 0.014" (0.36mm) | |
| Length: 200cm and 300 cm | ||
| Core Wire | Stainless Steel | Stainless Steel |
| Distal Tip | Shapeable | |
| Length: 35cm | ||
| Material: Nitinol | Shapeable | |
| Length: 35cm | ||
| Material: Nitinol | ||
| Stiffness Profiles | Range from extra support (stiff) to | |
| support (less stiff) | Range from support (stiff) to soft (flex) | |
| Coatings | Distal End: Hydrophilic | |
| Proximal End: PTFE | Distal End: Hydrophilic | |
| Proximal End: PTFE | ||
| Radiopaque Marker | Radiopaque marker at distal tip | Radiopaque marker at distal tip |
| Centering Coil | One (1) Centering coil | One (1) Centering coil |
| Guidewire Introducer | ||
| (Accessory) | Provided with each guidewire | Provided with each guidewire |
| Torque Device | ||
| (Accessory) | Provided with each guidewire | Provided with each guidewire |
| Sterilization Method | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) |
The subject device, Zoom 14 Guidewire, has one technological characteristic difference when compared to the predicate device. This differing technological characteristic does not result in new materials used or new questions of safety or effectiveness, nor does it result in new risks for the subject device. Testing of the subject device has been performed, demonstrating the safety and effectiveness of the device.
6
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
The materials used in the manufacture of the subject device Zoom 14 Guidewire are identical to those used in the manufacturing of the predicate device Aristotle 14 Guidewire, as seen in the table below.
The Zoom 14 Guidewire uses the same manufacturing assembly equipment and processes as the Aristotle 14 Guidewire. The Zoom 14 Guidewire and the Aristotle 14 Guidewire differ in the stiffness profile, with no overall dimensional or material differences. Since the Zoom 14 is identical to the Aristotle 14 in this respect, with no new materials or processes, the product has already been tested for biocompatibility and chemical analysis.
| Characteristic | Subject Device
Zoom 14 Guidewire | Aristotle 14 Guidewire |
|-------------------------|-------------------------------------|-------------------------------------------------|
| Overall
Dimensions | NO CHANGE | O.D.: 0.014" (0.36mm)
Length: 200cm to 300cm |
| Core Wire | NO CHANGE | Stainless Steel |
| Distal Tip | NO CHANGE | Length: 35cm
Material: Nitinol |
| Coatings | NO CHANGE | Distal End: Hydrophilic
Proximal End: PTFE |
| Radiopaque
Marker | NO CHANGE | 1 radiopaque marker at distal tip |
| Centering Coil | NO CHANGE | 1 centering coil |
| Sterilization
Method | NO CHANGE | 100% Ethylene Oxide (EO) |
Sterilization
100% EO is used to sterilize the device to achieve a SAL of at least 10°. The Zoom 14 Guidewire and the Aristotle 14 are similar with regards to all device and packaging characteristics that could affect the ability to sterilize the devices.
Functional Testing
Functional testing on the subject device was performed after conducting a risk assessment in accordance with EN ISO 14971:2012 Medical Devices - Risk Management. This testing was performed in accordance 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). Table 2 summarizes the functional tests performed and test results obtained to demonstrate substantial equivalence to the predicate device:
7
| Test | Test Method Summary | Results |
|---|---|---|
| Visual Inspection | Tests per ISO 11070: | |
| Visual inspection per engineering | ||
| drawings. | The Zoom 14 Guidewires met | |
| testing acceptance criteria. | ||
| Dimensional | ||
| Verification | Tests per ISO 11070: | |
| Dimensional inspection per engineering | ||
| drawings. | The Zoom 14 Guidewires met | |
| testing acceptance criteria. | ||
| Tensile Testing | Tensile testing per ISO 11070. | The Zoom 14 Guidewires met |
| testing acceptance criteria | ||
| Column Buckling | The force required to buckle the tip of | |
| the guidewire at 5mm, 10mm, 20mm. | The Zoom 14 Guidewires met | |
| testing acceptance criteria | ||
| Flexing | Tests per ISO 11070: | |
| Inspection for defects and damage or | ||
| flaking of the coating after flexing. | The Zoom 14 Guidewires met | |
| testing acceptance criteria | ||
| Fracture | Tests per ISO 11070: | |
| Inspection for fracture, loosening, or | ||
| failure after wrapping around mandrel. | The Zoom 14 Guidewires met | |
| testing acceptance criteria | ||
| Torqueability | Measurement of torque response | |
| (average input to output lag) in an | ||
| anatomical model. | The Zoom 14 Guidewires met | |
| testing acceptance criteria | ||
| Torque Strength | Torque turns to failure in an anatomical | |
| model. | The Zoom 14 Guidewires met | |
| testing acceptance criteria | ||
| Model Evaluation | Anatomical model designed to simulate | |
| the tortuous anatomy of the | ||
| neurovasculature used for simulated use | ||
| testing | The Zoom 14 Guidewires met | |
| testing acceptance criteria |
Table 2:Summaries of Functional Tests Conducted to Support this Premarket Notification for the Modified (Subiect) Device, Zoom 14 Guidewire
CONCLUSION:
Scientia Vascular, LLC has presented information in this premarket notification supporting the Zoom 14 Guidewire as substantially equivalent with respect to technological characteristics and indications for use to the predicate device.