(30 days)
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.
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 provided text describes the Zoom 14 Guidewire, a modification of Scientia Vascular's Aristotle 14 Guidewire. The submission is a 510(k) premarket notification, which means the manufacturer seeks to prove "substantial equivalence" to a legally marketed predicate device, rather than entirely new safety and effectiveness.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by "met testing acceptance criteria") | Reported Device Performance (Zoom 14 Guidewire) |
|---|---|---|
| Visual Inspection | Conformity to engineering drawings and absence of defects. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Dimensional | Conformity to engineering drawings. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Tensile Testing | Conformity to ISO 11070 requirements. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Column Buckling | Force required to buckle the tip at 5mm, 10mm, 20mm meets specified criteria. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Flexing | Absence of defects, damage, or flaking of coating after flexing. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Fracture | Absence of 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) meets specified criteria in an anatomical model. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Torque Strength | Torque turns to failure in an anatomical model meets specified criteria. | The Zoom 14 Guidewires met testing acceptance criteria. |
| Model Evaluation | Successful simulated use in a tortuous neurovasculature model. | The Zoom 14 Guidewires met testing acceptance criteria. |
Note: The specific numerical or qualitative "acceptance criteria" are not explicitly detailed in the document but are implied by the statement "met testing acceptance criteria" for each test. The tests were performed in accordance with ISO 11070:2014 and the FDA Guidance Document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019)."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each functional test. The tests are non-clinical (bench testing and model evaluation) rather than human studies. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" for a test set in the traditional sense of clinical data does not apply here. The data provenance is from the manufacturer's internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The functional tests described are objective engineering and performance tests, not subjective evaluations requiring expert consensus for "ground truth" in the way clinical images or diagnoses would.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective functional tests, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This is a 510(k) submission for a guidewire, which relies on non-clinical performance data and substantial equivalence to a predicate device, not a comparative clinical study with human readers assessing diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical medical guidewire, not an algorithm or AI system. The "performance" described relates to its physical and mechanical properties.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests is based on:
- Engineering specifications and drawings: For visual and dimensional verification.
- International standards (ISO 11070:2014): For tensile testing and other general guidewire performance.
- FDA Guidance Document "Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling (2019): Guiding the types of tests and likely acceptable ranges for performance.
- Risk assessment (EN ISO 14971:2012): To determine which tests were necessary.
- Anatomical models: For torqueability, torque strength, and simulated use evaluation.
Essentially, the ground truth is established by objective, verifiable technical standards and engineering benchmarks.
8. Sample Size for the Training Set
This information is not applicable. The "Zoom 14 Guidewire" is a physical medical device, not an AI or machine learning model that requires a training set. The device's design is based on the predicate device (Aristotle 14 Guidewire) and engineering principles, not statistical learning from a data set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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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
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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 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
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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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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 LLC3487 West 2100 South Suite 100West Valley City, UT 84119Tel (888) 385.9016 |
|---|---|
| Contact Person: | Amy McManus,Regulatory Affairs ManagerTel: (888) 385.9016E-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) |
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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 ●
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- 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 DeviceZoom 14 Guidewire | PredicateAristotle 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 | ShapeableLength: 35cmMaterial: Nitinol | ShapeableLength: 35cmMaterial: Nitinol |
| Stiffness Profiles | Range from extra support (stiff) tosupport (less stiff) | Range from support (stiff) to soft (flex) |
| Coatings | Distal End: HydrophilicProximal End: PTFE | Distal End: HydrophilicProximal 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.
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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 DeviceZoom 14 Guidewire | Aristotle 14 Guidewire |
|---|---|---|
| OverallDimensions | NO CHANGE | O.D.: 0.014" (0.36mm)Length: 200cm to 300cm |
| Core Wire | NO CHANGE | Stainless Steel |
| Distal Tip | NO CHANGE | Length: 35cmMaterial: Nitinol |
| Coatings | NO CHANGE | Distal End: HydrophilicProximal End: PTFE |
| RadiopaqueMarker | NO CHANGE | 1 radiopaque marker at distal tip |
| Centering Coil | NO CHANGE | 1 centering coil |
| SterilizationMethod | 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:
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| Test | Test Method Summary | Results |
|---|---|---|
| Visual Inspection | Tests per ISO 11070:Visual inspection per engineeringdrawings. | The Zoom 14 Guidewires mettesting acceptance criteria. |
| DimensionalVerification | Tests per ISO 11070:Dimensional inspection per engineeringdrawings. | The Zoom 14 Guidewires mettesting acceptance criteria. |
| Tensile Testing | Tensile testing per ISO 11070. | The Zoom 14 Guidewires mettesting acceptance criteria |
| Column Buckling | The force required to buckle the tip ofthe guidewire at 5mm, 10mm, 20mm. | The Zoom 14 Guidewires mettesting acceptance criteria |
| Flexing | Tests per ISO 11070:Inspection for defects and damage orflaking of the coating after flexing. | The Zoom 14 Guidewires mettesting acceptance criteria |
| Fracture | Tests per ISO 11070:Inspection for fracture, loosening, orfailure after wrapping around mandrel. | The Zoom 14 Guidewires mettesting acceptance criteria |
| Torqueability | Measurement of torque response(average input to output lag) in ananatomical model. | The Zoom 14 Guidewires mettesting acceptance criteria |
| Torque Strength | Torque turns to failure in an anatomicalmodel. | The Zoom 14 Guidewires mettesting acceptance criteria |
| Model Evaluation | Anatomical model designed to simulatethe tortuous anatomy of theneurovasculature used for simulated usetesting | The Zoom 14 Guidewires mettesting 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.
§ 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.