(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.
§ 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.