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510(k) Data Aggregation
(11 days)
PIVOT STEERABLE MICROCATHETER
The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.
The "PivotTM" Steerable Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.017". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.
The "Pivot™" Steerable Microcatheter was evaluated against several performance criteria, demonstrating its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformity to ISO 10555-1 | Performance testing was conducted in accordance with ISO 10555-1, "Sterile, Single-Use Intravascular Catheters -- Part 1." |
| Dimensional Inspection | Verification testing included dimensional inspection. The results were acceptable. |
| Hub Integrity | Verification testing included hub integrity. The results were acceptable. |
| Flow Rate Measurements | Verification testing included flow rate measurements. The results were acceptable. |
| Burst Strength | Verification testing included burst strength. The results were acceptable. |
| Tensile Strength | Verification testing included tensile strength. The results were acceptable. |
| Guidewire Compatibility | Verification testing included guidewire compatibility. The results were acceptable. |
| Performance under Simulated Conditions | Verification testing included performance under simulated conditions. The results were acceptable. |
| Torsional Strength | Torsional strength tests were conducted. The results were acceptable. |
| Torqueability | Torqueability tests were conducted. The results were acceptable. |
| Corrosion Resistance | Corrosion resistance tests were conducted. The results were acceptable. |
| Substantial Equivalence | The "Pivot™" Steerable Microcatheter effectively demonstrates substantial equivalence to predicate devices based on indications for use, technological characteristics (basal tubular design, dimensions, polymeric materials and construction, hydrophilic coating), and safety and performance testing. No new questions regarding safety and efficacy were raised. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a separate "test set" in the context of clinical trials or data for algorithm performance. The performance evaluation was based on bench testing and simulated conditions, which typically do not involve human subjects or a distinct "test set" in the way an AI/ML device would. Therefore, sample sizes for a test set and data provenance (e.g., country of origin, retrospective/prospective) are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the evaluation was based on bench testing and simulated conditions of a physical device, there were no "experts" establishing ground truth in the context of interpreting medical images or clinical data. The acceptance criteria were based on engineering and performance standards (ISO 10555-1 and specific mechanical tests).
4. Adjudication Method for the Test Set
As the evaluation was based on bench testing and simulated conditions, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable. The assessment was likely based on standardized testing protocols and objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a physical microcatheter, and the evaluation was based on its physical and mechanical performance, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The "Pivot™" Steerable Microcatheter is a physical medical device, not an algorithm or AI model. Therefore, "standalone algorithm performance" is not relevant to its evaluation.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established through objective measurements against predefined engineering standards and specifications. This includes:
- Compliance with ISO 10555-1.
- Results from physical tests such as dimensional inspection, hub integrity, flow rate, burst strength, tensile strength, guidewire compatibility, performance under simulated conditions, torsional strength, torqueability, and corrosion resistance.
8. The Sample Size for the Training Set
This question is not applicable. The "Pivot™" Steerable Microcatheter is a physical device, not an AI/ML model, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a physical microcatheter.
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