(12 days)
The Renegade™ Hi-Flo™ Fathom™ Kit is intended for peripheral vascular use. The Fathom guidewire can be used to selectively introduce and position the Renegade Hi-Flo microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Renegade Hi-Flo Fathom Kit includes a Renegade Hi-Flo Microcatheter, a Fathom-16 Steerable Guidewire, a steam shaping mandrel, a rotating hemostatic valve (RHV), a guide wire torque device, and a guide wire introducer.
The Renegade Hi-Flo Microcatheter lumen is able to accommodate steerable guidewires that are ≤ 0.018 in (0.46 mm) in diameter. The outer surface of the microcatheter distal segment is coated and has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the microcatheter is steam shapeable using the included steam shaping mandrel and the proximal end of the microcatheter incorporates a standard luer adapter to facilitate the attachment of the rotating hemostatic valve (RHV).
The Fathom-16 Steerable Guidewire has a maximum diameter of 0.016 in (0.41 mm). The distal portion of the device is coated for lubricity and is radiopaque to facilitate fluoroscopic visualization. The torque device included with the guidewire attaches to the proximal end of the guidewire and functions as a steering mechanism. The guidewire introducer facilitates insertion of the guide wire into the microcatheter hub and/or hemostatic valve and may be used to shape the guidewire distal tip.
The provided document is a 510(k) summary for the Boston Scientific Renegade™ Hi-Flo™ Fathom™ Kit. This type of submission is for demonstrating substantial equivalence to a predicate device, and thus typically relies on non-clinical performance data rather than a full-scale clinical comparative effectiveness study with pre-defined acceptance criteria for a new device's performance.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|---|
| Subject Kit Components Compatibility | Demonstrate compatibility of the new Fathom-16 Steerable Guidewire with the existing Renegade Hi-Flo Microcatheter kit components. | Results demonstrate the impact of the modification (replacing the Transend-18 Guidewire with the Fathom-16 Steerable Guidewire) is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided in this summary, but implied by "demonstrate impact" and "supports substantial equivalence"). |
| Packaging Performance/Functional Testing | Evaluate the impact of modifications to the predicate kit packaging. | Results demonstrate the impact of modifications to the predicate kit packaging is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided, but implied by "demonstrate impact" and "supports substantial equivalence"). |
| Performance Testing of Kit Guidewire Post-Sterilization | Evaluate the impact on the Fathom-16 Steerable Guidewire resulting from the contract sterilizer and sterilization cycle used for the predicate kit. | Results demonstrate the impact to the Fathom-16 Steerable Guidewire from the sterilization process is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided, but implied by "demonstrate impact" and "supports substantial equivalence"). |
| Sterilization Qualification Summary | Confirm that the sterilization process for the Fathom-16 Steerable Guidewire is qualified and effective under the existing sterilization cycle. | Results demonstrate the impact to the Fathom-16 Steerable Guidewire from the sterilization qualification is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided, but implied by "demonstrate impact" and "supports substantial equivalence"). |
Note: The acceptance criteria for these tests are generally inferred to be successful completion without adverse effects or performance degradation compared to the predicate device, thereby supporting substantial equivalence. Specific quantitative thresholds are not detailed in this summary. The document explicitly states: "All testing performed and data included in submission demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the non-clinical performance tests. These are typically internal validation tests, and the exact number of units tested is not usually included in a 510(k) summary.
- Data Provenance: The tests are non-clinical performance data, likely conducted in a laboratory or manufacturing setting by Boston Scientific. The country of origin of the data is implied to be internal to Boston Scientific's R&D/testing facilities (e.g., Maple Grove, MN). The data is retrospective in the sense that it's generated for submission after the device design is finalized, but it's new data generated for the modified device, not historical patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the study described is a non-clinical performance study of a medical device, not a diagnostic or AI-based system requiring expert-established ground truth for a test set. The "ground truth" for these tests would be objective measurements and engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. As stated above, this is a non-clinical performance study, not one requiring adjudication by human experts for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." Therefore, no MRMC study was conducted or reported for this submission. The device is a physical medical device (microcatheter kit), not a diagnostic or AI-assisted interpretation system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
- The "ground truth" for these non-clinical performance studies typically involves engineering specifications, material properties, mechanical test standards, and established biocompatibility/sterilization validation protocols. For example, compatibility would be verified by proper fit and function, packaging integrity by established test methods (e.g., ASTM standards), and sterilization by demonstrating sterility assurance levels (SAL) according to ISO standards.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device's non-clinical performance validation. This is a physical medical device, not an AI model that undergoes training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).