(25 days)
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions in native peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:
- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (175cm Working Length)
- 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
- 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . (275cm Working Length)
- Safe-Cross RF System Console with Display and Footswitch .
The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within OCK mpat on the connector is alles. The RF connector is connected to the RF output on the vessol of havigation practical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.
The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Ice orosing 'Are wided in a separate peel pouch. The packaged RF Crossing Wire 1 on. 71 Torquer is provided oxide) and non-pyrogenic, and is intended for single use only.
The provided text is a 510(k) summary for the Safe-Cross® Radio Frequency Total Occlusion Crossing System. This type of document is for regulatory clearance based on substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through clinical studies. Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance) is not available in these FDA submission documents.
Here's a breakdown of what can be extracted from the document based on the request:
Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: The key "acceptance criterion" for this 510(k) submission is that the modified Safe-Cross RF System is substantially equivalent to its predicate device (Safe-Cross Radio Frequency Total Occlusion Crossing System, K033929). This implies that the device performs as intended and is as safe and effective as the predicate. | Equivalence to Predicate: The submitter concludes, "The Safe-Cross System is substantially equivalent to the predicate device." This is based on: |
- Same components and technological characteristics as the predicate device.
- Bench testing and software verification/validation conducted to qualify changes.
- Intended Use: Facilitating placement of devices in vascular interventions in native peripheral arteries with total occlusions (not for carotid arteries). This is the same as the predicate. |
Study Information:
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on bench testing and software verification/validation, not a clinical test set with human data for performance evaluation in a clinical context.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for clinical performance studies (e.g., expert consensus on medical images) is not relevant here, as there isn't a clinical test set being evaluated in that manner.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no clinical test set requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical catheter system, not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter system), not an algorithm. Bench testing and software verification/validation were performed on the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated in terms of clinical ground truth. The "ground truth" for this submission would be defined by engineering specifications and functional performance metrics established during bench testing and software validation. These are evaluated against predetermined thresholds or against the performance of the predicate device.
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The sample size for the training set: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that sense.
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How the ground truth for the training set was established: Not applicable, for the same reason as above. If "training set" were interpreted as the data used for the design and development of the device, then the "ground truth" for design would be derived from clinical needs, engineering principles, and performance requirements for a device of this type.
§ 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.