(65 days)
The F.A.S.T.™ System SED and CXD are indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- The non-surgical removal of thrombi from synthetic grafts.
- Temporary use in vessel/graft occlusions.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft.
- Catheter placement over a guidewire.
The F.A.S.T.™ System - SED (Self-Expanding Device) and F.A.S.T.™ System - CXD (Controlled Expansion Device) are sterile, disposable, thrombectomy systems for the non-surgical removal of emboli and thrombi from blood vessels or grafts.
The F.A.S.T.™ System -- SED consists of a self-expanding nitinol basket mounted on a core wire. The device is compressed and sheathed in an introducer designed to facilitate loading and advancement of the device into the proximal hub of an 0.021-in (0.533-mm) microcatheter. When advanced to the distal end of a microcatheter, the compressed basket is deployed by withdrawing the microcatheter over the basket may be reconstrained back into the microcatheter.
The F.A.S.T.™ System - CXD Device consists of an expandable nitinol basket mounted on a hollow tube and core wire. Basket expansion and contraction to the desired diameter is controlled by the operator at the proximal end of the device. Using the handle control, the basket is contracted prior to withdrawing the device back into the microcatheter.
Both the F.A.S.T.™ System - SED and the F.A.S.T.TM System - CXD have markers at the proximal and distal ends of the basket to facilitate visualization under fluoroscopy and are compatible with 0.021 inch (0.533-mm) inner diameter (ID) microcatheters.
This is a 510(k) summary for a medical device (F.A.S.T.™ System SED and CXD) seeking substantial equivalence to a predicate device. As such, it does not typically include detailed performance criteria and specific study results (like sensitivity, specificity, AUC) that would be found in a clinical trial report for novel devices or AI/ML-driven diagnostics. The goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, often by showing similar technological characteristics and performance through non-clinical testing.
Therefore, many of the requested elements (e.g., specific performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies, specific ground truth methods) are not typically present in this type of regulatory document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of quantitative acceptance criteria with specific numerical targets (e.g., "sensitivity > X%"). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device and showing "adequate device performance" through "verification testing."
| Acceptance Criteria (Inferred from 510(k) summary) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device | The F.A.S.T.™ System SED and CXD share the same or similar: indications for use, fundamental scientific technology, general device operation, materials, sterilization process, and packaging requirements, and, therefore, are substantially equivalent for use in minimally invasive vascular applications to the Genesis Medical Interventional™ F.A.S.T.™ System (K040010). |
| Adequate Device Performance | Verification testing conducted... demonstrates the devices are substantially equivalent to the predicate device and do not raise new questions regarding safety and effectiveness. |
| No new questions of safety and effectiveness | As described in this 510(k) Summary, the F.A.S.T.™ System SED and CXD are substantially equivalent ... based on a comparison of intended uses and the results of in-vitro and in-vivo testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing mentioned is "in-vitro and in-vivo testing" and "verification testing," which typically involves engineering or bench testing and potentially animal studies for medical devices like this, rather than a clinical "test set" of patient data as understood in AI/ML.
- Data Provenance: Not specified. Given it's a technical verification of a device, the data origin would likely be laboratory or animal studies, not patient data in terms of "country of origin."
- Retrospective or Prospective: Not applicable in the context of device verification testing described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a thrombectomy catheter for mechanical removal of clots, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment on a test set. The validation would involve performance against engineering specifications and potentially clinical outcomes in animal models, not expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No mention of expert adjudication for a "test set" in the context of this device's validation.
5. 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. This device is a mechanical thrombectomy system, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm. Its operation inherently involves a human operator (e.g., a physician).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document refers to "in-vitro and in-vivo testing" (Page 5, Section VIII). For medical devices like this, "ground truth" for performance would be established through:
- In-vitro: Bench testing against predetermined engineering specifications (e.g., thrombectomy efficacy in a simulated vessel model, catheter steerability, basket deployment/retraction, material strength, flow rates).
- In-vivo: Animal studies to assess device safety and performance characteristics in a living system (e.g., ability to remove thrombi, impact on vessel walls, patency).
- Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that the device performs at least as well as and shares fundamental characteristics with the legally marketed predicate device, without raising new safety or effectiveness concerns.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).