(190 days)
Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.
Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.
Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter consists of a catheter body tube made out of polyvinyl chloride (PVC) or nylon (3F only) of 40, 60, or 80 cm lengths. The catheter contains a latex balloon at the distal end and a PVC hub at the proximal end for connection to a syringe for balloon inflation. They contain a soft, rounded tip, which promotes easy arterial insertion. The model with an “S” has a stylet at the proximal end to support the inflation lumen during shipping and storage. These devices are provided sterile and labeled for single use only.
Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe consists of a single-lumen polyvinyl chloride (PVC) catheter body with a latex balloon at the distal end. A hub at the proximal end is used for balloon inflation. A flexible stylet is provided with Fogarty Biliary Balloon Probe. The stylet is of a designed stiffness intended to avoid perforation and yet maintain enough shape to facilitate introduction of the probe into areas of sharp angulation. These devices are provided sterile and labeled for single use only. The Fogarty Biliary Balloon Probe is not intended to be used with other devices.
This is a 510(k) summary for a medical device called the Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's efficacy through extensive clinical trials with acceptance criteria directly tied to patient outcomes or AI performance metrics.
Therefore, the typical questions about acceptance criteria for AI/CADe devices, such as performance metrics (sensitivity, specificity), expert involvement in ground truth, sample sizes for test/training sets, and MRMC studies, are not applicable here.
Instead, the "acceptance criteria" in this context are related to demonstrating that the changes made to existing, legally marketed predicate devices (primarily packaging and associated manufacturing/labeling updates) do not negatively impact the device's safety and effectiveness.
Here's how to interpret the provided document in the context of your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of specific numerical acceptance criteria and performance for a diagnostic algorithm. Instead, the acceptance criteria are met by demonstrating that the modified device (new packaging configuration for an existing device) maintains the same performance and safety profile as the predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary from K193379) |
|---|---|
| Functional/Performance | Product Performance testing evaluation and Product Test / Balloon Inflation test demonstrated that the final device is not affected by the change in packaging configuration. The device's fundamental function (e.g., balloon inflation, catheter body integrity) remains consistent with the predicate. |
| Packaging Integrity | Packaging testing in accordance to ISO 11607-1 (Packaging for Terminally Sterilized Medical Devices) was successfully completed. This ensures the packaging maintains sterility and protects the device throughout its shelf life and distribution. |
| Sterilization Efficacy | Sterilization testing in accordance to ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide) was performed to ensure the new packaging configuration can be effectively sterilized while meeting established requirements for development, validation, and routine control of the sterilization process. |
| Biocompatibility/Safety | EO/ ECH residuals evaluation in accordance to ISO 10993-7:2008 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals) was conducted. This ensures any residues from the ethylene oxide sterilization process are within safe limits, indicating continued biocompatibility. Biocompatibility evaluations were conducted to ensure the change in final packaging did not alter the performance or safety of the subject devices (though specific tests aren't detailed, ISO 10993 series are often used). |
| Overall Equivalence | "The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe models have successfully passed performance, packaging, sterility assurance and EO/ECH residuals testing demonstrating that the subject devices are substantially equivalent to the predicate devices." The core "performance" is that the device (catheter) physically performs as intended for its stated Indications for Use, which is implicitly demonstrated by the absence of negative impact from packaging changes and by comparing it to the pre-amendment predicate device. The new model numbers, labels, and IFU updates stemming from the packaging change were also part of this evaluation. |
2. Sample size used for the test set and the data provenance
This is not applicable to this type of 510(k) submission. The "test set" here refers to the actual physical devices and packaging subjected to the engineering and biocompatibility tests. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for balloon inflation, how many packaging samples for integrity). Data provenance (country of origin, retrospective/prospective) is not relevant to these engineering and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of device performance in this 510(k) is established by adherence to recognized international standards (e.g., ISO 11607-1, ISO 11135, ISO 10993-7) and internal company specifications for manufacturing and quality control. There isn't an "expert" panel adjudicating test results in the same way they would for a diagnostic AI's clinical performance.
4. Adjudication method for the test set
Not applicable. Test results are evaluated against predetermined pass/fail criteria defined by the relevant standards and internal specifications, rather than through an adjudication process involving multiple human experts.
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 physical embolectomy catheter and biliary balloon probe, not a diagnostic AI or CADe system. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/algorithm-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed (packaging, sterilization, material safety, basic functional performance) is based on:
- International standards: ISO 11607-1, ISO 11135, ISO 10993-7 provide the objective criteria for what constitutes acceptable performance and safety.
- Predicate device characteristics: The modified device must perform equivalently to the existing, legally marketed predicate device, which inherently established its "ground truth" for safety and effectiveness in its original clearance.
- Engineering specifications: The manufacturer's own design and quality specifications for the device's materials, dimensions, and function.
8. The sample size for the training set
Not applicable. There is no training set for a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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).