(37 days)
The Embol-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.
The EMBOL-X Intra-aortic Filter is provided in a cartridge that locks into the filter lumen of the EMBOL-X Access Device/Aortic Cannula, and is inserted through the lumen by depressing a syringe like plunger mechanism. The filter then opens to fill the diameter of the ascending aorta. The filter is intended to be inserted temporarily during CPB. Filters are manufactured in 5 sizes to conform to patient anatomy.
This document is a 510(k) summary for the Edwards Lifesciences EMBOL-X Intra-aortic Filter. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for establishing new performance criteria through a standalone study.
Therefore, many of the requested details about acceptance criteria and a study proving a device meets them are not applicable to this type of submission. This document focuses on demonstrating comparability to an already legally marketed device.
Here's a breakdown of the relevant information provided:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for this device. The core "acceptance criterion" for a 510(k) is substantial equivalence to a predicate device.
- Reported Device Performance:
Characteristic Reported Performance (via comparison to predicate) Design Comparable Intended Use Comparable Materials Comparable Principle of Operation Comparable
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission is based on a comparison to a predicate device, not on a new clinical or performance study that would generate a test set with a specific sample size. The "Functional/Safety Testing" section explicitly states: "Not required for this change. Safety data are not new for this change."
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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. See point 2.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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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. This device is a physical intra-aortic filter, not an AI-driven diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical intra-aortic filter, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this 510(k) is the existing understanding and performance of the predicate device.
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The sample size for the training set:
- Not applicable. No new training set or study was conducted for this 510(k). The device relies on demonstrating equivalence to an existing product.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of the Study (Comparison to Predicate Device):
The "study" or justification presented in this 510(k) is a comparative analysis demonstrating that the EMBOL-X Intra-aortic Filter is substantially equivalent to its predicate device (also named EMBOL-X Intra-aortic Filters). This comparison is based on:
- Design
- Intended use
- Materials
- Principle of operation
The submission explicitly states: "Functional/Safety Testing: Not required for this change. Safety data are not new for this change." This indicates that no new performance or safety studies were conducted specifically for this 510(k) application. The FDA's letter confirms substantial equivalence, allowing the device to be marketed.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”