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This single use device is for radiological identification of the aortic anastomosis in coronary artery bypass surgery

This 4.5mm outer diameter suturing washer is manufactured from either stainless steel (ASTM F-138) or titanium (ASTM F-136). It is permanently implanted and must be sterilized prior to use.

The provided text is a 510(k) summary for a medical device called "Suturing Washer." This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a study.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, or 9. It does not describe any specific studies with acceptance criteria or performance data.

Instead, it asserts that the Suturing Washer is substantially equivalent to a predicate device (Cook® Vein Graft Ring Marker, K864101) based on similarities in:

• Intended Use: Radiological identification of the aortic anastomosis in coronary artery bypass surgery.
• Performance Characteristics: Not explicitly detailed, but implied to be similar to the predicate.
• Materials of Construction: Stainless steel (ASTM F-138) or titanium (ASTM F-136).
• Manufacturing Methods: Not detailed, but asserted to be similar to the predicate.
• Design: A circular device with an outer diameter of 4.5mm, inner diameter of 1.5mm, and approximately 1mm thickness, similar to the predicate's ring marker design.

The FDA's letter (K052642) confirms the finding of substantial equivalence, allowing the device to be marketed. This process relies on the assumption that if a new device is substantially equivalent to a legally marketed predicate, it shares the same safety and effectiveness.

In summary, there is no information in the provided text about acceptance criteria, performance studies, sample sizes, expert involvement, or adjudication methods for the "Suturing Washer."

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