(89 days)
THE HEMORRHAGE OCCLUDER PIN IS INDICATED TO BE USED TO STOP MASSIVE PRESACRAL HEMORRHAGE DURING SURGERY
HEMORRHAGE OCCLUDER PIN (HOP) is of 7mm length and 8mm pinhead. It is made out of medical grade Titanium suitable for implantation.
The provided text is a 510(k) summary for the HEMORRHAGE OCCLUDER PIN (HOP), which is an implantable staple. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth), and training set details cannot be extracted from this document as such a study is not described.
The summary states:
- "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)"
- "Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution."
This indicates that the submission relies on demonstrating similarity to a previously approved device rather than presenting a new clinical performance study with specific acceptance criteria and detailed results.
In summary, the document does not contain the information required to populate the outlined sections.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.