(189 days)
The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location.
It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.
The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers.
This document is a 510(k) premarket notification for a medical device called the "MicroMark Clip." It seeks to establish substantial equivalence to a legally marketed predicate device, the "BMI Surgical Staple Marker." This type of submission generally focuses on comparisons to existing devices rather than extensive clinical studies with acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.
Based on the provided text, a formal study with acceptance criteria and reported device performance, as well as details about sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, was not performed or is not described in this document.
Instead, the submission primarily relies on:
- Technological Characteristics Comparison: The core argument for substantial equivalence is that the MicroMark Clip has technological characteristics "substantially equivalent" to the predicate device.
- Identical Design, Construction, and Materials: The document explicitly states: "The design, construction, materials, nominal specifications are identical to the marketed predicate device." Both devices are described as consisting of a non-absorbable, X-ray compatible material.
- Identical Intended Use: The intended use of both devices is to "be applied to soft breast tissue during open or percutaneous procedures and radiographically mark the surgical location."
Therefore, I cannot provide the requested table or detailed study information because it is not present in this 510(k) submission. The FDA's letter confirms substantial equivalence based on the provided information, which emphasizes the similarity to the predicate device rather than independent performance testing against defined acceptance criteria.
To elaborate on why this information is missing:
- 510(k) Process: A 510(k) premarket notification is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. The core of a 510(k) is to demonstrate this equivalence, often by comparing design, materials, technological characteristics, and intended use. It typically does not require new clinical studies demonstrating safety and effectiveness against specific performance criteria if equivalence can be established through other means (e.g., bench testing, material comparisons, and comparison to the predicate's known performance).
- "Acceptance Criteria" in 510(k): While a 510(k) doesn't typically define "acceptance criteria" for clinical performance in the same way a clinical trial would, the "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to the predicate device, which the FDA concluded was met.
In summary, the document you provided does not contain the information requested in points 1-9 because this type of 510(k) submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and corresponding performance data.
§ 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.