(74 days)
The 8 Gauge MicroMark II Tissue Marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.
The 8 Gauge MicroMark II Tissue Marker is a sterile, single patient use device comprised of a small stainless steel marker (clip) and a disposable Introducer and Applier. The Introducer consists of a flexible tube, a distal ramp, and a lateral port. The applier consists of a flexible shaft, a deployment mechanism and a handle. The marker is located at the distal end of the applier.
The 8 Gauge MicroMark II Tissue Marker is used with the currently marketed Ethicon Endo-Surgery, Inc. Mammotome® Hand-Held 8 Gauge Probe, which functions as a standard rigid coaxial Introducer.
The Tissue Marker is used with imaging guidance (stereotactic and ultrasound).
The provided text is a 510(k) summary for the 8 Gauge MicroMark™ II Tissue Marker. It describes the device, its indications for use, and technological characteristics. However, it does not contain detailed information about acceptance criteria or specific studies proving the device meets these criteria.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Study for the 8 Gauge MicroMark™ II Tissue Marker
The provided 510(k) summary does not explicitly state acceptance criteria or provide a detailed study report demonstrating how the device meets them. It generally refers to "bench testing" to show the device performs as intended, which is common for predicate device submissions focused on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document focuses on demonstrating substantial equivalence to a predicate device, the MicroMark Clip, and mentions design changes (increase in introducer diameter) but not specific quantitative or qualitative acceptance criteria. | "Bench testing was performed to demonstrate that the device will perform as intended." |
| The document does not provide details of the "bench testing" or its results. It states that the implantable stainless steel marker (clip) is identical to the marketed predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document only mentions "bench testing," implying laboratory-based testing, but does not provide details on data origin or whether it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The review is for a medical device (a tissue marker), not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation. The "ground truth" for a device like this would relate to its physical properties, safe deployment, and ability to mark tissue effectively, which are evaluated through engineering tests, not expert interpretation of outputs.
4. Adjudication method for the test set
- Not applicable and not provided. See explanation for point 3.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- No, a MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This device is a physical marker.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical tissue marker, not an algorithm.
7. The type of ground truth used
- For a device like this, the "ground truth" would be established by engineering specifications, material properties, and functional performance tests (e.g., successful deployment, retention in tissue, visibility under imaging). The document broadly states "Bench testing was performed to demonstrate that the device will perform as intended," implying these types of evaluations were conducted, but specific details of the ground truth (e.g., a measured dimension, a successful deployment rate) are not provided.
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical medical device, not an AI or machine learning algorithm.
Summary of Missing Information in the 510(k) Summary:
The provided 510(k) summary is very high-level and, by its nature as a summary, omits many details that would be found in a full submission. Specifically, it lacks:
- Quantitative or qualitative acceptance criteria.
- Detailed descriptions of the "bench testing" study, including methods, protocols, sample sizes, and specific results.
- Any information related to human readers, experts, or ground truth establishment in a diagnostic context, as the device is a physical marker.
The regulatory approval (K020276) for this device was based on a finding of substantial equivalence to a predicate device (MicroMark Clip), which often relies on demonstrating that the new device's design and performance are comparable to the previously cleared device, rather than extensive de novo clinical trials or detailed performance metrics against novel acceptance criteria. The claim of "bench testing was performed to demonstrate that the device will perform as intended" is the extent of the performance data provided in this public summary.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.