(60 days)
The UltraCor® Twirl® Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.
The ULTRACOR® Twirl® Breast Tissue Marker consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.
The provided text describes a 510(k) premarket notification for the UltraCor Twirl Breast Tissue Marker. However, it explicitly states that no performance data (bench testing or clinical analysis) was warranted due to the nature of the change.
The key information regarding acceptance criteria and study details is as follows:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | No new or increased risks identified from the updated Indications for Use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No test set was used for a performance study.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable.
5. 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:
- MRMC Study: No. This device is not an AI-assisted diagnostic tool, but rather an implanted marker.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This device is an implanted marker, not a diagnostic algorithm.
7. The type of ground truth used:
- Ground Truth Type: Not applicable. The submission is based on an update to the Indications for Use, supported by a literature review and physician statements on existing clinical practice, rather than a direct performance study to establish a ground truth.
8. The sample size for the training set:
- Sample Size: Not applicable. No training set was used.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable.
Explanation from the document:
The 510(k) submission (K180061) for the UltraCor Twirl Breast Tissue Marker focused on an update to its Indications for Use to include axillary lymph nodes. The manufacturer explicitly states:
- "The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted." (Page 5, Section 8. Performance Data)
- "The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements." (Page 5, Section 9. Clinical Analysis)
Therefore, this submission did not involve a study to prove performance against specific acceptance criteria in the traditional sense of a diagnostic or therapeutic device. Instead, it leveraged existing knowledge and clinical practice to justify the expanded indication of an already cleared device.
§ 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.