(21 days)
The Breast Tissue Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
The StarchMark® Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker. The marker contains six polysaccharide (starch) pellets and one polylactic/polyglycolic acid-based copolymer (PLA/PGA) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PLA/PGA pellet contains a Stainless Steel Ribbon or "V" shaped wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The StarchMark® Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
The StarchMark UltraCor™ Breast Tissue Marker is a sterile, single use device, comprised of a disposable applicator and an implantable marker contains four polysaccharide (starch) pellets and one polyethylene glycol (PEG) pellet which are essentially resorbed by the body after approximately 2 weeks. The polysaccharide pellets absorb body fluids to help in the control and management of bleeding. The PEG pellet contains a Stainless Steel "V" shaped wireform. The wireform is intended for longterm radiographic marking of the biopsy site. The StarchMark UltraCor™ Breast Tissue Marker is intended for breast tissue marking during a breast biopsy procedure.
This submission for K131654, for the StarchMark® Breast Tissue Marker and StarchMark UltraCor™ Breast Tissue Marker, is a Special 510(k) for a device modification. This type of submission is used when changes to a legally marketed device do not affect the fundamental scientific technology of the device and do not raise new questions of safety or effectiveness.
In this specific case, the only modification is to the labeling, specifically moving a statement regarding allergic reactions from the warnings section to the contraindications section. Because the change does not affect the device's design, materials, performance specifications, packaging, or sterilization, no new performance testing was deemed necessary or performed to demonstrate that the device meets acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not applicable to this particular 510(k) submission. There is no new study performed to demonstrate device performance against acceptance criteria for this modification.
Here's a breakdown of what can be derived from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. No new performance testing was conducted for this Special 510(k) modification. The basis for substantial equivalence relies on the unchanged design and performance of the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No new test set or data provenance details are provided as no new performance testing was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No new ground truth establishment process was needed as no new performance testing was performed.
4. Adjudication Method for the Test Set:
Not applicable. No new test set or adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. An MRMC study was not done. This type of study would typically be conducted for new diagnostic devices where human reader performance is a key metric. This submission is for a tissue marker, and the modification does not relate to diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
No. This device is a physical tissue marker, not an algorithm, so standalone performance testing in this context is not applicable.
7. The Type of Ground Truth Used:
Not applicable. No new ground truth was established for this modification. The device's safety and effectiveness were previously established through the predicate device's clearance.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a training set as it's a physical medical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As above, there is no training set for this 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.