(283 days)
The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The HydroMARK Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices.
The HydroMARK Breast Biopsy Site Marker has a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.
The provided text describes the regulatory clearance of the HydroMARK Breast Biopsy Site Marker, primarily focusing on demonstrating substantial equivalence to a predicate device, especially with an expanded Indication for Use to include axillary lymph nodes. It does not contain information about a study proving the device meets specific acceptance criteria related to a machine learning or AI algorithm.
The document mainly covers:
- Acceptance Criteria for Device vs. AI Algorithm: The "acceptance criteria" here refer to regulatory requirements for demonstrating "substantial equivalence" of a medical device to a previously cleared predicate device, rather than criteria for an AI algorithm's performance. The performance criteria for the device itself are related to visibility under imaging and biocompatibility.
- Device Performance: The document states that the device meets "all system requirements" and is "substantially equivalent" to the predicate. The performance is assessed through non-clinical bench testing for biocompatibility and design verification, as well as a literature search and clinician survey for the expanded indication.
Based on the provided text, the device itself (HydroMARK Breast Biopsy Site Marker) is a physical marker, not an AI algorithm. Therefore, the questions related to AI algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to the information contained in this FDA 510(k) summary.
Therefore, I cannot provide the requested information regarding an AI algorithm's acceptance criteria and study data because the provided document describes a physical medical device (a biopsy site marker), not an AI-powered diagnostic or assistive tool.
The acceptance criteria discussed in the document are primarily related to:
- Safety and Effectiveness: Demonstrated through biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subchronic Toxicity, Implantation, Genotoxicity, Carcinogenicity).
- Functional Performance: Visibility under ultrasound for at least 6 weeks, permanent visibility by x-ray and MRI.
- Substantial Equivalence: Comparison to a predicate device (Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker K210752) in terms of Indications for Use, design, functionality, materials, packaging, and sterilization.
- Expanded Indication for Use (Axillary Lymph Nodes): Supported by a literature search and clinician survey to show that this expanded use does not raise new safety or effectiveness concerns.
To directly answer the prompt's implied request for AI algorithm-specific details based only on the provided text, the relevant sections are empty as this is not an AI device submission.
§ 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.