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Bone and Bone marrow biopsy devices – Ben, Best Lisas, and Mielo-Can are indicated to harvest bone and / or bone marrow specimens. The pediatric bone marrow needle is intended for the purpose of obtaining access to the medullary cavities for the purpose of initiating resuscitative infusion or for aspirating marrow in pediatric patients. Soft Tissue Devices – Spring-Cut, Bio-Cut, Fast-Gun and Colt are indicated to provide tissue samples of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate, for diagnostic sampling of abnormalities. They are designed to provide tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Sterylab family of biopsy products which include different needles and handles for various procedures. The configurations include manual, semi-automatic and automatic systems. They incorporate various needles styles to optimize capture of the biopsy samples and minimize patient discomfort. The soft tissue devices use a spring-powered mechanism. Some may be used in MRI environments.

The provided text is a 510(k) premarket notification for biopsy devices (needles and instruments). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria that would typically be described with performance metrics.

Therefore, the document does not contain the information requested in the prompt, such as acceptance criteria, reported device performance, study details (sample size, data provenance, expert analysis, adjudication), MRMC studies, standalone performance, or ground truth establishment.

Instead, the document focuses on:

• Device Description: What the devices are (various biopsy needles and handles for manual, semi-automatic, and automatic systems).
• Indications for Use: What the devices are intended for (harvesting bone/bone marrow specimens and providing tissue samples from various soft organs).
• Predicate Devices: Listing similar devices already on the market (MD Tech products).
• Comparison to Predicate Devices: Stating that "There are no significant differences between the proposed devices and the predicates and raise no new safety or efficiency concerns." (This is the core of a 510(k) submission).
• FDA Substantial Equivalence Determination: The FDA's letter confirming that the device is "substantially equivalent" to legally marketed predicate devices.

In summary, this document is a regulatory submission for substantial equivalence, not a clinical study report proving performance against acceptance criteria.

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