Search Results

The Safety Biopsy Needle System (Safety Biopsy Needle and Safety Coaxial Needle with Finger Guard) is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes.

When used for breast biopsy, the product is for diagnosis only. The extent of histological 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 histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.

The Safety Biopsy Needle System consists of two main components: The Safety Biopsy Needle and the Safety Coaxial Needle with Finger Guard.

The Safety Biopsy Needle is composed of two primary assemblies: the biopsy needle and the safety mechanism. The material used to manufacture both the biopsy needle and the safety mechanism is polycarbonate. The needle sheath is made of polyethylene. The available gauges for the safety biopsy needle ranges in size from 14 to 20, with lengths ranging up to 20 centimeters.

The Safety Coaxial Needle with Finger Guard is composed of two primary assemblies, the coaxial needle cannula and the stylet. The material used to manufacture the assembly and introducer cannula, and for trocar stylet, is stainless steel. The needle sheath is made of polyethylene. The available gauges for the safety coaxial needle with finger guard ranges in size from 15 to 19, with lengths ranging up to 17 centimeters.

The Safety Biopsy Needle System is sterilized via Ethylene Oxide (EtO) and is designed for single use only.

This document describes the 510(k) summary for the Safety Biopsy Needle System. Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The primary "study" proving the device meets acceptance criteria is a series of non-clinical bench tests and biocompatibility tests. The acceptance criteria are implicitly met by the successful completion of these tests, demonstrating the device's functional integrity, safety features, and material compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance values. Instead, it lists the types of performance tests conducted and then states a general conclusion about their successful outcome.

Implicit Acceptance Criteria (based on tests conducted) and Reported Device Performance:

The summary explicitly states: "All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications." and "The biocompatibility tests conducted on the Safety Biopsy Needle System demonstrate that the device meets the requirements of ISO 10993-1:2009."

2. Sample size used for the test set and the data provenance

The document lists "non-clinical bench tests" and "biocompatibility tests" as the performance evaluation methods. It does not specify the sample sizes used for these tests. Data provenance is not applicable in the sense of patient data, as these are bench tests. The tests are conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For bench tests, the "ground truth" is typically the established engineering and safety standards, and the adherence of the device to its design specifications. Expert consensus in a clinical diagnostic sense (e.g., radiologists interpreting images) is not relevant for this type of device and testing.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human reviewers for clinical data. This is a technical bench test evaluation, not a clinical study involving human judgment on diagnostic results.

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

Not applicable. This device is a biopsy needle system, not an AI or diagnostic imaging device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used

The ground truth used for these performance tests is engineering specifications, established international standards (e.g., ISO, AAMI/ANSI), and the device's intended use parameters. For example, "Force to activate the Safety Biopsy Needle" would be measured against a predetermined, acceptable force range specified in the design. For biocompatibility, the ground truth is the pass/fail criteria defined by ISO 10993-1:2009.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument evaluated by bench testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable (as above).

Ask a specific question about this device