(62 days)
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:
| Acceptance Criteria Category/Test | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Ability to extract a biopsy tissue sample | Performs according to intended use |
| Average Tissue Length | Performs according to intended use |
| Edge of Cut Sample Evaluation | Performs according to intended use |
| Force to Arm the Safety Biopsy Needle | Performs according to intended use |
| Force to Activate the Safety Biopsy Needle | Performs according to intended use |
| Multiple Arming-Activation of the Safety Biopsy Needle | Performs according to intended use |
| Penetration Force of the Safety Biopsy Needle | Performs according to intended use |
| Force to advance the Depth Stop on the Safety Coaxial Needle | Performs according to intended use |
| Force to penetrate tissue on the Safety Coaxial Needle | Performs according to intended use |
| Safety Features Performance (Anti-Needle Stick): | |
| Force to overcome the Anti-Needle Stick Feature Safety Biopsy Needle | Performs according to intended use |
| Force to Break Safety Tape Safety Biopsy Needle | Performs according to intended use |
| Force to detach Safety Tape from Adapter | Performs according to intended use |
| Force to detach Safety Tape from Spool | Performs according to intended use |
| Force to peel Safety Tape after being affixed to each other | Performs according to intended use |
| Force to overcome the Anti-Needle Stick Feature Safety Coaxial Needle | Performs according to intended use |
| Force to Break Safety Tape Safety Coaxial Needle | Performs according to intended use |
| Force to detach Safety Tape from Trocar Hub | Performs according to intended use |
| Simulated Clinical Use: | |
| Simulated Clinical Use Evaluation | Performs according to intended use |
| Sharps Injury Prevention Evaluation | Performs according to intended use |
| Biocompatibility: | |
| ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1) | Device meets the requirements of ISO 10993-1:2009 |
| ISO 10993-7:2008 (Ethylene Oxide Sterilization Results) | Performs according to intended use (implied by overall summary) |
| Sterilization: | |
| ISO 11135:2007 (Sterilization of Healthcare Products Ethylene oxide) | Performs according to intended use (implied by overall summary) |
| Risk Management: | |
| ISO 14971:2007 (Medical Devices - Risk Management for Medical Devices) | Performs according to intended use (implied by overall summary) |
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).
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.