(90 days)
FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment.
The FNA needles are comprised of a cannula and stylet assembly connected to a handle for ease of insertion into soft tissues of the body.
Here's an analysis of the provided text regarding the Baxter Fine Needle Aspiration Needle:
This submission is a 510(k) Summary of Safety and Effectiveness for a medical device. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through clinical studies as would be required for a novel or high-risk device. The provided text does not contain information related to acceptance criteria or a study demonstrating the device meets such criteria in terms of diagnostic performance or clinical outcomes.
Instead, the summary focuses on:
- Intended Use: Defining what the device is for.
- Substantial Equivalence: Showing that the new device is as safe and effective as existing predicate devices.
- Summary of Testing: Focusing solely on biocompatibility testing of the materials used in the device.
Therefore, many of the requested sections below cannot be filled from the provided text.
Analysis of K962907 - Baxter Fine Needle Aspiration Needle
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for diagnostic performance. | Not specified in the document for diagnostic performance. |
| Material Biocompatibility: |
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Hemolysis
- Pyrogenicity | Material Biocompatibility:
- Meet the requirements of ISO 10993, Part 1 ("Biological Evaluation of Medical Devices") and found to be acceptable for the intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable for diagnostic performance as no such study is described. For biocompatibility, the sample size and nature of "test subjects" (e.g., animal models, cell cultures) are not specified.
- Data Provenance: Not applicable for diagnostic performance. For biocompatibility, the origin of the data is the internal testing conducted by Baxter Healthcare Corporation, as outlined by ISO 10993. The study is prospective in the sense that the tests were performed specifically for this submission, following established protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No diagnostic performance study with ground truth establishment is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No diagnostic performance study with ground truth establishment is described.
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
- MRMC Study: No. This device is a manual aspiration needle, not an AI-powered diagnostic tool. The document does not describe any human-in-the-loop diagnostic studies, let alone MRMC studies involving AI.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is a manual medical instrument; it does not involve any algorithms or AI for standalone performance.
7. The type of ground truth used
- Type of Ground Truth: Not applicable for diagnostic performance. The "ground truth" demonstrated here relates to the biological safety of the materials, which is established by adherence to ISO 10993 standards and the resulting "acceptable" status.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This document does not describe the development or training of any diagnostic or AI model.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
Summary of Device Evaluation in this Document:
The K962907 submission for the Baxter Fine Needle Aspiration Needle primarily relies on demonstrating substantial equivalence to predicate devices (Baxter's Skinny Chiba Needles and Hart Enterprises Soft Tissue Biopsy Needles) based on having the same intended use and same performance attributes.
The "Summary of testing" explicitly focuses on biocompatibility testing of the materials used, confirming they meet ISO 10993 standards for cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, and pyrogenicity. This demonstrates the safety of the materials with which the device is constructed, but it does not address the clinical diagnostic performance or how well the device performs its function of obtaining cell samples for analysis in terms of accuracy, yield, or impact on patient outcomes. For a device like an aspiration needle, the performance attributes not explicitly tested here but implied by substantial equivalence could include needle sharpness, ease of penetration, structural integrity, and ability to extract sufficient sample material, but no studies proving these are detailed in the provided text.
§ 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.