(75 days)
The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.
The NBN-D is a dual cannula device made from stainless steel hypodermic needles. The device requires suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue. The device is designed to be used with the Radionics CRW system.
This submission is for a medical device called the Radionics Nashold Biopsy Needle - Single Use, a disposable biopsy needle intended for stereotactic biopsy of brain tumors. The provided text is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information regarding detailed study design, acceptance criteria, and specific performance results for the device itself is not available in the provided text.
However, I can extract the available information and highlight what is missing based on your request.
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Functional Performance | This information is not explicitly stated in the provided 510(k) summary or FDA letter. For a device like a biopsy needle, typical acceptance criteria would involve: |
- Tissue Acquisition Efficacy: Ability to consistently obtain sufficient tissue samples for diagnosis.
- Cutting Mechanism Effectiveness: Clean and precise tissue cutting.
- Biocompatibility: No adverse reactions with biological tissue.
- Sterility: Maintenance of sterility.
- Usability with CRW system: Compatibility and proper functioning when used with the specified Radionics CRW system.
- Structural Integrity: Resistance to bending, breaking, or dulling during use. | This information is not explicitly stated in the provided 510(k) summary or FDA letter. The submission relies on substantial equivalence to predicate devices, implying that its performance is comparable to established biopsy needles. Specific quantitative performance data (e.g., success rate of tissue acquisition, sample size, or integrity after use) is not given. |
| Intended Use | The device is intended for single patient use in stereotactic biopsy of brain tumors. | The device's intended use matches the stated criteria: "The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors." This is a qualitative match. |
| Material Composition | The device is made from stainless steel hypodermic needles. | The device description states: "The NBN-D is a dual cannula device made from stainless steel hypodermic needles." This is a qualitative match. |
| Mechanism of Action | Requires suction provided by a syringe to draw tissue, inner cannula rotated to cut tissue. | The device description states: "The device requires suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue." This is a qualitative match. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. A 510(k) submission primarily focuses on demonstrating substantial equivalence to existing predicate devices, often through comparison of design, materials, and intended use, rather than presenting a novel clinical study with a test set of patient data to prove effectiveness. If any testing was done (e.g., bench testing for mechanical properties), details about the sample size and data provenance are not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. Given that this is a 510(k) submission for a biopsy needle and not an AI/diagnostic device, the concept of "ground truth" and expert adjudication in the context of a test set for performance evaluation is generally not applicable in the same way as for an image analysis or diagnostic support system. If any expert evaluation for tissue integrity or diagnostic quality was performed on samples, it is not detailed here.
4. Adjudication Method for the Test Set
This information is not provided. As with point 3, the concept of an adjudication method for a test set is typically associated with studies involving diagnostic performance or interpretation, which is not the primary focus of this 510(k) submission for a biopsy needle.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
This information is not applicable and not provided. A MRMC comparative effectiveness study is relevant for AI-assisted diagnostic tools (e.g., image analysis software). The Radionics Nashold Biopsy Needle is a physical medical device, not an AI or diagnostic software, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable and not provided. This type of study is relevant for algorithms performing tasks independently. As the device is a physical biopsy needle, this concept does not apply.
7. The Type of Ground Truth Used
This information is not explicitly stated or readily applicable in the context of this 510(k) submission. For a biopsy needle, "ground truth" might refer to histological confirmation of tissue obtained by the needle, or the accuracy of the biopsy procedure itself. However, the provided document does not detail such studies or the ground truth establishment method.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms. The Radionics Nashold Biopsy Needle is a physical, mechanical device, and does not involve an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As explained in point 8, there is no training set for this type of device.
Summary of Available Information from the 510(k) (K032054):
The provided text from K032054 primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices (MRI Devices Corporation's Daum Neurocut Neurobiopsy Needle, Ad-Tech's Brain Biopsy Needle For Stereotaxic, and Elekta Instrument's Leksell Sedan Biopsy Needle). It describes the device's design, materials, and intended use. It does not contain detailed performance studies, specific acceptance criteria with quantitative results, or information about clinical trials, test sets, or ground truth establishment that would be typically found for novel diagnostic algorithms or devices requiring extensive clinical validation. The FDA's decision to clear the device is based on its similarity to legally marketed devices, subject to general controls.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).