(277 days)
The Brain Biopsy Needles are used during guided procedures and by methods deemed safe by the physician/surgeon to remove a targeted tissue for biopsy.
Brain Biopsy Needles are used to remove a targeted sample of brain tissue for analysis. These Brain Biopsy Needles are side-cutting needles. Side-cutting needles can extract several tissue samples without requiring a new trajectory.
Biopsy needles are used to sample brain tissue or to extract brain tissue samples to determine tissue abnormality or any deviation from healthy brain tissue. These Brain Biopsy Needles substantially consist of two cannulae that fit inside one another. Both cannulas have a sampling window opening in the distal tip. The inner cannula window opening has a sharp edge. The Brain Biopsy Needle is placed into tissue to the desired depth. An aspiration syringe may be attached to the brain biopsy to support aspiration of a small amount of tissue into the sampling window. The inner cannula is rotated such that the sampling window removes a tissue sample. The inner cannula is removed. The tissue sample from the inner cannula is removed for analysis. The inner cannula may be passed back through the outer cannula and additional biopsies can be taken as directed by the surgeon.
This document describes the Ad-Tech Medical Instruments Corporation's Brain Biopsy Needle and its 510(k) summary for MRI Conditional labeling.
1. Table of Acceptance Criteria and Reported Device Performance
For this specific submission (K112094), the acceptance criteria and reported device performance are related to the MRI Compatibility of a specific variation of the Brain Biopsy Needle.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| MRI Compatibility (for Model MDBM-08-28) | Acceptable performance under expected MRI conditions | Demonstrated acceptable performance through MR modeling and MRI testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a clinical or observational study with a certain number of patient cases or samples. Instead, the testing relates to the physical device's interaction with MRI environments.
- Sample Size: The testing was performed on the Model MDBM-08-28 Brain Biopsy Needle variation. The document does not specify a number of individual units of this variation that were tested, but rather refers to "MRI modeling and MRI testing."
- Data Provenance: The testing was conducted by or for Ad-Tech Medical Instruments Corporation. The document does not specify country of origin for the data or whether it was retrospective or prospective, as it pertains to engineering/device characterization rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission concerns the physical characteristics and safety of a medical device in an MRI environment, not diagnostic accuracy requiring expert interpretation for ground truth. The "ground truth" here is established by engineering standards and validated MRI testing protocols.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication of findings.
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, not an AI-powered diagnostic tool. The submission is for a 510(k) premarket notification for an MRI-conditional label, not an AI/CAD device.
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 an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating MRI compatibility was based on established engineering principles, MRI safety standards, and validated testing protocols (e.g., for magnetic field interactions, RF heating, and image artifact assessment). The document specifically mentions "MR modeling and MRI testing."
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/Machine Learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this device.
§ 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).