Search Results
Found 4 results
510(k) Data Aggregation
(28 days)
Disposable Pre-calibrated Brain Biopsy Needle 2.0
The Disposable Pre-calibrated Biopsy Needle for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Pre-calibrated Biopsy Needle is provided in a set.
The Disposable Pre-calibrated Biopsy Needle is a dual cannula device made from stainless steel. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue.
Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.
Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.
Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.
There are different versions of the Disposable Brain Biopsy Needle 2.0 for following use-cases:
Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide. Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position.
Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.
Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Pajunk GmbH Medizintechnologie regarding their Disposable Pre-calibrated Brain Biopsy Needle 2.0. The core of the information provided for acceptance criteria and device performance relates to MRI conditional labeling.
Here's an analysis of the provided information, structured to address your questions. Please note that many of your points (e.g., sample size for training set, number of experts for ground truth, multi-reader multi-case studies) are not applicable to this specific submission because it pertains to a physical medical device (a biopsy needle) and not an AI/ML algorithm or software as a medical device (SaMD). The acceptance criteria here are for the device's physical safety and compatibility, specifically in an MRI environment.
Acceptance Criteria and Device Performance for Disposable Pre-calibrated Brain Biopsy Needle 2.0
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Test Method Summary | Reported Device Performance / Result |
|---|---|---|
| MRI Safety: Magnetically Induced Displacement | According to ASTM F2052-15 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment". The medical device is suspended by a string in an MR system near the bore entrance. The angular deflection of the string from the vertical is measured. Acceptance Criterion (implicit based on ASTM F2052-15): If the device deflects less than 45°, then the deflection force induced by the MR System's magnetic field is less than the force on the device due to gravity (its weight). This is generally considered acceptable for "MR Conditional" labeling. | No magnetically induced displacement was detectable for the test object "Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm" used within this test and in the described MR environment of a 3 Tesla Siemens Magnetom Vida MR scanner. This result meets the implicit acceptance criterion of ASTM F2052-15. |
| MRI Safety: Usage within 5 Gauss line marking | Testing was conducted to demonstrate the device is safe to be used in an MR environment if a 5 Gauss line (0.5 mTesla) is clearly marked on the floor around the MR scanner. This likely implies that the device does not pose a significant hazard when brought into proximity of an MR scanner, provided appropriate safety zones are respected. | The document states that testing was conducted to demonstrate safety under these conditions. The "Conclusion" section indirectly confirms this by stating the device is "as safe and effective as the legal predicate devices" due to this testing. No specific quantitative result is provided beyond the statement of safety. |
| Biocompatibility | (Implied) Evaluation against ISO 10993-1. | ISO 10993-1 compliant material & set components. Result: Identical to predicate device, indicating compliance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the MRI testing. It refers to "the test object 'Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm'". This wording suggests that the testing was performed on at least one representative unit of the device. For physical device testing, particularly for magnetic properties, often a single, representative sample is sufficient if the manufacturing process ensures consistency.
- Data Provenance: The testing was conducted in a laboratory setting, likely in Germany (where Pajunk GmbH Medizintechnologie is located), using a Siemens Magnetom Vida MR scanner. This is a controlled, prospective laboratory study to assess device properties. It is not patient or clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- N/A. This submission is for a physical medical device (biopsy needle), not an AI/ML or diagnostic software. Ground truth in this context refers to physical properties tested in a lab, not expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
- N/A. As above, this is laboratory testing of a physical device, not an interpretation task requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a study involving human readers or diagnostic interpretation. It is a study on the physical properties of a medical device (MRI compatibility).
6. Standalone (Algorithm Only) Performance
- N/A. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
- The ground truth for the device's MRI compatibility testing was established by physical measurement against a recognized standard (ASTM F2052-15) using a 3 Tesla MR scanner. The "truth" is whether the device exhibits magnetic displacement, as defined by the standard's criteria (e.g., deflection less than 45 degrees).
8. Sample Size for the Training Set
- N/A. There is no "training set" as this is a physical device, not an AI/ML model.
9. How the Ground Truth for the Training Set was Established
- N/A. As above, there is no training set.
In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a brain biopsy needle) to a predicate device, with a specific emphasis on the addition of "MR Conditional" labeling. The "study" in question is a performance test (specifically, magnetic displacement) conducted under lab conditions, adhering to an ASTM standard, to prove the device's safety in an MRI environment.
Ask a specific question about this device
(142 days)
Disposable Brain Biopsy Needle 2.0
The Disposable Brain Biopsy Needle 2.0 for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Brain Biopsy Needle 2.0 is provided in a set.
Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.
Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.
Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.
There are different versions of the Biopsy Needle for following use-cases:
Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide, Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position.
Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.
The provided text describes a 510(k) premarket notification for a medical device, the Disposable Brain Biopsy Needle 2.0. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets acceptance criteria, especially not for an AI/ML powered device. This submission focuses on comparing the new device's design and performance characteristics to a previously cleared predicate device (K060808, BrainPro/BrainPro ACCESS).
Here's why the requested information cannot be fully provided based on the given text:
- No new clinical study details: The 510(k) process for this type of device (a modified existing device with unchanged intended use) often relies on design verification and validation testing to show that the modifications do not negatively impact safety or effectiveness, and that the new device performs comparably to the predicate. It does not typically involve human subject clinical trials with AI/ML-specific acceptance criteria.
- Focus on Substantial Equivalence: The document explicitly states, "Performance of the subject device is verified and validated through testing with the predicate device as well as by additional testing." This implies bench testing and non-clinical performance comparisons, not a clinical trial with human readers or AI algorithms.
- No AI/ML Component: The device described is a physical biopsy needle, not an AI/ML software device. Therefore, acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, reader improvement, standalone performance) are not applicable.
However, I can extract information related to the device's comparison to its predicate, which serves a similar function to demonstrating "acceptance" within the 510(k) framework for this type of device.
Based on the provided document, here's an attempt to address your questions, highlighting where the requested information is not applicable or not present:
The information provided describes a 510(k) premarket notification for a physical medical device (a brain biopsy needle), not an AI/ML-powered software. Therefore, many of the questions related to AI/ML specific performance studies (e.g., MRMC studies, standalone algorithm performance, expert consensus for AI ground truth) are not applicable to this submission. The "acceptance criteria" here are framed within the context of demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) for a physical device where the intended use is identical and modifications are primarily design updates, "acceptance criteria" revolve around ensuring the new device performs as safely and effectively as the predicate. The document states:
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: The fundamental technical design and mechanism of action (e.g., dual cannula, vacuum suction, rotating cutting mechanism, navigation via marker, blunt tip) should remain consistent with the predicate device, ensuring equivalent functional performance for tissue acquisition. | "The fundamental technical design of the brain biopsy needle as well as of brain biopsy needles in general - sterile supply, Sedan type blunt tip, vacuum suction chamber, rotating cutting mechanism, navigation via marker, labelling - basically remains unaltered." |
| "Performance of the subject device is verified and validated through testing with the predicate device as well as by additional testing." | |
| "The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue." (Identical to predicate description). | |
| Material Equivalence/Compatibility: Materials (e.g., stainless steel) should be equivalent or have demonstrated compatibility, especially if MRI compatibility is added. | "The Disposable Brain Biopsy Needle 2.0 is a dual cannula device made from stainless steel." (Predicate could be stainless steel or titanium, but the new device explicitly states stainless steel). |
| "The Disposable Brain Biopsy Needle 2.0 is labelled as MRI conditional." (This is an added performance characteristic, not a change to the fundamental mechanism, but part of the stated equivalence). | |
| Safety and Sterility: The sterilization method and sterile supply to the end-user should be maintained, and the device should be free from identified safety concerns. | "Sterilization method: Ethylene Oxide, disposable device supplied sterile to the end user." (Consistent with industry practice for such devices). No safety concerns are mentioned in the positive determination letter. |
| Intended Use and Indications for Use Equivalence: The scope of use, target patient population, and user group should be identical to the predicate. | "Neither the intended use nor the indications for use are altered." |
| "Intended use as well as Indications for use, sequence of use, target patient population and user target group remain unaltered." | |
| "The Intended Use of the Predicate device and of the subject device is identical. The indications for use of the Predicate device and of the subject device is identical. In order to provide state of the art information, MRI information has been added. The subject device is substantially equivalent to the predicate device." | |
| Performance (Bench Test) Equivalence: Bench testing should demonstrate comparable or equivalent performance characteristics (e.g., cutting ability, tissue acquisition, navigation compatibility if applicable, and adherence to specifications). This is implied by the "Design verification process" and "validated through testing with the predicate device." Specific metrics are not provided in this summary but would be detailed in the full 510(k) submission. | "So substantial identity of the modifications is based on earlier submissions by the sponsor and verified through Design verification process." |
| "Performance of the subject device is verified and validated with the predicate device." | |
| "Each of the devices subject to this modification of a cleared 510(k) has been validated and verified initially and is under constant batch monitoring and testing/inspection according to the specifications cleared." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary. Performance testing for this type of device (bench testing) would typically involve a sample size sufficient to demonstrate consistency and equivalence, but it's not a "test set" in the context of clinical AI/ML validation data.
- Data Provenance: The testing is likely retrospective (on manufactured devices/materials) and conducted by the manufacturer (PAJUNK® GmbH Medizintechnologie) in Germany. It refers to "Design verification process" and "testing with the predicate device," implying lab-based, non-clinical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, and the "ground truth" for its performance is established through engineering design verification and validation (bench testing, material testing, functional testing), not through expert clinical interpretation of data as it would be for an AI/ML algorithm.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this isn't a study involving human readers or AI requiring adjudication of results. "Adjudication" for this device would refer to internal design control processes and quality assurance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- No. An MRMC study is a clinical study design used to evaluate the diagnostic accuracy of imaging interpretations, especially with AI assistance. This device is a biopsy needle, not an imaging interpretation tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to engineering specifications, functional performance requirements (e.g., ability to acquire tissue, cut precisely), material properties, and sterility assurance, as demonstrated through a rigorous design verification and validation process (bench testing, mechanical testing, material compatibility, sterilization validation). This is typically compared directly to the predicate device during testing.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The development process involves design and manufacturing, not model training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above.
Ask a specific question about this device
(277 days)
BRAIN BIOPSY NEEDLE
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.
Ask a specific question about this device
(36 days)
DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
The Orion Medical Disposable Brain Biopsy Needle is an aspiration biopsy needle to remove and sample tissue within the brain in conjunction with a sterotactic head frame. The following statement describes the indications for use of Orion Medical's 14 gauge, and 18 gauge sterotactic disposable brain biopsy needle:
- Sterotactic biopsy needle used to sample brain tissue or to extract brain tissue samples to . determine tissue abnormality or any deviation from healthy brain tissue.
- . Tissue samples are extracted via the cannula using a syringe to aspirate. The cannula is then removed and the tissue sample is placed on a glass slide or sample dish, which is sent to anatomical pathology for smear analysis to determine tissue type.
- . Needle to be used in conjunction with a sterotactic frame with a center-of-the-arc of 21cm. The needles are 21cm from the hub of the needle to the sharp front cutting edge.
The Orion Medical Inc. three piece disposable Brain Biopsy Needle for sampling brain tissue is to be used in conjunction with a sterotactic head frame. The Orion Medical disposable Brain Biopsy Needle is inserted in the brain through a burr hole via a sterotactic head frame to a desired target that is obtained by a CT image. Tissue samples are obtained by aspirating through the Orion Medical disposable Brain Biopsy Needle is then removed from the brain and the sterotactic system and the sample is expelled from the brain biopsy needle onto a slide for analysis. The Orion Medical disposable Brain Biopsy Needle is similar in geometry, safety, function, and intended use as currently available brain biopsy needles.
The provided text is a 510(k) Summary for a medical device (Orion Medical Inc. Disposable Brain Biopsy Needle) and does not describe any acceptance criteria or studies to prove the device meets them.
The document states that the device is "substantially equivalent in geometry, safety, function, and intended use as currently available brain biopsy needles." This is the basis for its 510(k) clearance, meaning it was compared to predicate devices already on the market, rather than requiring new performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text as it is not present.
Ask a specific question about this device
Page 1 of 1