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510(k) Data Aggregation
(263 days)
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
The Semi-automatic Biopsy-Needle - BIM and Automatic Biopsy Needle - BAM are sterile, spring loaded, disposable percutaneous soft tissue biopsy systems. It consists of the following major components: handle, spring, cannula, stylet, trigger and spring guide. It is used to obtain multiple core biopsy samples from soft tissue such as breast, kidney, liver and prostate. The needle has to be inserted by a qualified physician under MR image guidance.
The FDA 510(k) summary for the Automatic Biopsy Needle BAM and Semi-Automatic Needle BIM provides details of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device (K222462). This report focuses on the performance of the device itself rather than a software AI or human-in-the-loop system. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, or number of experts for AI ground truth) is not applicable to this submission.
Here's a breakdown of the acceptance criteria and study results based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1) Penetration of the needle (Stylet perforation capacity) | Stylet tip could easily and effortlessly penetrate tissue (muscle, liver, kidney) without causing tears or lacerations to create a good entry path for the cannula. | "For all tested biopsy devices the insertion was appropriate and conducted effortlessly with no difficulties at all. The acceptance criteria were met. This demonstrates that the device works as intended." |
| 2) Shot of the needle (Release mechanism) | Device spring has sufficient power for the cannula to completely cover the tip of the stylet that contains the notch. | "The test showed that the device spring has sufficient power for the cannula to cover the tip of the stylet that contains the notch completely." (Tested for 10mm and 18mm notch). |
| 3) Quantity of the sample taken (Length of collected samples) | ≥ 5 mm for the 10 mm notch and ≥ 9 mm for the 18 mm notch. | "The results showed that the device met the acceptance criteria (e.g., ≥ 5 mm for the 10 mm notch and ≥ 9 mm for the 18 mm notch) and the dimensions of the samples were comparable to the dimensions of the sample acquired using the predicate." |
| 4) Quality/integrity of the sample taken | Samples are cylindrical, intact, and abundant. | "All samples were cylindrical, intact and abundant. The acceptance criteria were met. The samples collected using the subject device were comparable to the samples acquired using the predicate." |
| 5) MRI Safety Evaluation | Conditions of safe use established. | "MRI safety evaluation was performed to develop conditions of safe use." (Details of specific safety criteria not fully elaborated in this section, but stated as being performed). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that for the penetration, shot, and sample quantity/quality tests, "different Semiautomatic Biopsy Needles - BIM and Automatic Biopsy Needles - BAM has been used. 18G and 16G biopsy needles were used. Two lengths were used: 150 mm and 200 mm." It also states, "The testing was conducted after the validated EO sterilization of all devices. Therefore the tests were conducted on final finished devices." However, specific numerical sample sizes for each test are not provided (e.g., how many needles of each size/length, or how many biopsy samples were collected).
- Data Provenance: The tests were conducted using various tissue types (muscle, liver, kidney) and optionally "animal tissue" for the shot test. Given the nature of these tests for a physical device, the data provenance is likely prospective wet lab/bench testing. The country of origin for the data is not specified, but the applicant, ITP Innovative Tomography Products GmbH, is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for these performance tests (e.g., visual inspection for penetration, measurement with a ruler for sample length, video microscopy for sample quality) was established through direct observation and measurement during the non-clinical testing. There is no mention of external human experts (like radiologists or pathologists) being used to establish a "ground truth" as would be the case for image-based diagnostic AI. These are engineering and functional performance tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are direct measurements and observations of the device's physical performance, not subjective assessments requiring adjudication by multiple individuals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is typically performed for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. This submission is for a physical biopsy needle, not an AI or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates without AI, the tests describe its physical function in relation to a "human-in-the-loop" application (a physician inserting and triggering the needle). The provided tests are "standalone" in the sense that they assess the device's functional characteristics independently of a diagnostic interpretation loop that characterizes AI.
7. The Type of Ground Truth Used
The ground truth used was empirical / physical measurement and observation. For example:
- Penetration: Visual confirmation of effortless penetration and lack of tears.
- Shot: Visual confirmation that the cannula completely covered the stylet tip.
- Sample Quantity: Direct measurement of sample length with a ruler.
- Sample Quality: Observation under video microscope for cylindrical shape, intactness, and abundance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this physical device.
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(158 days)
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
The semiautomatic Biopsy needle– BM is a sterile, spring loaded, disule biopsy system. It consists of the following maior components: handle stylet. tincer and coring nuide.
Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study that proves the device meets them:
Device: Semi-automatic Biopsy-Needle (BIM series)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Needle penetration capacity | Optimal and effortless insertion; stylet tip penetrates tissue easily without causing tears/lacerations. | "For all tested biopsy devices the insertion was optimal and conducted effortles sty with no difficulties at all. The acceptance criteria were met. This demonstrates that the devices works for penetration and is safe." |
| 2. Shot of the needle | Release mechanism triggers correctly; cannula covers the stylet tip (notch completely) and has enough power to push the cannula over the notch to cut tissue. (Tested for 10 mm and 20 mm notches) | "For all tested hions v device the not the not the case for hotch notch sizes (10 mm and 20 mm ) From this it can be concluded that the spring is strong enough. The acceptance criteria were met and the device works and is safe." |
| 3. Quantity of the collected samples (10 mm notch) | Collected sample length for the liver and apple tissue equals the notch size. Muscle tissue sample length > 5 mm. | "Each sample for the liver and apple equals the notch size. For muscle tissue taken with the 10 mm notch the average length is 6.72 mm... Every sample was larger than the acceptance criteria of 5 mm... The average sample size over all tissues is 8.82mm for the 10 mm notch." |
| 3. Quantity of the collected samples (20 mm notch) | Collected sample length for the liver and apple tissue equals the notch size. Muscle tissue sample length > 10 mm. | "Each sample for the liver and apple equals the notch size. For muscle tissue taken with the... 20 mm notch 11.77 mm. Every sample was larger than the acceptance criteria of... 10 mm. Therefore the criteria is met. ... The average sample size over all tissues is... 17.22 mm samples [for 20 mm notch]." |
| 4. Quality/integrity of the collected samples | Samples are cylindrical, intact, and abundant. | "All samples are cylindrical, intact and abundant. The acceptance criteria were met. Because of this the device is effective and safe." |
| 5. MR-compatibility (Artifacts & Visibility) | Needle is clearly visible under MR-guidance without any major artifacts. | "Based on the MR-tests the device is MR-compatible. The new any major artificats and is cleary visible especially compared to the needle with stainless steel." |
| 6. MR-compatibility (Heating & Induction) | No heating occurs. | "In addition no heating or cured during these tests." |
| 7. Biocompatibility | Proof of biocompatibility via Cytotoxicity, Sensitization, Acute Systemic Toxicity, and Pyrogenicity tests. | "Biocompatibility were proofen with the conducted tests." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "For the present report different Semiautomatic Biopsy Need. The 5 samples have been manufactured in 5 different lots."
- It is not explicitly stated if this means 5 distinct biopsy needles, or 5 lots of various needles (e.g., varying gauges and lengths). However, it is mentioned that "14G, 16G and 18G biopsy needles were used. The lengths ranged from 100 mm." This suggests a variety of configurations.
- Data Provenance: The tests utilized "animal tissue and apples" for penetration, shot, and sample quantity/quality tests. The document does not specify the country of origin or whether these were retrospective or prospective studies. Given the nature of a 510(k) submission, these are non-clinical (laboratory/benchtop) tests, not human clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The tests performed are primarily objective benchtop assessments (e.g., visual inspection for penetration, measurement of sample length, microscopic observation of sample integrity, MRI scans for visibility and heating). Expert opinion is implied in setting the "acceptance criteria" for these objective measurements but not explicitly stated as involved in a ground truth establishment process for the test results themselves.
4. Adjudication Method for the Test Set
- This information is not provided. Given that the tests are largely objective measurements and visual assessments, a formal adjudication process may not have been deemed necessary, or at least wasn't detailed in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a semi-automatic biopsy needle, a physical medical instrument, not an AI-assisted diagnostic tool or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm or AI system. The tests evaluate the physical performance of the needle itself.
7. The Type of Ground Truth Used
- For the physical performance tests (penetration, shot, sample quantity/quality): The ground truth is established by pre-defined objective criteria and measurements (e.g., visual confirmation of intact penetration, measurement of sample length against a standard, visual confirmation of sample morphology).
- For MR-compatibility: Ground truth is established by objective measurements from the MRI system (e.g., lack of artifacts, no measured heating).
- For Biocompatibility: Ground truth is established by standardized laboratory tests to detect specific biological reactions.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set" in the context of AI/ML. All samples mentioned were for testing the final device performance.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
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