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510(k) Data Aggregation
(103 days)
MEDONE Soft tissue automatic disposable biopsy system: MEDONE biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.
MEDCUT automatic disposable biopsy system : MEDCUT biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.
MEDEM Mallarmé bone marrow aspiration needle: MEDEM biopsy needle must be used for bone marrow aspiration from sternum or iliac crest.
MEDBONE Bone marrow biopsy system: MEDBONE biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy.
MEDLOCK Bone marrow biopsy and aspiration system: MEDLOCK biopsy system must be used for bone marrow aspiration and the posterior iliac crest biopsy.
Medax Biopsy Systems II portfolio is composed by single use devices intended to obtain biopsy samples from soft tissue or bone (depending on product family) for histological examinations. Devices are available in different gauge dimensions (identified by different colors) and needle length.
This document, K172344, describes MEDAX S.R.L. Unipersonale's Medax Biopsy Systems II. It is a 510(k) summary for new biopsy systems. The information provided is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance of an AI-powered device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, and MRMC studies, are not applicable here.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit acceptance criteria juxtaposed with quantitative device performance metrics in the way a diagnostic AI study would. Instead, it states that the devices met acceptance criteria defined in their product specification and performed comparably to predicate devices based on in vitro bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ISO 9626:2016 (Stainless steel needle tubing requirements) | Met requirements and test methods of ISO 9626 |
| Conformance to ISO 10993 series and FDA Guidance (Biocompatibility) | Biocompatibility tests performed according to ISO 10993 series and FDA Guidance |
| Bioburden and Sterility tests | Tests performed to confirm appropriate bioburden and sterility |
| Validation of EtO Sterilization process | Validation performed |
| EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol according to EN ISO 10993-7 | Residue levels met requirements |
| Packaging validation | Validation performed |
| Labeling evaluation | Labeling evaluated for compliance |
| Performance comparable to predicate devices | Results from performance evaluation demonstrated comparable performance to predicate device |
2. Sample Sizes used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable as this is not a diagnostic AI study. The "test set" here refers to physical devices undergoing bench testing. The specific number of devices tested for each performance characteristic is not detailed.
- Data Provenance: Not applicable. The "data" comes from physical, in vitro bench tests of the devices, not patient data.
3. Number of Experts used to establish the ground truth for the test set and qualifications
Not applicable. "Ground truth" in this context refers to the physical and chemical properties of the biopsy devices as measured by standard engineering and biocompatibility tests, not a diagnostic interpretation by medical experts.
4. Adjudication method
Not applicable. This is not a study involving human readers or diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This document concerns the regulatory clearance of a physical medical device (biopsy systems), not an AI-powered diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) Study
Not applicable. This is not an AI algorithm. The performance evaluation is for the physical biopsy systems themselves (e.g., strength of material, sterility, biocompatibility).
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of these biopsy systems is based on established international standards and regulatory guidance for medical device manufacturing, material properties, sterility, and biocompatibility. This includes:
- ISO 9626:2016 for stainless steel needle tubing requirements.
- ISO 10993 series and FDA Guidance for biocompatibility.
- ISO 11607-1.2006 for packaging.
- ISO 11737:2006 for microbiological methods.
- ASTM F899-12b for wrought stainless steels.
- EN ISO 10993-7 for EtO residuals.
8. Sample Size for the Training Set
Not applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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