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510(k) Data Aggregation
(212 days)
The CareFusion Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
The Gold Tissue Marker is a sterile, single use device comprised of a gold marker and disposable delivery device. The delivery device has 1cm reference marks and echogenic marks on the distal tip to aid in ultrasound guided marker placement. The Gold Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
This document is a 510(k) Pre-market Notification for the CareFusion Gold Tissue Marker. It demonstrates substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics for the device in the way one might expect for a diagnostic or AI-driven system. Instead, it lists the standards and tests performed to demonstrate safety and performance for a physical implantable device. The "acceptance criteria" are implied to be meeting the requirements of these standards.
| Characteristic / Test Category | Standard/Test/FDA Guidance | Reported Device Performance (Implied) |
|---|---|---|
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing | Meets standard requirements |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - Part 6 Tests for Local Effects After Implantation | Meets standard requirements |
| Residuals (Ethylene Oxide Sterilization) | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals | Meets standard requirements |
| Biocompatibility (Systemic Toxicity) | AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 Tests for Systemic Toxicity | Meets standard requirements |
| Biocompatibility (Chemical Characterization) | AAMI/ANSI/ISO 10993-18: 2006 Biological Evaluation of Medical Devices - Part 18 Chemical Characterization of Materials | Meets standard requirements |
| Performance (General Requirements for Non-active Implants) | ISO 14630: 2012: Non-active Surgical Implants - General Requirements | Meets standard requirements |
| Performance (Gold Wire for Semiconductor Lead Bonding) | ASTM F72: 2006 Section 4: Standard Specification for Gold Wire for Semiconductor Lead Bonding | Meets standard requirements (relevance is for the gold marker material) |
| Performance (Magnetically Induced Displacement Force in MR Environment) | ASTM F2052: 2006: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment | Meets standard requirements (safe for MRI) |
| Performance (MR Image Artifacts from Passive Implants) | ASTM F2119: 2007: Standard Test Method for the Evaluation of MR Image Artifacts from Passive Implants | Meets standard requirements (minimal artifacts in MRI) |
| Performance (Radiofrequency Induced Heating in MRI) | ASTM F2182: 2011A: Standard Test Method for the Measurement of Radio frequency Induced Heating on or Near Passive Implants During MRI | Meets standard requirements (safe for MRI heating) |
| Performance (Magnetically Induced Torque in MR Environment) | ASTM F2213: 2006, RA 2011: Standard Test Method for the Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment | Meets standard requirements (safe for MRI torque) |
| Performance (Stainless Steel Needle Tubing) | BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of Medical Devices | Meets standard requirements (relevance for delivery device) |
| Sterilization (Microbiological Methods) | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 & 2 | Meets standard requirements |
| Sterilization (Ethylene Oxide Validation) | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization | Meets standard requirements |
| Sterilization (Ethylene Oxide Process Equivalency) | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization | Meets standard requirements |
| Performance (Bench Top Testing) | Marker securement, force to deploy, dimensional verification, and strength of connections | Meets design specifications/requirements |
| Performance (Simulated Use) | Implantation, visualization under ultrasound, MRI and radiograph, marker integrity after repeated compression | Meets design specifications/requirements |
The general conclusion states: "The results of the non-clinical tests show that the CareFusion Gold Tissue Marker meets or exceed all performance requirements, and is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve a "test set" in the context of diagnostic performance evaluation using patient data. The studies are non-clinical, primarily bench-top and simulated use testing. Therefore, information on sample size for a "test set" of patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical tissue marker, not an AI or diagnostic system requiring expert-established ground truth from images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" requiring adjudication in the context of diagnostic interpretation.
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
No. This is a submission for a physical medical device (tissue marker), not an AI-assisted diagnostic tool. Therefore, a multi-reader, multi-case comparative effectiveness study or analysis of human reader improvement with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is not an algorithm or software. It is a physical implantable marker.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the objective metrics and criteria established in the referenced industry standards (e.g., ISO, ASTM) and internal design specifications. For example, for biocompatibility, the ground truth is that the device material does not elicit an adverse biological response when tested according to the specified ISO standards. For MRI compatibility, the ground truth is that the device meets safety thresholds for displacement, torque, and heating, and produces acceptable artifact levels as defined by ASTM standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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