(38 days)
The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) at up to 4.0 Tesla field strength.
BiomarC Fiducial Marker is supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device. The deployment device consists of a cannula with handle, a push rod with plunger, and bone wax as a marker retaining mechanism.
This document describes the BiomarC Fiducial Marker, a device intended for use in stereotactic radiosurgery and radiotherapy target localization. The submission is a 510(k) premarket notification, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies. As such, the information provided focuses on demonstrating equivalence rather than a detailed "study that proves the device meets the acceptance criteria" in the way one might expect for a novel device with specific performance metrics beyond what is provided in the substantial equivalence comparison.
Here's an analysis of the provided text in the context of your questions:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the BiomarC Fiducial Marker's performance. Instead, it aims to demonstrate substantial equivalence to predicate devices by comparing their characteristics and showing that the proposed device is just as safe and effective. The "reported device performance" is inferred through this comparison and the various safety and biocompatibility tests.
The closest we get to "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" for the proposed device (BiomarC Fiducial Marker) is that it meets or matches these characteristics.
| Characteristic | Acceptance Criteria (Predicate Devices' Characteristics) | Reported Device Performance (BiomarC Fiducial Marker) |
|---|---|---|
| Indications for Use | The BiomarC Tissue Marker (K063193) is indicated for radiographic marking of soft tissue. The Fiducial Markers (K071614) are intended for stereotactic radiosurgery and radiotherapy target localization. | The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. (This expands on K063193's use and aligns with K071614) |
| Material | K063193: Pyrolytic carbon coated zirconium oxide; K071614: Gold | Pyrolytic carbon coated zirconium oxide |
| Use | Single use (Both K063193 and K071614) | Single use |
| Sterility | Sterilized by EO with an SAL of 1x10-6 (Both K063193 and K071614) | Sterilized by EO with an SAL of 1x10-6 |
| Pyrogens | Pyrogen free (K063193); Unknown (K071614) | Pyrogen free |
| Biocompatibility | Cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, implantation (muscle and bone/tissue), haemocompatibility tests demonstrating non-toxicity, non-sensitizing, non-irritating, non-mutagenic, non-hemolytic per ISO 10993 series (similar for both predicates) | Cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, implantation (muscle and bone), and haemocompatibility tests demonstrating non-toxic, non-sensitizing, non-irritating, non-mutagenic, and non-hemolytic per ISO 10993 series |
| Visualization | K063193: Visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT), ultrasound, and MRI; K071614: Visible on EPID, film, kV and CR. | Visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT), ultrasound, and magnetic resonance imaging (MRI) |
| Device Body Contact Category | Implant device, tissue/bone, permanent (Both K063193 and K071614) | Implant device, tissue/bone, permanent |
Summary of the "Study" Proving Equivalence:
The "study" described is a comparison to predicate devices and performance testing (primarily biocompatibility and visualization demonstrations), rather than a clinical trial with specific performance endpoints. The core argument is:
- The BiomarC Fiducial Marker is identical to the BiomarC Tissue Marker (K063193) except for its expanded indications for use.
- The expanded indications are consistent with those of another predicate, the Fiducial Markers (K071614).
- Biocompatibility and performance testing confirms that the BiomarC Fiducial Marker is substantially equivalent to the Fiducial Markers for the expanded indications for use. (This is the key claim for approval).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. A 510(k) submission based on substantial equivalence to existing devices often relies on the established safety and performance of those predicates and standardized lab testing (e.g., ISO 10993 for biocompatibility) rather than new clinical trials with patient test sets.
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)
This information is not provided. Given the nature of the submission (demonstrating equivalence through material properties and standard tests), there wouldn't typically be a "test set" with expert adjudicated ground truth in the way one would for diagnostic AI devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. There is no mention of a clinical "test set" requiring adjudication in the document.
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
This information is not applicable. The device is a physical fiducial marker, not an AI or imaging diagnostic software, so MRMC studies or AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical fiducial marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this device is primarily based on:
- Standardized testing methods: Such as ISO 10993 series for biocompatibility, which has established protocols for determining safety.
- Physical properties: Demonstrating visibility on various imaging modalities (x-ray, CT, MRI, ultrasound).
- Predicate device characteristics: The established safety and effectiveness of the legally marketed predicate devices (K071614 and K063193) serve as the "ground truth" for what constitutes acceptable performance and safety for this type of device.
There is no mention of expert consensus, pathology, or outcomes data being used directly for this specific 510(k) submission as a new ground truth.
8. The sample size for the training set
This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are likely informed by prior experience with K063193 and general medical device engineering knowledge.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as point 8.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.