(15 days)
The Breast Immobilization and Biopsy Device Models Bl 160-O, Bl 160-PA, and Bl 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.
The BI 160-O, BI 160-PA, and Bl 160-CC device is a breast immobilization and biopsy accessory compatible with breast array coils and has the benefit of shaping the breast tissue into a "brick" shape, through mild compression. This allows for more efficient slice utilization. (i.e., fewer slices are needed to image the same amount of tissue).
The needle positioning devices allow the needle to be aimed at the lesion identified on the MR scan. Either MR compatible biopsy needles or MR compatible wire localization needles may be used.
The provided text describes a 510(k) premarket notification for a medical device: the Breast Immobilization and Biopsy Device BI 160-O, BI 160-PA, and BI 160-CC.
However, the documentation explicitly states: "No accuracy claims are made for the device." It further clarifies that "Slice warp in the MR image, needle deflection, and other factors will affect the accuracy of placing the needle into the breast lesion of interest. It is imperative that the clinician perform a scan with the needle in the breast to ensure that the needle has indeed entered the lesion of interest."
Therefore, based on the provided text, there are no specific acceptance criteria for performance, and no study is presented to demonstrate that the device meets such criteria because the device itself does not make accuracy claims. The review focuses on its substantial equivalence to a predicate device, specifically noting that it "does not alter the performance of the coil in which it is placed."
Given this, I cannot fill out the requested table or provide details about a study proving the device meets acceptance criteria, as the document clearly states that no such claims or studies related to accuracy are part of this 510(k) submission.
Summary based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not applicable as the device makes no accuracy claims.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: No.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: No, this is a physical medical device accessory, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The submission focuses entirely on substantial equivalence to a predicate device (MR-BIOPSY MR BI 160, K010570), stating that the new device is a "modification" and that "Any differences between the predicate and subject devices will not affect safety or efficacy." The performance data section explicitly states that the device "does not alter the performance of the coil in which it is placed."
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.