(132 days)
The Mammotome Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
- The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or the imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion) the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Mammotome Biopsy System for Molecular Imaging (MI) consists of four major components: a disposable Biopsy Probe; a disposable Universal Targeting Set; a reusable Holster, and a reusable Control Module. The following accessories are also provided with the system: a disposable vacuum tubing set and canister, a reusable control module cart, and a reusable interlock box.
The provided text describes a 510(k) premarket notification for the Mammotome Biopsy System for Molecular Imaging. However, it explicitly states that clinical testing was not performed in support of this submission (Section 2, "Clinical testing: Clinical testing was not performed in support of this submission."). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as no such study was conducted for this specific submission.
The submission is based on the device being a modification of an existing, already marketed device (Mammotome MR Biopsy System K042753) for use in a Molecular Imaging environment. The manufacturer claims substantial equivalence based on the intended use, technical characteristics, and performance characteristics remaining equivalent, with risk mitigation for the new environment.
Because no clinical study was performed or is referenced in this document, the following requested information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
- Adjudication method for the test set: Not applicable, no clinical test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a biopsy system, not an AI algorithm.
- The type of ground truth used: Not applicable, no clinical test set.
- The sample size for the training set: Not applicable, this is a physical medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable, this is a physical medical device.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.