(87 days)
Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue.
Both the Auto Suture* ABBI* Breast Biopsy System, and Bard® Biopty® Instrument Biopty-Cut® Needle (K871390) are indicated for obtaining soft tissue samples under imaging control.
This 510(k) summary describes a manual surgical instrument and does not appear to involve an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, ground truth, and reader studies for an AI/ML device is not applicable to this submission.
The "PERFORMANCE" section in the provided document merely states that "Both the Auto Suture* ABBI* Breast Biopsy System and the Bard Biopsy Needle (K871390) are effective in removing a sample of tissue for biopsy." This is a general statement of intended function rather than a detailing of specific performance metrics or a study demonstrating their achievement.
For a medical device like this biopsy system, performance is typically demonstrated through:
- Bench testing: Verifying aspects like cutting efficiency, sample integrity, and mechanical function.
- Biocompatibility: Ensuring materials are safe for human contact (as noted with ISO Standard #109931).
- Sterility validation: Confirming the device can be sterilized effectively.
- Comparison to predicate device: Demonstrating substantial equivalence to a legally marketed device (the Bard Biopty instrument).
However, none of these are elaborated with specific acceptance criteria or study results in the provided summary as would be relevant for an AI/ML product.
§ 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.