(112 days)
The Disposable Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.
The disposable automatic core biopsy instrument is divided into QZDA and QZDB in accordance with different configuration. QZDA contains automatic core biopsy instrument. QZDB contains automatic core biopsy instrument and coaxial biopsv needle. The automatic core biopsy instrument consists of canula, stylet, protecting sheath and mechnical powering parts. The coaxial biopsy needle consists of canular housing, canula, marker, stylet, stylet housing and protecting sheath. The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. Both the QZDA and QZDB of the device have printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, and green= 14G). The needles have a protecting sheath. The disposable automatic core biopsy instrument is a spring-loaded automatic biopsy needle that is visible in CT (computed tomography) and ultrasound. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging. During use, the position of the device is monitored using imaging technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. The materials used for construction of disposable automatic core biopsy instrument are typical for this type of medical device. The only material in direct patient contact is the stainless steel 06Cr19Ni10. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided document is a 510(k) Premarket Notification for a Disposable Automatic Core Biopsy Instrument. It details the device's characteristics, intended use, and a comparison to a predicate device.
Crucially, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance study.
The submission focuses entirely on a physical medical device (a biopsy instrument) and its substantial equivalence to a legally marketed predicate device through engineering bench testing, biocompatibility testing, and sterilization validation.
Therefore, I cannot provide answers to questions 1-9 as they pertain to AI/Machine Learning device studies, which are not present in this document.
The document explicitly states:
"No clinical study is included in this submission." and "Summary of Non-Clinical Testing".
The "acceptance criteria" and "device performance" mentioned in the document relate to the physical and functional aspects of the biopsy instrument (e.g., depth projection, penetration force, mechanical durability, tip configuration, ultrasound visibility, etc.), demonstrated through bench testing. These are not related to AI model performance (e.g., sensitivity, specificity, AUC) or human reader performance with AI assistance.
§ 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.