(240 days)
The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.
The Biopsy Needle is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the 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.
The Biopsy Needle are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. As the device is single use device, which is individually packaged sterile devices. In the package, there is a whole device with the structure shown in the picture above without any accessories. 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.
This document describes the Ushare Medical Inc. Biopsy Needle (K191472) and its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and performance testing. However, it does not contain information about the device's diagnostic performance or any studies related to human-in-the-loop performance, as it is a medical instrument (biopsy needle) and not a diagnostic AI/ML device.
Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available for this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" for diagnostic performance, as the device is a biopsy needle and not a diagnostic tool. Instead, it outlines performance testing to demonstrate substantial equivalence to the predicate device in terms of mechanical, biological, and sterilization characteristics.
| Characteristic | Acceptance Criteria (Implied by testing to standards/predicate) | Reported Device Performance (Summary from text) |
|---|---|---|
| Biocompatibility | Meet ISO 10993 requirements | Met ISO10993-1, ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11 |
| Sterilization | Meet ISO 11135, ISO 11138, ASTM F1980, ISO 11737-1, ISO 10993-7, ISO 11607 requirements | Met ISO11135, ISO11138, ASTM F1980, ISO11737-1, ISO10993-7, ISO11607 |
| Device Shelf-life (5 years simulated) | Maintain seal strength, dye penetration, vacuum leak, bacterial performance after accelerated aging | Aged subject devices (60°C, 162 days, |
§ 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.