(83 days)
This instrument has been designed to be used with the ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
DISPOSABLE ASPIRATION NEEDLE NA-200H is a modified version of NA-10J-1 Aspiration Needle, which was cleared #K973128. When compared with the predicate device, the following modifications have been made to the NA-10J-1 needle:
- The NA-200H is provided pre-assembled, sterile single use disposable.
- The NA-200H includes a sterile single use disposable syringe for aspiration.
The K12-MS2666 Syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-200H. These devices will be provided sterile single use. We are offering these devices together to improve convenience to the customer. The syringe to be included in the package has been cleared by FDA as a cardiologist or radiologist during angiographic or radiologic, it is intended to be used for aspiration in this submission.
The provided document is a 510(k) summary for a medical device called the "DISPOSABLE ASPIRATION NEEDLE NA-200H." It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, this document does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, expert involvement, or adjudication methods.
The document primarily focuses on:
- Identifying the applicant and contact persons.
- Classifying the device.
- Establishing substantial equivalence to existing legally marketed devices (predicates).
- Describing minor modifications from the predicate device (pre-assembled, sterile, single-use, includes a sterile syringe).
- Stating the intended use.
- Concluding that the changes do not affect safety or effectiveness compared to the predicate.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present in the 510(k) summary. Such details would typically be found in a separate performance testing report or a more detailed technical submission, which is not included here.
§ 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.