(104 days)
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.
The Expect™ Pulmonary device is comprised of the following: Expect™ Pulmonary needle, Expect™ Pulmonary adaptor, Syringe, Stopcock. The Expect™ Pulmonary needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure. Expect™ Pulmonary adaptor is an accessory to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can be used to expel the samples after the procedure.
The provided text is a 510(k) summary for the Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on clinical outcomes or a standalone algorithm performance.
Therefore, many of the requested categories for describing acceptance criteria and a study to prove device performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test and training sets) are not applicable or not present in this type of submission.
This document describes a pre-market notification for a medical device that functions as a tool for obtaining tissue samples. The "acceptance criteria" here are related to the device's physical and functional properties, primarily demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.
Here's the information extracted and formatted, with "N/A" for criteria not applicable or not found in the text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the successful completion of the performance tests, demonstrating that the device functions as intended and is comparable to predicate devices. The reported device performance is that all tests were successfully completed. No specific numerical performance metrics (e.g., "flexibility must be
§ 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.