(176 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 tracheobronchial tree. Do no use this instrument for any purpose other than its intended use.
The ExpectTM Pulmonary device is comprised of the following:
- Expect™ Pulmonary needle
- Expect™ Pulmonary adaptor
- Syringe
- Stopcock
The Expect™ Pulmonary device is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. 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 document is a 510(k) summary for the Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI/software device.
Therefore, the information required to populate a table of acceptance criteria and reported device performance related to AI/software functionality, as well as details about sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.
This submission focuses on the physical and functional aspects of a medical device (a needle) and its accessories, not on a diagnostic algorithm or AI.
Here's why the requested information cannot be extracted from this document:
- Nature of the Device: The device is a "Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle." This is a physical medical instrument used for tissue sampling. It is not an AI or software device.
- Type of Submission: A 510(k) submission primarily aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is done through comparing technological characteristics and performance data (often bench testing, biocompatibility, sterilization) to show that the new device is as safe and effective as the predicate. It does not typically involve clinical efficacy trials or AI performance evaluations as would be required for a novel diagnostic algorithm.
- Performance Data Section: The "Performance Data" section (Section 7) describes:
- Biocompatibility Testing: Ensuring the materials are safe for human contact.
- Sterilization Testing: Ensuring the device can be properly sterilized.
- Performance Testing Summary: A list of 21 "bench tests" (e.g., Device Flexibility, Needle Sharpness, Handle actuation force, Tensile strength). These are engineering/mechanical tests on the physical device, not evaluations of diagnostic accuracy or AI performance.
In summary, this document does not contain the information required to address your specific questions about acceptance criteria for an AI/software device and the study proving it, because the device in question is a physical medical instrument, not an AI/software product.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.