(129 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 Expect™ Pulmonary device is comprised of the following:
- One (1) Expect™ Pulmonary needle
- One (1) Expect™ Pulmonary adaptor .
- One (1) Syringe .
- One (1) Stopcock .
The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle 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 component of the Expect™ Pulmonary device. This needle adaptor is attached and locked onto the biopsy port of the bronchoscope. It allows the Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. The adaptor is also designed to seal off the biopsy port while using the suction feature on an EBUS bronchoscope. The proposed Expect™ Pulmonary adaptor will facilitate scope flushing by allowing the adaptor to be attached to the bronchoscope.
Syringe and stopcock accessory components provide and control the vacuum suction to aspirate the sample. They can also be used to expel the samples after the procedure.
The provided text describes the performance data for the Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle with a modified needle adaptor. This device is an accessory to a bronchoscope and is used for fine needle aspiration (FNA) of lesions in the tracheobronchial tree. The study focuses specifically on the changes introduced by the modified adaptor.
Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Non-Clinical Bench Tests | |
| Adaptor Lock and Unlock Force | Met pre-defined performance specifications (Same requirement as predicate device). |
| Adaptor Suction | Able to seal off the bronchoscope biopsy port under suction after needle passes (Same requirement as predicate device). |
| Adaptor Flushing Compatibility | New requirement: Seal allows fluid to pass through without causing leakage at the adaptor. |
| ISO 594-1 Liquid Leakage Testing | New requirement: Conical female luer connection meets ISO 594-1 liquid leakage test. |
| Biocompatibility | |
| Cytotoxicity | Passed. |
| Sensitization | Passed. |
| Intracutaneous Reactivity (Irritation) | Passed. |
| Acute Systemic Toxicity | Passed. |
| Material-Mediated Pyrogenicity | Passed. |
| Sterilization | Meets requirements of ISO 11135-1:2007 (SAL of 10^-6), and EO residual levels conform to ISO 10993-7:2008 (R:2012). |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Four (4) non-clinical bench performance tests have been performed on the proposed Expect™ Pulmonary device with the modified needle adaptor." This implies a limited sample size, likely representative samples of the device, for these bench tests. The exact number of devices tested for each of the four bench tests is not specified beyond "Four (4) non-clinical bench performance tests."
The data provenance is from non-clinical bench testing, meaning it was conducted in a laboratory setting. There is no information provided regarding geographical origin (country) for the testing, nor whether it was retrospective or prospective in the sense of patient data. This is product performance verification, not a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the described tests are non-clinical bench tests rather than clinical studies requiring expert consensus on ground truth. The "ground truth" for these tests would be the established engineering and ISO standards themselves, against which the device's physical performance is measured.
4. Adjudication Method for the Test Set:
This information is not applicable as the described tests are non-clinical bench tests. Adjudication methods like 2+1 or 3+1 typically refer to the resolution of discrepancies between multiple human readers in clinical image interpretation or similar expert-driven evaluations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance:
This information is not applicable. The device described is a physical medical instrument (a needle and adaptor for FNA), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
This information is not applicable. The device is a physical instrument, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used:
For the non-clinical bench tests, the ground truth is based on established engineering specifications, performance requirements, and ISO standards. For example, the ISO 594-1 liquid leakage test directly uses a standard to determine acceptance. The biocompatibility tests also rely on international standards (ISO 10993-1) for evaluation. Sterilization effectiveness is measured against ISO 11135-1.
8. The Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 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.