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The Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

Device Description

The Olympus Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. These devices are single-use, disposable, sterile (Ethylene Oxide) needles available in two models with different specifications:

• NA-201SX-4021:

Working Length: 700mm
Maximum Insertion Portion Diameter: 1.9mm
Needle Width: 21G
Normal Needle Length: 20mm
Maximum Needle Length: 40mm

• NA-201SX-4022:

Working Length: 700mm
Maximum Insertion Portion Diameter: 1.8mm
Needle Width: 22G
Normal Needle Length: 20mm
Maximum Needle Length: 40mm

Both models feature an adjustable sheath length and are intended for single use.

AI/ML Overview

This document is a 510(k) clearance letter for a physical medical device (Single Use Aspiration Needle), not an AI/Software-as-a-Medical-Device (SaMD). Therefore, the requested information pertaining to AI/SaMD performance evaluation criteria (such as test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable and is not present in the provided document.

The document discusses the substantial equivalence of the new aspiration needles to a predicate device based on their physical and functional characteristics. The performance data section refers to bench testing of physical attributes, not computational performance or diagnostic accuracy.

Therefore, I cannot provide the requested information as it relates to AI/SaMD. I can, however, extract the acceptance criteria and reported device performance for the physical device based on the provided text.

Acceptance Criteria and Reported Device Performance (Physical Device)

This section summarizes the performance data for the Single Use Aspiration Needle (NA-201SX-4021 and NA-201SX-4022), based on the provided FDA 510(k) summary. These criteria relate to the physical and functional performance of the device, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/SaMD specific questions:

As stated previously, the provided document is for a physical medical device (Single Use Aspiration Needle), not an AI/SaMD device. Therefore, the following information is not applicable and not provided in the source text:

Sample size used for the test set and the data provenance: Not applicable. Performance testing was physical bench testing, not data-driven AI evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established by engineering specifications and direct measurement, not expert review of AI outputs.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This applies to AI-assisted diagnostic or interpretive systems.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical needle refers to its engineered specifications and expected mechanical/biological performance, verified through bench testing.
The sample size for the training set: Not applicable. This applies to machine learning models.
How the ground truth for the training set was established: Not applicable. This applies to machine learning models.

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Performance Test	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Insertion performance into the endoscope	Smooth insertion and effective tissue penetration	All results met acceptance criteria for smooth insertion and effective tissue penetration
Piercing performance of the needle	Effective tissue penetration	All results met acceptance criteria for effective tissue penetration
Ultrasound visibility of the needle	Visibility of the needle under ultrasound imaging	All results met acceptance criteria for visibility of the needle under ultrasound imaging
Needle extraction and retraction performance	Safe and effective needle extraction and retraction	The device met all predefined criteria for safe and effective needle extraction and retraction
Needle aspiration performance	Successful aspiration of target material under test conditions	The device successfully aspirated target material under test conditions
Withdrawal performance from the endoscope	Smooth and safe withdrawal from the endoscope	The needle was withdrawn smoothly and safely from the endoscope
Needle slider performance	Reliable functioning for needle deployment and retraction	The slider mechanism functioned reliably for needle deployment and retraction
Limitation of needle depth	Effective limitation of needle extension to within specified parameters	The device effectively limited needle extension to within specified parameters
Needle-to-luer joint pull strength	Withstood required tensile forces without failure	The joint withstood required tensile forces without failure
Sheath-to-handle joint pull strength	Connection between sheath and handle remained secure under stress	The connection between sheath and handle remained secure under stress
Needle breakage strength	Sufficient structural integrity under load	The needle demonstrated sufficient structural integrity under load
Coil separation	Coil remained intact and did not separate under test conditions	The coil remained intact and did not separate under test conditions
Biocompatibility (various tests per ISO 10993-1)	Met acceptance criteria for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility, and aged cytotoxicity	All tests met acceptance criteria, confirming biological safety and biocompatibility
Sterilization (Ethylene Oxide)	Achieved a sterility assurance level of 10⁻⁶ and met endotoxin limits	Achieved a sterility assurance level of 10⁻⁶ and met endotoxin limits
Shelf-life	Validated a three-year shelf life through accelerated aging and simulated distribution, with packaging integrity and product performance tests passing acceptance criteria	Validated a three-year shelf life, with all packaging integrity and product performance tests passing acceptance criteria