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510(k) Data Aggregation
(60 days)
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.
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.
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
| 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 |
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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(90 days)
The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.
The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
The subject device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well. The device is a single-use sterile device.
Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve.
The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.
The ViziShot 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.
The ViziShot 2 FLEX is a single-use aspiration needle used with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of lesions in the tracheobronchial tree. The device is identical to a previously marketed device (K163469) in formulation, processing, sterilization, and geometry, with the proposed addition of "fine needle biopsy (FNB)" to its Indications for Use, which aligns with the primary predicate device (Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle, K160229).
Here's the breakdown of its acceptance criteria and the study conducted to prove it:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO 10993-1, -4, -5, -10, -11, USP , USP ) | All patient-contacting surfaces were tested and found to be biocompatible, demonstrating compliance with the specified international and national standards. The device is classified as external communicating, blood path (indirect), and limited duration ( |
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