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510(k) Data Aggregation
(200 days)
Flexible 19G EBUS Needle
The Flexible 19G EBUS Needle has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.
The Flexible 19G EBUS Needle is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.
The 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.
To perform biopsies, the flexible catheter portion is first inserted into a bronchoscope's working channel (2.2mm) then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope using an adapter biopsy valve. 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 of the handle. The device is available with a needle size of 19 qauqe (19G).
Here's an analysis of the acceptance criteria and study information based on the provided FDA 510(k) document for the Flexible 19G EBUS Needle:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria with specific numerical thresholds for each test. Instead, it indicates that "All testing met the predetermined acceptance criteria as outlined in the test protocols." and reports "Pass" for each test. The acceptance criteria were either identical to the predicate or established to verify design differences.
| Acceptance Criteria (General Description) | Reported Device Performance |
|---|---|
| Testing to Specifications Identical to Predicate | |
| Insertion and Withdrawal Force | Pass |
| Stylet Insertion and Withdrawal Force | Pass |
| Activation Force | Pass |
| Plastic Deformation Angle | Pass |
| Durability | Pass |
| Handle Durability | Pass |
| Testing to Specifications Developed for 19G Needle | |
| Bronchoscope Angulation | Pass |
| Penetration Force¹ | Pass |
| Transmission Force | Pass |
| Vacuum Leak Test | Pass |
| Sheath to Handle Joint Strength | Pass |
| Echogenicity² | Pass |
| Biopsy Sample Size¹, ² | Pass |
| Simulated use - ex vivo (bovine lung) bench testing | Pass |
| Additional Testing | |
| Sterilization Validation | Pass |
| Packaging and Shelf Life | Pass |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Systemic Toxicity) | Pass |
¹ For direct comparison to a commercially available device of the same size, testing was also conducted on the Boston Scientific 19G Scientific eXcelon Transbronchial Aspiration Needle.
² Testing also conducted on the predicate 21G Olympus Aspiration Needle.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for each individual test conducted. It generally refers to "bench testing" and "ex vivo testing."
Regarding data provenance:
- Country of Origin: Not specified. It's likely the testing was conducted by the manufacturer, Spiration, Inc., based in Redmond, WA, USA, or a contract lab.
- Retrospective or Prospective: The testing described is prospective as it involves the evaluation of the new device's performance against predefined criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this specific submission. The device is a medical instrument (FNA needle), not a diagnostic algorithm that requires expert-established ground truth from a dataset. The performance evaluation focuses on physical and functional characteristics, not diagnostic accuracy based on expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. No expert adjudication method (like 2+1, 3+1) was required or described for assessing the physical and functional performance of a medical instrument.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI algorithms where human interpretation plays a role and comparison of performance with and without AI assistance is needed. This document focuses on the physical and functional performance of a medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the engineering and material specifications and established performance benchmarks for aspiration needles, as well as the behavior of the predicate device and a comparable 19G device. For example:
- Physical measurements and engineering tolerances: For forces, angles, dimensions.
- Standardized test methods: For durability, vacuum integrity, and biocompatibility.
- Observed functional performance: In simulated use (ex vivo bovine lung) and comparison to the predicate and a similar 19G device for aspects like biopsy sample size.
- Biocompatibility standards: ISO 10993-1.
8. Sample Size for the Training Set
Not applicable. This device is a physical instrument and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for it.
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