(32 days)
The Transbronchial Aspiration Needle is indicated for use in aspiration in carinal, paratracheal, hilar, and peripheral lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
The Modified Transbronchial Aspiration Needle is a device used for aspiration in the bronchial tree. It has a double lumen cross section and a retractable needle. It is available in catheter lengths of 150 cm, outer catheter OD of 1.8, needle sizes of 18, 19, & 21 Ga, and needle lengths of 14 & 20 mm.
The provided text describes a 510(k) premarket notification for a medical device called the "Modified Transbronchial Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical performance studies with detailed acceptance criteria and supporting data for an AI-powered diagnostic device.
Therefore, many of the requested categories related to AI performance, such as sample size for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this document.
However, I can extract information related to the device's performance as demonstrated for substantial equivalence.
Here's the information based on the provided text:
Acceptance Criteria and Study for Modified Transbronchial Aspiration Needle
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, particularly in terms of descriptive, technological, and performance characteristics. The reported device performance is presented as being comparable or equivalent to these predicates.
| Acceptance Criterion (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Modified Transbronchial Aspiration Needle) |
|---|---|
| Intended Use Equivalence | "Aspiration in carinal, hilar, paratracheal, and peripheral lesions" - Equivalent to predicate devices, which also perform aspiration. |
| Route of Administration Equivalence | "Bronchoscope" - Equivalent to predicate devices. |
| Design Feature Equivalence (Cross Section) | "Double Lumen" - Equivalent to Boston Scientific's TBAN predicate, and one configuration of Mill-Rose's predicate. |
| Design Feature Equivalence (Retractable Needle) | "Yes" - Equivalent to both predicate devices. |
| Dimensional Equivalence (Catheter Length) | "150 cm" - Equivalent to Boston Scientific's TBAN predicate, and similar to Mill-Rose's 140cm predicate. |
| Dimensional Equivalence (Outer Catheter OD) | "1.8" - Equivalent to both predicate devices. |
| Dimensional Equivalence (Needle Size) | "18, 19, & 21 Ga" - Overlaps significantly with Boston Scientific's TBAN (18 & 21 Ga) and Mill-Rose's (19-22 Ga) predicate devices. |
| Dimensional Equivalence (Needle Length) | "14 & 20 mm" - Overlaps with Boston Scientific's TBAN (13 & 20 mm) and Mill-Rose's (13 & 15 mm) predicate devices. |
| Biocompatibility | "biocompatibility assessment was performed on the patient- and fluid-contact materials... with satisfactory results." - Demonstrated to be safe for patient contact. |
| Sterilization Efficacy | "sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization." - Conforms to recognized sterilization standards. |
| Pyrogenicity | "Pvrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels." - Ongoing monitoring for safety. |
| General Safety and Performance | "Laboratory testing regarding characteristics was performed... to verify its safety and performance." "The information presented provides assurance that the Modified Transbronchial Aspiration Needle will meet the minimum requirements that are considered acceptable for its intended use." - General claim of satisfactory lab performance to ensure safety and function, necessary for substantial equivalence demonstration. |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A). This is a 510(k) submission for a physical medical device, not an AI diagnostic device. The "test set" primarily refers to comparative analysis against predicate device specifications and laboratory testing, not a clinical data set in the context of AI performance.
- The data provenance is from internal "Laboratory testing" and comparison to existing predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of expert review for diagnostic accuracy is not relevant to this device type or submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods for diagnostic interpretation are not relevant to this device type or submission.
5. 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:
- N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the comparative analysis: Predicate device specifications and characteristics.
- For the new device's performance: Laboratory testing results (e.g., biocompatibility, sterilization efficacy, physical dimensions, functional performance characteristics).
8. The sample size for the training set:
- N/A. This is not an AI diagnostic device requiring a training set.
9. How the ground truth for the training set was established:
- N/A. This is not an AI diagnostic device.
§ 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.