(80 days)
For use in the delivery of fluids via the instrument channel of a bronchoscope. For single use only.
The Y-Adapter is a device that provides a passage through which fluids can be delivered via the instrument channel of a bronchoscope without requiring the removal of bronchoscopic accessories from the instrument channel. The Y-Adapter attaches to the instrument channel port, and provides two ports to the channel: one for use with a catheter or other bronchoscopic accessory and one for use in the delivery of fluids.
The provided document, a 510(k) Premarket Notification for the Asthmatx Y-Adapter, does not detail a study involving human readers or AI assistance. The device is a bronchoscope accessory, and the performance verification focuses on technical and material compliance rather than diagnostic accuracy. As such, information regarding AI performance, human reader improvement with AI, expert adjudication of ground truth for AI, MRMC studies, or standalone algorithm performance is not applicable or available in this document.
Here's an analysis of the available information:
Acceptance Criteria and Reported Device Performance
The "Performance Verification" section outlines categories of characteristics that will be verified prior to marketing, rather than presenting results from an already conducted study. Therefore, the "Reported Device Performance" column reflects the planned verification, as specific results are not included in this summary.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Planned Verification) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2003 (Biological evaluation of medical devices – Part 1: Evaluation and testing) and "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 (G95-1)" | Will be formulated to comply with FDA-recognized biocompatibility standard ISO 10993-1:2003. |
| Sterilization | Compliance with ISO 11137-1:2006 (Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices) and "Updated 510(k) Sterility Review Guidance, August 30, 2002 (K90-1)" | Conformance to the requirements. |
| Packaging | Compliance with ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) | Conformance to the requirements. |
| Physical Dimensions | Not specifically defined, but implies meeting design specifications. | Will be verified. |
| Compatibility with Common Bronchoscopes | Not specifically defined, but implies functional fit and performance. | Will be verified. |
| Compatibility with Common Fluids | (e.g., saline, lidocaine solution) | Will be verified. |
| Maintenance of Vacuum | Not specifically defined, but implies preventing air leakage. | Will be verified. |
| Prevention of Leaks | Not specifically defined, but implies maintaining fluid integrity. | Will be verified. |
Study Information:
- Sample size used for the test set and the data provenance: Not applicable. The document describes a "Performance Verification" plan for a medical device (Y-Adapter) that does not involve a diagnostic algorithm or a test set of data in the common sense for AI/ML evaluation. The verification focuses on the device's physical and functional properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., diagnostic labels) is not relevant to the performance verification of this bronchoscope accessory.
- Adjudication method 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 device is a bronchoscope accessory, not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: For the physical and functional characteristics, the "ground truth" would be established through engineering specifications, validated test methods, and compliance with industry standards (e.g., ISO, FDA guidance). It doesn't involve clinical outcomes, pathology, or expert consensus in the diagnostic sense.
- The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 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.