(28 days)
The Microvasive® Zero Tip™ Airway Retrieval Basket is intended to be used to endoscopically remove foreign from the airway.
The Microvasive® Zero Tip™ Airway Retrieval Basket is used to access the airway tree via a bronchoscope for the purpose of removing foreign objects. The major components of this device are the sheath, basket, and introducer.
The provided 510(k) summary for the Microvasive® Zero Tip™ Airway Retrieval Basket does not contain information about a study with acceptance criteria and reported device performance in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.
This document pertains to a physical medical device (a basket grasper) and the regulatory submission focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than a performance study with specific metrics and ground truth as would be relevant for an AI system.
Therefore, many of the requested fields cannot be populated from the provided text. I will explain why for each point.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| Explanation: This 510(k) submission is for a physical medical device (retrieval basket) and uses the "substantial equivalence" pathway. The primary "acceptance criteria" for clearance are that the new device shares fundamental technological characteristics and similar intended use with legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. There are no performance metrics like sensitivity, specificity, or accuracy that would require a study with an independent test set as is common for AI. The comparison is based on design features, material, and intended use as shown in the provided table contrasting the proposed device with predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The submission does not describe a performance study with a test set. The substantial equivalence argument is based on a comparison of device characteristics and intended use to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set or ground truth was established as part of this submission for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
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
- Not applicable. This submission is for a physical device, not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device; there is no algorithm or standalone performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established for a performance study. The "ground truth" equivalent in a substantial equivalence pathway is the established safety and effectiveness record of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no training set mentioned or implied for this physical device submission.
9. How the ground truth for the training set was established
- Not applicable. There is no training set or ground truth described in this submission.
Summary of the K020765 Submission:
This 510(k) summary for the Microvasive® Zero Tip™ Airway Retrieval Basket demonstrates substantial equivalence to two predicate devices: the Microvasive® Zero Tip Stone Retrieval Basket (exempt) and the Olympus® Basket Grasping Forceps (K962367).
The core of the submission is a detailed comparison of the proposed device's characteristics (Indication, Tip Design, Basket # of Wires, Basket Style, Basket Size OD, Working Length, Sheath OD, Luer Lock Connector, Handle, Introducer) with those of the predicate devices, as presented in the table in section {2}.
The conclusion is that the proposed device is substantially equivalent because its technological characteristics and indications for use are sufficiently similar to legally marketed predicate devices, and any differences do not raise new questions of safety or effectiveness. This is a common path to market for physical medical devices and does not typically involve the elaborate performance studies required for software or AI-driven devices.
§ 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.