(180 days)
The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.
The Galileo Endoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope.
This is a 510(k) premarket notification for endoscopes, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria like those expected for novel AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, and ground truth establishment for AI performance metrics is not present in this document.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain specific acceptance criteria and reported device performance in the manner of a quantitative study showing diagnostic accuracy, sensitivity, specificity, or other performance metrics for an AI/ML algorithm. The submission is for a medical device (endoscope) that relies on established technology and claims substantial equivalence.
The "acceptance criteria" here are implicitly related to the device meeting the same functional and safety standards as the legally marketed predicate devices. The performance is described in terms of its ability to visualize anatomical structures, which is an inherent function of endoscopes.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Visualization of body cavities, hollow organs, and canals | "The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals." |
| Functionality in various configurations (rod/lens and fiber optic designs) | "Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope" and "Galileo Fiber Optic Design Endoscope." Both described with light transmission and image capture. |
| Use of standard external high-intensity light source | Explicitly stated for both designs: "light being transmitted from a standard external high intensity light source." |
| Compatibility with common viewing methods (direct eyepiece, video camera) | "The image can be viewed-directly or it may be transmitted through a video camera to a video monitor." |
| Intended uses: thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy | Explicitly stated as indications for use. |
| Material similarity to predicate devices | "similar stainless steel materials." |
2. Sample Sizes Used for the Test Set and Data Provenance
Not applicable. This document describes a physical medical device (endoscope), not an AI/ML algorithm that requires a test set of data. Therefore, there's no mention of sample sizes for a test set or data provenance in this context.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
Not applicable. As this is not an AI/ML device where ground truth is established by experts for performance evaluation, this information is not present.
4. Adjudication Method for the Test Set
Not applicable. No test set for an AI/ML algorithm is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are typically for evaluating the impact of AI assistance on human reader performance. This submission is for a physical endoscope and does not involve AI assistance.
6. If a Standalone Performance Study Was Done
Not applicable. "Standalone performance" in the context of AI refers to the algorithm's performance without human interaction. This document describes a medical device, not an algorithm. The "standalone performance" of the endoscope is its ability to transmit an image, which is described functionally rather than through a formal study with quantitative metrics.
7. The Type of Ground Truth Used
Not applicable. Ground truth for an AI/ML algorithm is not relevant to this submission. The "ground truth" for an endoscope's function is simply its ability to provide a clear view of body cavities.
8. The Sample Size for the Training Set
Not applicable. This document is not about an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This document is not about an AI/ML algorithm that requires a training set and ground truth establishment.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" or justification for the Galileo Endoscopes meeting acceptance criteria, as presented in this 510(k) submission, is based on a substantial equivalence comparison to predicate devices.
The document details how the Galileo Endoscopes are similar to legally marketed endoscopes in several key aspects:
- Intended Use: Both the Galileo Endoscopes and the predicate devices are "rigid endoscopes intended to be passed through a lumen of an introducer or into natural body cavities for visualization of body cavities, tissues, organs or canals."
- Design: Both offer "various configurations including rod/lens or fiberoptic design, several OD's and lengths, and use external light sources, and similar stainless steel materials."
- Technological Characteristics: Both "offer a channel for viewing body cavities, tissues, organs or canals."
The principle of substantial equivalence in 510(k) is that if a new device has the same intended use and technological characteristics as a predicate device, and raises no new questions of safety or effectiveness, it can be marketed without a full premarket approval (PMA) process that would require extensive clinical trials to establish efficacy de novo. The provided safety and effectiveness are implicitly demonstrated by the predicate devices.
Therefore, the "proof" that the device meets its (implicit) acceptance criteria is the detailed comparison showing that its intended use, design, and technological characteristics are substantially equivalent to those of multiple already legally marketed endoscopes, implying similar performance and safety. No specific new study demonstrating de novo performance for the Galileo Endoscopes is described, as it is not required for a typical 510(k) submission of this nature.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.