(104 days)
E.G. Scan™ II Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.
E.G. Scan™ II Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ II Probe takes pictures of the esophagus of human and sends image data to E.G. Scan™ II Controller. E.G. Scan™ II Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis. The E.G Scan™ II Esophagoscope Probe is disposable. E.G. Scan™ II Esophagoscope system is a transnasal esophagoscope designed to capture images of the esophagus. Captured images are viewed via the E.G. View™ Software for diagnosis of diseases related to the esophagus.
This 510(k) submission does not contain information about a study that proves the device meets specific acceptance criteria in the way described in the prompt. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative performance metrics. The submission states the device "has the same device characteristics as the predicate device" and "conforms to IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2" (safety standards). | "Substantially equivalent" to the predicate device in areas of design, indication for use, technological characteristics, function, application, safety, and effectiveness. Conformity to: Biocompatibility (ISO 10993-1)Medical electrical equipment safety (IEC 60601-1)Specific safety for endoscopic equipment (IEC 60601-2-18)Electromagnetic compatibility (IEC 60601-1-2) |
2. Sample size used for the test set and the data provenance:
- Not applicable. No specific performance study with a test set is described in relation to clinical or diagnostic performance. The testing mentioned (biocompatibility, safety, EMC) would involve material samples or electrical measurements, not a patient test set for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No such clinical or diagnostic performance study is described.
4. Adjudication method for the test set:
- Not applicable. No such clinical or diagnostic performance study is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is an esophagoscope system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical imaging device, not an algorithm being evaluated in isolation for diagnostic performance. Its function is to capture images for human interpretation.
7. The type of ground truth used:
- Not applicable. Since no diagnostic performance study is presented, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for the device's claims are its stated technical characteristics and adherence to safety and performance standards, proven through physical testing rather than clinical study.
8. The sample size for the training set:
- Not applicable. This submission is for an imaging system, not a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
Summary of what the document does provide:
The document focuses on establishing substantial equivalence to an existing legally marketed device (the E.G. Scan™ Esophagoscope System, K111030, and Vision-Science, Inc.'s Modified Flexible Trans-Nasal Esophagoscope, K072088). This is a common pathway for 510(k) clearances, where extensive new clinical performance data is often not required if the new device is technologically similar and has the same indications for use as a predicate.
The main evidence provided for safety and effectiveness is:
- Comparison to predicate device: Stating "The E.G. Scan™ II Esophagoscope System and predicate device are substantially equivalent in the areas of design, indication for use, technological characteristics, function, application and safety and effectiveness."
- Compliance with recognized standards:
- Biocompatibility (ISO 10993-1)
- Medical electric equipment safety (IEC 60601-1)
- Specific safety for endoscopic equipment (IEC 60601-2-18)
- Electromagnetic compatibility (IEC 60601-1-2)
Therefore, the "acceptance criteria" here are primarily framed as compliance with these standards and demonstrated substantial equivalence, rather than specific quantitative performance metrics from a clinical diagnostic study.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. 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 flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.