(210 days)
The EsoCheck CCD Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age and older.
The Lucid Diagnostics EsoCheck™ CCD Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.
The provided text describes the 510(k) premarket notification for the EsoCheck CCD Cell Collection Device. While it outlines the device's purpose, design, non-clinical tests conducted (verification and validation), and its substantial equivalence to predicate devices, it does not contain information regarding the acceptance criteria for device performance, nor details of a study that proves the device meets specific performance criteria related to diagnostic accuracy (e.g., sensitivity, specificity, or human reader improvement with AI assistance).
The document focuses on:
- Device Description: How the EsoCheck CCD Cell Collection Device works to collect esophageal cells.
- Intended Use: For collection and retrieval of surface cells of the esophagus from adults 22 years and older.
- Substantial Equivalence: Comparison to previously cleared predicate devices (Brandt Cytology Balloon, Cytosponge, Hobbs Medical Cytology Brush) based on intended use, population, anatomical location, design, principles of operation, and single-use disposition.
- Nonclinical Tests: Lists various verification (e.g., visual inspection, balloon inflation/deflation, tensile tests) and validation (biocompatibility, sterilization, shelf life, user validation) tests. These are primarily engineering and safety tests rather than performance tests for diagnostic accuracy.
Therefore, I cannot fulfill your request for the following information based solely on the provided text:
- A table of acceptance criteria and the reported device performance: The document lists non-clinical tests but does not provide specific performance metrics (e.g., cell yield, diagnostic accuracy) or their acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth and their qualifications: Not mentioned, as no diagnostic performance study is detailed.
- Adjudication method for the test set: Not applicable based on the provided information.
- MRMC comparative effectiveness study: Not conducted or mentioned. The device is a cell collection tool, not an AI-assisted diagnostic tool.
- Stand-alone (algorithm only) performance: Not applicable, as it's a physical device, not an algorithm.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable, as there's no mention of an algorithm requiring a training set.
- How ground truth for the training set was established: Not applicable.
The "user validation" listed under validation testing (page 5) might imply some form of study involving users, but the details (methodology, sample size, outcome metrics, acceptance criteria) are not provided in this regulatory letter and 510(k) summary. This submission is for a cell collection device based on substantial equivalence, not a novel diagnostic method requiring extensive clinical performance studies for de novo clearance or PMA.
§ 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.