(28 days)
The EndoFLIP® System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
The EF-325 series of catheters can make pressure and dimensional measurements in the esophagus, pylorus, and anal sphincters; whereas the BF-325 series and EF-825 catheters can make dimensional measurements in the esophagus, pylorus, and anal sphincters. The EF-620 catheter can make dimensional measurements in the esophagus.
Other indications for use include:
- To estimate the size of a stoma produced by a gastric band (all EndoFLIP® catheters)
- For use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery, where it is suitable for diameter measurements for 22 to 60Fr sleeves (EF-620 catheter)
The modification to the EndoFLIP® System is the addition of display functionality. This functionality is software and is referred to as the FLIP Topography module which is a supplemental accessory.
The addition of the supplemental accessory FLIP Topography module does not modify the predicate EndoFLIP® System or change the intended use of the device. This modification does not alter the fundamental scientific technology; the EndoFLIP® System algorithm or change the hardware and accessories associated with the EndoFLIP® System.
FLIP Topography displays the traditional EndoFLIP® data plus FLIP Topography adds historical data graphs (live data for the last 40 seconds) for use by the clinician.
This document is a 510(k) Summary for the FLIP Topography module, an accessory to the EndoFLIP® system. It outlines various aspects of the device but explicitly states that no clinical investigation was needed because the modification (adding display functionality) does not change the fundamental scientific technology or hardware/software performance. Therefore, detailed information about acceptance criteria and a study proving those criteria are met is not present in the provided text.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Verification activities for the modification were performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not list what those predetermined acceptance criteria were or the specific reported performance against those criteria.
The verification activities included:
- Data acquisition
- Display characteristics (labels, accuracy, etc.)
- Data management
- Communication
The "Performance" row in the comparison table simply states: "No performance testing for a display device only." This implies that the performance expectations were primarily around accurate data display and handling, rather than new physiological measurements.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as no clinical investigation or specific "test set" for performance evaluation of the FLIP Topography module was conducted or described in this document. The document explicitly states, "As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation."
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)
This information is not provided as no clinical investigation or expert-driven ground truth establishment was conducted for the FLIP Topography module, as per the submission's rationale.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical investigation or expert adjudication process was conducted for the FLIP Topography module.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The FLIP Topography module is a software display functionality that presents existing data from the EndoFLIP® system, not an AI or diagnostic algorithm that would typically be evaluated in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done in the context of this submission for the FLIP Topography module. The module is described as display functionality, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no new ground truth establishment was required for this accessory, which primarily displays data. The core EndoFLIP® system, to which this is an accessory, would have had its own ground truth established during its original clearance process (K160725 and K092850), but this document does not detail it.
8. The sample size for the training set
This information is not provided. The FLIP Topography module is a display functionality and not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established
This information is not provided. As above, no training set or its ground truth establishment is discussed for this display module.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).