(46 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 EndoFLIP® system and its accessory catheters are identical to the reference Crospon EndoFLIP® K120997. The proposed modifications to the EndoFLIP® system is to expand the anatomical locations to encompass the measurement of pressures and dimensions in the esophagus, pylorus, and anal sphincters.
The provided document is a 510(k) Pre-Market Notification for the EndoFLIP® System. It describes the device's indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. However, it does not contain specific acceptance criteria or a detailed study report with the requested performance metrics, sample sizes, ground truth establishment, or expert information typically found in a clinical study section.
Instead, it relies on a comparison to previously cleared devices and cites independent clinical studies as evidence supporting the expanded indications for use.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be gathered, with caveats:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states "no design changes to the system or catheters and therefore no change in performance" and "No comparative bench testing was required as there are no design changes to the system or catheter." This implies that the performance of the current device is considered equivalent to its previously cleared versions.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for a specific test set directly tied to this 510(k) submission. The document cites 11 independent clinical studies that have "been performed for the cited anatomical locations." The sample sizes and data provenance (country of origin, retrospective/prospective) would need to be extracted from the individual cited publications, which are not included in this document.
3. Number of Experts and Qualifications
This information is not provided in the document. This would be specific to how the ground truth was established within the cited independent clinical studies.
4. Adjudication Method
This information is not provided in the document. This would be specific to how the ground truth was established within the cited independent clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the document. The device is a "Gastrointestinal motility monitoring system" for measuring pressure and dimensions, not an imaging device typically evaluated with human readers and AI assistance in an MRMC study.
6. Standalone (Algorithm Only) Performance Study
As this is a measurement device for physical parameters (pressure and dimensions) and not an AI-based diagnostic algorithm, a standalone algorithm-only performance study as typically understood for AI devices is not applicable and therefore not mentioned.
7. Type of Ground Truth Used
The type of ground truth used would be based on the nature of measurements in the cited independent clinical studies. Given the device measures "pressure and dimensions," the ground truth would likely involve direct physical measurements obtained through established medical procedures or validated alternative measurement techniques, as conducted by medical professionals in a clinical setting. However, the document does not explicitly state the type of ground truth for the cited studies.
8. Sample Size for the Training Set
This information is not provided. The document describes a medical device for measurement, not an AI/ML-based device that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As above, it's not applicable for this type of medical device's submission.
Summary of what can be extracted from the document:
- Device Name: EndoFLIP® System
- Regulation Number: 21 CFR § 876.1725
- Regulation Name: Gastrointestinal Motility Monitoring System
- Regulatory Class: II
- Product Code: FFX
- Predicate Device: K991288 - G&J Electronics, Distender Series II Barostat
- Reference Devices: K120997 – EndoFLIP® system – Crospon Ltd., K092850 - EndoFLIP® system - Crospon Ltd.
- Indications for Use (Expanded in this submission): To measure pressure and dimensions in the esophagus, pylorus, and anal sphincters as an adjunct to other diagnostic methods for patients with symptoms consistent with gastrointestinal motility disorders. Also, to estimate stoma size with gastric bands and measure gastric sleeve size during bariatric surgery.
- Technology/Design/Features/Materials/Performance Specifications: Identical to previous EndoFLIP® systems (K092850), implying no changes from previously cleared performance.
- Clinical Evidence: The submission supports its expanded indications by citing 11 independent clinical studies that have evaluated the device for the new anatomical locations (anal sphincter, pylorus, upper esophageal sphincter). The details of these studies (sample size, ground truth, etc.) are not in this document but are found in the cited scientific literature.
§ 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).