(64 days)
The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.
Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.
The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.
In all cases the catheters are to only be used with the EndoFLIP® system.
Here's an analysis of the provided text regarding the EsoFLIP® ES Balloon Dilation Catheter, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new, specific acceptance criteria for performance metrics like sensitivity, specificity, or image quality, which are more common for diagnostic AI/imaging devices. Instead, the acceptance criteria revolve around engineering specifications and material compatibility.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Accuracy Test (EsoFLIP® Accuracy Test) | Met performance specifications |
| Dilation Catheter Bonds Test (EsoFLIP® Dilation Catheter Bonds Test) | Met performance specifications | |
| Balloon Fatigue Test (EsoFLIP® Balloon Fatigue Test) | Met performance specifications | |
| Catheter Torque Tests (EsoFLIP® Catheter Torque Tests) | Met performance specifications | |
| Balloon Burst Test (EsoFLIP® Balloon Burst Test) | Met performance specifications | |
| Catheter Balloon Compliance (EsoFLIP® Catheter Balloon Compliance) | Met performance specifications | |
| Catheter Assembly Tests (EsoFLIP® Catheter Assembly Tests) | Met performance specifications | |
| Inflation Pressure | 2.0 atm (Matches predicate K983373, higher than K132337) | |
| Measurement Range | 8 to 20 mm (Matches predicate K132337 for minimum, lower maximum than K132337) | |
| Measurement Resolution | 0.1 mm (Identical to K132337) | |
| Measurement Accuracy | ± 1mm (at 95% confidence) rounded to nearest integer (Identical to K132337) | |
| Material Compatibility / Biocompatibility | ISO 10993-1 Biocompatibility Testing | All materials have passed biocompatibility tests in accordance with ISO 10993-1 (for all relevant materials, including Nylon 12 for the balloon and existing materials for shaft/tip). |
| Shelf Life | 2 Year Shelf Life Test (EsoFLIP® 2 Year Shelf Life Test) | Met performance specifications |
2. Sample Size Used for the Test Set and Data Provenance:
This submission describes non-clinical bench testing rather than human clinical trials or studies with patient data. Therefore, the concept of a "test set" in the context of collected patient data (e.g., images for an AI algorithm) is not applicable here.
- Sample Size: Not specified in terms of patient data. For bench tests, the number of catheter units tested would be the "sample size," but this is not explicitly stated.
- Data Provenance: Not applicable as it's mechanical/material bench testing, not derived from a patient population or geographical region.
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided and is not applicable to the type of testing described. Ground truth for these engineering tests would be established by validated measurement equipment and adherence to engineering specifications and international standards (e.g., ISO 10993-1).
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable. Adjudication methods are typically used for expert review of human data, particularly in clinical studies or AI algorithm validation to resolve discrepancies in diagnoses or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for evaluating diagnostic aids where human readers' performance with and without the device is compared. The EsoFLIP® ES is a therapeutic device (dilation catheter) with measurement capabilities, not a diagnostic imaging aid.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Yes, in a sense, a standalone study (bench testing) was performed. The "Non-clinical Testing Summary - Bench Testing" section lists various tests (e.g., Accuracy Test, Balloon Burst Test, Fatigue Test) that evaluate the device's inherent mechanical performance and capabilities (e.g., measurement range and accuracy) without direct human intervention in the performance measurement itself, beyond setup and data collection. The device itself performs the "measurement" function to provide an estimated diameter (Dest).
7. Type of Ground Truth Used:
The ground truth for the bench testing would be established by:
- Engineering Specifications: Pre-defined design limits and performance expectations for the device components.
- Reference Standards: Calibrated measurement equipment and established testing methodologies (e.g., for accuracy, burst pressure, fatigue).
- International Standards: Compliance with standards like ISO 10993-1 for biocompatibility.
8. Sample Size for the Training Set:
This information is not applicable. The EsoFLIP® ES is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.