(131 days)
The EsoFLIP® ES-310 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-310 balloon catheter is to be used only with the EndoFLIP® system.
The EsoFLIP® ES-310 catheter is a balloon dilation catheter. It is used by surgeons or gastroenterologists to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux, and radiation therapy. This indication for use is identical to the predicate EsoFLIP® ES-series (ES-320) predicate, K142000.
The EsoFLIP® catheter connects to the EndoFLIP® imaging system in the same fashion as the predicate EsoFLIP® catheter, to display an image of the cross-sectional-areas (CSAs) of the dilation balloon, and to allow the balloon to be inflated using the EndoFLIP® syringe driver.
In all cases the catheters are to only be used with the EndoFLIP® system.
The provided document is a 510(k) summary for the EsoFLIP® ES-310 balloon catheter and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a clinical study with acceptance criteria and a detailed analysis of device performance against those criteria in the way a clinical trial report would.
Instead, the document details non-clinical comparative performance and specifications, primarily through bench testing, to show that the new device operates similarly to the predicate device and meets its stated specifications.
Here's an analysis based on the provided text, addressing your questions where possible:
Acceptance Criteria and Study for EsoFLIP® ES-310 Balloon Catheter
The EsoFLIP® ES-310 balloon catheter underwent non-clinical bench testing to demonstrate its performance and substantial equivalence to its predicate device, the EsoFLIP® ES-series (ES-320) (K142000). The "acceptance criteria" are implied by the device's specifications and the need to demonstrate equivalent performance to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied to be that the device performs to its stated specifications and is safe and effective for its intended use, similar to the predicate device. The document doesn't explicitly list "acceptance criteria" but rather "specifications" for the device, which are implicitly the targets for acceptance.
| Performance Characteristic | Acceptance Criteria (Implied/Predicate) | Reported Device Performance (EsoFLIP® ES-310) |
|---|---|---|
| Dilation Capability | Similar to predicate for esophageal strictures | Performed to specifications (dilation) |
| Diameter Measurement Accuracy | Accuracy: ± 1mm (at 95% confidence) (Same as predicate) | Accuracy: ± 1mm (at 95% confidence) rounded to nearest integer |
| Diameter Measurement Resolution | Resolution: 0.1 mm (Same as predicate) | Resolution: 0.1 mm |
| Maximum Balloon Inflation Pressure | 2.0 ATM (Predicate) / 1.5 ATM (Reference ES-330) | 1.5 ATM (similar to reference device K132337) |
| Balloon Fatigue | N/A (Tested and demonstrated appropriate performance) | Tested and demonstrated that the device performed to its specifications |
| Balloon Compliance | N/A (Tested and demonstrated appropriate performance) | Tested and demonstrated that the device performed to its specifications |
| Balloon Burst | N/A (Tested and demonstrated appropriate performance) | Tested and demonstrated that the device performed to its specifications |
| Catheter Assembly | N/A (Tested and demonstrated appropriate performance) | Tested and demonstrated that the device performed to its specifications |
| Biocompatibility | Materials in contact with patient identical to predicate | Materials (Balloon - Nylon 12, Shaft - Pebax 7233 SA01, Tip - Pebax 2533 SA01) identical to predicate (K142000) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for individual bench tests (e.g., how many balloons were tested for burst pressure or fatigue). It states "The Performance Testing included..." and lists the tests.
- Data Provenance: The data is from non-clinical bench testing. The country of origin for the testing is not explicitly stated, but the company is Crospon Ltd. from Galway, Ireland. The tests were performed to support substantial equivalence to a legally marketed predicate device in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This is a non-clinical bench testing report. Therefore, there were no human experts establishing ground truth in the context of clinical interpretation, as would be the case for an AI diagnostic device. The "ground truth" for bench testing is established by engineering specifications, validated measurement equipment, and standardized testing protocols.
4. Adjudication Method for the Test Set
- Not applicable as this is a non-clinical bench testing report and does not involve human interpretation or clinical adjudication.
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
- No. This document is for a physical medical device (a balloon catheter for dilation), not an AI software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter designed for use in conjunction with the EndoFLIP® system and by a clinician. It is not an algorithm evaluated for standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the bench testing, the "ground truth" refers to the established engineering specifications, physical measurements from calibrated instruments, and standardized test methods (e.g., a burst pressure test aims to find the actual burst pressure, which is the "truth" for that specific sample under the test conditions).
8. The Sample Size for the Training Set
- Not applicable. This document describes a physical medical device. There is no concept of a "training set" in the context of software algorithms or machine learning models for this device. The design and manufacturing processes are validated, not "trained."
9. How the Ground Truth for the Training Set was Established
- Not applicable for the reasons stated in point 8.
§ 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.