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510(k) Data Aggregation
(73 days)
The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.
The EsoFLIP® balloon dilation catheter is a modification of the predicate Crospon EndoFLIP® catheters. The EsoFLIP® is a small catheter with an inflatable balloon which is inserted into the gastro-esophageal junction of a patient with Achalasia. It is connected to the EndoFLIP® controller system (K I20997) and the catherer is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The EsoFLIP® catheter is inserted by the clinician. The proposed balloon dilation catheter, EsoFLIP®, can also make diameter measurements electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system. K 120997.
This document is a 510(k) Premarket Notification for the EsoFLIP® Balloon Dilation Catheter. It outlines the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance metric with specific thresholds. Instead, it states that "The results demonstrate that the EsoFLIP® has met the performance specifications." and that the device is "substantially equivalent" to predicate devices. The performance data provided is primarily a comparison to the predicate device's specifications.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical to Cook Endoscopy Achalasia Balloon K 900924 (dilation of esophageal strictures, specifically for Achalasia patients). | The EsoFLIP® catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia. (Identical to K900924) |
| Technology (Dilation) | Maximum diameter 30 mm, working length 80 mm, use with guidewire (similar to K900924). | Balloon inflates to 30mm diameter, along a working length of 80mm. Features a guidewire tip. (Identical to K900924) |
| Technology (Measurement) | Similar measurement technique to EndoFLIP® K120997, with minor modifications (reduction in measurement points). | Provides an Estimated Diameter (Dest) of the balloon at 14 points along its length when inflated with saline solution. |
| Environment of Use | Hospital and surgery centers (identical to predicates). | Hospital and surgery centers (identical to predicates). |
| Patient Population | Patients with Achalasia (identical to K900924). | Patients with Achalasia (Identical to K900924). |
| Materials | Identical to predicate EndoFLIP® catheters, K 120997. Biocompatibility based on G95-1 and ISO 10993-1. | Patient contacting materials are identical to predicate EndoFLIP® catheters, K 120997. Considered surface contacting, mucosal membrane, limited duration (<24h). |
| Performance (Measurement Range) | Similar to EndoFLIP® K120997 (5 to 25 mm) and Cook Endoscopy Achalasia Balloon K900924 (30 mm for product G24893). | Range: 8 to 30 mm. |
| Performance (Measurement Resolution) | Similar to EndoFLIP® K120997 (0.1 mm). | Resolution: 0.1 mm. (Identical to K120997) |
| Performance (Measurement Accuracy) | Similar to EndoFLIP® K120997 (± 1mm at 95% confidence). | Accuracy: ± 1mm (at 95% confidence) rounded to nearest integer. (Identical to K120997) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Bench Testing" reports (e.g., DHF_1343, DHF_1290, DHF_1296, etc.) which indicate non-clinical lab-based testing. However, the specific sample sizes used for these tests are not provided within this document. The provenance of this data is from the manufacturer, Crospon Ltd. in Ireland, as indicated by the company's address. The testing is non-clinical, so "retrospective or prospective" does not directly apply in the same way it would for clinical data, though it represents new testing performed for this submission.
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 document details bench testing (non-clinical), not clinical trials involving human subjects or expert assessment of medical images for ground truth. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable and not provided in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this document describes bench testing, there is no adjudication method for a test set involving human interpretation of results. The "ground truth" for the bench tests would have been established by the test protocols and measurement instruments.
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
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. This submission is for a medical device (catheter) and focuses on its physical and functional equivalence to predicate devices through non-clinical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a physical medical device (catheter) with a measurement function described as "electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system." While there is a "measurement" aspect, it's not an AI algorithm in the typical sense that would have a standalone performance evaluated for "algorithm only" against human-in-the-loop. The performance listed (range, resolution, accuracy) refers to the device's ability to measure diameter, which is a standalone function of the device and its associated controller.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be established by controlled experimental conditions, metrology standards, and validated measurement equipment. For example, in "Balloon Compliance Tests," the ground truth for displacement or pressure would come from calibrated sensors and known physical properties. There is no expert consensus, pathology, or outcomes data relevant to these non-clinical tests.
8. The sample size for the training set
This document describes a medical device, not an AI algorithm that requires a "training set." Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this information is not applicable and not provided.
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