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510(k) Data Aggregation
(102 days)
PID
The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.
The subject dilation balloon consists of an PET balloon attached to a 75 cm that is secured to a white Pebax Y junction with two extension lines leading with a wire guide hub and an inflation hub. The catheter has four black ink markers on the catheter.
The dilation balloon is composed of PET, with a patient contacting length of 8 cm which can be inflated to a single size of 30 mm or 35 mm in diameter. The balloon has a 1.16" long tip made of white Neuthane. Three tantalum radiopaque bands are placed underneath the balloon to assist in fluoroscopic visualization of the balloon.
The provided text describes a medical device, the Wilson-Cook Achalasia Balloon, and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study involving AI or human readers.
Therefore, I cannot provide the requested information in the format of acceptance criteria, device performance, sample sizes, expert qualifications, or MRMC studies, as these details are completely absent from the given FDA letter and associated summary.
The document focuses on the regulatory clearance process for a traditional medical device (a balloon dilator) and its comparison to a predicate device. The information provided is primarily about:
- Device Name: Wilson-Cook Achalasia Balloon
- Intended Use: To dilate the lower esophageal sphincter in patients with Achalasia (adult use only).
- Predicate Device: Rigiflex II Single-Use Achalasia Balloon Dilator (K050232)
- Comparison: The subject device is considered "substantially equivalent" to the predicate, with minor differences outlined (materials, patient contacting length, dimensions, non-sterile packaging, and higher maximum inflation pressure). These differences are stated not to raise new questions of safety or effectiveness.
- Non-Clinical Testing: A list of performance tests conducted (e.g., Balloon Diameter and Length, Pressure Verification, Distensibility, Tensile Testing, Dimensional Verification, Functional Testing, Shelf Life Testing, Biocompatibility). These tests demonstrate that the device performs as intended, but specific acceptance criteria or quantitative results are not detailed in this summary.
In summary, the provided text describes the regulatory clearance of a physical medical device and its non-clinical testing for performance and equivalence to a predicate, not an AI/ML-driven device or study with the characteristics requested in your prompt.
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(73 days)
PID
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 ( |
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(38 days)
PID
The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
The Rigiflex™ II Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end.
I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Rigiflex™ II Single-Use Achalasia Balloon Dilator) and confirms its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, details of a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, or other elements you've requested.
The section "PERFORMANCE DATA" briefly mentions that "functional testing support a determination of substantial equivalence," but it does not elaborate on the data itself, the criteria it met, or the specifics of the study design. It also refers to a general FDA guidance document, not a report of specific study results for this device.
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