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510(k) Data Aggregation
(147 days)
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.
The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.
The Coaxial Accordion ERCP Device is a medical device intended for the endoscopic removal of stones in the biliary system and for contrast injection.
Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Data (e.g., efficacy in stone removal, safety, durability) | Not Required |
Explanation: The documentation explicitly states "Performance Data: Not required" for this 510(k) submission. This indicates that Percutaneous Systems, Inc. did not conduct a specific performance study with defined acceptance criteria for this device. Instead, the device's clearance was based on demonstrating substantial equivalence to predicate devices already on the market.
2. Sample Size Used for the Test Set and Data Provenance
Since a dedicated performance study was "Not required," there is no test set sample size or data provenance information provided in this submission for the Coaxial Accordion ERCP Device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as no dedicated performance study using a test set was conducted.
4. Adjudication Method for the Test Set
This information is not applicable as no dedicated performance study using a test set was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not conducted as no dedicated performance study was required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical device (biliary catheter), not an algorithm or AI product. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
This information is not applicable as no dedicated performance study was conducted.
8. The Sample Size for the Training Set
This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device.
Summary of Device Acceptance and Study:
The Coaxial Accordion ERCP Device gained market clearance through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices:
- Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc.
- Fusion Extraction Balloon with Multiple Sizing, Cook Medical
The study that proved the device met the acceptance criteria was the substantial equivalence comparison. This comparison focused on demonstrating that the Coaxial Accordion ERCP Device has the same intended use, indications for use, principles of operation, and very similar technological characteristics as the already legally marketed predicate devices. Because of this similarity, the FDA determined that a separate, dedicated performance study with specific acceptance criteria was "Not required" for this submission. The assumption of substantial equivalence implies that the new device carries the same safety and effectiveness profile as the predicate devices that have established performance.
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