(188 days)
The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is recommended for dilation of the nephrostomy tract.
The Gvrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate the nephrostomy tract.
The manufacturer, Gyrus ACMI, Inc., submitted a 510(k) premarket notification for their Nephro - EZDilate Nephrostomy Balloon Dilation Catheter. This application describes the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
Based on the provided text, the device in question is a medical device (a balloon dilation catheter), not an AI/ML powered device. Therefore, many of the requested fields (such as multi-reader multi-case studies, standalone performance, ground truth establishment, training set details) are not applicable to this submission.
Here's the information that could be extracted regarding the device's acceptance criteria and the supporting "study" (which in this context refers to performance testing rather than clinical trials or AI model validation):
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material/Design | Compliant with relevant ISO and ANSI/AAMI standards, similar to predicate device for safety/effectiveness | Polycarbonate two-way hub, polyurethane strain relief, polyamide outer tube, Polyethylene Terephthalate balloon, non-patient contacting loaded polyamide inner catheter body. |
| Sterilization | Sterile, Ethylene Oxide sterilization method, single patient use | Ethylene Oxide sterilization, sterile. |
| Shelf Life | Not explicitly stated as acceptance criteria, but a shelf life of one year is reported. | One year |
| Intended Use | Dilation of the nephrostomy tract | Recommended for dilation of the nephrostomy tract. (Matches) |
| First Article Inspection | Not specified (assumed to meet design specifications) | Conducted |
| Balloon Burst Testing | Not specified (assumed to meet performance requirements) | Conducted |
| Balloon Kink Testing | Not specified (assumed to meet performance requirements) | Conducted |
| Durability Testing (cycle testing) | Not specified (assumed to meet performance requirements) | Conducted |
| Compliance Testing | Not specified (assumed to meet specified compliance standards) | Conducted |
| Balloon Shape Characteristics Testing | Not specified (assumed to meet design specifications) | Conducted |
| Balloon Insertion Force Testing | Not specified (assumed to meet performance requirements) | Conducted |
| Bond Strength | Not specified (assumed to meet design specifications) | Conducted |
| Fluoroscopy Testing | Not specified (assumed to demonstrate visibility) | Conducted |
| Amplatz Sheath Visibility and Compression Testing | Not specified (assumed to meet performance requirements) | Conducted |
| Substantial Equivalence | Same intended use, design, and scientific technology as the Predicate Boston Scientific NephroMax Balloon Dilation Catheter (K121614), with no new issues of safety or effectiveness. | Determined to be substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes performance tests conducted on the device itself (e.g., balloon burst, kink, durability tests). These are engineering/device-centric tests, not clinical studies involving patient data. Therefore, the concept of "test set" and "data provenance" in the context of patient data is not applicable. The tests are performed on manufactured device units. No specific sample sizes for these tests are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device premarket notification for substantial equivalence, not an AI/ML device requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for device performance tests in this document.
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
Not applicable. This is not an AI/ML powered medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered medical device.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" would be the engineering specifications and performance requirements established by the manufacturer and relevant industry standards (ISO, ANSI/AAMI). For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML powered medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML powered medical device.
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