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510(k) Data Aggregation
(174 days)
ATRION MEDICAL QL INFLATION DEVICE
The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.
The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.
The provided text describes a 510(k) premarket notification for the "Atrion Medical QL® Inflation Device". It is a submission for a medical device, and as such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood in the context of clinical trials for diagnostic algorithms or AI models does not directly apply here.
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices like this. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).
Here's an analysis based on the provided text, addressing the points you requested where applicable, and highlighting why some points are not relevant to this type of device and submission:
Analysis of Acceptance Criteria and Device Performance for Atrion Medical QL® Inflation Device (K032840)
1. Table of Acceptance Criteria and Reported Device Performance:
For a device like the Atrion Medical QL® Inflation Device, the "acceptance criteria" are primarily based on demonstrating that it performs equivalently to predicate devices in its fundamental functions and does not raise new questions of safety or effectiveness. The document states:
| Criterion/Parameter (Implicit "Acceptance Criteria") | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence | "The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon." This is identical to the stated function of predicate devices. |
| Operating Pressure Range | "The Atrion Medical QL® Inflation Device has an operating pressure range of vacuum to [missing number for max pressure, but implies a range similar to predicates]." |
| "While the predicate devices have a [missing number] alln, depending on the manometer [missing number] ending on the predicate." | |
| Implication: The operating pressure range is comparable and suitable for its intended use with balloon dilatation catheters. | |
| Material Biocompatibility | "The materials of the device which contact the solution in use have been tested using [unspecified methods, but states that] these studies indicate that the product is safe for its intended use." |
| Absence of New Safety/Effectiveness Concerns | "There are no other characteristics that distinguish the two devices [new vs. predicate], and no differences that should pose a risk to patient safety." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable to this type of 510(k) submission. The "test set" and "data provenance" as described in the context of AI/diagnostic algorithm validation (e.g., country of origin, retrospective/prospective) are not relevant here. This submission relies on engineering testing and comparison to predicate device specifications, rather than clinical data sets in that sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable. The "ground truth" for a device like an inflation device is based on objective engineering specifications (pressure, material safety, leak integrity, etc.) and its functional equivalence to predicate devices, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not how the performance of an inflation device is evaluated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This information is not applicable. MRMC studies are used to assess the impact of a diagnostic tool on human reader performance. The Atrion Medical QL® Inflation Device is a surgical accessory, not a diagnostic tool requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's safety and effectiveness determination is primarily based on:
- Engineering Specifications and Performance Testing: Demonstrating the device meets its functional requirements (e.g., pressure range, leak-free operation, material integrity).
- Predicate Device Equivalence: Showing that its design, materials, and intended use are substantially equivalent to previously cleared devices.
- Biocompatibility Testing: Ensuring materials in contact with body fluids are safe.
8. The sample size for the training set:
This information is not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The design and testing are based on engineering principles and regulatory standards.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
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