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510(k) Data Aggregation
(538 days)
EasyMap MAP catheters are indicated for simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart.
EasyMap MAP is a single-use disposable quadropolar catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the catheter tip are a Silver-Chloride Electrode (AgCI), a Silver Electrode (Ag) and two orthogonally placed Silver Electrodes (Ag). These electrodes enable mapping of cardiac electrochemical potentials. The catheter tip can be deflected in a single direction up to 270 degrees.
This document is a 510(k) premarket notification for a medical device called the EasyMap MAP Catheter. It outlines the device's characteristics, intended use, and a comparison to a predicate device, as well as a summary of the testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the provided text to answer your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it lists the tests performed and whether the device "Passed Test." The underlying acceptance criteria are implied to be that the device successfully meets the requirements of the applied standards or internal test methods.
| Test | Applied Standard | Reported Device Performance | Implied Acceptance Criteria (based on "Passed Test") |
|---|---|---|---|
| Corrosion Test | ISO 10555 | Passed Test | The device's materials must resist degradation (corrosion) when exposed to conditions simulating the human body, as per ISO 10555. |
| Dimension Tests | Internal Test Method | Passed Test | Device dimensions (e.g., diameter, length, electrode spacing) must conform to design specifications, as outlined in the internal test method. |
| Electrical Tests (Continuity, Short Circuit, Isolation/Leakage, High Voltage 1kV) | EN 60601 | Passed Test | The device must meet electrical safety standards (e.g., no unintended current paths, adequate insulation, withstand specified voltage) as defined by EN 60601. |
| Mechanical Test - Mechanical Strength after moisture storage | ISO 10555 | Passed Test | The device must maintain mechanical integrity and specified strength after exposure to moisture mimicking physiological conditions, as per ISO 10555. |
| Mechanical Test - Steerability | Internal Test Method | Passed Test | The catheter tip must be able to deflect to the specified angle (up to 270 degrees) and maintain its steerability as defined by the internal test method. |
| Mechanical Test - Fixation Push / Pull Control | Internal Test Method | Passed Test | The catheter's pushability and pullability, and the control of these actions, must meet the specified requirements of the internal test method. |
| Compatibility with existing products - Bending | Internal Test Method | Passed Test | The catheter must exhibit appropriate bending characteristics and compatibility when used with existing products/systems, as defined by the internal test method. |
| Compatibility with existing products - Dimensions | Internal Test Method | Passed Test | The catheter's dimensions must ensure compatibility when used with existing products/systems, as defined by the internal test method. |
| Biocompatibility | ISO 10993 | Passed Test | The device must not cause unacceptable adverse biological reactions (e.g., cytotoxicity, irritation, sensitization) when in contact with human tissue, complying with ISO 10993. |
| Shelf Life Test | Internal Test Method | Passed Test | The device must maintain its safety and performance characteristics for its specified shelf life, as demonstrated by the internal test method. |
| Packaging Validation | ISO 11607-1 | Passed Test | The packaging must protect the device, maintain sterility, and withstand handling and storage conditions, as validated according to ISO 11607-1. |
| Sterilization Validation | EN 550; ISO11135 | Passed Test | The sterilization process (EO gas) must consistently achieve the required sterility assurance level (SAL) for the device, as validated according to EN 550 and ISO 11135. |
| X-Ray Test / Visibility | Internal Test Method | Passed Test | The device must be adequately visible under X-ray imaging to facilitate proper placement and monitoring during procedures, as determined by the internal test method. |
| Overall Performance Statement | "Performance Based upon the documentation presented in this 510(k)" | Safe and effective | The device is deemed safe and effective for its intended use, based on the aggregate results of all tests and the comparison to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests listed are primarily bench (laboratory) tests performed on the device itself, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The tests performed are engineering and materials science tests, not diagnostic performance evaluations requiring expert-established ground truth.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. No adjudication method is mentioned as the tests are objective measurements against standards or internal methods, not subjective evaluations requiring expert consensus.
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 study or any AI assistance in this document. The device is an electrode recording catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
For the engineering and material tests, the "ground truth" used is defined by accepted industry standards (ISO, EN) and the manufacturer's own validated internal test methods and specifications. For instance, for the corrosion test, the ground truth is compliance with ISO 10555. For dimension tests, the ground truth is the engineering drawing specifications.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not a machine learning algorithm.
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