(140 days)
The CARTO™ XP EP Navigation System is intended to acquire real time catheter based cardiac electrophysiolgical maps in patients who are eligible for a conventional electrophysiological study. The CARTO™ XP EP Navigation System is restricted for use by licensed medical practitioner who participated in a CARTO™ training course. There are no special contraindications when using the CARTO™ XP EP Navigation System.
The intended use of the CARTO™ XP mapping system is catheter-based atrial and ventricular mapping.
The intended use of the modified device is the same as for Predicate Device A cleared under 510(k) Number K020863. The indications for use have been expanded to include the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.
The CARTO™ XP EP Navigation system is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
The CARTOMERGE module provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps. The CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.
The provided text does not contain detailed information about acceptance criteria for device performance or a specific study proving the device meets those criteria. The 510(k) summary focuses on the device description, indications for use, and a statement of substantial equivalence to predicate devices, rather than detailed performance metrics and study results.
However, based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of electro-anatomical maps | Not explicitly stated in terms of quantitative metrics. The device is designed to "acquire, analyze, and display electro-anatomical maps of the human heart" and "reconstruct maps using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations." Implies accuracy for its intended purpose. |
| Real-time display of cardiac maps | The device "allows real-time display of cardiac maps in a number of different formats" and "acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen." |
| Ability to import, process, visualize, and analyze pre-acquired cardiac images (CT/MRI) and superimpose them with CARTO XP maps. | The CARTOMERGE module "provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps." It "supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format." |
| Safety and Effectiveness | "The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed devices to which it is being compared and does not raise any new questions of safety or effectiveness." (This is a general statement, not specific quantitative criteria or performance). |
| Compliance with Safety Standards | UL 2601-1:97/CSA C22.2 NO.601.1; IEC 60601-2-25:93 and A1(99); IEC 60601-2-27:94 |
Missing Information for this Section:
- Specific quantitative acceptance criteria (e.g., "mapping accuracy must be within X mm," "image registration error must be less than Y mm").
- Detailed reported device performance metrics against these criteria.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "non-clinical bench and animal testing" but does not give sample sizes for these tests or for any human clinical test sets.
- Data Provenance: Not specified. It's likely the "non-clinical bench and animal testing" were conducted internally by the manufacturer (Biosense Webster, Inc., with manufacturing in Israel), but no country of origin for specific data is provided. The tests are described as "non-clinical bench and animal testing," which implies prospective studies in controlled environments, but this is not explicitly stated for a "test set" in the context of human 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 provided in the given text.
4. Adjudication method for the test set
- This information is not provided in the given text.
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
- This information is not provided in the given text. The device is a "EP Navigation System" that aids in mapping, and while it processes information, it's not described as an AI system that improves human readers in a diagnostic sense that would typically involve an MRMC study comparing AI-assisted vs. unassisted performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- While the system "acquires, analyzes, and displays" information, its intended use is to assist a "licensed medical practitioner." The text does not describe a standalone algorithm-only performance evaluation, but rather emphasizes its role in conjunction with human expertise in electrophysiological studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided in the given text. For electro-anatomical mapping, ground truth would typically be established by highly experienced electrophysiologists based on combined electrical and anatomical data, but the document does not detail this.
8. The sample size for the training set
- This information is not provided in the given text. Given the device's nature as an EP navigation system for mapping rather than a machine learning model trained on large datasets for diagnosis, the concept of a "training set" in the modern AI sense might not be directly applicable or detailed. The functionality is described more as signal processing and display.
9. How the ground truth for the training set was established
- This information is not provided in the given text, and for the reasons mentioned above, a "training set" as commonly understood in AI/ML might not be central to the device's development as described.
In summary: The provided 510(k) summary is a high-level regulatory document focused on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and technical specifications. It lacks the detailed performance study information, including specific acceptance criteria, sample sizes, ground truth methodology, and expert involvement, that would be found in a comprehensive clinical or technical validation study report.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).