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K Number
K013083
Device Name
CARTO XP EP NAVIGATION SYSTEM
Manufacturer
BIOSENSE WEBSTER, INC.
Date Cleared
2001-11-21

(68 days)

Product Code
DQK
Regulation Number
870.1425
Type
Special
Panel
CV
Reference & Predicate Devices
K000248
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the CARTO XP mapping system is catheter-based atrial and ventricular mapping.

The CARTO XP mapping system allows real-time display of cardiac maps in a number of The CARTO AT mapping system and no no roar cardiac electrical activation maps, cardiac difficient formation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface maps and cardiac impodation may also be displayed in real time on the display screen.

Device Description

The CARTO™ XP mapping system is designed to acquire, analyze, and display electroanatomical 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. In the CARTO XP mapping system the location information needed to create the cardiac maps is acquired using locatable-tip catheters equipped with a magnetic location sensor.

AI/ML Overview

The provided text is a 510(k) summary for the CARTO™ XP Mapping System. It briefly describes the device, its intended use, and states that non-clinical bench and animal testing demonstrate its safety and effectiveness compared to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information regarding sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the table or answer the specific questions directly from the provided text.

Based on the provided text, the following information can be extracted, though it does not fully answer the request:

Acceptance Criteria and Device Performance:

  • The document states: "The non-clinical bench and animal testing show that the device is as safe and as effective I he noti-cinneal belief and allinal testing the which it is being compared and does not raise any new questions of safety or effectiveness." This is a general statement about meeting safety and effectiveness, but no specific performance metrics or acceptance criteria are listed.

Additional Information Not Available in the Document:

  1. Sample size used for the test set and the data provenance: Not mentioned.
  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
  4. 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 mentioned. The device is a "mapping system" and not explicitly stated as an AI-driven diagnostic aid that assists human readers.
  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
  7. The sample size for the training set: Not mentioned.
  8. How the ground truth for the training set was established: Not mentioned.

§ 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).