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K Number
K022894
Device Name
EPICOR MEDICAL ABLATION SYSTEM
Manufacturer
EPICOR MEDICAL, INC.
Date Cleared
2004-02-26

(541 days)

Product Code
NTB,OCL
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K010956,K013873,K011722,K020919,K003978,K013946,K013392,K013901,K021010,K022008
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.

Device Description

Epicor Medical Ablation System, including the UltraWand Ablation Device, Ablation Control System, and Connecting Cable

AI/ML Overview

The provided text is a 510(k) premarket notification letter and summary for the Epicor Medical Ablation System. It confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness. However, the document does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the format of AI/ML evaluation as requested.

The document states:

  • "Results of in vitro and in vivo testing demonstrate that the Epicor Medical Ablation System is safe and effective for its intended use."
  • "The materials used in the Epicor Medical Ablation System meet the requirements of ISO 10993-1."
  • "Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices."

This is a general statement of compliance and substantial equivalence, not a detailed report of acceptance criteria and the performance against them with numerical metrics, expert adjudication, or sample size specifics as typically found in an AI/ML device submission. The FDA 510(k) pathway often relies on demonstrating substantial equivalence to existing devices rather than entirely novel performance criteria.

Therefore, I cannot extract the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device because this information is not present in the provided text. The device described, the "Epicor Medical Ablation System," is an electrosurgical cutting and coagulation device, not an AI/ML diagnostic or predictive tool.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.