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K Number
K143235
Device Name
RF20000a Controller, FLOW 50 Wand
Manufacturer
ARTHROCARE CORPORATION
Date Cleared
2015-10-23

(347 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K082666,K083306
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The RF20000a Coblation System, comprised of the FLOW 50 Wand and the RF20000a Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow), Hip, Knee, Shoulder, Wrist.

Device Description

The RF20000a Coblation System is an electrosurgical system consisting of a bipolar radiofrequency Controller with Integrated Fluid Outflow Regulator; a sterile, disposable, single-use FLOW 50 Wand; and a non-sterile, reusable Foot Control. This System utilizes bipolar technology specifically designed for the resection, ablation and coagulation of soft tissues and hemostasis of blood vessels in various arthroscopic and orthopedic procedures. The System offers five distinct Modes of operation: Hi (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis). Each Ablation (Coblation) mode allows for precise ablation with minimal damage to surrounding healthy tissue. The COAG mode allows for consistent and precise hemostasis of blood vessels.

AI/ML Overview

Since the provided document is a 510(k) premarket notification for an electrosurgical device rather than an AI/ML medical device, it does not contain the specific information requested in the prompt regarding acceptance criteria and studies for AI/ML performance.

Therefore, I cannot provide:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document focuses on electrical safety, software validation, and tissue effect testing (histology, thermal margins) to demonstrate substantial equivalence to predicate devices, which is typical for electrosurgical devices. It does not involve AI or algorithms that require such performance metrics.

§ 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.