K Number
K032504
Manufacturer
Date Cleared
2003-08-21

(8 days)

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

The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic ProceduresJoint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Ablation and Debridement
• ACL/PCLKnee
• AcromioplastyShoulder
• Articular CartilageAll Joints
• BursectomyAll Joints
• ChondroplastyAll Joints
• FaciaAll Joints
• LigamentAll Joints
• NotchplastyKnee
• Scar TissueAll Joints
• Soft TissueAll Joints
• Subacromial DecompressionShoulder
• SynovectomyAll Joints
• TendonAll Joints
Excision and Resection
• Acetabular LabrumHip
• Articular LabrumAll Joints
• CapsuleAll Joints
• Capsular ReleaseKnee
• Cartilage FlapsKnee
• CystsAll Joints
• Discoid MeniscusKnee
• Frozen Shoulder ReleaseShoulder
• Glenoidale LabrumShoulder
• Lateral ReleaseKnee
• LigamentAll Joints
• Loose BodiesAll Joints
• Meniscal CystectomyKnee
• MeniscectomyKnee
• Plica RemovalAll Joints
• Scar TissueAll Joints
• Soft TissueAll Joints
• Synovial MembraneAll Joints
• TendonAll Joints
• Triangular Fibrocartilage (TFCC)Wrist
• VillusectomyKnee
Coagulation
• ACL/PCLKnee
• Articular CartilageAll Joints
• Carpal LigamentsWrist
• Glenohumeral CapsuleShoulder
• LigamentAll Joints
• Medial RetinaculumKnee
• Rotator CuffShoulder
• TendonAll Joints
• Wrist TendonsWrist
Device Description

The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

AI/ML Overview

This document is a 510(k) summary for the ArthroCare System, an electrosurgical device. It details the device's intended use, its substantial equivalence to a predicate device, and confirms that modifications do not significantly affect safety or efficacy. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to its performance metrics.

The document discusses:

  • Device Description: A bipolar, high-frequency electrosurgical system comprising a Controller, disposable Wands, and a reusable Patient Cable.
  • Intended Uses: Resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in various arthroscopic and orthopedic procedures across multiple joints.
  • Substantial Equivalence: The current submission (K032504) proposes modifications to performance specifications, dimensional specifications, and labeling of an already cleared device (K030551). It explicitly states that "The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System remain the same as in the predicate cleared 510(k)." The document concludes that the modifications are not substantial and do not significantly affect safety or efficacy.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and a study demonstrating the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

§ 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.