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K Number
K161481
Device Name
Ambient HipVac 50 Wand with Integrated Finger Switches
Manufacturer
ARTHROCARE CORPORATION
Date Cleared
2016-10-21

(143 days)

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

The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) for Ablation/Debridement of Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar Tissue, Soft Tissue, Synovectomy, Tendon and for Excision/Resection of Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon. Hip for Excision/Resection of Acetabular Labrum. Knee for Ablation/Debridement of ACL/PCL, Notchplasty and for Excision/Resection of Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy. Shoulder for Ablation/Debridement of Acromioplasty, Subacromial Decompression and for Excision/Resection of Frozen Shoulder Release, Glenoid Labrum. Wrist for Excision/Resection of Triangular Fibrocartilage.

Device Description

Not Found

AI/ML Overview

I regret to inform you that the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Ambient HipVac 50 Wand with Integrated Finger Switches."

This document primarily states:

  • The FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices.
  • The indications for use for the device, which specify the arthroscopic and orthopedic procedures and the tissues (for ablation/debridement and excision/resection) the device is intended for.

It does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes for test sets, data provenance, or expert qualifications.
  • Information on adjudication methods or multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Results from standalone algorithm performance studies.
  • Details about ground truth establishment for test or training sets, or training set sample sizes.

Therefore, I cannot fulfill your request based on the provided text.

§ 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.