(29 days)
The FLOW 90 Wand, used with Qualified 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)
- Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar, Tissue, Soft Tissue, Synovectomy, Tendon)
- Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane,Tendon)
Hip
- Excision/Resection - (Acetabular Labrum)
Knee
- Ablation/ Debrideement - (ACL/PCL, Notchplasty)
- Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy)
Shoulder
- Ablation/ Debrideement - (Subacromial Decompression)
- Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum)
Wrist
- Excision/Resection - (Triangular Fibrocartilage)
The FLOW 90 Wand is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. The FLOW 90° Wand is compatible with Qualified controllers (WEREWOLF® COBLATION® Systems (includes WEREWOLF® (K162074), WEREWOLF® ENT, (K192027) and WEREWOLF® + (K210423)) and INTELLIO® SHIFT ® System (K232290)).
The FLOW 90 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the Qualified Controller and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the Qualified Controllers to support the use of the modified FLOW 90 Wand.
The provided text is a summary of a 510(k) premarket notification for a medical device called the FLOW 90° Wand. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The relevant section, "NON-CLINICAL Testing," mentions electrical safety and bench testing (flow rate, fluid ingress, suction tube kinking, finger switch testing, and packaging validation), but these are for a physical electrosurgical device, not an AI/ML system.
Therefore, I cannot provide the requested information as it is not present in the given document.
§ 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.