Product Approval Summaries

DEVICES

FDA has cleared a Conavi Medical 510(k) for the Foresight ICE System for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels. The company describes it as the first catheter-based ultrasound system capable of providing both 2D and 3D ultrasound images of cardiac anatomy around the circumference of the catheter’s tip. It also includes a dual display imaging console for enhanced viewing, it says.

K2M Group Holdings has received FDA 510(k) clearance for the Cascadia Lateral Interbody System featuring Lamellar Titanium Technology that uses 3D printing with the goal of allowing for bony integration throughout the spinal implant. “Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity,” the company says. The device features a reverse hourglass implant design that allows for increased endplate contact compared to K2M’s Aleutian implant. The system includes a full range of implant sizes and is designed to work in conjunction with the Ravine Lateral Access System, which the company says offers a full line of instrumentation for the far lateral transpsoas approach.

FDA has cleared a NeuroMetrix 510(k) for an upgraded version of Quell, the company’s over-the-counter, drug-free chronic pain relief wearable device. The clearance covers the device’s controllability via the Quell Relief smartphone app. It also includes extended battery life and advanced sleep tracking. NeuroMetrix says Quell uses the company’s new technology — wearable intensive nerve stimulation, that is clinically proven to manage chronic pain. The device is designed to be worn below the knee and activated by clicking a button.

Olympus has received FDA has clearance of a 510(k) for the TJF-Q180V duodenoscope with modifications to the device design and labeling. The company says the device is a flexible gastrointestinal endoscope used in procedures such as endoscopic retrograde cholangiopancreatography, which is most commonly performed to diagnose and treat conditions in the pancreas, bile duct and gallbladder.

OptMed Inc. has gained 510(k) clearance from FDA for its BondEase product, a topical skin adhesive intended for the closure of surgical incisions and lacerations as an alternative to sutures and staples. The biocompatible, topical skin adhesive combines a novel polymer technology with a user-friendly delivery device, according to the company.

FDA has cleared a Siemens Healthcare 510(k) for the Sysmex CS-5100 System, a hemostasis system that enables automated, standardized sample management as well as automated detection of unsuitable samples. The company says it’s the first analyzer in its hemostasis solutions portfolio equipped with “simultaneous multi-wavelength Preanalytical Sample Integrity checks, or PSI technology, enabling high-volume laboratories to achieve first-run accuracy.”

HUMAN DRUGS

Impax Laboratories has received FDA approval of its supplemental NDA for Emverm (mebendazole) 100 mg chewable tablets, indicated for treating Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), and Necator americanus (American hookworm) in single or mixed infections.