FDA Device Clearances: Airway Inflammation Measurement Device, Intraosseous Infusion System, Metatarsal Resurfacing Implant System

Jill Taylor

March 11, 2008

March 11, 2008 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a handheld device for the measurement of airway inflammation, an intraosseous infusion system for use in establishing a sternal intraosseous access route in adult patients requiring vascular administrations of drugs or fluids to facilitate emergency resuscitation, and a metatarsal resurfacing implant system for the treatment of patients with degenerative and posttraumatic arthritis in the metatarsophalangeal joint.

Handheld Device ( Niox Mino) for the Measurement of Airway Inflammation

On March 3, the FDA granted 510(k) clearance for a handheld device (Niox Mino, Aerocrine Inc) for the measurement of fractional exhaled nitric oxide for the assessment of asthma-related airway inflammation.

Asthma is a chronic disorder in which the airways become inflamed, causing episodic wheezing, coughing, and shortness of breath. According to the Centers for Disease Control and Prevention, an estimated 15.7 million American adults have asthma, resulting in an annual 12.8 million visits to physicians and 1.8 million visits to hospital emergency rooms.

Traditionally, inflammatory airway disease has been monitored by measurement of symptoms and lung function. The newly cleared device provides a mechanism by which physicians can measure the underlying inflammation, allowing for better prediction of therapeutic response and risk of relapse.

Intraosseous Infusion System (Fast1) for Sternal Intraosseous Access

On February 13, the FDA granted 510(k) clearance for an intraosseous infusion system (Fast1, Pyng Medical Corporation) for use in establishing a sternal intraosseous access route in adult patients requiring vascular administrations of drugs or fluids to facilitate emergency resuscitation.

Intraosseous infusion is the delivery of fluids into the blood circulation via the marrow space of a bone, usually the sternum or the tibia. The technique is performed in emergency situations when the intravenous delivery of fluids is difficult or impossible.

Previously cleared in 1997, the current device model has been modified to allow the infusion tube to be removed from the patient's sternum by directly pulling on the tubing, as opposed to requiring a specific tool for removal.

Metatarsal Resurfacing Implant System (OsteoMed Metatarsal) for Degenerative and Posttraumatic Arthritis

On February 21, the FDA granted 510(k) clearance for a metatarsal resurfacing implant system (OsteoMed Metatarsal, OsteoMed LP) for the treatment of patients with degenerative and posttraumatic arthritis in the metatarsophalangeal joint.

Arthritis occurs naturally in joints as a part of the wear and tear of aging, but it may also occur as the result of trauma or disease. In the foot, symptoms of arthritis may include swelling, pain, or tenderness that can result in a loss of motion, making walking difficult.

The device is a one-piece implant designed to replace the distal head of the metatarsal and provide a smooth articular surface for the adjacent phalangeal base. It is intended for use in the presence of good bone stock and integrity of the phalangeal base in patients with hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.

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