Antibody Test - OraQuick HCV Rapid Antibody Test - P080027

This medical device was FDA approved on June 25, 2010.  The medical device is used to detect hepatitis C virus (HCV).  It works by detecting if a patient has been exposed to the hepatitis C virus.  If this is the case the body elicits an immune response and produces antibodies to fight off the virus.  The test allows clinicians to determine if the antibodies are present in the blood.

The medical device works by attaching themselves to the antibodies – a chemical reaction causes the test strip to change color indicating the presence.

False positives should be verified with other tests to rule out error.

Ophthalmic - Implantable Miniature Telescope™ - P050034

This medical device was FDA approved on July 1^st, 2010.  It is an implantable miniature telescope that is used to treat patients with age-related macular degeneration (AMD).

Macular Degeneration is a disease that affects adults over the age of 60 and is the leading cause of vision loss.

It is denoted  by a loss of “central vision” which is critical for doing such tasks as reading or driving.  The macula is the region of the eye that helps with seeing fine detail when it begins to become affected vision loss can occur.  Sometimes it happens slowly and affects both eyes or can have a rapid onset.

Defibrillator - Boston Scientific Cardiac Resynchronization Therapy Defibrillators - P010012/S230

This medical device was FDA approved on September 16, 2010.  The Resynchronization Therapy Defibrillator (CRT-D) is an implantable (below the collar bone under the skin) medical device that is used for therapy – by delivering small electrical impulses to the heart.  The pulses help synchronize heart beats.

The three leads of the medical device are placed: the right atrium (of the heart), the right ventricle and the last lead is placed on the coronary vein of the left ventricle.

The medical device senses and works to correct problems (abnormal heart rhythms) also know as arrhythmias.

An arrhythmia is a heart disorder that affects the rhythm of the heart.  This can result if the heart beats come at abnormal pulses (i.e. irregular pattern) or if the heart beats too fast or too slow (bradycardia, tachycardia respectively).

Intraocular Lens - EC-3 Posterior Chamber Intraocular Lenses (IOLs)

EC-3 Posterior Chamber Intraocular Lenses (IOLs), Models EC-3 and EC-3 Precision Aspheric Lens (PAL) - P100016

The medical device was FDA approved on October 19, 2010.

This device is used to replace the natural lens of the eye and restore image. It is used after the lens is removed during cataract surgery.

The difference between the two is the shape of the circular portion of the artificial lens.

It is indicated for patients who have had their natural lens removed during cataract surgery.

Cancer Test - Dako HER2 FISH pharmDx™ - P040005/S005

Dako HER2 FISH pharmDx™ - P040005/S005

This medical device was FDA approved on October 20, 2010.

The HER2 FISH pharmDx™ is a lab test that uses fluorescent dye to detect the HER2 gene located on Chromosome #17.  The tagged DNA probes attach themselves allowing the detection of the gene.  The method is also known as the FISH or fluorescent in situ hybridization method.

The method has been used for the detection of breast cancer and now has the new indication for detecting metastatic (spreading) stomach cancer.

Fig.1 Fish or fluorescent in situ hybridization method – allows researchers to visualize the genetic material in a subject’s cells. It has the specificity of single gene or even segments of a gene which is referred to Locus specific probes.  It doesn’t have to be performed on cells that are actually undergoing division.

KODAK DirectView CR Mammography System - P080018

KODAK DirectView CR Mammography System - P080018

FDA Approved on November 3^rd, 2010, the product is manufactured by Carestream Health – a subdivision of Kodak

This medical device is a mammography system that utilizes the Kodak Directview CR Mammography Cassette.   It utilizes an X-ray generator to produce mammography images on both hard copy (printed on film) and soft copy (digital image format).

The device is used for diagnosis in mammography but also has the indication for screening (i.e. for cancer, abnormalities, etc).

Note: Since the FDA Approval of this product the FDA has come out with less stringent regulations for submitting applications.  They are now accepting 510(k) applications for CR Mammography units that have appropriate medical device predicats.