510k

INTRODUCTION: A novel piscine acellular fish-skin graft product has 510k clearance on the US market. This product (Omega3, Kerecis, Isafjordur, Iceland) is to be used similarly to extracellular matrices (ECMs) on the market (eg, bovine and porcine) except that it contains fats, including omega-3 polyunsaturated fatty acids that have been associated with anti-inflammatory properties in many studies. While many current ECMs are effective on open wounds, studies have largely excluded application to hard-to-heal ulcers...

Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity...

A patient with atrial fibrillation (AF) has a greater than 5% annual risk of major stroke, a 5-fold increase compared to the general population. While anticoagulation remains the standard stroke prevention strategy, the nature of lifelong anticoagulation inevitably carries an increased risk of bleeding, increased stroke during periods of interruption, increased cost, and significant lifestyle modification. Many patients with atrial fibrillation have had their left atrial appendage (LAA) ligated or excised by surgeons during cardiac surgery, a decision based largely on intuition and with no clear evidence of efficacy in stroke risk reduction...

On July 1st, 2013, about two years after the FDA's drafting of the guidance for companion diagnostics (CoDx), the Ministry of Health, Labour, and Welfare in Japan issued an official notification regarding the co-development of CoDx with a drug which requires dedicated diagnostic tests or medical devices to predict the efficacy of or adverse reactions to the drug. Both recommend to co-develop CoDx and drugs as well as indicate the approved tests and devices on the package insert of the drug. However, since many useful predictive biomarkers may be discovered after the commercial launch of a drug, the more effective use of laboratory developed tests (LDT) should be considered in order to avoid a biomarker test lag...

Left atrial appendage (LAA) occlusion or ligation is a novel approach to stroke prevention in atrial fibrillation that may obviate the need for long-term anticoagulation. The Lariat device has received Food and Drug Administration 510K clearance for the approximation of soft tissue and has been applied to transcatheter LAA ligation using a combined trans-pericardial and transseptal approach. The occurrence of late leak after transcatheter LAA ligation and its percutaneous management has not been previously reported...

OBJECTIVE: Neural interface technology suitable for clinical translation has the potential to significantly impact the lives of amputees, spinal cord injury victims and those living with severe neuromotor disease. Such systems must be chronically safe, durable and effective. APPROACH: We have designed and implemented a neural interface microsystem, housed in a compact, subcutaneous and hermetically sealed titanium enclosure. The implanted device interfaces the brain with a 510k-approved, 100-element silicon-based microelectrode array via a custom hermetic feedthrough design...

BACKGROUND AND PURPOSE: The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. METHODS: A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events...

No abstract text is available yet for this article.

In a recent evaluation of 1017 device trials listed on a clinical trials register (www.clinicaltrials.gov) between 2005 and 2009, only 84 (8.2%) represented orthopedic device evaluations. These device trials notably had few numbers of patients and few centers and represented approximately 7% of drug trials on the same registry. The relatively small proportion of device trials in orthopedics may represent a lack of interest; however, given the device focus of the field, the answer is more likely to be a lack of necessity—historically, regulatory pathways to implant approvals have not required clinical trials and have largely focused on preclinical and early case-series evaluations...

Moisturization of the skin is important for both medical and cosmetic purposes. The development of prescription device moisturizers, receiving 510K approval on the basis of the physical reduction in transepidermal water loss, provided a new dermatologic category. This investigator-blinded research utilized a split body model in 60 subjects to examine the effect of a traditional moisturizer as compared to a prescription device moisturizer in the treatment of mild to moderate symmetrical eczema of the arms or legs...

OBJECTIVE: To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. DESIGN: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes...

BACKGROUND CONTEXT: With the existing VSP plate using "no-cut," or low profile screws, with a 5-mm spacer on the screw, it is difficult or impossible to stack a second plate onto the existing in situ plate. In order to extend a fusion above or below, the plate must be explanted and replaced with a longer plate. PURPOSE: Situations exist where it would be advantageous to leave an existing plate in situ and couple a second plate onto the existing plate. A new device is described for in situ coupling of a plate to plate and a rod to plate using the VSP and lsola systems...

The Safe-Cross radiofrequency guidewire (IntraLuminal Therapeutics, Carlsbad, California) combines 3 capabilities: (1) steerability of a conventional 0.014-in intermediate-stiffness guidewire, (2) optical coherence reflectometry to warn the operator when the wire tip approaches within 1 mm of the vessel wall, and (3) delivery of radiofrequency energy pulses to the wire tip to facilitate passage through an occluded segment. The Guided Radio Frequency Energy Ablation of Total Occlusions Registry was a prospective, nonrandomized, multicenter registry that enrolled 116 patients who had long-term coronary total occlusions and in whom a >10-minute good-faith attempt to cross the occlusion using conventional guidewires had failed...

Receiver operating characteristics (ROC) analyses to evaluate and compare the diagnostic accuracy of Food and Drug Administration (510K)-cleared natural rubber latex (NRL)-specific immunoglobulin E (IgE) antibody immunoassays have not been performed using well-characterized skin-testing reagents. Sera were collected from 311 subjects (131 latex puncture skin test [PST] positive and 180 PST negative). All masked, coded sera were analyzed for latex-specific IgE antibodies in the Diagnostic Products Corporation microplate AlaSTAT, HYCOR HY-TEC RAST, and Pharmacia-Upjohn CAP System RAST FEIA (CAP)...

BACKGROUND: In the absence of Food and Drug Administration-approved natural rubber latex skin testing reagents, latex-specific IgE antibody immunoassays are used in the diagnosis of latex allergy. Comparative diagnostic performance of these tests has not been definitively determined. OBJECTIVE: We sought to study the predictive value of available Food and Drug Administration (510K)-cleared latex-specific IgE antibody immunoassays in the diagnosis of latex allergy...

Most physicians, and certainly the lay public, have only limited knowledge of the responsibilities and limits of the Food and Drug Administration (FDA) of the United States of America. Although laws as early as 1902 protected the public from unrestricted sale of unsafe drugs, it was not until 1976 that devices came under regulation. An obvious difference existed between regulatory control of drugs vs devices. The drug-based approach for evaluation was rejected in favor of a new system based on device class and its degrees of risk...

Long-term investigational device exemption (IDE) clinical trial evaluation, as currently monitored by the Food and Drug Administration (FDA) regulatory process, is time-consuming, burdensome, and extremely costly to the product developers and ultimately to the consumer. Thus, almost all devices introduced in the past decade have not been clinically tested; they have been introduced under a "510k" grandfather provision that does not address the safety and efficacy of the product. As a result, joint replacement devices have been sold and used with serious failure consequences for the consumer...