scholarly journals Resolver Device Component

2020 ◽  
Author(s):  
Keyword(s):  
Device Component

scholarly journals New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions

2021 ◽  
Author(s):  
Nobuo Uemura ◽  
Hiroshi Kasanuki ◽  
Mitsuo Umezu
Keyword(s):  
The United States ◽  
New Combination ◽  
Biological Product ◽  
Regulatory Scheme ◽  
Early Access ◽  
Dimensional Group ◽  
Device Component ◽  
Intended Use ◽  
Component Function

Abstract Objective The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization. Method We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA’s 129 capsular decision cases of device–drug and device–biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme. Results By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function. Conclusions The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.

scholarly journals System Accuracy Assessment of a Combined Invasive and Noninvasive Glucometer

2019 ◽  
Vol 14 (3) ◽  
pp. 575-581 ◽  
Author(s):  
Andreas Pfützner ◽  
Filiz Demircik ◽  
Johannes Pfützner ◽  
Kim Kessler ◽  
Stephanie Strobl ◽  
...  
Keyword(s):  
Accuracy Assessment ◽  
Glucose Monitoring ◽  
Reference Method ◽  
Relative Difference ◽  
Invasive Component ◽  
Self Testing ◽  
Free Glucose ◽  
Data Points ◽  
Device Component ◽  
Glucose Prediction

Background: The pain associated with pricking the fingertip for blood glucose self-testing is considered to be a major burden in diabetes treatment. This study was performed to evaluate the system accuracy of the invasive TensorTip Combo Glucometer (CoG) device component in accordance with ISO15197:2015 requirements and to explore the accuracy of the noninvasive tissue glucose prediction component. Methods: One hundred samples were obtained from people with type 1 and type 2 diabetes and healthy volunteers (43 females, 57 males; age: 53 ± 16 years), with glucose distribution as requested by the ISO standard. Three strip lots were tested twice by healthcare professionals in comparison to YSI 2300 Stat Plus reference method followed by a noninvasive tissue glucose reading (NI-CoG). Mean Absolute (Relative) Difference (MARD) was calculated and a consensus error grid (CEG) analysis was performed. Results: The ISO system accuracy criteria were met with the invasive strip technology by 586/600 of the data points (97.1%) and for each strip lot separately. All invasive results (100%) were within CEG-zone A and total MARD was calculated to be 7.1%. With the noninvasive reading, 99% of raw data points were in A + B (91.1% and 7.8%), and the total MARD was calculated to be 18.1%. Discussion: The invasive component of the CoG device was shown to be in full compliance with the current ISO15197 criteria. Good results were also obtained with the NI-CoG tissue glucose prediction. This noninvasive technology would potentially be suitable for frequent pain-free glucose monitoring in many people with diabetes.

Rapid Prototyping of a Hand Model for Rehabilitation

2012 ◽  
Vol 245 ◽  
pp. 85-89
Author(s):  
Mircea Ionescu ◽  
Ileana Constanţa Roșca
Keyword(s):  
Rapid Prototyping ◽  
Medical Devices ◽  
Fused Deposition Modeling ◽  
Virtual Model ◽  
Fused Deposition ◽  
Specialized Software ◽  
Hand Model ◽  
Fluidic Actuators ◽  
Deposition Modeling ◽  
Device Component

Studies and researches in medical devices made evident the need of new systems and technologies for locomotors recovery of human body as to reduce the reintegration time in normal activities and, not the least, to improve the recovery quality, to give the possibility to perform natural movements identical to those before the suffered injury. Thus, the purpose of this paper is to obtain the 3D virtual model of a mechanism describing the hand kinematics, and a real medical prototype device to be used in locomotors recovery of the hand. In order to perform the movements, pneumatic fluidic actuators are used, considering that they are flexible, small, made especially for this project. A specialized software for assisted design is used to obtain the virtual model and for the fabrication of device component parts Rapid-Prototyping technology is applied, the Fused Deposition Modeling principle (FDM).

scholarly journals Printed multifunctional flexible device with an integrated motion sensor for health care monitoring

2016 ◽  
Vol 2 (11) ◽  
pp. e1601473 ◽  
Author(s):  
Yuki Yamamoto ◽  
Shingo Harada ◽  
Daisuke Yamamoto ◽  
Wataru Honda ◽  
Takayuki Arie ◽  
...  
Keyword(s):  
Health Care ◽  
Modular Design ◽  
Low Cost ◽  
Flexible Sensors ◽  
Reusable Component ◽  
Prediction And Prevention ◽  
Printed Sensors ◽  
Device Component ◽  
Health Care Monitoring ◽  
Cost Components

Real-time health care monitoring may enable prediction and prevention of disease or improve treatment by diagnosing illnesses in the early stages. Wearable, comfortable, sensing devices are required to allow continuous monitoring of a person’s health; other important considerations for this technology are device flexibility, low-cost components and processing, and multifunctionality. To address these criteria, we present a flexible, multifunctional printed health care sensor equipped with a three-axis acceleration sensor to monitor physical movement and motion. Because the device is designed to be attached directly onto the skin, it has a modular design with two detachable components: One device component is nondisposable, whereas the other one is disposable and designed to be worn in contact with the skin. The design of this disposable sensing sheet takes into account hygiene concerns and low-cost materials and fabrication methods as well as features integrated, printed sensors to monitor for temperature, acceleration, electrocardiograms, and a kirigami structure, which allows for stretching on skin. The reusable component of the device contains more expensive device components, features an ultraviolet light sensor that is controlled by carbon nanotube thin-film transistors, and has a mechanically flexible and stable liquid metal contact for connection to the disposable sensing sheet. After characterizing the electrical properties of the transistors and flexible sensors, we demonstrate a proof-of-concept device that is capable of health care monitoring combined with detection of physical activity, showing that this device provides an excellent platform for the development of commercially viable, wearable health care monitors.

scholarly journals Testing of Selected Accuracy Parameters for the Single Axis Positioner at the Automated Workplace

2021 ◽  
Vol 21 (2) ◽  
pp. 47-54
Author(s):  
Marek Vagaš ◽  
Ján Semjon ◽  
Alena Galajdová ◽  
Dušan Šimšík ◽  
Róbert Rákay ◽  
...  
Keyword(s):  
Experimental Verification ◽  
Measurement Techniques ◽  
Third Party ◽  
Robotic Arm ◽  
Welding Technology ◽  
Device Component

Abstract Although some authors realized various measurement techniques and relevant standards in the experimental verification, the existing contributions still did not mention more complex automated workplaces with industrial robotic arm participation. To solve this, we provide a different view of the interconnection between individual devices (positioner, robot, etc.) controlled by third-party methods (Siemens products). Also, to obtain the necessary effectiveness, we tested and verified selected accuracy parameters for the participating device component (positioner). The proposed work tries to fulfill expectations for a precise welding technology (to ensure simultaneous movements of both the industrial robotic arm and positioner) to achieve higher quality and productivity. However, the components are from different manufacturers.

Causes of Artificial Urinary Sphincter Failure and Strategies for Surgical Revision: Implications of Device Component Survival

2019 ◽  
Vol 5 (5) ◽  
pp. 887-893 ◽  
Author(s):  
Arnav Srivastava ◽  
Gregory A. Joice ◽  
Hiten D. Patel ◽  
Madeleine G. Manka ◽  
Nikolai A. Sopko ◽  
...  
Keyword(s):  
Artificial Urinary Sphincter ◽  
Surgical Revision ◽  
Urinary Sphincter ◽  
Device Component

Thermal expansion properties of thermoelectric generating device component

2007 ◽  
Author(s):  
Y. Hikage ◽  
S. Masutani ◽  
T. Sato ◽  
S. Yoneda ◽  
Y. Ohno ◽  
...  
Keyword(s):  
Thermal Expansion ◽  
Device Component
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