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The AuroLase System is intended for use in delivering up to 9 Watts of continuous wave radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporization of soft tissues in open and endoscopic surgical procedures including in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedic.

The AuroLase® System (AS) is a portable, cart-based integrated liquid cooled laser system for use in professional healthcare facilities. The AuroLase System is used to generate photothermal ablation of selected soft tissues using 1-9W of near infrared optical power via 1 or 2 optical fibers either individually or simultaneously while providing liquid coolant to moderate the temperature at the fiber surface. The laser is delivered to the tissue of interest via an optical fiber system, the Nanospectra Laser Delivery Device (LDD), cleared via K202953. It is for prescription use only. Central to the AuroLase System is the AuroLase Laser Device (ALD), a dual channel, continuous-wave, class IV GaAs diode laser (Figure 1 - red section) that provides the optical energy used to excite to soft tissues to ablative temperatures. The ALD incorporates an integrating sphere power meter (optometer) which is used to adjust the laser output that is delivered to the patient to the power shown on the display. Enabling the ALD's functionality is the AuroLase Control Unit (Figure 1 - green section) which incorporates: a) a peristaltic pump for providing sterile coolant to the Laser Delivery Devices, b) dual ultrasonic sensors to assure that coolant flows through the LDDs, c) a footswitch to control laser activation, d) temperature monitors for up to two optional external thermocouples, and e) a software application that controls, integrates, and monitors these functions. A medical-grade power supply is near the base of the unit to provide electrical service to the rest of the system as well as mechanical stability. The AS is designed and tested for operation in a professional healthcare facility. AuroLase System Incorporates: AuroLase Laser Device (ALD) - The ALD is a dual-channel 810nm laser system capable of 1-9W of output power per channel, adjustable in 0.25W increments. - The optical outputs of the ALD are configured to insert their optical energy into mated SMA-905 terminated optical fibers with diameters of >=600µm and numerical apertures of <= 0.37. - An integrating sphere optometer head is used to calibrate the laser power extant at the termination of the diffuser-tipped optical fibers. - Separate laser channel display information, e.g., channel standby/ready status, power output, and system alerts and alarms. - A laser ON tone which is either continuous or periodic to distinguish between the two laser channels. - A laser "watchdog" timer in order to allow for re-positioning of the laser catheters without the laser returning to standby mode for up to 10min. AuroLase Control Unit (ACU) - Conveys essential information to the OR staff, including: - separate laser ready status - coolant flow status - system warnings and alerts Fluid Handling Unit - houses the coolant pump and electronics. - houses the two coolant flow sensors and electronics. - houses two thermocouple ports and electronics. Storage - The ACU has covered drawers for storing: - safety eyewear, 8-10 pair External Mounting Hardware - A hook for mounting 0.5-3.0L saline or water coolant supply bags. - A hook for mounting two 1.5L Coolant Recovery Bags. Laser Actuation Footswitch - Footswitch actuation is a momentary switch to enable "tap-on/tap-off" operation rather than continuous depression. - The footswitch simultaneously actuates the laser, coolant pump, and countdown timer. Medical Grade Power Supply - Located in base to provide mechanical stability.

The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.

The LumiRex Single-Use Bronchoscope is a flexible video-based medical device designed for insertion through the mouth or nose into the trachea and bronchial tubes. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the airways. The bronchoscope also features a working channel that allows for the passage of various instruments, such as biopsy forceps, brushes, and suction devices, facilitating endoscopic procedures. The device is available in different diameters to accommodate a range of patient anatomies and clinical needs. The Bronchoscope can be used wired or wireless through a Wired Scope Adapter or Wireless Scope Adapter. The adapters transmit images from the bronchoscope to the Video Processor Unit where the user can view the image from the bronchoscope, control the LED, and save and export images from the bronchoscope onto USB removable media.

The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures.

The LumiRex Single-Use Ureteroscope is a flexible video-based medical device designed for insertion through the urethra into the urinary tract. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the urinary tract and interior of the kidney. The ureteroscope also features a working channel that allows for installation of fluids, the passage of various instruments, such as biopsy forceps, cytology brushes, biopsy brushes, and stone retrieval baskets to facilitate urology and ureteroscopy procedures. The ureteroscope can be used wired or wireless through a Wireless Scope Adapter or Wired Scope Adapter. The adapters transmit images from the ureteroscope to the Video Processor Unit where the user can view the image from the ureteroscope, control the LED, and save and export images from the ureteroscope onto USB removable media.

The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.

The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time). The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience. The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time. The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components: - Monitor Cable Assembly - Hub - Alert Button - Battery Pack - SensorFit™ Garment - Charger

For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module (3.3). Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.

The Sectra Digital Pathology Module (3.3) [henceforth referred to DPAT (3.3)] is a digital slide viewing system. The DPAT (3.3) is intended for use together with FDA-cleared whole-slide image scanner GT 450 DX and Dell U3223QE display. The DPAT (3.3) can only be used as an add-on module to Sectra PACS. Sectra PACS consists of Sectra Workstation IDS7 (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). Sectra PACS is not part of the subject device. Sectra Workstation is the viewing workstation in which the Pathology Image Window is run. Pathology Image Window is the client component of the subject device. The system capabilities include: - retrieving and displaying digital slides, - support for remote intranet access over computer networks, - tools for annotating digital slides and entering and editing metadata associated with digital slides, and - displaying the scanned slide images for primary diagnosis by pathologists. The subject device is designed to accurately display colors. The monitor is not part of the subject device. Digital pathology images originating from WSI scanners other than those listed in the Indications for Use will be marked with the disclaimer "For Non-clinical Use Only" in the Pathology Image Window. Image acquisition will be managed by the scanner which is not part of the subject device: - The scanner delivers images with a tag in the file header that identifies the originating scanner. - The scanner includes applications for controlling the scanning process and performing related quality control (e.g., ensuring that images are sharp and cover all tissue on the slide). The DPAT (3.3) supports reading digital slides on a Dell U32230E display monitor, enabling pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in performing a primary diagnosis based on viewing the digital slide on a computer monitor. These capabilities are provided by the Pathology Image Window.

The VIO System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue - including blood vessels, collagen, pigment, stratum corneum, hair shafts or follicles, solar elastosis, atypia, and epidermal disarray - in and through epidermis for review by physicians to assist in forming a clinical judgment. Physicians who interpret VIO System images must have dermatology medical qualifications with skin histology assessment training.

The VIO System (REF V-1000) is a light-based in vivo microscope intended to provide images of skin tissue for review by physicians to assist in forming a clinical judgment. The device does not provide image analysis or diagnostic information. The VIO System uses a handheld reflectance confocal and multiphoton microscope that contacts the skin and optically scans at a depth where most skin conditions originate, without disrupting the tissue. The VIO System delivers low power laser light of a single wavelength (780 nm infrared, Class 1M) into the skin in brief pulses. The resulting signals are acquired while imaging the skin and each signal is assigned to one of four (4) channels: RCM (Reflectance Confocal Microscopy), SHG (Second Harmonic Generation), 2PS (2-Photon Autofluorescence Short), and 2PL (2-Photon Autofluorescence Long). For each image capture, the VIO System combines the four (4) channels to display a single, multi-color image on the VIO System, referred to as "Tetrachrome™." Three (3) view modes are accessible to the user on the VIO System: Standard View, Superficial Zoom, and Deep Zoom. Acquired images are not stored on nor analyzed by the VIO System. The images are saved on a USB flash drive, which is used to transfer images to a commercially available DICOM viewer for interpretation by a physician.

The OScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDT A whole blood: - White blood cell count (WBC) - · Neutrophils (NEUT#) - · Lymphocytes (LYMPH#) - · Monocytes (MONO#) - · Eosinophils (EOS#) - · Basophils (BASO#) - · Immature Granulocytes (IG#) - · Percent Neutrophils (NEUT%) - Percent Lymphocytes (LYMPH%) - · Percent Monocytes (MONO%) - · Percent Eosinophils (EOS%) - · Percent Basophils (BASO%) - · Percent Immature Granulocytes (IG%) - · Neutrophil to Lymphocyte Ratio (NLR)

The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. It includes the QScout Lab analyzer, the QScout RLD (Rapid Leukocyte Differential) test, software, and handheld barcode scanner. The QScout system reports white blood cell count and neutrophil to lymphocyte ratio and enumerates and classifies six white blood cell types including immature granulocytes. The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.

The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program that requires the BD Kiestra™ Laboratory Automation Solution in order to operate. The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is applied to digital images of BD BBL™ CHROMagar™ MRSA II culture plates inoculated with anterior nares samples. Algorithms are applied to digital images to provide a qualitative assessment of colony growth and colorimetric detection of target colonies for the detection of nasal colonization by MRSA and to serve as an aid in the prevention and control of MRSA infection. Applied algorithms provide the following results: - "No growth", which will be manually released individually or as a batch (with other no growth samples) by . a trained microbiologist upon review of the digital plate images. - . "Growth - other" (growth without mauve color), which digital plate images will be manually reviewed by a trained microbiologist. - "Growth MRSA Mauve" (growth with mauve color), which digital plate images will be manually reviewed ● by a trained microbiologist. The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin. The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is indicated for use in the clinical laboratory.

The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be optional for the BD Kiestra™ Laboratory Automation Solution and will support laboratory technologists in batching no growth on the BD BBL™ CHROMagar™ MRSA II, growth with no key colony color detected for MRSA ("Growth – other"), and growth with key colony color detected for MRSA ("Growth MRSA Mauve"). These classifications will be characterized as "no growth" and "growth with mauve color" from BD BBLTM CHROMagar™ MRSA II media, from anterior nares samples. The technologist has the ability to create work lists in BD Synapsys™ informatics solution based on the classifications (growth, no growth or growth with mauve color). These work lists will be used for followup work and batching of results, at the sample level. The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will apply Image Algorithms to the digital images to determine if the plate contains "growth" or "no growth". At the individual plate level when the Image Algorithms detects colony growth and potential mauve color the classification will be "growth with mauve color". When the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is not capable of automatically generating the outputs (visual attributes: growth with or without mauve color/no growth), the laboratory technologist will be required to read the digital image of the plate on the computer screen and decide on follow-up action as is the current standard laboratory practice.

ViewFinder is a dedicated softcopy review environment for both screening and diagnostic digital breast tomosynthesis. Its user interface and workflow have been optimized to support qualified interpreting physicians in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. ViewFinder provides visualization and image enhancement tools to aid a qualified interpreting physician in the review of digital breast tomosynthesis datasets. The qualified interpreting physician is responsible for making the diagnosis of the images presented.

ViewFinder is software which displays two Digital Breast Tomosynthesis (DBT) views of the same breast and dynamically indicates correlated (matched) tissue. The benefit is that clinicians can compare matched tissue quickly and with less cognitive load. It works by simulating the tissue movements between Cranio-Caudal (CC) and Medio-Lateral Oblique (MLO) compressions and views for a gross approximation of tissue matching, followed by a second fine tuning using locked Artificial Intelligence (AI). Users operate the device by pointing the cursor at tissue in one view and ViewFinder indicates the matching tissue in the other view. ViewFinder is a standalone software application or can be integrated into medical image management and processing systems. ViewFinder is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of DBT. ViewFinder runs on a PC and can be used for digital breast tomosynthesis image review together with monitors cleared for mammography diagnostics.

The Aurolase Therapy, Laser Delivery Device is a fiber-optical laser delivery device to be used with a compatible 810nm laser device for laser-based applications and procedures that are cleared for the compatible laser.

Laser light generated by the Laser Module is delivery Device (LDD) Assembly, that is comprised of three components: the Laser Catheter Assembly (LCA), the Optical Fiber Diffuser (OFD), and the Coolant Supply Set (CSS). The LCA and OFD transmit laser energy to the tissue situated at their distal regions, to achieve the desired effect of the intended use. The use of coolant provides cooling for the surfaces of the CSS in contact with both the tissue and the LCA.