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The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components: - a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and - a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable"). The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.

Bioptimal Bipolar Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

Bioptimal's Bipolar Pacing Catheter is made of radiopaque polyurethane catheter tubing at a usable length of 110 cm that allows the use of fluoroscopy for guiding the catheter during insertion or to verify its position when necessary. The catheter has radiopaque bands marked every 10 cm along their length to assist the physician in determining the depth of catheter insertion. The Bipolar Pacing Catheter has an electrode lumen, which provides electrical conductor isolation from electrodes to the connector pins. It has two metal electrodes attached to the distal end of the catheter and the distal electrode forms its distal tip. The proximal electrode is 10 mm apart from the distal electrode. Bipolar Pacing Catheters are available in two generic models: balloon-guided floatation (with balloon) and semi-floated (without balloon), with or without contamination shield. All models have the same basic design, construction and material. The balloon-guided models(BP2502-10 and BP2502CS-10) includes a latex balloon mounted between the distal and proximal electrodes and associated balloon lumen and tubing extension for inflating and deflating the balloon. The balloon is used for the advancement of the catheter tip by means of balloon flotation in the blood flow. The models with a contamination shield (BP2502CS-10 and BPX2502CS-10) have an expandable shield up to 110cm that provides a sterile environment for the enclosed catheter, and hence prevents the contamination of a catheter as it is inserted into and withdrawn from a body cavity or lumen. Balloon guided models are supplied with a 1.0cc syringe for balloon inflation. Bipolar Pacing Catheters are supplied sterile (through ethylene oxide sterilization), non-pyrogenic and are for single use only. The catheter primary packaging: the catheter is packed in a blue thermoformed polystyrene tray and is covered with a clear APET cover held in place by snap buttons. White label printed with the product name, model ID, manufacturer and authorized representative's information, lot number, expiry date, UDI, symbols and other product information is pasted on the clear APET tray cover. The catheter tray is placed inside a sealed Tyvek bag which forms a single sterile barrier primary packaging. The catheter is supplied sterile in a box of 5 units of single sterile barrier primary packaging with IFU.

FLUOBEAM LX and FLUOBEAM LM are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries. The FLUOBEAM LX and FLUOBEAM LM can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM LX and FLUOBEAM LM devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues. Upon interstitial administration and use of ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

FLUOBEAM LX and FLUOBEAM LM are imaging systems intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG or the pafolacianine and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM LX and FLUOBEAM LM consist of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT LX or FLUOSOFT LM imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the optical head or via the FLUOSOFT LX imaging software and the FLUOSOFT LM imaging software on the computer. The subject devices FLUOBEAM LX and FLUOBEAM LM have therefore exactly the same principle of operation of the predicate device. Only aesthetic aspects are different between FLUOBEAM LX and FLUOBEAM LM. This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the usage in the lymphatic system with the use of an ICG consistent with its approved label. This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine, for use with infrared imaging.

The Cardiac Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Cardiac Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Cardiac Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV). Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

The Cardiac Guidance software is a radiological computer-assisted acquisition guidance system that provides real-time guidance during echocardiography to assist the user capture anatomically correct images representing standard 2D echocardiographic diagnostic views and orientations. This Al-powered, software-only device emulates the expertise of skilled sonographers. Cardiac Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include: - Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below. - Prescriptive Guidance: The prescriptive guidance feature in Cardiac Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view. - Auto-Capture: The Cardiac Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it. - Save Best Clip: This feature continually assesses clip quality while the user is scanning and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.

The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera. The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects. The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring. The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's physical health condition. The pulse rate measurements it provides should complement, not replace, professional medical care and/or medication.

PanopticAl Vital Signs is a medical software device that uses remote photoplethysmography (rPPG) to measure a person's pulse rate. The app utilizes the surrounding light as the light source and works by capturing and measuring the subtle color changes on the skin caused by light absorption and reflection by the blood vessels beneath the skin. The app uses the front camera of an iPhone or iPad to capture videos of the subject. Then, the algorithm in the app detects and tracks the subject's face to capture the subtle light changes reflected in the changes in RGB pixel values. This information is sent to PanopticAl's cloud server for further processing to calculate the pulse rate. The pulse rate value is then returned to the PanopticAl Vital Signs app, and the result is displayed on the app.

LGO-Surgical Laser Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified laser with operational wavelengths between 500 nm - 2200 nm equipped with SMA 905 standard or freestanding ferrule connector, as per the indications of the laser device used with.

LGO-Surgical Laser Fibers are a group of single use or reusable with up to 10 total uses EtO sterilized laser powered surgical instruments. They are intended for use in healthcare facilities or hospitals by physicians being familiar with the handling of medical laser devices, and with the therapeutic application of sterile medical optical fibers. There are two primary product subgroups: Bare Fiber and Side Fire Fiber. Each subgroup encompasses various models on the market, which primarily vary in their distal end design, jacket materials, diameter, length, and usage (single use or 10x reusable). All variations of the LGO-Surgical Laser Fibers feature an SMA-905 connector or a custom special connector at the proximal end for compatibility with appropriate medical laser devices.

Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.

The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable. The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored. The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images. The transfer of images to the AI Optics Server is carried out via Wi-Fi communication. The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design and indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned Replacement Wear, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance. DISPOSABLE WEAR When prescribed for Disposable Wear, the lens is to be discarded after each removal.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The lenses are clear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4. Each finished lens is supplied in a plastic blister container with A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.

TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer. The device is for a single patient's use only and can be reused throughout the entirety of the treatment course. The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use. The device is restricted to sale by on the order of a physician and is by prescription only.

TrueFit/TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the radiation therapy bolus (TrueFlex) by 3D Bolus Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. A TrueFit Bolus is 3D printed by MJF technology using polyamide or polyurethane material. A Final TrueFlex Bolus device is manufactured by filling a mould with silicone. The bolus is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The bolus acts as a tissue-equivalent material placed on the patient skin to account for the buildup region of the treatment beam.

The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.