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The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS and FD. FD patients for whom IB-Stim is indicated have also been shown to experience reduction of nausea symptoms.

IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient's ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses. IB-Stim is a device system that consists of a (1) percutaneous electrical nerve field stimulator (PENFS); (2) sterile multi-pin wire harness array; (3) round bandages to fasten the appliance leads, stimulator skin adhesive, alcohol swab, transparent dressing, biohazard bag, and Patient ID card; (4) tweezers; (5) surgical marker; and (6) transilluminator for use in transillumination technique that aids in needle implantation. The wire harness array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array. The transilluminator emits a light for use in the trans-illumination technique to aid the clinician in identifying the nerve bundles in the ear.

The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system. In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.

The Alere NT-proBNP for Alinity i assay is an automated, two-step immunoassay for the in vitro quantitative determination of NT-proBNP in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample and anti-NT-proBNP coated paramagnetic microparticles are combined and incubated. The NT-proBNP present in the sample binds to the anti-NT-proBNP coated microparticles. The mixture is washed. Anti-NT-proBNP acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of NT-proBNP in the sample and the RLU detected by the system optics.

RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.

RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.

The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.

IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient's ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses. IB-Stim is a device system that consists of a (1) percutaneous electrical nerve field stimulator (PENFS); (2) sterile multi-pin wire harness array; (3) round bandages to fasten the appliance leads, stimulator skin adhesive, alcohol swab, transparent dressing, biohazard bag, and Patient ID card; (4) tweezers; (5) surgical marker; and (6) transilluminator for use in transillumination technique that aids in needle implantation. The wire harness array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array. The transilluminator emits a light for use in the trans-illumination technician in identifying the nerve bundles in the ear.

The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older - requiring tissue sampling.

The EndoCore is intended to be used with endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI) data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2- weighted MR images to suggest likely volumes of fluid distribution. The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or image-guided surgical plans, especially for the creation of plans for the placement of intracranial catheters.

Molecular Flow Simulations is a software tool running on a standard, standalone computer (PC or Laptop), or being accessible via the intranet connection, that can be used by surgeons for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems. The system is a software-only medical device to be installed on common IT hardware.

The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum. The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed. The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.

The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Axis Spine Technologies ALIF is an interfixated interbody system consisting of a modular interbody spacer manufactured from Ti6Al4V. The system is designed to be assembled in vivo. The spacer comprises of two endplates and a central core. Each component is available in a variety of shapes and sizes to allow the assembled device to suit the individual pathology and anatomical conditions of the patient. The Axis Spine Technologies ALIF System intervertebral fusion device is designed to address lumbar pathologies utilizing placement through an anterior approach. The device's hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft to help promote a solid fusion. A rough surface on the device endplates serves to grip the adjacent vertebrae to resist migration and expulsion of the device, alternately models with protrusions on the device endplates grip the adjacent vertebrae to resist migration and aid in expulsion resistance. The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The Axis Spine Technologies ALIF implant is composed of: - one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. - . one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. - . one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. - . three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. - . one (1) cover plate manufactured from PEEK-Optima HA Enhanced.