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The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.

The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities. The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults. The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions. The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults. The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers. The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi. Devices with Masimo technology are only indicated for use with Masimo accessories. **Radius VSM Accessories:** Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact. Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate. As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula: MAP = 1/3* Systolic + 2/3*Diastolic. The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.

Masimo W1™ and the integrated Masimo W1 Module are intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Masimo W1 also displays ECG rhythms, and the Masimo W1 Module detects the presence of atrial fibrillation. The Masimo W1 and the integrated Masimo W1 Module are intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. Masimo W1 Module ECG software is an over-the-counter (OTC) software that operates on the Masimo W1 Module that can be used with compatible watches (e.g., Masimo W1). The software is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG) for informational use only in adults 22 years and older. It supports the classification of either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The software is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The Masimo W1™ and the integrated Masimo W1 Module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the Masimo W1 Module, which is the device that is responsible for the physiological signal detection and algorithm used to support the different parameters. The Masimo W1 Module incorporates spot check ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG and Masimo SET pulse oximetry parameters. As part of this submission, Masimo is requesting clearance for an automated atrial fibrillation "AFib" Classification Feature that is used to analyze the single channel ECG waveform. The parameter outputs from the Masimo W1 Module are communicated and displayed on the watch screen so that the data can be viewed and recorded. Masimo W1 also supports wireless communication of monitored data to a compatible smart device application. The sharing of the parameter data to the applications allows the users to see and track their data using their smart phones. Smart phone applications can also help to share information to caregivers and healthcare professionals.

The Shadow Catheter™ is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

The Shadow Guidewire Positioning Catheter is a dual lumen over-the-wire catheter, compatible with a 6F or larger guiding catheter and 0.014" guidewires. The Catheter is designed to support and aim steerable guidewires. The Catheter consists of a distal tip with markers, torque shaft and guidewire introducer. The distal end of the Catheter (the nosecone) has two ports, one to load a tracking guidewire axially (via distal port) and the other for the positioning guidewire to exit radially (via side port). The distal nosecone is coated with a hydrophilic coating. The Shadow Catheter™ has three markers in the nosecone. The guidewire introducer accommodates an on-axis tracking guidewire, a tracking guidewire flush port, as well as a positioning guidewire introducer port that doubles as a flush port. The handle may be rotated or orientated to adjust or aim the direction of the positioning guidewire exiting the side port at the distal end. The Catheter is placed in a packaging hoop, sealed in a Tyvek® pouch, and packaged in a shelf carton. There are no diagnostic or therapeutic agents known to be incompatible with the Shadow Catheter™. The Shadow Catheter™ is sterilized with ethylene oxide.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of X-ray based images for 2D review and 3D reconstruction - Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Sim&Size is a Software as a Medical Device (SaMD) for simulating neurovascular implantable medical devices. The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of simulating neurovascular implantable medical devices in the artery or in the aneurysm to be treated through endovascular surgery and provides support in the treatment for the sizing and positioning of implantable medical devices. Each type of implant device is simulated in a simulation module of Sim&Size: - FDsize, a module that allows pre-operationally planning Flow-Diverter (FD) devices. - IDsize, a module that allows pre-operationally planning Intrasaccular (ID) devices. - STsize, a module that allows pre-operationally planning Stent (ST) devices. - FCsize, a module that allows pre-operationally planning First and filling coils (FC) devices. Associated with these four modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.

TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). TumorSight Viz also includes user-configurable features for visualizing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.

TumorSight Viz is an image processing system designed to assist in the visualization and analysis of breast DCE-MRI studies. TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application. Available features support: - . Visualization (standard image viewing tools, MIPs, and reformats) - . Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering) - . Communication and storage (DICOM import, retrieval, and study storage) The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer.

Masimo W1 and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides the spot-checking of other continuous parameters (e.g., pulse oximetry). The Masimo W1 and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The W1 Module incorporates ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG parameters and Masimo SET pulse oximetry parameters. As part of this submission, Bluetooth connectivity has been added to the Masimo W1 to support the wireless communication of monitored data to a compatible smart device application, such as the Masimo SafetyNet. The sharing of the parameter data to applications like the Masimo SafetyNet allows for users to see and track their data using their smart phone applications can also help to share information to caregivers and healthcare professionals.

The Wolff's Law Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: • Degenerative Disc Disease (DDD) – as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; - · Spondylolisthesis; - Spinal Stenosis: - · Trauma (including fractures); - · Tumor; - · Deformity (i.e., scoliosis, kyphosis, and/or lordosis); - · Pseudoarthrosis; and - · Failed previous fusions

The Spinal Simplicity Wolff's Law Anterior Cervical Plate System is a dynamic cervical plate designed for the anterior cervical spine (C2-C7). The Wolff's Law Plate System consists of one-level plates in multiple lengths with both fixed- and variable-angle screws. The plates are translatable and use a nitinol Compression Element to provide continuous compression at each level. The Wolff's Law Cervical Plate consists of components made from titanium alloy Ti6Al4V ELI per ASTM F136 and superelastic nitinol per ASTM F2063. The fixed and variable screws are made from Titanium alloy Ti6Al4V ELI per ASTM F136. The Anterior Cervical Plate System is provided to the end-user sterile and is single use.