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The HemoSphere Stream™ Module when used with a Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor. The device is designed for use in clinical environments requiring continuous assessment of blood pressure waveform morphology, without the need for an invasive catheter.

The HemoSphere Stream™ Module when used with the Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor.

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The single-use Biopsy Port Adapter (BPA) converts the biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port. This adapter supports luer-lock-connector fine needle biopsy (FNB) and fine needle aspiration (FNA) devices used during an EndoSound EUS endoscopic procedure, while maintaining scope suction.

The Biopsy Port Adapter (BPA) converts the non-luer-lock biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port to support Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) luer endoscopic procedures using luer-lock-type needles. The adapter also seals the port during use and maintains the ability of the scope to provide suction throughout the procedure. The BPA works in tandem with the EndoSound Vision System™ when performing ultrasound-guided FNA and FNB procedures.

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The MOSkin radiation measurement system intended use is a dosimeter to measure radiation dose delivered by a radiation source to the location of an Radiation Dosimeter (RD) sensor on the patient in a clinical use environment. The system is intended for the verification of the output of radiation producing devices.

The output of the system is not used to directly adjust the radiation dose to the patient.

The Electrogenics Laboratories Ltd MOSkin Radiation Measurement System consists of the following components to provide secondary verification of dose from various radiotherapy and diagnostic imaging devices:

• MOSFET (Si-based metal-oxide-semiconductor field-effect transistor) Dosimeter (RD) to record radiation during radiation exposure.
• Reading device (HUB) for reading the radiation dose recorded by the dosimeter.
• MOSkin Software Application, a simple software tool that the user interacts with for radiation dose calculation, dose reporting, managing and storing data.

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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:

Table 1:

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material milling machine and associated tooling and accessories.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ functions as an interface between a dental implant and a zirconia superstructure. It attaches to the implant using the included prosthetic screw and connects to the zirconia superstructure through cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottom-half and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

The Elos Accurate® Hybrid Base™ is available for two types: Engaging and Non-Engaging

• The Hybrid Base™ Engaging which is intended for single tooth dental restorations and having an indexing feature, which avoid the Hybrid Base from rotating in the implant.
• The Hybrid Base™ Non-Engaging is intended for multiple tooth dental restorations and has no indexing feature, which allows the Hybrid Base to rotate in the implant.

The Elos Accurate® Hybrid Base™ is available with 4 different collar heights and is provided with a 7.5mm chimney which can be cut down to several heights by the user, to minimum 3.5 mm.

The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:

*The post height is defined as the cementable height of the abutment.

The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Prosthetic Screw, also made of Titanium Alloy (ASTM F136), provided for the Elos Accurate® Hybrid Base™ is used to secure the final prosthetic restoration to the implant in the patient's mouth. The Prosthetic Screws have a hexalobular driver connection interface. The driver intended to be used with the Elos Accurate® Hexalobular Prosthetic Screws is the Elos Prosthetic Screwdriver 18mm, 26mm or 34mm (Ref. No. 042.0018, 042.0026 or 042.0034). These screwdrivers are Class I Exempt devices per FDA product code NDP.

The Elos Accurate® Hybrid Base has a gold anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K242025.

The subject prosthetic screws are provided are either non-coated or surface coated with DLC (identical to the DLC coating in reference device K201860).

The Elos Accurate® Hybrid Base™ and the Prosthetic screw is delivered non-sterile, and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient. The recommended sterilization procedure is full cycle pre-vacuum steam sterilization at a temperature of 132 °C (270°F) for 4 minutes. Dry time: 20 minutes.

The Elos Accurate® Hybrid Base™ is packed in 1 pc. packaging with the Elos Accurate® Hexalobular Prosthetic screw. The Screw is also available packed alone in 1 pcs packaging.

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The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single-use device and can be inserted orally or transnasally. The 110 cm gastroscope is intended to be used in adult and pediatric populations. The 85 cm gastroscope is intended to be used in the pediatric population.

The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

The EvoEndo Endoscopy System is comprised of three regulated components:

• EvoEndo Model LE Single-Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Reusable Video Cable (hereafter referred to as the Video Cable)
• EvoEndo Controller (hereafter referred to as the Controller)

The EvoEndo Endoscope is a sterile, single-use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:

• Handle
• Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
• Endoscope shaft with HD Camera

The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.

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ProKnow DS is intended to be a data archive and processing software which supports review, analytics, and clinical decision-making with a focus on the data specific to radiation oncology patients.

ProKnow DS should be used in healthcare facilities by trained medical professionals including, but not limited to physicians, medical technologists, physicists and dosimetrists.

ProKnow DS provides a high-performance, scalable medical image management and processing system. It allows users to archive, inspect, analyze, and interact with radiation therapy patient data for both retrospective and prospective studies. Its features are centered on two primary areas of interaction: (1) single patient datasets and (2) collections of patient datasets, i.e., patient cohorts. Users are able to import patient data from existing imaging, contouring, and treatment planning systems (via DICOM formats). Once imported, patient data is archived for long-term storage and is also available for inspection and analysis (examples of supported inspection and analysis tasks include: visualizing images, structures, and dose distributions; inspecting plan information; inspecting dose volume histograms; and extracting metrics).

ProKnow DS also allows users to edit physical models associated with a patient for use in retrospective studies or to be exported to commercially available radiation treatment planning systems. Once a set of patients have been established in ProKnow DS, users may create collections of related patients allowing them to analyze and correlate dosimetric values of interest and clinical endpoints across large treatment populations.

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The MetaFore Small Screw System is indicated for the fixation of bone fractures and for bone reconstruction in hand and forefoot surgery.

The MetaFore Small Screw System consists of implantable screws, and accessories for use in arthrodesis procedures of the hand and forefoot. The screws consist of 2.0mm solid snap-off, 2.5 and 3.0mm cannulated headless and 3.0 and 4.0mm cannulated beveled available in various overall lengths and thread lengths. The screws are manufactured from titanium alloy (Ti-6Al-4V ELI) and provided sterile-packed. The instruments are manufactured primarily from surgical grade stainless steel and titanium and provided non-sterile.

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The Eminent Spine Posterior SI System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The Eminent Spine Posterior SI System is inserted through an SI posterior approach and packed with autogenous bone graft to facilitate fusion. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device and to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation, adding compression and transfixation in the SI joint. The device is intended to provide mechanical support to the implanted level until fusion is achieved.

The cages are made from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6Al-4V ELI per ASTM F136.

The SI posterior system cages are available in one footprint with a lordotic angle. The anterior face of the cage has one screw anti-backout plate that rotates to cover the screw heads and prevent the screws from backing out of the cage after insertion. The screws are available in two diameters (Ø3.50mm, Ø3.75mm), in lengths ranging from 10-18 mm. The screws are positioned to span and compress the cortices of the ilium and sacrum of the SI joint.

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The BreatheBand® device is intended to deliver high-frequency chest wall oscillation (HFCWO) therapy to promote airway clearance and aid in general bronchial drainage when external chest manipulation or manipulation of the thorax is the physician's treatment of choice to enhance mucus transport.

It is indicated for adult patients (22 years of age and older) experiencing difficulty with secretion clearance.

The BreatheBand® device is intended for use in the home-care environment.

The BreatheBand® device is non-invasive, reusable, and intended for single-patient use.

The BreatheBand® Model 1000 (BreatheBand®) consists of the following major components:

• 2 Bands, each Band has 4 actuator 'Pods,' a control box, and fasteners.
• 1 Remote, which is a touchscreen device for controlling the Bands.
• 3 Charging Power Supplies for charging both Bands and the Remote simultaneously.
• 1 Carrying Case, which can house and protect the system when not in use.
• 1 Instructions For Use (IFU) document.

The Bands are worn across the thorax in an "X" configuration as demonstrated in the IFU. The Remote communicates with the Bands to control the actuators' settings, such as frequency, intensity, and duration of treatment, to implement the prescribed treatment as specified by a physician. In addition, error messages are displayed on the Remote screen when indicated. The treatment status, such as settings and length of the treatment remaining, as well as the system status (battery levels), are displayed on the Remote screen.

The Bands are adjustable in terms of overall length (to fit larger or smaller torso sizes). Once adjustments are made to the fit, the user can remove and replace the Bands without re-adjusting.

Charging the Bands and Remote batteries is accomplished between therapy sessions, and the system will not provide therapy while connected to a charger. The battery capacity is sufficient for three typical therapy sessions on one full battery charge.

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