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The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.

The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut offs:

The Evidence MultiSTAT DOA Urine Multiplex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) and the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For In Vitro Diagnostic use only.

FOR PRESCRIPTION USE ONLY

The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.

The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.

Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.

The Evidence MultiSTAT DOA Urine MultiPlex (EV4393) will be supplied as a test kit comprising:

• 12 x Urine Test Cartridges
• 6 x 1 ml Urine Cut Off Material (lyophilized)
• 4 x 1 ml Urine Positive Control Material (lyophilized)
• 2 x 10 ml Reconstitution Buffer
• 1 x Batch Barcodes

Each kit is supplied with the Evidence MultiSTAT Accessory kit (EV4116) which contains:

• 12 x MultiSTAT Tip Cartridges
  • 1 x Tip/Waste Cartridge
  • 6 x 1000 µl Pipette Tip
  • 1 x Liquid Absorber

Reagent Composition
MultiSTAT DOA Urine MultiPlex Assay Diluent
20 mM phosphate buffer, pH 7.0 containing protein, detergents, and preservatives. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Conjugate
20 mM Tris based buffer, pH 7.0 containing protein, preservatives, and horseradish peroxidase - labelled drug derivatives. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Biochip
Solid substrate containing immobilized antibody discrete test regions. This is contained within the cartridge.

MultiSTAT DOA Urine MultiPlex Wash Buffer
20 mM Tris buffered saline, pH 7.4, containing surfactant and preservatives. This is contained within the cartridge.

LUM-EV934/PX
Luminol-EV934 and Peroxide are contained within the cartridge and are mixed in a ratio of 1:1 by the analyser to give the working signal reagent

MultiSTAT DOA Urine MultiPlex Cut Off
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives and drug concentrations at the assay cut off values (detailed in Table 3 above).

MultiSTAT DOA Urine MultiPlex Positive Control
Lyophilised, 20 mM phosphate buffer, pH 7.2 containing stabilizers, preservatives, and drug concentrations.

MultiSTAT Reconstitution Buffer
A solution at a neutral pH containing preservatives.

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The DeltaWave Nasal Pillow System channels airflow noninvasively to a patient from a noninvasive positive airway pressure device (PAP) such as CPAP, bi-level.

It is intended for adult patients weighing ≥66lbs (30 Kg), and for whom positive airway pressure has been prescribed. It is intended for single patient reuse in the home and hospital/institutional/sleep center environment.

The DeltaWave Nasal Pillow System is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea. The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.

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ChartCheck is intended to assist with the quality assessment of radiotherapy treatment plans and on treatment review.

The ChartCheck device is software that enables trained radiation oncology personnel to perform quality assessments of treatment plans and treatment chart reviews utilizing plan, treatment, imaging, as well as documentation data obtained from an Oncology Information System database(s).

ChartCheck contains 3 main components:

a. An agent service that is configured by the user to monitor an Oncology Information System (OIS) database. The agent watches for new treatment plans, treatment records, documentation, and images. The agent uploads data to a checking service.

b. A checking service that compares the treatment records to the treatment plan and calculates check states as new records are uploaded from the agent. The checking service processes on-treatment imaging data and interfaces with outside software platforms for dose calculation activities.

c. A web application accessed via a web browser that contains several components.
i. Chart checking mode, which allows a medical physicist to review treatment records and check state results, record chart check comments, and mark the chart check as approved.
ii. An image viewer that allows a medical physicist to review on-treatment imaging, on-treatment dose calculation results, and perform deformable registration editing.
iii. Settings mode, which allows an administrator to set check state colors, configure settings, define check state templates, set up check alerts, documentation generation, and billing settings.

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RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

RayStation consists of multiple applications:

• The main RayStation application is used for treatment planning.
• The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
• The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.

The device to be marketed, RayStation 2024A SP3, adds the RayTreat application compared with last cleared version, the predicate RayStation 2024A SP3 (without RayTreat), K240398.

The RayTreat application was previously cleared with RayStation 11B, K220141. Since then some RayTreat functions have been changed:

• RayTreat is now session focused
• Usability improvements
• Bug fixes

The RayStation applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data.

As a treatment planning system, RayStation aims to be an extensive software toolbox for generating and evaluating various types of radiotherapy treatment plans. RayStation supports a wide variety of radiotherapy treatment techniques and features an extensive range of tools for manual or semi-automatic treatment planning.

The RayStation applications are divided into modules, which are activated through licensing.

The RayTreat application
RayTreat manages treatment delivery. An approved plan can be assigned to fractions in a treatment course and sent to the treatment delivery device. Treatment records from the treatment delivery device are recorded and sent to RayCarePACS.

Note that all real-time monitoring of actual delivery is handled by treatment delivery device software, not by RayStation.

Scientific concepts that form the basis for the device and significant performance characteristics:

RayStation is a stand-alone software medical device intended for radiation therapy. Input to the device is patient, disease and treatment unit information, output from the device is one or more treatment plans. The treatment plans include treatment unit parameter settings for optimal beam arrangements, energies, field sizes, and ultimately fluence patterns to produce as safe and effective radiation dose distribution as the predicate.

The scientific concepts of a treatment planning system are patient and beam modeling, and algorithms for dose calculation and plan parameter optimization.

The patient model is a computerized representation of the patient tissue and densities, identifying the target regions and particular organs at risk. The model is based on medical images of the patient and must have the desired level of accuracy. Likewise, the beam modeling is a computerized representation of the treatment unit, defined by fluence type, energy distribution, machine specific geometry, and beam modifiers such as MLC, flattening filters, wedges etc. The algorithms for dose calculation and plan parameter optimization must take into account all geometries and materials that affect irradiation transport through the treatment unit and the patient. The optimization algorithm iterates treatment plan parameters until the desired treatment plan and dose distribution have been obtained. Also here, all steps must be done to the desired level of accuracy.

Significant physical characteristics of the device, material used, and physical properties:

The device is a standalone software medical device. It has no physical properties or materials. The device design information can be found in the subsection above "Device design information".

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ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

The ClearCalc Model RADCA V2.6 device is software that uses treatment data, image data, and structure set data obtained from a supported Treatment Planning System and Application Programming interfaces to perform a dose and/or monitor unit (MU) calculation on the incoming treatment planning parameters. It is designed to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

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STAR Apollo™ Mapping System assists users in the interpretation and manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo Mapping System (v1.8) is a software driven system designed to assist operators in identifying Early Sites of Activation (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use with FDA cleared electroanatomic mapping systems specifically:

• CARTO™ 3 EP Navigation System (V8.1) (K252302) (Biosense Webster) and
  • OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) (Biosense Webster)

for exporting geometry data, electrograms and electrode locations over ethernet connection during the electrophysiology procedure with CARTO 3 API (K231207) to provide input data for the STAR Apollo Mapping System.

• Ensite Precision Model EE 3000 Cardiac Mapping System (V2.6) (K201148) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• EnSite X EP System (V 1.1.1, V 2.0, V 3.0) (K213364) (K221213) (K231415) (Abbott Medical) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• Ensite X EP System (V 3.1) (K242016) (Abbott Medical) and either:
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
  • Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K242016) (Abbott Medical)

for exporting geometry data, electrograms and electrode locations via a portable external storage device or over ethernet data connection (Ensite X EP System (V 3.0, V 3.1) with LiveSync module) (K231415) (K242016) during the electrophysiology procedure to provide input data for the STAR Apollo Mapping System.

The principle of STAR Apollo Mapping System analysis is to use data on multiple individual wavefront trajectories to identify Repetitive Patterns of Activation (RPA) or regions of the atrium that represent Early Sites of Activation (ESA) which most often precede activation of neighboring areas, with the aim of helping clinicians to identify regions of the atria that may be the origins for AF activation. The system consists of proprietary STAR Apollo Mapping System software and a hardware component. STAR Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 11 Operating System. STAR Apollo Mapping System software is pre-installed onto the laptop.

The STAR Apollo Mapping System uses export data from the compatible Mapping System that has been collected with the compatible Mapping Catheter during the electrophysiology procedure. The Mapping Catheter is used to collect anatomy and electrogram data in the atria. Recordings are made for at least 30 seconds with the Mapping Catheter in a stable position and in contact with the atrial wall. These ≥30 second acquisitions are made in multiple, non-overlapping locations, to generate recordings over the entire atrial chamber. The data is exported via an external portable storage device or by streaming via an ethernet data cable connected to the data ethernet port of the EnSite X or CARTO 3 workstation. It is transferred to the laptop computer running the STAR Apollo Mapping System. The export data accepted from the Mapping Systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data is imported utilizing the portable external data storage device or via ethernet into the STAR Apollo Mapping System and then processed by the STAR Apollo Engine to generate a STAR Apollo Map visualized by the GUI. The STAR Apollo Map will highlight sites deemed to be Early Sites of Activation (ESA), as a red sphere at the endocardial locations corresponding to the recording electrode position. These sites are areas where the myocardium has initiated activation earlier than its neighboring sites on multiple occasions and therefore may be a potential site of AF initiation or maintenance. The more repetitive these sites are, the larger the red sphere appears on the STAR Apollo Map. The system will rank the ESA according to their repetition frequency and cycle length and identify the most relevant 3 sites. The system is designed to show the physician Repetitive Patterns of Activation (RPA). These are shown as colored arrows, which start from the leading electrode position, following the summarized activation sequence. The more repetitive or consistent that activation pattern is, the wider the white arrow. Based on this information the physicians may then use this as an additional guide for further mapping of the AF, using FDA cleared mapping system catheters.

The STAR Apollo Mapping System operates outside the sterile field and is only connected to the EnSite Precision, EnSite X EP or CARTO 3 workstation and not to the amplifier, patient, or any other devices used in the procedure. No data is transferred from the STAR Apollo Mapping System back to the EnSite Precision, EnSite X EP mapping system, or CARTO 3 i.e., data transfer is only in one direction. No modifications to the EnSite Precision, EnSite X EP mapping systems or CARTO 3 are made to accommodate the STAR Apollo Mapping System. The STAR Apollo Maps may be used to give physicians additional information about the AF activations. The physician may use them as an additional aid to identify areas within the atria that may warrant further and close examination using the mapping system, and the compatible Mapping Catheter. The STAR Apollo System is never directly connected to a patient, nor does it deliver therapy. It is used as a software tool that provides supplementary information to the physician in an electrophysiology procedure.

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The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician-approved plan.

The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan.

For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under "FDG Medical Imaging Agent Information".

The RefleXion X2 System is a hybrid imaging and treatment platform designed to deliver multiple forms of external beam radiation therapy, including Intensity-Modulated Radiation Therapy (IMRT), Stereotactic Body Radiation therapy (SBRT), Stereotactic Radiotherapy (SRT), Stereotactic Radiosurgery (SRS), and biology-guided radiotherapy (BgRT).

The subject device (X2 System) is based on the same fundamental design as the X1 System (predicate device, DEN220014). Both systems integrate radiation delivery, imaging (CT and PET), and treatment planning capabilities into a single device.

• 6 MV photon radiotherapy delivery
• Positron Emission Tomography (PET) imaging
• Kilovoltage (kV) X-ray CT imaging
• Treatment planning

The radiation delivery subsystem includes a LINAC mounted within the therapy plane, utilizing a fixed primary collimator, adjustable upper and lower jaws, and a multileaf collimator (MLC) to shape and modulate the treatment beam. PET detector arcs are also mounted within the therapy plane to detect emissions from radiotracers during treatment, enabling biology-guided radiotherapy (BgRT). The kVCT imaging subsystem operates in a separate imaging plane and provides anatomical imaging for patient setup and verification prior to treatment delivery.

The X2 System incorporates several design updates relative to the X1 System, including enhancements to the PET subsystem, updates to kVCT components, hardware improvements aimed at manufacturing reliability and serviceability, software infrastructure upgrades, usability enhancements such as intrafraction PET image viewing and multi-target treatment workflows, and cybersecurity improvements. These changes do not alter the device's intended use, fundamental scientific technology, or safety and effectiveness.

No new patient-contacting materials, contamination pathways, or reprocessing requirements have been introduced. Consequently, the risk profile of the device, including the risk of infection or other adverse events, remains unchanged from the predicate device.

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Elecsys Anti-SARS-CoV-2 is an immunoassay intended for the in vitro qualitative detection of total antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and Li-heparin, K2-EDTA and K3-EDTA plasma collected on or after 15 days post-symptom onset. The test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzer.

Elecsys Anti-SARS-CoV-2 is a qualitative, serological, double-antigen sandwich principle immunoassay to be used on the cobas e 601 analyzer with an 18-minute test time. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. The Elecsys Anti‑SARS‑CoV-2 assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS‑CoV‑2.

The reagent working solutions include: rackpack (kit placed on the analyzer)

• M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.
• R1 SARS-CoV-2-Ag~biotin, (gray cap), 1 bottle, 16 mL: Biotinylated SARS‑CoV‑2‑specific recombinant antigen (E. coli) < 0.5 mg/L; HEPES^a) buffer 50 mmol/L, pH 7.7; preservative.
• R2 SARS-CoV-2 Ag~Ru(bpy) (black cap), 1 bottle, 16 mL: SARS‑CoV‑2‑specific recombinant antigen labeled with ruthenium complex < 0.5 mg/L; HEPES^(b) buffer 50 mmol/L, pH 7.7; preservative.

^(a) HEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid

The Elecsys Anti-SARS-CoV-2 assay includes two liquid calibrators, which are packed with the test kit:

• ACOV2 Cal1 Negative calibrator 1 (white cap), 2 bottles of 0.67 mL: Human serum, non-reactive for anti‑SARS‑CoV‑2 antibodies; buffer; preservative.
• ACOV2 Cal2 Positive calibrator 2 (black cap), 2 bottles of 0.67 mL: Human serum, reactive for anti‑SARS‑CoV‑2 antibodies; buffer; preservative.

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FOP NM-10 is an ophthalmic non-mydriatic digital camera using iPhone SE3 which captures images of the fundus of the human eye and surface as well as surrounding areas of the human eye.

The FOP NM-10 is designed for imaging of the fundus and surface as well as surrounding area of the human eye, in a compact, portable format, with an inherent simplicity built in its operation and use. The application software (Remidio FOP) is loaded on top of the iOS operating system to enable the user to view, save, archive and retrieve the captured images of fundus and surface area of the human eye. It is a compact, battery-operated device that enables high-quality fundus photography without requiring pupil dilation. The device can be used in Hospitals and Ophthalmic clinics. The FOP NM-10 incorporates a 40° field of view (FOV) optical system optimized for high-resolution retinal imaging. The device employs infrared and white LED illumination to achieve adequate retinal illumination without causing discomfort to the patient. The device is built on a modular smartphone-based design, ensuring portability and ease of operation. The Remidio FOP app enables wireless control of illumination intensity, focus adjustments, capturing the images in Auto and manual modes, saving, editing and archiving images.

Physical Specifications

• a) Field of View: 40° (for a minimum pupil size of 3mm)
• b) Material: ABS, Silicone Rubber
• c) Diopter Correction: -16D to +16D
• d) Working Distance: 33mm

Output and Performance Characteristics

• a) Illumination (Light Source): Infrared LED and Cool White LED
• b) Camera Resolution: 64 line pairs per millimeter (lp/mm) (at the center)
• c) ISO Range: ISO 200 and 400
• d) Focus Adjustment: Manual and Tap to Focus
• e) Internal Fixation: 8 fixation points
• f) Operating temperature: 10° to 40°C
• g) Relative Humidity: 10% to 85%
• h) Atmospheric Pressure: 750 to 1060 hpa

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• Cementation of all-ceramic, composite, and metal crowns, bridges, inlays, onlays, dental posts; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (contraindicated for patients with bruxism or periodontitis).
• Cementation of fiber posts.
• Cementation of all-ceramic, composite, and metal restorations on implant abutments.

TopCEM Vigor SA Self-Adhesive Resin Cement is a dual-curing (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The cement contains inorganic fillers, and the inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. The mixing ratio, based on volume, is 1 part base paste: 1 part catalyst paste. TopCEM Vigor SA Self-Adhesive Resin Cement is delivered in double-barrel syringes. TopCEM Vigor SA Self-Adhesive Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

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