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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

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Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, and rods. The system is supported by a comprehensive set of instruments to install the implants within the system for percutaneous and minimally invasive access. All implant components are manufactured from the materials listed in the table below.

Materials: Ti-6Al-4V ELI (ASTM F136), CP Titanium Grade 4 (ASTM F67), CoCrMo Alloy (ASTM F1537), Elgiloy CoCrNi Alloy (ASTM F1058), Nitinol #1 (ASTM F2063)

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The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures.

Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The OptoMonitor 3 with Display Unit Software update to v1.3.0 and Capture Unit when compared to the OptoMonitor 3 cleared under K241418 includes the following changes:

New PhysioVU Software Functionality:

The PhysioVU functionality added to the OptoMonitor 3 provides a feature designed to support the cardiologist PCI workflow by displaying a time-synchronized playback of angiogram and coronary physiological pullback values such as Pd/Pa or dPR. This feature can be utilized on angiography systems compatible with PhysioVU requirements. The validation of PhysioVU's compatibility and overall latency performance was evaluated on three representative angiography systems at 7.5 fps and 15 fps.

dPR Pullback:

A dPR Pullback display optimization has been incorporated to meet the time-synchronization requirements of PhysioVU functionality and is called Pullback 2. Pullback 2 provides an adequate delay between the angiography image and the dPR calculation and can be used as a standalone or a PhysioVU pullback.

New Capture Unit (Hardware):

The Capture Unit component is optional but required for the PhysioVU functionality. The Capture Unit is used to capture angiography images that are sent to the Display Unit. This enables the Display Unit to subsequently replay recordings of these angiograms synchronized with physiological pullback values such as Pd/Pa or dPR.

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The Orthoscan TAU MVP system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

The scope used with Orthoscan TAU MVP system is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.

The proposed Orthoscan TAU MVP (Multi Viewing Platform) Mini C-Arm system models 1000-0022, 1000-0023 retain identical function as the predicate Orthoscan TAU Mini C-Arm (K250587) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-Arm support attached to the image workstation.

The proposed Orthoscan TAU MVP Mini C-Arm system models 1000-0022, 1000-0023 represent a modification of our presently legally marketed devices Orthoscan TAU Mini C-Arm (K250587). The proposed Orthoscan TAU MVP Mini C-Arm System will consist of the Orthoscan TAU Mini C-Arm X-ray System with additional arthroscopic imaging capability to further standardize the product platform by incorporating components currently available in predicate devices into the Orthoscan TAU MVP system.

The proposed new Orthoscan TAU MVP system is a collaborative effort to display the fluoroscopic and arthroscopic image concurrently.

The proposed modifications to the predicate encompass the incorporation of hardware and software from MIDASVu arthroscopic imaging system reusable tablet (K243020) utilizing a modified mechanical design to incorporate a video processing unit imaging control board, umbilical cord and arthroscopic imaging system comprised of sterile, single-use scopes (K243020). The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and the TAU MVP Mini C-Arm system work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.

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The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.

The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula is not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.

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The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY® components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM® GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin/vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medullary canal and can mate directly with the native acetabulum or an acetabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use for more than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

The OsteoRemedies' REMEDY Hip Spacer and REMEDY SPECTRUM GV Hip Spacer families (K112470, K172906, K191981, K192995) are legally marketed devices that are used in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The 510(k)-cleared Hip Spacer is a temporary hip spacer device consisting of independent components (femoral stem, head, and cup components). All hip spacer constructs include component(s) manufactured from PMMA with gentamicin (REMEDY Hip Spacers) or PMMA with gentamicin and vancomycin (REMEDY SPECTRUM GV Hip Spacers); the stems are structurally reinforced with a stainless steel core.

The subject REMEDY POLY+PLUS Acetabular Cup and REMEDY CoCr Modular Femoral Head Components are intended to be a line extension to the REMEDY Hip Spacer and REMEDY SPECTRUM GV Hip Spacer families (K112470, K172906, K191981, K192995).

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The oxygen concentrator P2-O5E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

The oxygen concentrator P2-O5E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. The oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, fans, solenoid valves, molecular sieve beds, circuit control system, heat dissipation system, and a flow control device. Accessories include power cord, air intake filter box, air intake filter cotton.

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This product is intended for delivery of respiratory gases to adult patients in hospitals.

This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals.

Qualitative carbon dioxide (CO2) sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.

This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care or airway management.

This product is not intended for apneic ventilation.

This product is not indicated for use during CPR.

The Optiflow™ Switch+ Filtered Nasal Interface with CO2 Sampling interface is intended to deliver respiratory gases to the patient.

The subject device includes a CO2 sampling tube that provides a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer.

The subject device has been designed to allow for mask ventilation without the need to remove the nasal interface from the patient during therapy. To support this function, a Flow Diverter (K234053) is required.

The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.

This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).

It is intended to be used in combination with a compatible respiratory humidifier, Optiflow Oxygen Kit and the Optiflow Flow Diverter (K234053).

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• Instrument for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions. Marking of lesions.
• The OTSCneo clip is indicated for clip placement within the GI tract for the purpose of:
  • Endoscopic marking
• Hemostasis for:
  • Mucosal/submucosal defects < 3 cm
  • Bleeding ulcers
  • Arteries < 2 mm
  • Polyps < 1.5 cm in diameter
  • Diverticuli in the colon
• Closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

NOTE: The OTSCneo System Set is not indicated for stent fixation. For stent fixation, use the stentfix OTSC® System Set.

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments or suction are used via endoscope working channels for mobilization and retraction of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a manual thread mechanism.

Contents of the OTSCneo System Set are:

• Application cap (with spout, application ring, thread, clip mounted on the cap)
• Hand Wheel
• Thread Retriever

In line with cleared indications, clip application with the subject device can be used for hemostasis, treatment of lesions, or marking of lesions in the GI tract.

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