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510(k) Data Aggregation
(71 days)
The manual wheelchair is to provide mobility to persons limited to a sitting position.
A wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. The device is intended for adults only.
W50 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W50 has a physical dimension of 1130mm x 840mm x 950mm (depth x width x height) with the seat itself has a dimension of 525mm x590mm x 470mm (depth x width x height). The device has a weight capacity of 227 kilograms, and weighs about 24 kilograms. The color is dark black.
Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.
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(132 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The digitally designed personalized copings to be used with the Direct Connection Screw to Multi-Unit Abutment are to be:
- Sent to Straumann for manufacture at a validated milling center, or
- Manufactured following the Neodent InLab Validated Workflow.
The Neodent InLab Validated Workflow is indicated for the design and fabrication of screw-retained multi-unit restorations for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories.
The purpose of this premarket notification is to obtain market clearance to expand the options for fabrication of digitally designed personalized copings for use with the Neodent Direct Screw to multiunit abutment (MUA) from a "validated milling center" (cleared in K242686), to include a digital dentistry workflow.
The Neodent InLab Validated Workflow is integrated by multiple components of digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories. This new workflow employs optical impression files that document the topographical characteristics of teeth and traditional dental impressions, which are transferred to the CAD software (CARES® Visual, 3Shape or Exocad) and allows the design of the desired restorations, according to the Direct Screw to MUA dimensions. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration by the indicated milling equipments (Roland and Zirkonzahn).
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(261 days)
The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for individuals (men, women, pediatrics) who are unable to promote natural urine flow or have a significant volume of residual urine following a natural bladder-voiding episode.
The catheter is inserted into the urethra to reach the bladder, allowing urine to drain and ensuring bladder emptying.
Ready to use Nelaton Catheter is a sterile, single use catheter, intended to be inserted through the urethra to the bladder for intermittent urine drainage. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of adult and pediatric patients (including males and females).
The catheter is made of polyurethane, and is not made with PVC. It is prelubricated with a hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel at the proximal end can be connected to a urine collection container. There is a gripper on the catheters for adult males (length of 40cm), which serves as protection from the user's touch and aids the user during insertion.
The catheter is sealed in a foil pouch with the hydration liquid (distilled water) in one compartment, so the coated catheter is lubricated by direct contact with the hydration liquid and can be ready to use. Ready to use Nelaton Catheter is sterilized by E-beam irradiation, and the shelf life is 3 years.
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(111 days)
ARMI® Hysteroscopy System 2.0 is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The ARMI® Hysteroscopy System 2.0 (subject device) is a hysteroscope and compatible accessories consisting of the following components:
- ARMI® Endoscopic Video Image Processor (non-sterile, reusable), JY-MIP-3000
- ARMI® Single-Use Hysteroscope (sterilized with ethylene oxide), SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C
- Disposable Electronic Hysteroscope (sterilized with ethylene oxide) (510(k) cleared under K210270),
- Power cord and Power adapter (non-sterile, reusable),
- Hysteroscope cable (non-sterile, reusable), and
- HDMI cable (non-sterile, reusable) (optional)
Both hysteroscopes are single-use and the rest of the components are reusable.
The image processor is powered by an AC adapter (100 – 240V AC, 50/60 Hz) or battery (7.4V DC).
The subject device includes 13 models of the ARMI Single-Use Hysteroscope. The models have a working length of 245 mm. The models have different image resolutions, tip angles, insertion diameters, and instrument channel diameters.
The subject devices are noted to contain two different LED models (0301, 9653) and three different image sensors (ovm6946/ochsa10/ov9734).
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(163 days)
GM Helix Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Helix Implant System with 3.75 and 4.0 diameter and 18 mm length are indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Implants in the pterygoid indication should be used in splinted applications that utilize at least two implants.
GM Helix LG Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The GM Helix LG Implant System is indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
GM Mini Conical Abutment 45°:
The Mini Conical Abutments 45° and 60° are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
GM Mini Conical Abutment 45° Slim:
The Mini Conical Abutments 45° and 52° are indicated for surgical procedures in Zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.
This premarket notification seeks to expand the indications for use of the subject implants and abutments, in order to include anchorage in the pterygoid region. These devices were previously cleared under 510(k) K163194, K190958, K190718 and K232099 for the functional and esthetic oral rehabilitation of the upper or lower jaw in edentulous or partially edentulous patients. The proposed implants and abutments remain with the same design and features already cleared in the original submission.
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(96 days)
ARIX Femur Nail System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
Anti-Rotation Lag Screw and Telescopic Lag Screw in ARIX Femur Nail System are made of Titanium Alloy which meets ASTM F136 and only 'Anti-Rotation Pin' section of Anti-Rotation Lag Screw is made of Nickel-Titanium Alloy which meets ASTM F2063. ARIX Femur Nail System is provided Sterile or Non-Sterile.
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(91 days)
The W45 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The W45 Manual Wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by a caregiver using the rear push handles. The device is intended for adults only (age ≥22 years). W45 is a mechanical wheelchair including four wheels, features an aluminum frame, polypropylene hand grip and foot pedals, and a nylon upholstery that is flame resistant. W45 has a physical dimension of 1010mm × 610mm × 920mm (overall length × overall width × handgrip height) with the seat itself has a dimension of 470mm × 457mm × 449mm (effective depth× effective width × height at front edge). The device has a weight capacity of 115 kilograms, and weighs about 12 kilograms. The armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle. The device features hand brake levers on the rear push handles, with a squeeze-locking mechanism that functions as a parking brake.
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(91 days)
The W47 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
A wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. W47 is a mechanical wheelchair including four wheels, a steel frame and a seat and back upholstery that is flame resistant. W47 has a physical dimension of 1340mm × 690mm × 950mm (overall length × overall width × handgrip height) with the seat itself has a dimension of 580mm × 450mm × 465mm (effective depth × width × seat height at front edge). The device has a weight capacity of 136 kilograms, and weighs about 24 kilograms. The armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle. The device features hand brake levers on the rear push handles as well as wheel locks (parking brakes).
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(88 days)
The Articulator™ Arthroscopic Bur is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip, to provide abrasion, resection, debridement, and removal of bone and cartilage.
The Articulator Arthroscopic Bur can be used to abrade, cut and excise tissue and bone in arthroscopic surgeries.
The arthroscopic bur components include a bur attached to a constant velocity joint that is attached to a long rod rotating within a long hollow stainless steel housing. The bur is shielded on one side by its housing, allowing the bur to cut one structure while tissues on the opposite side of the shield are protected. A pushrod stabilizes the burr housing and holds the articulation into one of three preset flexion angles chosen by the user. A trigger mechanism on the proximal end of the bur allows the user to ergonomically flex and release the working angle of the bur with one hand. This system attaches to a motorized handpiece that drives the internal bur inside the outer housing and provides suction to pull the cut tissue away from the surgical site.
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(29 days)
Cryon-X Pro
The private-label Cryon-X Pro device combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post-traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) is indicated.
The device may optionally provide DVT therapy, intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
This device is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Cryon-X One
The private-label Cryon-X One device combines cold and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
This submission includes two models JKH-152 (private labelled as Cryon-X Pro) and JKH-151 (private labelled as Cryon-X One) as the subject devices. The private-label Cryon-X Pro has all the same features of combining cold, heat, contrast, and compression therapies as its original 510(k) cleared device in K223541, and Cryon-X One has the simplified features of cold and compression, which are the same as those of its original 510(k) cleared device in K223541. Each of the subject devices is an AC powered, software-controlled multimodality device, intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device is a prescriptive device, which is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy are indicated. It is optionally intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
The subject device and its accessories are clean and non-sterile. The device has a power switch, and then conducts the remaining operations on its touch screen, including the treatment temperature adjustment, air compression adjustment, and treatment time adjustment. The device works by circulating cooled or heated water and air through a treatment wrap that is placed on the treatment body area. The cooled or heated water circulates through the treatment wrap and provides cold or hot therapy, and the air compression inflates and deflates the treatment wrap to compress around the treatment body area. A connecting tube/hose is used to connect the device to the treatment wrap. The disposable or reusable wraps come with a variety of options to cover different body areas, including the universal, back, shoulder, ankle/foot, hip, knee, etc. To avoid any potential adverse skin reactions such as redness, irritation, and cod/hot injury, the sock/clothing should be worn by the patient prior to use.
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