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510(k) Data Aggregation
(162 days)
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(194 days)
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(65 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Y-Knotless™ Flex Anchors may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:
- Shoulder Labrum
- MPFL Reconstruction
- Foot and Ankle
- Biceps
- Meniscal Root Repair
The Y-Knotless™ Flex Anchors are a non-absorbable, all-suture, knotless implant, that are supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The implant anchors are composed of a white flat braided ultra-high molecular weight polyethylene (UHMWPE) suture anchor, a tapered #2 Hi-Fi® repair suture either white/black or green/white/black, and a #2-0 Hi-Fi® shuttle suture, blue and black. The implants are pre-loaded on a disposable driver with sutures cleated to the handle. The anchors require a 1.8 mm pre-drilled bone hole created using Class I, exempt instrumentation.
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(251 days)
PhenoMATRIX is a WASPLab optional module intended for the automatic sorting of images of blood-based agar, chocolate agar, MacConkey agar, and CHROMagar Orientation culture media plates according to classification parameters based on Image Analysis Software results and clinical and demographic data.
Image Analysis Software performs semi-quantitative and/or qualitative analysis of culture media plates by detecting microbial growth, estimating colony counts and differentiating isolates based on phenotypic colony characteristics.
The system determines how the images should be sorted based on image analysis results in addition to patient data according to expert rules defined by the laboratory.
All images shall be evaluated by trained personnel for final assessment and result definition.
The PhenoMATRIX is an in vitro diagnostic software for automated classification of images of solid culture media plates streaked with microbiological samples derived from the human body.
The PhenoMATRIX comprises software modules intended for image analysis and automatic classification of high-resolution digital images captured by WASPLab device for semi-quantitative and qualitative assessment of microbial growth.
WLPostProcessing, its plugin and the Imaging Product SET perform microbial growth detection, colony counts estimations and isolates differentiation basing on phenotypic colony characteristics. The image analysis result is combined with LIS data (such as demographic data, clinical data and / or sample data) according to customizable logic rules defined by the laboratory, for image classification. The classification is used for image sorting into dedicated digital folders associated to suggested results.
The PhenoMATRIX requires the WASPLab in order to operate. WASPLab is an in vitro diagnostic device for handling, incubation, digital imaging and sorting of agar culture plates.
After PhenoMATRIX processing, the physical plates are left inside the WASPLab and images are available for digital inspection by the trained microbiologist through the WASPLab User Interface. The trained microbiologist shall assess the plate images in each digital classification folder. To each digital image a suggested result is assigned according to rules previously defined by the laboratory. The trained microbiologist reviews the plate images, folder by folder, and confirms (or changes) the assigned folder and result. After that, the plates follow the workflow that has been defined by the laboratory according to the assigned result.
The main functionalities of PhenoMATRIX are:
- Assignment of classification parameters to media plate images based on criteria defined by the user (e.g., LIS information, Image Analysis).
- Result assignment according to the classification folder.
- Visualization of media plate images in the WASPLab User Interface for digital inspection.
All plate images shall be reviewed by trained microbiologist before any result definition.
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(63 days)
The Cultiv8 Genie MAX is intended to be inserted into the vasculature to provide a conduit for introducing intravascular devices while providing a hemostatic seal to minimize blood loss.
The Genie MAX is a large bore introducer sheath system used for providing a conduit for introduction of intravascular devices while providing a hemostatic seal. The system includes an introducer sheath, protector, dilator and a 3cc syringe.
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(298 days)
DRX-Evolution Plus X-ray System
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.
DRX-Compass X-ray System
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body,including the skull, spinal column, extremities, chest, abdomen, and other body parts. The device is not indicated for use in mammography.
Lux HD Detectors
Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general–purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications.
Lux HD Digital Flat Panel Detectors (35x43, 43x43 sizes)
Lux HD 35x43 and 43x43 detectors are high-definition detectors (100um) designed with a Cesium Iodide (CsI) scintillator for the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by a diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics to form an image by transmitting to the device PC through the user interface. The CsI scintillator provides a high spatial resolution image which helps to increase the diagnostic confidence. The detectors use a glass free technology which makes the overall detector weight lighter and mitigates the risks related to device breakage. Lux HDs are designed with Digital Exposure Control (DEC) functionality which uses a wireless connection to communicate with a DEC control box, which in turn connects to the generator for x-ray control. This DEC feature also enables AEC functions to be used with out-of-bucky exams and mobile imaging without a physical wired connection.
Carestream In-Room X-ray Systems
The DRX Evolution Plus (K233381), DRX Compass (K223842) are permanently installed diagnostic x-ray systems for general radiographic x-ray imaging. These systems consist of a combination of components including an x-ray generator, workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). Currently, the DRX Evolution Plus X-ray system is designed to use a standalone automatic exposure control (AEC) chamber placed in front of the detector to control the x-ray exposures. Lux HD will be compatible with these systems. The DRX-Compass will not support the DEC feature; however the Lux HD detectors can still be used for general radiography.
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(57 days)
The CooperSurgical Milex™ pessaries are intended to provide support to pelvic organs when inserted in the vagina.
The following Indications for Use are associated with each of the following pessary styles:
Milex™ Incontinence Dish Pessaries and Incontinence Dish Pessaries with Support:
Incontinence dish pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.
Milex™ Cube Pessaries and Cube Pessaries with Drainage Holes:
Cube pessary is indicated for nonsurgical management of pelvic organ prolapse in Stage III prolapse including rectocele and/or cystocele.
Milex™ Incontinence Dish Pessaries, Incontinence Dish Pessaries with Support, Cube Pessaries, and Cube Pessaries with Drainage Holes are intended for support to pelvic organs when inserted into the vagina. Milex™ Pessaries are made of silicone and distributed in a non-sterile condition. The Milex™ Pessaries are available in a variety of styles, each having a range of sizes. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex™ Pessaries are manufactured in pink for single patient use.
This submission includes the following designs of Milex™ Pessaries: Incontinence Dish Pessary (Dish without Support, Dish with Support) and Milex™ Cube Pessary (Cube without Drainage Holes, Cube with Drainage Holes).
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(63 days)
The Diagnostic Ultrasound System Aplio beyond Model CUS-ABE00, Aplio me Model CUS-AME00 are indicated for the visualization of structures, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.
This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping.
This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.
The Aplio beyond, Model CUS-ABE00 and Aplio me, Model CUS-AME00, V2.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 20MHz.
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(186 days)
Curiteva Porous PEEK Cervical Interbody System
The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended to be used with supplemental fixation. The Curiteva Porous PEEK Cervical Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Curiteva Porous PEEK Lumbar Interbody System
The Curiteva Porous PEEK Lumbar lnterbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.
Curiteva Porous PEEK Laminoplasty System
The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
Curiteva Porous PEEK Standalone ALIF System
The Curiteva Porous PEEK Standalone ALIF devices are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
Curiteva Porous PEEK ALIF System (Without Integrated Fixation)
The Curiteva Porous PEEK ALIF devices are intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
The previously cleared devices consist of a variety of interbody implants and spacers to provide support in the cervical, thoracic, lumbar, and/or lumbosacral regions of the spine. The system implants feature a proprietary nanomaterial surface treatment. This nanoscale surface texture is engineered to produce a uniform nanocrystalline hydroxyapatite layer approximately 10 – 20 nm thick, with individual crystals averaging 91.5 nm in length, and an average width of 10 nm. The surface has demonstrated the ability to reduce contact angle (i.e., increase hydrophilicity) as compared to uncoated and micro-sized HA coated control surfaces and demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.
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(226 days)
The Xpert GI Panel, performed on the GeneXpert® Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and virus are identified using the Xpert GI Panel:
Pathogens Detected:
- Bacteria: Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1/stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae
- Parasites: Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia), Cryptosporidium
- Virus: Norovirus GI/GII
Pathogens Reported:
- Bacteria: Campylobacter, STEC stx1, STEC stx2, Salmonella, Shigella EIEC, Yersinia, V. parahaemolyticus, V. cholerae
- Parasites: Giardia, Cryptosporidium
- Virus: Norovirus
Results are meant to be used in conjunction with other clinical, laboratory and epidemiological data and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out co-infection with pathogens not included in the Xpert GI Panel. The pathogen detected may not be the definite cause of the disease. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
The Xpert Gastrointestinal (GI) Panel test, performed on Cepheid GeneXpert® Instrument Systems equipped with 10-color modules, is an automated in vitro diagnostic test for qualitative detection and differentiation of eleven (11) pathogens in stool in Cary Blair specimens collected from individuals suspected of gastrointestinal infection (GI). The results from the Xpert GI Panel test will be available in approximately 74 minutes.
The Xpert GI Panel is performed on the Cepheid GeneXpert® Instrument Systems equipped with GeneXpert 10-color modules running software version 6.4 and higher (GeneXpert Dx), software version Xpertise 7.1 or higher (GeneXpert Infinity) or software version COS 2.1 or higher (GeneXpert with Touchscreen). The GeneXpert® Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences from clinical specimens using reverse transcription (conversion of RNA template into DNA) followed by real-time polymerase chain reaction (real-time PCR) and melt curve analysis. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. Each test requires the use of a single-use disposable GeneXpert cartridge that contains target-specific reagents and carries out the reverse transcription and PCR processes.
The Xpert GI Panel test includes reagents needed: (i) for sample preparation and (ii) to detect the different bacteria, parasites, and virus. A Sample Processing Control (SPC), an Internal Control (IC) and a Probe Check Control (PCC) are also included in the cartridge. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The IC is present to ensure adequate processing of RNA targets and monitor the presence of inhibitor(s) in the PCR reaction. The SPC is present to control for adequate extraction and processing of the target sequences in the PCR reaction. The SPC also acts as a control for functionality of melt curve analysis.
The Xpert GI Panel test results are interpreted by GeneXpert Instrument Systems from measured fluorescent signals and embedded calculation algorithms and will be reported as positive or negative for each of the targets.
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