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510(k) Data Aggregation
(31 days)
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(220 days)
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(122 days)
The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The test is intended for in vitro diagnostic use as an aid in the diagnosis of RSV infections.
Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or patient management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an FDA-cleared molecular assay.
The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The nasopharyngeal swab from individuals is processed by the extraction buffer in buffer tube. After the extracted sample is added into the specimen well, the respiratory syncytial virus (RSV) nucleoprotein antigen in the sample will react with anti-RSV antigen antibody conjugated with color micro particles to form an antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated anti-RSV antigen antibody. If the specimen contains RSV nucleoprotein antigen, a colored line will appear in the test line (T) region indicating a positive result. If the specimen does not contain RSV nucleoprotein antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line (C) region indicating that proper volume of specimen has been added and membrane wicking has occurred.
The test result should be read at 15-20 minutes after adding the extracted sample is added into the specimen well. One line in the control line region (C), and another line in the test line region (T) indicates a positive result, regardless of color intensity. When only One line is present in the control region(C) and no line is present in the test line region (T) results are negative result. If the control line(C) fails to appear, the result is invalid, and the operator should review the procedure and repeat the test with a new test cassette.
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(265 days)
This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
The subject device, Cholangioscope Visualization System, comprises two components: the Single-use Video Cholangioscope and the Full HD Visualization Endoscopic Image Processor.
The Single-use Video Cholangioscope is a single use sterile device. It is composed of working channel, control wheel, operation section, insertion section (integrated with a video image sensor and lighting components), plug section, connection cable, water supply channel, suction channel and accessory- irrigation valve.
The operation section allows users to connect and operate the product. It includes two control wheels (large/small control wheel) to control the bending section at the insertion section to bend in four directions, a lock mechanism can be rotated clockwise to lock the control wheel in its current position, a working channel port can be used for inserting accessories and suction, a bundle mechanism is used to fix the Single-use Video Cholangioscope to the duodenoscope, a water supply port for connecting to the water supply tube, a suction port for connecting to suction tube with a flow control value, and a plug section for connecting with the image processor.
The insertion section can be inserted in patient entirely, and it includes a bending section and a distal end. The bending section can be bent >=50 degrees in four directions by the control wheel. The distal end includes a miniature Complementary Metal Oxide Semiconductor (CMOS) camera, two light-emitting diode (LED) illumination module, two water supply channels for inserting accessories and one working channel for discharging liquid to the suction tube.
The accessory-irrigation value can be connected to the working channel port to expand the working channel, and provide an injection-suction dual-purpose port that can be used for liquid supply or suction through the working channel.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images within the field of view from the body cavity on its LCD display and/or external monitor. The Full HD Visualization Endoscopic Image Processor has four models, they have the same hardware and the difference is mainly in the image adjustment functions.
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(39 days)
The device is indicated for temporary use during the creation of anastomosis for medical conditions requiring beating heart coronary artery bypass procedures.
The disposable intracoronary shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material with 14 mm between the ends. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. These devices are sterile, nonpyrogenic, disposable and intended for single use only. They are sterilized using ethylene oxide and are categorized as external communicating devices, with limited contact (<=24 hours) circulating blood contact.
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(31 days)
The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
The CARTO™ 3 EP Navigation System V9.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO™ 3 System V9.0 consists of the following hardware components:
- Patient Interface Unit – (PIU Plus or PIU)
- Workstation with Graphic User Interface (GUI)
- Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port
- Power Supply
- Patches Connection Box and Cables (PU)
- Pedals
- Location Pad (LP)
- Signal Processing Unit (SPU) – supported with PIU only
All hardware components of the CARTO™ 3 system V9.0 are the same as those found in the predicate device, with improved Patient Interface Unit (PIU Plus).
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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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(108 days)
CoolTone device is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen
- Strengthening, toning and firming of buttocks and thighs
When intended to stimulate healthy muscles to improve or facilitate muscle performance, CoolTone induces muscle contractions to enhance muscle function and may therefore be considered a technique of muscle training.
In addition, the CoolTone is indicated to be used for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle reeducation
- Maintaining or increasing the range of motion
CoolTone may also be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Furthermore, CoolTone device may be used to stimulate neuromuscular tissue for bulk muscle excitation in the legs for rehabilitative purposes.
The CoolTone system is a non-invasive, therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, CoolTone helps to strengthen, tone and firm the abdomen, buttocks and thighs.
The device is a mobile standalone unit with four wheels, and the device housing protects the patient from electrical shock and mechanical injury.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. CoolTone is equipped with a securement system, designed to maintain the position of the applicator throughout treatment.
A large color touch screen facilitates the use of the device. The on-screen information guides the user, step-by-step, through the entire treatment process. The treatment is operated through variable parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.
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(29 days)
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 autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally box-shaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.
The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).
The purpose of this submission is to update the indications for use and to introduce new sizes to the Curiteva Porous PEEK Cervical Interbody Fusion System.
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(173 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The gloves was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs".
The following drugs have been tested with these gloves:
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Bendamustine HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Bleomycin Sulfate, 15 mg/ml (15,000 ppm) | >240 min |
| Busulfan, 6 mg/ml (6,000 ppm) | >240 min |
| Carboplatin, 10 mg/ml (10,000 ppm) | >240 min |
| Carmustine 3.3 mg/ml (3,300 ppm) | 10.0 min |
| Chloroquine, 50 mg/ml (50,000 ppm) | >240 min |
| Cisplatin, 1mg/ml (1000 ppm) | >240 min |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 min |
| Cytarabine HCl (Cytosine), 100 mg/ml (100,000 ppm) | >240 min |
| Dacarbazine (DTIC), 10 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 min |
| Epirubicin HCl, 2 mg/ml (2,000 ppm) | >240 min |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 min |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 min |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 min |
| Gemcitabine HCl, 38 mg/ml (38,000 ppm) | >240 min |
| Idarubicin HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Ifosfamide (IFEX), 50 mg/ml (50,000 ppm) | 80.0 min |
| Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Melphalan HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Methotrexate, 25mg/ml (25,000ppm) | >240 min |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 min |
| Mitoxantrone HCl (2.0 mg/mL) (2000 ppm) | >240 min |
| Oxaliplatin, 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 min |
| Rituximab, 10 mg/ml (10,000 ppm) | >240 min |
| Thiotepa, l0mg/ml (10,000ppm) | 20.0 min |
| Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) | >240 min |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 min |
| Vinorelbine, 10 mg/ml (10,00 ppm) | >240 min |
| Opioid Drug | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 min |
*Please note that the following drugs have low permeation times:
Carmustine: 10.0 minutes, Thiotepa: 20.0 minutes
Warning: Do not use with Carmustine & Thiotepa.
Caution: Testing showed breakthrough time of 80.0 minutes with Ifosfamide IFEX (50.0 mg/mL).
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