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510(k) Data Aggregation
(84 days)
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(53 days)
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(87 days)
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(263 days)
The miDiagnostics HSV-1&2 CSF Test is an in vitro polymerase chain reaction (PCR) assay intended for use with the miDiagnostics PCR Platform for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infection of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infection in the CNS.
Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
The test is not intended for use as a donor screening test. The test is for professional use only.
The miDiagnostics HSV-1&2 CSF Test is a real-time polymerase chain reaction (PCR) assay that enables the direct amplification, detection, and differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) DNA from cerebrospinal fluid (CSF) specimens, obtained via lumbar puncture, from individuals with signs and/or symptoms of HSV-1 or HSV-2 infection in the central nervous system (CNS).
The test consists of three major steps: (1) manual sample preparation, (2) manual PCR reaction preparation and (3) automated PCR run which includes targets amplification and detection by fluorescent probes for 1 target specific to HSV-1, 1 target specific to HSV-2 and a human DNA control target.
After manual sample and PCR reaction preparation, the miDiagnostics HSV-1&2 CSF test consists of three major steps: (1) manual sample preparation, (2) manual PCR reaction preparation and (3) automated PCR run on the miDiagnostics PCR Platform which is an automated in vitro diagnostic system for the amplification and detection of the target nucleic acid(s) using real-time polymerase chain reaction (PCR).
Description of the different components of miDiagnostics HSV-1&2 CSF Test:
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miDiagnostics HSV-1&2 CSF Detection Mix: contains a freeze-dried cake, stored in a tube, containing all the PCR components for amplification and fluorescent detection of HSV-1, HSV-2 and the Sample Processing Control (SPC). Each tube is individually packed in a pouch. The device consists of 24 pouches in a box.
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miDiagnostics HSV-1&2 CSF Dilution Buffer: contains 300 µL HSV CSF Dilution Buffer for diluting the CSF specimen. It also contains a SPC (RPP30, a human housekeeping gene). The device consists of 24 tubes packed in one box.
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miDiagnostics Concentration Device: consists of a combination of the miDiagnostics Concentration Column and 2 miDiagnostics Collection Tubes, to concentrate the viral material. The device consists of one bag with 24 miDiagnostics Concentration Columns and 48 miDiagnostics Collection Tubes.
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miDiagnostics HSV-1&2 CSF Algorithm: The software system that interprets fluorescence signals and reports test results. The miDiagnostics HSV-1&2 CSF Algorithm is embedded in the miDiagnostics Software.
The miDiagnostics PCR Platform is an automated in vitro diagnostics medical device intended to be used in combination with a selected miDiagnostics test for the amplification and detection of the target nucleic acid(s) using real-time polymerase chain reaction (PCR). The miDiagnostics PCR Platform is intended to be used by healthcare professionals (trained laboratory personnel) in laboratory environment.
Description of the different components of miDiagnostics PCR Platform:
- miDiagnostics PCR Reader 2.0 receives the miDiagnostics PCR Card 2.0 and is responsible for performing consecutive PCR cycles through thermocycling. The miDiagnostics PCR Reader 2.0 monitors the consequent polymerase chain reaction's progress with a four-channel camera system. It also contains a 2D barcode reader to identify the loaded miDiagnostics PCR Card 2.0 and is connected to the miDiagnostics Computer, from which it receives test-specific parameters for the PCR and to which it sends the camera images that contain the raw data of the PCR.
The firmware is an embedded software system running on the miDiagnostics PCR Reader 2.0 microprocessor with as main functionalities the thermocycling and the triggering of the camera.
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miDiagnostics PCR Card 2.0 is a single-use, disposable test accessory. The miDiagnostics PCR Card 2.0 is manually loaded with a small volume of sample mixed with PCR components of the selected miDiagnostics test (so called reaction mixture). Once loaded, the miDiagnostics PCR Card 2.0 is manually inserted in the miDiagnostics PCR Reader 2.0. The miDiagnostics PCR Card 2.0 includes a fluidic chip with the reaction chamber that enables a very fast polymerase chain reaction driven by the miDiagnostics PCR Reader 2.0. Each miDiagnostics PCR Card 2.0 is individually packed in a pouch. The device consists of 24 pouches in a box.
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miDiagnostics Computer connects to the miDiagnostics PCR Reader 2.0 via two USB-cables and can connect to the customer's network via ethernet or WiFi. It interacts with a user via a touchscreen, has an integrated barcode scanner that allows the user to scan the sample consumable identifiers, and it runs the miDiagnostics Software.
The miDiagnostics Software is the software of the miDiagnostics PCR Platform, that is installed on the miDiagnostics Computer. It controls the miDiagnostics PCR Reader 2.0, retrieves the camera captures, hosts the test specific algorithm that interprets the fluorescence signals, reports the test results, and provides a user interface for the operator to interact with the miDiagnostics PCR Platform.
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(110 days)
It is motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
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(255 days)
The Master Pin X (MP Pins with thread) are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow the fixation of resorbable, non-resorbable and titanium-reinforced membranes in the dense cortical bone
The Master-Pins X have been developed especially for the fixation of membranes. The pins are made of grade 5 titanium alloy and have a self-drilling thread that allows them to be inserted into the cortical bone. They have a total length of 3.2 mm and a declining thread diameter, with a maximum of 1.45 mm thread diameter.
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(56 days)
The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
- The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
- The liver in bariatric procedures
- The prostate and periprostatic tissue in prostatectomy procedures
- The colon, rectum, and pericolorectal tissue in colorectal procedures
The Grasper Tip 12.5 is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
- The pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures
Pediatric use:
The Magnetic Surgical System is indicated for use in adolescents (12-21) within a BMI range of 20 to 34 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
- The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
The Magnetic Surgical System comprises two hand-held instruments, the Magnetic Grasper and the external Magnetic Controller. The Magnetic Grasper, disposable and provided sterile for single use, comprises two main components: a detachable Grasper Tip (6.5cm overall length) and a shaft with Handle. An optional 12.5cm length Grasper Tip (also single use, disposable, and provided sterile) may be used as a replacement for the 6.5cm Grasper Tip and can be used interchangeably with the Shaft.
The Magnetic Grasper is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible >= 10 mm laparoscopic port to the surgical site and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller.
The Magnetic Controller is a non-sterile, reusable unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.
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(86 days)
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(29 days)
MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, via the venous route, of a contrast agent and 0.9% Sodium Chloride Injection USP (saline) to patients undergoing examinations in computed tomography (CT).
The system is intended for use by and under direct quasi-continuous supervision of trained healthcare professionals to assure the integrity of the contrast agent and the injection system, in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
For a complete list of compatible contrast agents for use with the MEDRAD® Centargo CT Injection System, refer to the Centargo CT Injection System Operation Manual.
The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast agents, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast agent containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first.
Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set.
The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.
The MEDRAD® Centargo CT Injection System (Centargo) is an automated contrast injection system intended to be used to inject intravenous contrast agents and saline into humans for diagnostic studies in CT applications. Centargo is intended for use with the approved contrast agent in a single-dose container and Imaging Bulk Package (IBP)
Centargo is based on well-established technologies for injection, using a piston-based electromechanical device. The system is designed to protect the patient against air injection by incorporating multiple sensors to detect air within the fluid pathway. The system is comprised of two main modules:
- Scan Room Unit – responsible for handling the contrast/saline and delivering injections
- Control Room Unit - controls, monitors, and communicates with the Scan Room Unit through wired or wireless connection
The Scan Room Unit is located within the scan room whereas the Control Room Unit is not. When communicating via wired or wireless connection, the Control Room Unit can remotely control the Scan Room Unit and initiate and execute injections. However, the Scan Room Unit can operate independently without the use of the Control Room Unit via the Scan Room Unit's graphical user interface (GUI).
The Scan Room Unit is available in two different configurations:
- Pedestal with battery and AC power
- Overhead mount with AC power only
The fluids are delivered from a multi-patient disposable set (Day Set) through a single use patient line (Patient Line). The Day Set is labeled for 24 hours or for a maximum of 25 bottles of contrast agents, whichever comes first. Fluid source spikes (Replacement Spike) are for single container use.
The system is intended to be used in a CT suite. It is intended to be operated by personnel with training and experience in CT procedures and use of CT injection systems. Operators will consist of radiological technologists trained in the use of the equipment. This system is intended for use on the general patient population, including adults and pediatrics.
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(139 days)
The Magic InBra™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.
The Magic InBra™ powered breast pump is intended for a single user.
This breast pump is intended to be used in a home environment.
The Magic InBra wearable breast pump is a single user pump to be used by lactating women to express and collect milk from their breasts in the home environment. Magic InBra is designed to fit most breast shapes and nursing bras allowing hands-free pumping. The pump is intended to be used by a single user for pumping on one breast with one Magic InBra breast pump or on both breasts at the same time with two Magic InBra breast pumps.
An optional smartphone application (app) for iPhone and Android, called "Medela Family Pump Control", connects to the breast pump via Bluetooth and, once connected, allows the user to control the breast pump remotely.
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