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The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, The Vest APX System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation. The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

The Vest APX System is a high-frequency chest wall oscillation device designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest APX System consist of a control unit, hoses, and an inflatable garment. Oscillating positive pressure air pulses are applied to the garment by the control unit. The Blower provides the baseline pressure to the system. The user will input the different intensity from 1 -10 on the Graphical User Interface (GUI) and the blower will produce different static pressure based on speed. The air pulse generator (APG) provides the air pulsations (oscillations) based on the frequency input (ranging from 5 to 20 Hertz) provided by user via the GUI. The APG is driven by the Brushless Direct Current (BLDC) motor. The resulting pressure pulses cause the garment to inflate and deflate against the chest of the patient, creating high-frequency chest wall oscillation and mobilization of bronchial secretions. This form of airway clearance therapy is referred to as high-frequency chest wall oscillation (HFCWO).

The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use. The U9000 Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system. C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient's blood volume.

The proposed device AK 98 Hemodialysis system, which is subject for this Traditional 510(k) premarket notification, consists of the following: - AK 98 dialysis machine - U9000 (Ultrafilter) - C-705 (Accessory Expansion chamber) AK 98 is a standalone, software controlled hemodialysis machine intended to be used in a chronic care dialysis or hospital care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload. The Ultrafilter product family (U9000, and its predicate device Diaclear) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The C-705 Accessory Expansion Chamber is a single use sterile medical device for hemodialysis intended to be connected to compatible bloodlines for hemodialysis that allow the channeling of blood from the body through its circuits into another device that carries out the hemodialysis effect of the treatment.

The EASYGRIP FLO-41 Precision MIS Delivery System is indicated for delivering compatible hemostatic agents to bleeding sites through a 5 mm or larger trocar.

The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe. The EASYGRIP FLO-41 System is used to deliver compatible hemostatic agents to bleeding sites. After preparation of compatible hemostatic agent per the instructions, the proposed device is filled by first attaching the compatible hemostatic agent syringe to the syringe port by a Luer lock connection and depressing the syringe plunger, which then fills the enclosed 5 mL reservoir syringe with the hemostatic matrix. The delivery of hemostatic agent to the bleeding site would be performed by actuating the device trigger handle, which can be performed using one hand. As an optional step, if application of the residual hemostatic agent that remains within the cannula is needed, an empty, disposable 1.5 mL syringe is provided and would be filled with non-heparinized saline. Following the same steps as with the hemostatic agent, the reservoir syringe would be filled with 1.5 mL of saline and the residual hemostatic agent would be expelled from the cannula by actuating the device trigger handle.