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The device is used for drawing osteomedullary substance and/or for bone marrow explantation.

Trap Easy is a bone marrow biopsy needle, consisting of a cannula with cylindrical tip and ergonomic handle, a removable pyramidal stylet, a sample trapping device integrated into the cannula and an extraction wire. The device is used for drawing osteomedullary substance and/or for bone marrow explantation. This device is intended to be used only by experienced and properly trained physicians and is intended to be used exclusively for bone marrow tissue biopsies. The device is available in different models: - 8G x 100 mm - 8G x 150 mm - 11G x 100 mm - 11G x 150 mm Trap Easy is supplied in sterile packaging and is designed for single use, non-reusable. At the end of its use, the device should be disposed of as infectious hospital waste.

Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

The devices subject of this submission, generator AGN-H-1.3, generator AGN-3.3 and AMICA-PROBE 17G & 18G applicators, belong to the HS AMICA devices family and they represent an evolution and implementation of previous models, already authorized by FDA under K182605. The working configuration of the HS AMICA commercial system consists of: - . A programmable generator for the generation and control of the energy required for the thermoablative treatment; - . Disposable applied parts (or applicators) for the direct release of energy into the patients or for temperature measurements inside the patient's body. The result is an integrated system for thermoablation of tissues through controlled emission of nonionizing electromagnetic radiations in the microwave and radiofrequency ranges. The generators and its accessories are able to emit only microwaves (MW, 2450 MHz), or only radiofrequency waves (RF, 450 kHz) or either microwaves or radiofrequency waves (not simultaneously). The new electrosurgical devices introduced by H.S. Hospital Service S.p.A. are the AMICA-GEN models named AGN-H-1.3 and AGN-3.3, along with 17G and 18G AMICA-PROBE disposable applicators.

Coagulation (thermo-ablation) of soft tissue. Not for use in cardiac procedures.

HS AMICA devices family is a fully featured soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures. AMICA-GEN is available in the following different models: AMICA-GEN AGN (Microwave generator only), AMICA-GEN AGN-R (Radiofrequency generator only), and AMICA-GEN AGN-H (Hybrid Microwave and Radiofrequency generator). The MW and RF outputs can never be activated simultaneously. The actual energy source in use depends on the applied part type, RF or MW, connected to the generator. There are several available variants of PROBE (i.e. the applied parts for direct energy delivery into the patient's body for percutaneous or intra-operative use): AMICA-PROBE (disposable device for MW energy delivery) and RF AMICA-PROBE (monopolar, straight, stainless steel electrode for RF energy delivery). HS AMICA devices family consists of non-sterile reusable electronic parts, and sterile disposable applied parts. The sterilization method used for all the sterile components is Ethylene Oxide. The microwave devices can be operated in continuous and PULSE mode. The PULSE mode is new operational mode with a duty cycle of 40% and a max output power of 190 Watts.

Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

HS AMICA devices family is an integrated system for thermoablation of tissues through controlled emission of non-ionizing electromagnetic radiations in the microwave and radiofrequency ranges. Especially the HS AMICA family consists of 3 devices and relative accessories emitting: 1. Only microwaves (MW) or 2. Only radiofrequency waves (RF) or 3. Either microwaves or radiofrequency waves (not simultaneously). The three devices emit the specific wavelength through their applicators (probes) that are inserted into the human body and deliver electromagnetic energy through their emitting tip, causing the thermoablation. Briefly, the HS AMICA devices family consists of two main components: 1) the generator; 2} the applicator (probe). The generator of the electromagnetic energy is available in the following variants, depending on the specific electromagnetic emission: 1. AMICA GEN AGN-H. This variant is characterized by both the MW and RF modules that must be selected by the physician. When the MW function is selected, the RF emission is disabled and viceversa and thus the modules operate in mutually exclusive fashion 2. AMICA GEN AGN. This variant has only the MW module. 3. AMICA GEN AGN-R This variant has only the RF module. In all cases, the AMICA GEN is provided with an electronic control unit (EC), for data exchange with the patient applied parts, the interpretation of user's commands through front panel controls or external peripherals (such as the footswitch for remote energy start/stop), the continuous update of the machine indicators, and the control of the energy generation modules MW and/or RF. The applicator (probe) is disposable and consists of the following variants, to be used for the MW or RF thermoablation: 1. AMICA PROBE. This variant is a microwave coaxial antenna of asymmetric dipole type allowing the emission of the MW energy 2. RF AMICA-PROBE. This variant is used for radiofrequency energy delivery through monopolar interstitial electrode.