Search Results

HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver. The device is for prescription use, to be used by physicians in hospitals and clinics.

Both the HS NOTA and the predicate device consist of a 304 stainless steel cannula and stylet. In both the devices the cannula and stylet inner handles are moved by springs that must be loaded, toward a charging lever positioned on the external housing of the needle, before firing the needle. Both PRECISA and HS NOTA are single patient use, disposable, sterile and non-pyroqenic products. The external plastic handle of HS NOTA has a different shape relative to the predicate device. This difference does not affect the performance or safety of the device as it does not affect the advancement and penetration of the needle inside the tissues, yet it just implies a different way for the user to handle the device. The charging lever for PRECISA needle is straight, it means operator must pull-it for charging, while the NOTA one is designed to be rotated for loading the springs. This difference is a consequence of the specific external plastic handles of HS NOTA relative to the predicate device and does not impact in safety and effectiveness of the needles. HS NOTA needle performs a biopsy of 2.5 cm of length inside the soft tissue. PRECISA needle can be adjusted to advance 1 cm or 2 cm of length. When considering PRECISA needle in 2 cm advancing configuration there is a total equivalence between the two devices. Indeed the additional run of 0.5 cm characterizing HS NOTA, is only due to the different inner mechanism of the HS NOTA compared to PRECISA and it does not affect safety and effectiveness: final outcomes in terms of quality and length of the bioptic samples depend on the notch realized on the stylet (shape of stylet tip) which is exactly the same for both HS NOTA and PRECISA. The sample notch size is 20 mm. So maximum length for core collected is 20 mm. The shape of cannula and stylet tips are exactly the same for HS NOTA and PRECISA. It means that the HS NOTA and PRECISA are substantially equivalent as capacity to cut the soft tissue. The Spring used inside the two devices are exactly the same, it means that the force moving the cannula and stylet of both the needle is exactly the same. Needles diameter characterizing both HS NOTA and PRECISA are 14G, 16G, 18G, and 20G. Furthermore both the devices are provided with needles characterizing by a length within the range 7 cm-25 cm. HS NOTA is provided with a safety element that is automatically activated as the spring has been loaded. The safety feature must be removed by the physician to fire the device. This mechanism allows to avoid accidental firing of the needle. The predicate device has been manufactured with an identical safety element. Inner mechanism: The inner mechanism for an automatic biopsy device is responsible for the automatic movements of both stylet and cannula composing the needle. The inner mechanism of HS NOTA is composed by: 1. 2 plastic handles, each plastic handle is attached to stylet and cannula distal part, both these handles slide inside the external plastic housing of the product, each plastic handle is provided with hooking means capable to retain the handle in charged position once the spring has been charged 2. Inner spring that must charged, they are responsible for the automatic advancing of the inner plastic handles. 3. A firing lever which is capable to pull back the inner plastic handles (loading the sprinq) during the charging phase and which is capable to act on the hooking means (which are part of the inner plastic handles) realising them and making possible the inner handles advancing. PRECISA inner mechanism is composed by the same functional elements. During the functioning of the product no mechanical damages on these parts must occur. Materials: The only part of HS NOTA coming in contact with the patient is represented by the cannula and stylet that are made of biocompatible AISI 304 material, identically to the predicate device. The external part of the device representing the plastic handle is made of nylon while PRECISA's plastic handle is made of ABS. This difference does not affect effectiveness and safety of the device since both nylon and ABS have equivalent characteristics: they are thermoplastic materials allowing the needle to move properly and providing adequate resistance to the force exerted by the spring on the device.

This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.

This device is an automated, disposable biopsy needle

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

Not Found

This device is intended to be used for taking biopsy sample, must be used on soft tissues and I has device is intended to be about to taming copies to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung , Bladder, Thyroid, Abdomen and Pancrease

SecurcutTM Aspiration Biopsy Needle