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The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

The Spinal Lumbar Puncture Manometer with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The manometer is considered a Class II medical device as defined in 21 CFR §880.2500, product code FMJ. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/ medical device manufacturers. Materials: PVC, Polycarbonate, HDPE. No patient contact.

The device is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

The Spinal Manometer is used as part of a lumbar puncture procedure in which cerebrospinal fluid is extracted for examination, and pressure of the spinal fluid is measured. The cerebrospinal fluid is generally used to diagnose if there are problems with the central nervous system or spinal cord. The procedure requires insertion of a spinal needle into the lumbar section of the spinal manometer is attached to the hub of the needle with a three-way stopcock. An extension tube may be used to reduce movement of the spinal needle and patient discomfort. The extension tube attaches to the spinal needle hub and the stopcock. The Cerebrospinal Fluid (CSF) pressure is measured while the needle is connected to the Spinal Manometer directly or through an extension tube. The normal range for CSF pressure is 80mm-180mm (8cm) H2O. CSF pressure over 200mm (20cm) H2O is considered high and pressure less than 80mm (8cm) H2O is low. The Spinal Manometer does not directly contact the patient nor does it contact body fluids intended to be re-introduced into the human body. The Spinal Manometer is composed of polyethylene and the luer lock and connector is composed of polycarbonate. The Spinal Manometer is a two-piece Spinal Manometer. The additional Spinal Manometer length is available if required. The two-pieces are connected using a polycarbonate connector. The Spinal Manometer is packaged as part of a convenience kit for lumbar puncture. The Spinal Manometer is placed in a rigid tray composed of high impact plastic (poly styrene). The tray is wrapped and packaged in a soft pouch with Tyvek lid. The pouch is heat-sealed. The convenience kit includes a variety of devices used in the lumbar puncture procedure including 20 gauge spinal needle with stylet, syringe with needle, 22 gauge needle, spinal manometer, 5" extension tube, three-way stopcock, three sponge sticks, three gauze pads, four vials with screw caps, fenestrated drape, towel, Lidocaine Hydrochloride, CSR wrap, and bandage.

The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Lumbar Puncture Kit. The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks. The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure intracranial pressure which can result from infection, tumor, hemorthage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

The SIMS Lumbar Puncture (LP) Kit is available in adult or pediatric configurations. The kit includes the preparatory and procedural components to perform Lumbar Puncture. A manometer may be included with the kit, depending upon the kit selected. The SIMS LP Kits with a manometer are used to measure cerebrospinal fluid pressure in centimeters of water (cm of H2O). The manometer consists of two calibrated sections of tubing with a connector welded to the upper portion of the tubing. Lumbar puncture is performed with standard prep and procedural componentry, similar to those used in spinal anesthesia kits, with the addition of a two part manometer, a 3-way stopcock and 5 inches of small bore extension tubing for the measurement of intracranial CSF pressure.