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The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.

The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal. The eG1 Wireless Hand Control System consists of two articles: 1) The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece. 2) The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console. The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.

Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.

The Anspach Helix™ Dissection Tools (otherwise known as burs) are part of a drill system that consists of a control console, a handpiece (motor), a control switch and various attachments and accessories. The Anspach Helix™ Dissection Tools are onepiece metal bone cutting and shaping devices that attach to the handpiece/attachment of a pneumatic or electric powered drilling system. The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism. The Anspach Helix™ Dissection Tools are provided sterile.

When used with the ANSPACH Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

The OCM-G1 (Otologic Curved Micro) Attachment is an accessory to the G1 electric drill system. It is a one-piece straight attachment that is manufactured from 17-4PH and 303 stainless steels (ASTM A564 and ASTM A582). The OCM-G1 Attachment can be connected and disconnected to the distal end of the handpiece via a locking mechanism by the user. After the OCM-G1 Attachment is secured to the handpiece, it will accept and hold an OCM curved burr support sleeve assembly (previously cleared). The OCM curved burr support sleeve assembly will rotate at a speed selected by the user for cutting and shaping bone, primarily in otology procedures such as cochleostomies. The OCM-G1 Attachment is provided non-sterile and is reusable.

The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.

The Anspach eG1 High Speed System, which consists of a control console, handpiece, and various attachments, is an electrically powered surgical drill that handles a range of surgical procedures ranging from power-demanding applications to delicate dissection.

The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium. When used with the ANSPACH® Systems, the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection. The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert. The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only.

Dissection tools are intended for cutting and shaping bone including spine and cranium.

The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems. The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system. Dissection Tools are sterilized, individually packaged, are for single use and disposable.

The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

The Cranial Perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument used in conjunction with a surgical motor and speed reducer attachment to drill holes through a patient's skull. The Cranial Perforator employs a clutch mechanism to disengage drilling action upon initial penetration of the skull to prevent plunging of the perforator tip into the underlying dura and brain tissues. The device is a Class II (USA) device. The Cranial Perforator is a device similar in design and construction to other devices currently on the market; (e.g.: Acra-Cut model DGR-1; 14/11mm). The Cranial Perforator is a compound drill which requires a motor to provide speed (70 - 80K RPM) and torque. But a speed reducer attachment is necessary to limit motor speed while delivering necessary torque. For this application the recommended motors are the Anspach Black Max. MicroMax and eMax motor systems. For speed reduction, it is recommended only the Anspach Speed Reducer attachments be used. The speed range when used with the listed Anspach equipment is 800 to 1200 RPM.

The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.

The eMax 2 Plus System is an electrically powered drill motor with a series of attachments designed for use on the bones of the cranium and spine. The system components include a control console, the motor hand piece and foot control switch. The control console supplies power to the motor through a detachable cable. This system is non-sterile.

The Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

The iMRI Surgical Drill System is a Class II medical device which includes a pneumatic drill motor and foot control; a variety of nosepiece attachments; and various bone dissection tools (cutters). To make the drill system "MRI useable", ferrous metals comprising each system component have been replaced with materials known to have significantly lower or no discernable magnetic susceptibility. The iMRI Drill System foot control was tested with the Drill System within Zone IV. The iMRI motor does not require continuous oiling and therefore runs at slower speeds (60 - 65k RPM) than noniMRI Anspach motors (80 - 85k RPM). Nosepiece attachments (bearing tubes) support the cutter to minimize vibration , wobble and whipping. iMRI cutters are identical to other Anspach non-iMRI cutters with exception of materials and indications for use.

Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

The Anspach Irrigation Pump System is a stand-alone pump and pump control system, designed to deliver a constant flow of irrigation fluid by means of a peristaltic pump. The Irrigation Tube, (the subject of this submission), is a fluid delivery device that functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range.