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The SurgiSure™ Tissue Removal System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

The SurgiSure™ Hysteroscopic Tissue Removal System consists of the following procedural components: - SurgiSure™ Tissue Removal Device - SurgiSure™ Control Unit - SurgiSure™ Foot Pedal The SurgiSure™ Control Unit contains an electric motor and firmware motor controller that drives the SurgiSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the SurgiSure Foot Pedal. The SurgiSure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The SurgiSure Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube. The device's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the SurgiSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The SurgiSure Tissue Removal System is compatible with commercially available fluid management systems and may be used with endoscopes that have a straight ≥3 mm working channel.

MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.

The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes. MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.

The MyoSURE™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The MyoSURE Hysteroscopic Tissue Removal System consists of the following procedural components: MyoSURE Control Unit, MyoSURE Tissue Removal Device, MyoSURE Foot Pedal. The MyoSURE Control Unit contains an electric motor and software controller that drives the MyoSURE Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSURE Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSURE Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a sidefacing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSURE Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSURE Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.

The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The MyoSURE™ Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 184 mm long stainless steel tube containing a series of rod lenses and a 3.0 mm working channel. At the distal end of the tube, an "objective" lens captures the image of the "object". The series of "rod" lenses relays the image along the length of the tube. The image is directed by a 45° prism to an offset eyepiece that also contains "rod" lenses which relay the image along the length of the eyepiece tube. At the proximal end of the eyepiece, an "ocular" lens forms the image for the human eye and/or camera. The hysteroscope features a 0° angle of view and an 80° field of view. The MyoSURE™ Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 3 mm working channel and a proximal seal. The 3 mm working channel is dimensionally compatible with the Interlace Medical Hysteroscopic Morcellator (K073690). Additionally, the MyoSURE™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD x 283 mm length outflow channel which may be inserted through the hysteroscope's working channel. The outflow channel includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes. The MyoSURE™ Rod Lens Hysteroscope is autoclavable and will be sold as a non-sterile, reusable device.

Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.

The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The system consists of the following components: Control Unit, Morcellator Handpiece, Single Use Morcellator, Footswitch. The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.