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The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.

The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contains a suction pump, electronics, and flexible cables to actuate the disposable microkeratome. The basic system sold consists of the control unit, 20 disposable microkeratomes (sold sterile), 5 practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.

The FLAPMAKER™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes the blade made from surgical-grade steel. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation.

The microkeratome is based upon the principle of the carpenter's plane. The blade, made from surgical stainless steel, oscillates at 12,500 rpm and is controlled by a unique patented flexible cable that is electronically driven. The blade extends a fixed distance from a transparent fixed plate and is at a 26° angle to the plate. Microkeratomes that create resection depths of 130 or 160 microns and resection diameters of 8.5mm and 10.5 mm are available. The microkeratome is mounted in a suction plate and is driven across the suction plate and protruding cornea at 6.8 mm/sec. by a patented flexible cable that is electrically actuated. The plastic suction ring, which supports the unit on the cornea, is made from biocompatible polycarbonate plastic.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by mechanical transmission cables. The motors are UL approved. The central unit also supplies the suction. One cable transmits the motion to cause the blade to oscillate, and the other drives the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the connections to the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

The provided document for the Hawken Industries FlapMaker microkeratome does not contain acceptance criteria or study data demonstrating device performance in a clinical context.

Instead, the submission relies on a claim of substantial equivalence to predicate devices, stating:

"This device is identical to the predicate devices, except that the motors have been moved to a central unit and the energy is transmitted by cables. Since there is no change in technology or principles, a clinical test is not required."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the given text.

The document focuses on:

• Device Description: Explaining the components and mechanism of the FlapMaker.
• Intended Use: Specifying its purpose (anterior lamellar corneal resections).
• Non-Clinical Tests: Mentioning electrical safety tests, biocompatibility of materials, and UL approval for motors.
• Claim of Equivalence: Arguing that clinical testing is unnecessary due to perceived technological similarity to existing devices.
• FDA Correspondence: The FDA's letter confirming substantial equivalence based on the provided information, not on new clinical performance data.

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