FORCEGUARD

{0} IMPACT MONITORS INC. K955034 APR 10 1996 1430 Nelson Rd, Ste 218 Longmont, CO 80501 Phone/Fax (303)684-6457 (800) 568-8009 # 510 (k) Summary Submitter: Impact Monitors, Inc. Address: 1430 Nelson Rd, Ste 218 Longmont, CO 80501 Phone/Fax: (303) 684-6457 Contact person: Susan Julio Date prepared: 10/13/95 Device Name Trade name: ForceGuard Common name: Overload alarm, Limb load monitor Classification: Alarm, Overload, External Limb, Powered Substantially Equivalent to: Force Guard I K882974 Impact Monitors, Inc. Pelimit K770405 Synthes (USA) K792241 Colmed Ltd. Intended Use ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value. ForceGuard will be used on patients who have bone, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb. {1} 510 (k) Summary ## Device Description ForceGuard Model 2090 consists of 3 components; electronics module, footpad, and leg band. The leg band is worn around the patient's ankle. The electronics module attaches to the leg band. The footpad, a flexible, fluid filled chamber, plugs into the electronics module and is worn under the plantar surface of the patient's foot inside suitable footwear. The function of the leg band is to secure the electronics module to the patient's ankle. The function of the footpad is to sense the weight being placed through the patient's lower extremity. The electronics module functions as the user interface, processes information from the footpad and alarms when the weight on the footpad exceeds the selected weight. ## Technological Modifications For purposes of demonstrating substantial equivalence we are comparing the new device, ForceGuard Model 2090, to two predicate Class II devices: Force Guard I and Pelimit Overload Warning Device. The following chart summarizes the similarities and differences: | Model 2090 Compared to Force Guard I Pelimit | | | | --- | --- | --- | | Technological Characteristics | | | | Design | similar | similar | | Energy Source | same | same | | Materials | similar | unknown | | Control Mechanism | different | different | | Weight Range | similar | similar | The new ForceGuard device design incorporates much of the prior design features with some modifications. The most significant change is the use of a microprocessor control that replaces portions of the analog circuitry. The microprocessor allows for continuous self-testing of the device. The electronics module has become a non sterile, multi-patient component with the addition of interchangeable, single patient use footpads. 10 - 2 {2} 510 (k) Summary The following chart summarizes the performance characteristics comparison. | Performance Characteristics | Model 2090 ForceGuard | Predicate Device Force Guard I | | --- | --- | --- | | Weight Selections | 20, 30, 50, 70, 90 | 20, 30, 50, 70 | | Durability | | | | Controller | 1 yr warranty | 90 day warranty | | Footpad | 90 day warranty | 90 day warranty | | Energy Source | replaceable | not replaceable | | Accuracy | +/- 5 lbs or up to 10% | +/- 5 lbs | | Safety | | | | Low battery alarm | audio | audio | | Malfunction alarms | audio and visual | audio | | Materials | common | common | There are now both a visual and audio cue to indicate any device malfunction. The ability of the device to self calibrate while using interchangeable footpads increases the accuracy and effectiveness. ## Conclusion We have concluded that the new device, ForceGuard Model 2090 is substantially equivalent to the Force Guard I predicate device. This determination is based on the fact that the only design change that could affect safety and effectiveness is the addition of a micro controller. The modifications made to the predicate device have served to improve both the safety and effectiveness of the new ForceGuard Model 2090 device. 10 - 3