(160 days)
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No
The description focuses on sensing weight and triggering an alarm based on a pre-selected value, which is a simple threshold-based system, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.
No.
The device functions as a monitor and alert system to help patients adhere to weight-bearing restrictions, rather than directly treating or curing a medical condition.
No
The device is designed to monitor and alert the user when a pre-selected weight limit is exceeded on the foot, which is a therapeutic rather than a diagnostic function. It does not provide information about the presence, absence, or nature of a disease or condition.
No
The device description explicitly lists three hardware components: footpad, electronics module, and leg band.
Based on the provided information, the ForceGuard device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The ForceGuard device directly interacts with the patient's foot to sense weight, not to analyze biological samples like blood, urine, or tissue.
- The intended use is to monitor and alert based on physical pressure. The device measures the mechanical force applied to the foot, which is a physical parameter, not a biological or chemical one.
- The device description focuses on mechanical and electronic components. The components described (footpad, electronics module, leg band) are designed for physical sensing and processing, not for handling or analyzing biological specimens.
Therefore, the ForceGuard device falls under the category of a medical device that provides a physical measurement and alert, rather than an IVD.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
ForceGuard Model 2090 consists of 3 components; footpad, electronics module, 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
plantar surface of the foot, lower limb, ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
wearer and/or therapist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5575 Powered external limb overload warning device.
(a)
Identification. A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
IMPACT
MONITORS INC.
APR 1 0 1996
11 955034
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
Device Description
electronics module, ForceGuard Model 2090 consists of 3 components; 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.
| 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 following chart summarizes the similarities and differences:
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.
2
510 (k) Summary
| Model 2090 | Predicate Device | |
|---|---|---|
| Performance Characteristics | ForceGuard | 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 |
The following chart summarizes the performance characteristics comparison.
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.