CAPSTONE 2

TEAM 2
FDA Homework
March 30, 2015
1. Determine what class your medical device is and describe why?
Ans: Our device is a 3DOF Admittance Control Robotic arm for facilitated training of
the hemiparesis /hemiperatic Hand. According to FDA its is a class II device. A Class II
devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing
methods are available to provide such assurances. In addition to complying with general controls, Class II devices
are also subject to special controls[1]. Our device is a class 2 Device because similar devices like our devise already
exist in the market and are used by the patients for rehabilitation and by the researchers in their study. Example of
such devices: Phantom Omni, haptic master
The device is a exoskeleton that allows the user to enable ambulation over the course of the day. The regulation
Medical Specialty of our device is the Physical Medicine. The review panel is the neurology and it would require a
510K submission.

2. Describe the step(s) you need to get your device approved by the FDA
a. Is your device identical to another existing device?
Yes
b. If so, what is the device?
The devices that our device is similar to are the Haptic Master and
Phantom Omni.
c. If so, is the device equivalent to another device?
Yes
d. If so, what about it makes it equivalent?
Our device has a similar design and workspace as that of the Phantom
Omni. Our device as well as the Haptic master are both controlled using
Admittance control Paradigm. Both this devices serve the purpose of
upper extremities rehabilitation. Same is the purpose of our device.
e. What process do you have to follow to get the approval?
Our device is a class II device. Our device also has equivalent devices
already existing in the market. For the FDA approval, we will have to
submit a 510K. A 510K is required when the device demonstrates a
substantial equivalence to another device legally marketed in the US. Our
robotic arm has the same intended use and technological characteristics
and the intended use as that of the Phantom Omni and haptic master.

3. Determine if there were any recalls associated with the devices similar to yours
a. If so, does your design address these issues?

b. if not, find a device similar to yours which has had recalls and address
question 3.a
Neither Phantom Omni nor the Haptic master have been ever recalled.
We could not find any product that are close enough to our product that were
ever recalled.

Though we found a couple of devices which had the intend of rehabilitation

and were recalled.
One of them is
Device
IF 8000; 1/F Interferential Electrical
Stimulation Device; NMES
(neuromuscular electrical stimulation)
mode.

Class
II

Recall Date
June 2, 2014

"Device Classes." Device Classes. N.p., n.d. Web. 30 Mar. 2015.