The FDA’s Orthopedic & Rehabilitation Devices advisory panel last week recommended that the watchdog agency classify spinal sphere devices into its highest risk Class III category because there is insufficient evidence of their safety and effectiveness when used in intervertebral body fusion procedures.
The panel also recommended that the FDA reclassify stair-climbing wheelchairs and mechanical wheelchairs as Class II devices with special controls. The safety bureau is not bound by its advisory panels’ recommendations, but often follows their suggestions.
Metallic or polymeric spinal sphere devices are inserted between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help promote intervertebral body fusion. They are intended for use with bone graft during arthrodesis and not designed for use in motion-sparing, non-fusion procedures, according to the FDA.
Panelists on the FDA-convened panel of experts, which met Dec. 12 in Gaithersburg, Md., unanimously agreed that spinal sphere devices present an unreasonable risk of illness or injury to the patient when used in fusion procedures. The agency identified several health risks associated with spinal sphere devices, including the need for removal and revision surgery, pain and neurologic impairment, which panelists said are enough to place these devices into the highest risk group.
Spinal sphere devices are currently not classified into any risk group and are reviewed under the less rigorous 510(k) clearance route, because they were commercially distributed prior to May 28, 1976 when the Medical Device Amendments became effective. Reclassification as Class III devices will mean that manufacturers must meet more stringent and expensive clinical trial requirements prior as part of the FDA’s pre-market approval process.
During a 2nd, same-day session, the panel agreed with an FDA proposal to down-classify stair-climbing wheelchairs from the more burdensome Class III to Class II with special controls, meaning they would be subject to less rigorous 510(k) requirements.
Stair-climbing wheelchairs are intended to provide mobility to people restricted to a sitting position and are capable of climbing stairs.
The FDA issued a proposed order earlier this year in response to an October 2012 reclassification request from DEKA Research & Development Corp.
The panel agreed with the FDA that stair-climbing wheelchairs are not life-supporting or life-sustaining and that these devices have proven to show a reasonable assurance of safety and effectiveness.
Panelists generally agreed with the risks to health associated with stair climbing wheelchairs noted by the FDA in June, and said the agency’s proposed special controls could be used to mitigate problems linked to the devices including pressure sores, bruising, user error, falls and associated injuries, but noted the proposed special controls may be too specific because of the potential variations in device designs, environmental conditions and user abilities.
Stair-climbing wheelchairs are Class III devices, but were introduced into commercial distribution prior to the Medical Device Amendments and therefore could get on the market with less strict premarket requirements than Class III devices that came onto the market after the amendments came into play.
Re-classification of chair-climbing wheelchairs into Class II with special controls will ensure that manufacturers of future devices of this type will not need to face an undue regulatory to get their devices on the market.
In the 3rd and final session of the day, the panel said the FDA should bump mechanical wheelchairs from the least burdensome Class I into the higher-risk Class II with special controls.
Mechanical wheelchairs are manually operated devices with wheels intended to provide mobility to persons restricted to a sitting position.
Unlike stair-climbing wheelchairs, the FDA has not yet issued a proposed order for reclassification of mechanical wheelchairs. Mechanical wheelchairs are being considered for both 510(k) notification Class II with special controls and exemption from premarket notification requirements as Class I.
Mechanical wheelchairs are currently regulated as Class I devices subject to 510(k) premarket notification requirements because they were in commercial distribution prior to enactment of the medical device amendments.
Risks associated with mechanical wheelchairs include mechanical failure, falls and associated injuries, pressure sores, bruising, and pinch points, according to the FDA.
The panel said there’s a reasonable assurance of safety and effectiveness for mechanical wheelchairs, that they are not life-supporting or life-sustaining and that special controls are enough to ensure continued reasonable assurance of safety and effectiveness. They suggested that static strength testing and sizing be incorporated as special controls.
The panel expressed concern that if mechanical wheelchairs remain Class I devices, exempt from 510(k) requirements, some of the associated safety concerns would not be addressed. But some panelists noted that smaller manufacturers of simple mechanical wheelchairs could be subject to overly burdensome requirements if the special controls are not carefully worded.
"We recommend reclassifying mechanical wheelchairs to Class II. However, there are some concerns about the maintenance of the 510(k) process and about the institution of amended special controls," chairman Dr. John Kelly of the University of Pennsylvania Sports Medicine in Philadelphia said.