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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Rules and Regulations established without any reports of patient or user injury or that the device does not have a significant history of risks associated with inherent characteristics of the device solely based on a non-substantial number of MDR
reports of patient or user injury.
Although there have been no MDRs submitted to the Agency in the past 5
years for powered portable stairclimbing chairs under product code ILK, since September 15, 1998, FDA has received four MDRs related to powered patient transport devices including two involving serious injury to the patient, one of which involved both patient and operator injury.
The petition includes a comparison to other devices, but because these other devices and powered portable stairclimbing chairs differ in technological characteristics and safety profiles, a comparison of the number of MDRs does not provide relevant information regarding the history of risks associated with the inherent characteristics of powered patient transports under 890.5150b, or powered portable stairclimbing chairs more specifically.
The petition also does not consider risks associated with powered wheelchairs, which must also be analyzed given that the FDA-cleared powered portable stair-climbing chairs adhere to wheelchair consensus standards, and the unique stair-climbing functionality of the powered portable stair-climbing chair can entail a higher degree of risk related to stability concern during stair climbing and greater possiblity of human/operator error.
Additionally, analysis of MDRs for purposes of determining risks associated with inherent characteristics of the device should be viewed in light of the intended population and environment for use. As compared to other powered patient-transport devices that are used more regularly, portable stair-climbing chairs are a less common option used to transport patients, used more frequently for emergencies or when a conventional elevator is not an option. In this case, there have only been three powered portable stair-climbing chairs cleared since 1990. Thus, the risks associated with the inherent characteristics of the device, as analyzed through infrequent premarket submissions spanning over the last 30 years, cannot be proved or disapproved with reasonable certainty from the MDR system due to the lack of information about prevalence and frequency of use. Therefore, this device, as compared to the other referenced exempted devices, does not present a lower risk and a premarket review is required to provide reasonable
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assurance of safety and effectivenss for this device type.
B. Characteristics of the Device Necessary for Its Safe and Effective Performance Are Well Established The petition states that characteristics of the devices necessary for their safe and effective performance are well established as demonstrated by adherence to the Quality System Regulation QSR 21 CFR part 820 and FDA-recognized consensus standards.
To illustrate, the petition compares certain features of the subject devices to other referenced devices exempt from premarket notification. FDA does not agree that adherence to the QSR and FDA-recognized consensus standards or that industry familiarity with characteristics of the subject device alone are adequate to provide assurance of safety and effectiveness of the devices or that the features of the referenced devices exempt from premarket notification are relevant to key characteristics of the subject devices.
The consensus standards referenced in the petition apply to devices classified under 890.5150b, and not just the subject device, powered portable stair-climbing chair. Adherence to consensus standards, as applicable to powered portable stair-climbing devices, would not be sufficient to ensure the devices are safe and effective throughout their lifecycle because existing standards do not cover important aspects of design e.g., lift mechanism, maintenance, alteration, and repair. There are certain key design characteristics, including the stairclimbing function, that can differ and would need to be reviewed on a caseby-case basis. Additionally, FDA has only cleared three portable stairclimbing chair devices with a different design of the stair-climbing function among the manufacturers, for instance one uses a climbing foot on each of the rear wheels while another uses a motor and chain driven lifting frame mechanism. Similarly, the other devices used as comparisons have designs that differ significantly from the cleared portable stair-climbing chair devices.
The petition does not provide any information to address how the safety and effectiveness of these devices, despite their design differences, can be assured through adherence to QSR and FDA recognized consensus standards even where industry may be familiar with characteristics of the subject device. Due to the small volume of devices cleared under the subject regulation and lack of an FDArecognized consensus standards covering all the design, maintenance,
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alteration, and repair features of these devices, the characteristics of the devices necessary for their safe and effective performance currently are not well established through existing clearances or comparison to other device types that are currently exempt from premarket notification.
C. Changes in the Device That Could Affect Safety and Effectiveness Will Either Be Readily Detectable by Users by Visual Examination or Other Means Such as Routine Testing, Before Causing Harm or Not Materially Increase the Risk of Injury, Incorrect Diagnosis, or Ineffective Treatment The petition states that changes in the devices that could affect safety and effectiveness will either be readily detectable by users or not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment. This statement is supported by referencing how adequate adherence to control processes under 21 CFR 820.30 and risk management under FDA recognized consensus standard International Organization for Standards ISO 14971
will adequately control safety and effectiveness. The petition also references the general labeling requirements under 21 CFR part 801
and FDA recognized consensus standard ISO 152231 for labeling symbols as effective management of changes in the device that could affect safety and effectiveness detectability for users.
FDA does not agree that changes in these devices that could affect safety and effectiveness will either be readily detectable by users or not materially increase the risk of injury. Based on the powered and portable nature of these devices, and based on the designs of the three devices FDA has cleared in this category, FDA is aware of certain design characteristics that could be changed without being readily detectable by users and could increase risk of injury.
For example, changes that would not necessarily be apparent to an end user could include, but would not be limited to, the devices motor, battery power source, and internal electrical and nonelectrical components. Such changes may not be fully addressed by control processes, risk management, and labeling alone in providing readily apparent detectability for device users, especially for less visible changes. Risks of injury that could be affected by changes to these characteristics include, but are not limited to, inadequate battery performance and safety, electromagnetic incompatibility emissions and immunity and other electrical safety, reduced resistance to ignition of upholstered parts, users
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