https://www.accessdata.fda.gov/cdrh_docs/reviews/den130034.pdf Course paper instructions:

• The paper shall be a minimum of 15 double-spaced pages with one-inch margins. This does not include the cover page and references/citations.
• The text shall be in 12-point Times Roman font.
• Each page shall be numbered.
• Originality: the paper must be written in your own words. Including paragraphs from other sources (even if properly cited, e.g., with quotes) is not allowed. You are responsible for the originality of your paper. It is advised that you review the Turnitin analysis of your submitted paper.
• References shall be used to support your analysis and conclusions. When you cite sources from the Internet, do not cite only the URL where you found the source. Instead, provide the source's title, the date that you last accessed the source, and the URL. Course Paper Outline: ExoWalk Powered Exoskeleton De Novo Classification Request

I. Device Information

A. Device Name and Description

• Device Name: ExoWalk Powered Exoskeleton
• Description: ExoWalk is a wearable, motorized orthoticdevice designed to assist individuals with spinal cord injuries in achieving ambulatory movement, such as walking. It fits over the user's lower limbs and part of the upper body, employing motors, sensors, and a wireless wrist controller to facilitate movement based on body shifts. ExoWalk is designed to enhance mobility and independence, incorporating safety features like controlled fall assistance to mitigate risks.

B. Intended Use / Indications for Use

• Intended Use: ExoWalk supports ambulatory functions for individuals with spinal cord injuries by assisting those with limited lower-limb mobility.
• Indications for Use:Suitable for patients with certain spinal cord injury levels who can safely operate the device with caregiver assistance and training.

C. Technological Characteristics

• Motorized Control System: Motors at the knee and hip joints are powered by a main batter, with a backup battery for additional support.
• Wireless Wrist Controller: Enables users to select between operational modes, including standing, walking, and sitting.
• Integrated Safety Mechanisms: Features include a controlled fall system, manual override, and a "graceful collapse" mode that assist users in case of power loss.

II. De Novo Classification Request

A. Risk Analysis

• Objective: To validate the ExoWalk as a Class II device by assessing and mitigating potential safety risks.
• Risk Mitigation Measures:
  • Stability and Fall Prevention: Performance testing to confirm theefficacy of fall prevention features across varied conditions.
  • Skin and Tissue Safety: Biocompatibility measures and ergonomic design to reduce risks of skin irritation or bruising.
  • Electrical and Battery Precautions: Testing to prevent power loss, overheating, or other electrical issues.

B. Regulatory Intelligence

• Regulatory Pathway: Proposal for De Novo classification based on the device's low-risk profile and unique functionality.
• Justification for Classification: Demonstrate that ExoWalk meets Class II criteria by detailing its safety features and reduced-risk profile, supporting its classification as a lower-risk device compared to Class III.

III. Labeling Requirements

A. Device and Packaging Labels

• Device Labeling: Include operational details such as model, serial numbers, power needs, and safety instructions.
• Packaging Labeling: Clear packaging instructions on safe usage, warning labels, and manufacturer contact information. Tracking information such as lot or serial numbers for quality control.

B. Instructions for Use (IFU)

• Operational Instructions: Provide steps for proper use, including putting on and removing the device, activating different modes, and operating controls.
• Maintenance and Safety: Recommendations for battery care, charging, and regular device checks to ensure safety and device longevity.

IV. Supporting Information

A. Safety and Effectiveness Documentation

• Non-Clinical Testing:Data on durability, biocompatibility, temperature control, and electrical safety to verify safe device performance under anticipated conditions.
• Clinical Evaluation: Relevant clinical data, if available, to support user outcomes and safety in real-world conditions.

B. Class II Classification Justification

• Safety Controls:Summary of special controls, including user training, device safeguards, and detailed labeling, supporting Class II classification.
• Classification Rationale:Conclude with a summary explaining how ExoWalk's controlled-risk profile, robust safety measures, and lower-risk status justify its Class II classification over Class III.