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ENT Endoscope Sheaths - Requirements for 510k Submissions

This guidance provides detailed information for manufacturers seeking marketing clearance through 510(k) premarket notification for ear, nose, and throat (ENT) endoscope sheaths used as protective barriers. The guidance covers requirements for demonstrating substantial equivalence, safety, and effectiveness of these Class II devices.

  1. Identify appropriate predicate device and document substantial equivalence
  2. Develop comprehensive test plan including:
    • Barrier effectiveness testing
    • Biocompatibility testing
    • Optical quality verification
    • Shelf life validation
  3. Establish quality control program including:
    • Finished device testing protocols
    • Sampling procedures
    • Documentation systems
  4. Prepare detailed labeling including:
    • Clear user instructions
    • Warnings and precautions
    • Reprocessing procedures
  5. Document sterilization validation and shelf life determination
  6. Compile complete 510(k) submission including:
    • Device description
    • Substantial equivalence documentation
    • Test reports
    • Quality system information
    • Proposed labeling
  7. Implement post-market surveillance system to monitor device performance and safety

Key Considerations

Clinical testing

  • Clinical testing may be required if application includes statements regarding prevention of disease transmission
  • Should include microbiological assays of endoscope surfaces or washings of sheath interior after removal

Non-clinical testing

  • Optical quality comparison between sheathed and unsheathed endoscope
  • Barrier testing of finished device using viral challenge
  • Material qualification testing per ASTM F1671-97a standard
  • Testing should consider pressure, time, temperature, organism size and real use situations

Human Factors

  • User instructions must include clear step-by-step description for sheath application and removal
  • Ergonomics should be considered to minimize potential user errors
  • Instructions should be tested for clarity and usability

Labeling

  • Must include caution statement per 21 CFR 801.109(b)(1)
  • Intended use statement with specific indications, clinical settings, target population
  • Clear instructions for aseptic application/removal
  • Maintenance and troubleshooting procedures
  • Contraindications, precautions, warnings
  • Single use/disposable designation
  • Sterility status and expiration date

Biocompatibility

  • Testing required for patient-contacting materials per FDA-modified ISO 10993, Part 1
  • Cytotoxicity, sensitization and irritation testing may be necessary
  • Documentation needed if materials identical to predicate device

Safety

  • Quality assurance and control programs required per QSR (21 CFR 820)
  • Finished device testing for integrity (burst pressure, leaks, etc.)
  • Shelf life determination through accelerated aging testing

Other considerations

  • ASTM F1671-97a: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
  • ISO 10993-1: Biological evaluation of medical devices
  • MIL-STD-105E: Sampling Procedure and Tables for Inspection by Attributes

Original guidance

  • ENT Endoscope Sheaths - Requirements for 510k Submissions
  • HTML / PDF
  • Issue date: 2000-03-11
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 4acc0a9d539b7962eb68a480ba774704
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