Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes

Recommended Actions

1. Prepare comprehensive device description including dimensions, materials, and components
2. Conduct and document thermal safety testing
3. Perform electrical safety testing if applicable
4. Validate optical performance specifications
5. Prepare detailed software documentation if applicable
6. Validate sterilization and cleaning procedures
7. Develop comprehensive labeling including all required warnings and instructions
8. Obtain biocompatibility data or certification
9. Create comparison documentation with predicate devices
10. Ensure compliance with referenced standards (IEC, ISO)

Key Considerations

Non-clinical testing

• Thermal safety testing showing temperature vs time plots for key locations (max 41°C except tip at 50°C)
• Electrical safety testing for devices with electrosurgical compatibility
• Electromagnetic compatibility testing for electronic components
• Optical performance testing (resolution, distortion)
• Mechanical testing including effects of sterilization

Software

• Software development and QA procedures documentation
• System and software requirements
• Structure chart of functional units
• Verification and validation activities documentation
• Test results summary
• Current version number and remaining bugs list

Labelling

• Detailed indications for use
• Contraindications
• Warnings and precautions
• Instructions for use including cleaning/sterilization
• Compatible equipment identification

Biocompatibility

• Testing results for patient-contacting materials
• Or certification of identical materials used in legally marketed devices

Safety

• Thermal safety requirements
• Electrical safety requirements
• EMC requirements if applicable

Other considerations

• Device description including dimensions and materials
• Sterilization validation and reprocessing instructions
• Optical performance specifications

  Relevant Guidances

• Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
• Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
• Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Content of Premarket Submissions for Device Software Functions
• Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation

Related references and norms

• IEC 601-2-18: Particular requirements for the safety of endoscopic equipment
• IEC 601-1-2: EMC requirements for medical devices
• ISO 10993: Biological evaluation of medical devices
• CISPR 11: EMC emissions standard

---

Original guidance

• Premarket Notification Requirements for Hysteroscopes and Gynecologic Laparoscopes
• HTML / PDF
• Issue date: 1996-03-07
• Last changed date: 2020-03-17
• Status: FINAL
• Official FDA topics: Medical Devices, 510(k), Premarket
• ReguVirta summary file ID: 7df9202091efa226cdcdcec00f68b219