Content and Format Requirements for Medical Laser 510k Submissions
This guidance document provides recommendations for the content and organization of premarket notifications (510(k)s) for medical lasers. It aims to assist both FDA reviewers and manufacturers in the preparation and review of 510(k) submissions for medical laser devices.
What You Need to Know? 👇
What are the key differences between “Intended Use” and “Indications for Use” in medical laser 510(k) submissions?
Intended Use refers to the general functional use of the device (the principal effect of radiation/tissue interaction), while Indications for Use refers to specific surgical, therapeutic, or diagnostic uses for particular diseases, conditions, or pathologies the device prevents, treats, cures, mitigates, or diagnoses.
When is an IDE (Investigational Device Exemption) required for clinical investigations of medical lasers?
An IDE is required for new surgical lasers being clinically investigated and for legally marketed surgical lasers being investigated for new indications for use. However, investigations within previously cleared intended use or indications for use are exempt from IDE requirements under 21 CFR 812.2.
What performance standards must all medical lasers meet for FDA clearance?
All medical lasers must meet the performance standard for light emitting products specified in 21 CFR 1040.10 and 1040.11. Additionally, they must comply with labeling requirements under 21 CFR 801 and demonstrate substantial equivalence to legally marketed predicate devices through appropriate performance data.
What types of performance data are typically required to demonstrate substantial equivalence for medical lasers?
Performance data may include bench testing of laser systems, in vitro tissue effects evaluation, in vivo animal studies with histopathology, and clinical data when bench and animal data alone cannot adequately predict comparable safety and effectiveness of the new device or indication.
How should laser accessories and components be labeled in relation to the main laser system?
Accessories should be labeled to direct users to the laser system’s user manual for full clinical use information. Accessory labeling must not add to or modify the main system’s clinical indications, contraindications, warnings, or precautions, except for power-related specifications or compatibility information.
What are the key elements required in the professional instructions for use section of medical laser labeling?
The instructions must include device description, general biological and physical characteristics, indications for use, contraindications, warnings, precautions, adverse effects, directions for use, and bibliography. The level of detail should match the complexity of the laser system and provide adequate safety information.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including specifications and materials
- Identify appropriate predicate device(s) and conduct detailed comparison
- Generate necessary performance data through bench, in vitro, in vivo, and clinical testing as required
- Develop complete labeling package following format guidance:
- Clear intended use/indications statements
- Comprehensive instructions for use
- All required safety information
- Validate software if device is software-controlled
- Document sterilization validation for sterile components
- Prepare 510(k) Summary or Statement
- Organize submission following recommended format with all required sections
- Review submission against guidance requirements before submitting to FDA
- Maintain complete documentation to support submission claims
Key Considerations
Clinical testing
- Clinical data necessary when bench and animal testing alone cannot adequately predict safety and effectiveness
- Clinical data must demonstrate that the laser and accessories:
- Allow surgeon to reach intended site
- Operate in controlled manner
- Achieve intended surgical effect and patient outcome safely and effectively
- Study design and parameters vary based on clinical questions to be answered
Non-clinical testing
- Bench testing required to validate specifications and compare operating characteristics
- In vitro testing including cell culture and tissue effects evaluation
- In vivo animal testing including histopathology comparing effects between proposed and predicate devices
Software
- Software validation information required if device is software controlled
- Must follow FDA Reviewer Guidance for Software Evaluation
Labeling
- Must meet 21 CFR 801 and 21 CFR 1040.10/1040.11 requirements
- Must include:
- Device labels and packaging
- User manual with installation, use instructions, maintenance procedures
- Promotional materials
- Clear statement of intended use and indications
- Warnings, precautions, contraindications
- Directions for use
- Bibliography supporting labeling claims
Biocompatibility
- Complete listing of all materials that may contact patient required
- For sterile components, must provide sterilization validation information
Safety
- Must meet performance standard for light emitting products (21 CFR 1040.10 & 1040.11)
- Safety warnings and precautions required in labeling
- Adverse effects must be listed and described
Other considerations
- Detailed device description required
- Side-by-side comparison to legally marketed predicate device
- Performance data requirements when descriptive comparisons insufficient
- Information on all accessories and components
- 510(k) Summary or Statement required
Relevant Guidances đź”—
- Content and Format Requirements for Medical Laser 510k Submissions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms đź“‚
- 21 CFR 1040.10 & 1040.11: Performance Standard for Light-Emitting Products
- 21 CFR 801: Labeling
- 21 CFR 812: Investigational Device Exemptions