Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers

What You Need to Know? 👇

What are the key differences between Track 1 and Track 3 ultrasound device submissions?

Track 1 is for devices that don’t follow the Output Display Standard (IEC 60601-2-37) and uses application-specific acoustic output comparisons to preamendments levels. Track 3 is for devices conforming to the Output Display Standard with real-time thermal and mechanical index displays, eliminating application-specific comparisons.

When can manufacturers modify ultrasound devices without submitting a new 510(k)?

FDA won’t enforce 510(k) requirements for modifications when ten specific conditions are met, including: unchanged intended use, well-established modes of operation, acoustic outputs within recommended limits, ultrasound parameters within specified ranges, and proper transducer element checks and temperature controls.

What are the maximum acoustic output levels for different ultrasound applications?

Preamendments levels vary by application: Peripheral Vessel (720 mW/cm² ISPTA.3), Cardiac (430 mW/cm²), Fetal Imaging & Other (94 mW/cm²), and Ophthalmic (17 mW/cm²). All applications have maximum MI of 1.9 except ophthalmic (0.23).

What biocompatibility testing is required for ultrasound transducers?

Patient-contact materials must undergo biocompatibility evaluation per ISO 10993-1 and FDA guidance. Previously cleared materials with identical formulation and processing don’t require new testing. The evaluation should match the type and duration of patient contact.

How should ultrasound transducers be reprocessed between patient uses?

Reprocessing depends on application: non-critical devices need cleaning and low-level disinfection; semi-critical devices require sterilization or high-level disinfection; critical devices must be sterilized. Sterile sheaths are recommended for semi-critical and critical applications but don’t eliminate reprocessing requirements.

What software documentation is needed for ultrasound device submissions?

Software documentation level depends on the device’s Level of Concern (LOC). Include cybersecurity information when appropriate, off-the-shelf software details, algorithm descriptions, and validation records. Changes must be validated with risk analysis per 21 CFR 820.30(g) and documented in Design History Files.

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What You Need to Do 👇

Recommended Actions

1. Determine appropriate regulatory track (Track 1 or 3) based on device features
2. Implement and validate:
   • Acoustic output measurements and controls
   • Safety features and alarms
   • Cleaning/disinfection procedures
   • Software verification and validation
   • Quality control procedures
3. Prepare documentation:
   • Complete device description
   • Test reports and validation data
   • Risk analysis
   • Labeling and user materials
   • Software documentation
4. Develop:
   • User training materials
   • Quality control procedures
   • Service procedures
   • Record keeping systems
5. Establish ongoing:
   • Production testing protocols
   • Statistical quality control
   • Complaint handling procedures
   • Post-market surveillance
6. Submit:
   • 510(k) with complete documentation
   • Responses to any FDA questions
   • Updates for significant changes

Key Considerations

Non-clinical testing

• Acoustic output measurements and validation
• Measurement of mechanical and thermal indices
• Statistical analysis of measurement data
• Validation of cleaning, disinfection and sterilization procedures
• Electrical safety testing according to standards

Human Factors

• Implementation of user interface features for acoustic output display and control
• ALARA education program for clinical end-users
• Clear instructions for use and warnings in labeling

Software

• Software documentation based on Level of Concern
• Validation of software changes
• Cybersecurity considerations for networked devices
• Documentation for off-the-shelf software

Cybersecurity

• Information on cybersecurity aspects for networked devices
• Compliance with FDA cybersecurity guidance
• Special considerations for devices with off-the-shelf software

Labeling

• Indications for use statement
• Warnings and precautions
• Acoustic output information
• Cleaning/disinfection instructions
• Clinical applications and limitations
• User manual with complete operating instructions

Biocompatibility

• Evaluation of patient-contacting materials
• Documentation of material composition
• Testing according to ISO 10993-1
• Validation data for reprocessed devices

Safety

• Electrical safety testing to IEC 60601-1
• Electromagnetic compatibility testing
• Temperature limits for invasive probes
• Protection against excessive acoustic output
• Transducer element integrity checks

Other considerations

• Quality control procedures
• Statistical sampling plans
• Record keeping requirements
• Reprocessing validation for reusable devices
• Special requirements for remanufactured devices

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Relevant Guidances 🔗

• Content of Premarket Submissions for Device Software Functions
• Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements

Related references and norms 📂

• IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2: Medical electrical equipment - Part 1-2: EMC requirements and tests
• IEC 60601-2-37: Medical electrical equipment - Part 2-37: Requirements for ultrasonic medical diagnostic equipment
• IEC 62359: Ultrasonics - Field characterization - Test methods for thermal and mechanical indices
• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing

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Original guidance

• Marketing Clearance Requirements for Diagnostic Ultrasound Systems and Transducers
• HTML / PDF
• Issue date: 2023-02-21
• Last changed date: 2023-02-21
• Status: FINAL
• Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Premarket, Radiological Health, Radiology
• ReguVirta ID: b5c681772f229950f1618872a8044655