FDA Guidance on Air Powered Dental Handpieces and Motors: Performance Criteria

Table of content

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to air-powered dental handpieces and air motors. In particular, the document describes performance criteria for Safety and Performance Based Pathway. 

The document also provides additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the relevant regulatory requirements. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor they are intended to introduce new rules or impose new obligations. 

Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance.

Testing Performance Criteria

The relevant section of the document outlines the recommended performance criteria and associated testing methodologies for dental handpieces and air motors submitted under the Safety and Performance-Based Pathway. Devices meeting these criteria do not require direct comparison testing against a predicate device to establish substantial equivalence. 

In particular, submitters should provide a summary of test results, including protocols and full reports when necessary, consistent with the relevant FDA guidance on non-clinical bench testing and the use of voluntary consensus standards. For all submissions, the FDA may request underlying data to verify compliance with identified performance criteria. 

The following key testing categories and their associated requirements are summarized:

Mechanical Bench Testing

Submitters should provide a Test Report Form and a Declaration of Conformity (DOC) to the FDA-recognized version of ISO 14457 for all tests in this category. Key tests include:

1. Drop Test: Devices should comply with the ISO 14457 standard for hand-held equipment durability.
2. Noise Level: Devices must not exceed an 80 dB A-weighted sound pressure value.
3. Surface Characteristics: Devices should meet ISO 14457 standards for surface quality.
4. Air-Powered Functionality: Devices must operate with a compressed air supply within specified pressure and flow parameters.

Specific Functional Tests

1. Water Supply (if applicable): Handpieces must provide a minimum coolant flow rate of 50 mL/min at specified pressures.
2. Handpiece Cooling Air: Motors with air-cooling systems must achieve airflow rates within the prescribed range.
3. Spray Air Supply: Handpieces with spray functionality must produce a cooling mist or achieve defined airflow rates.
4. Air and Water Pressure: Devices must withstand 50% above the recommended maximum operating pressure without rupturing.

Additional Design and Usability Tests

1. Operating Controls: Controls should minimize accidental activation and allow specified speed adjustments and directional control.
2. Usability: Devices must adhere to IEC 62366-1 for usability engineering.
3. Connection Mechanisms: Handpieces and motors must connect and disconnect without specialized tools.

Performance and Durability Criteria

1. Reprocessing Validation: Devices should withstand 250 sterilization cycles without degradation, unless a lower maximum is justified.
2. Leakage and Water Ingress: Devices must meet ISO 14457 standards for resistance to spillage and leakage.
3. Metallic Chuck Systems: As specified in ISO standards, Chuck systems must securely hold and transmit torque to rotary instruments.
4. Dimensions and Speed: Devices must meet tolerances for speed and structural dimensions as outlined in ISO 14457.
5. Eccentricity and Stall Torque: Devices must maintain dynamic stability and generate sufficient torque under load.

Biocompatibility Evaluation

Biocompatibility assessments should follow ISO 10993-1 and ISO 7405 standards for biological safety. 

Devices must be evaluated for:

1. Cytotoxicity: Evaluation of material compatibility with cells.
2. Sensitization: Assessment of potential to induce allergic reactions.
3. Oral Mucosal Irritation: Testing for adverse effects on mucosal tissues.

The authority also mentions that, where applicable, test results must demonstrate an acceptable biological response. The rationale may be provided instead of testing if the device is made from identical materials and processes as a predicate device with no significant design changes.

Reprocessing and Sterilization

Devices must be validated for cleanliness and sterility in accordance with FDA guidance and standards, such as:

• ISO 17664-1 and -2: Processing information for critical and non-critical devices.
• AAMI/ANSI ST 79 and ST 98: Sterilization and cleaning validation protocols.

Reprocessing instructions should include validated cleaning agents and detailed procedures.

Submission Requirements

According to the guidance, for all tests, submitters should include:

1. A Test Report Form per ISO 14457.
2. A Declaration of Conformity (DOC).
3. Full test reports or protocols as required by the FDA.

Conclusion

In summary, the guidance organizes the comprehensive performance testing criteria outlined by the FDA, providing a clear roadmap for manufacturers to demonstrate compliance through the Safety and Performance-Based Pathway.

Source

https://www.fda.gov/media/182279/download

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