Intended use

In a 510(k), the intended use must be the same as the predicate's, while the indications for use can differ within limits. Wording the intended use carefully is therefore one of the first decisions in a US submission.

use for which a product, process or service is intended according to the specifications, instructions and information provided by the MANUFACTURER [SOURCE: ISO 14971:2007, 2.5]

IEC 82304-1:2016, clause 3.8

use for which a product, process (3.14) or service is intended according to the specifications, instructions and information provided by the manufacturer (3.9) Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the intended use. [SOURCE: ISO/IEC Guide 63:2019, 3.4]

ISO 14971:2019, clause 3.6

• ‘intended use’: The MDR defines ‘intended purpose’, but not ‘intended use’. ‘intended use’ should be considered to have the same meaning as ‘intended purpose’.

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2

For purposes of substantial equivalence, the term “intended use” means the general purpose of the device or its function, and encompasses the indications for use.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology

The general purpose of the device or its function. The intended use of a device encompasses the indications for use.

FDA guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 2014), Appendix D, Glossary of Significant Terminology

MDCG 2020-6 treats 'intended use' as having the same meaning as the MDR's 'intended purpose'. The FDA guidances describe it as the general purpose or function of the device and say it encompasses the indications for use, which keeps the two terms separate for substantial equivalence.