How to Select and Analyze a Predicate Device

The success of your entire 510(k) submission hinges on one foundational element: your choice of a predicate device. This legally marketed device serves as the benchmark against which your new device is compared. A poor choice leads to delays, extensive questions from the FDA, and potential rejection.

What Makes a Good Predicate Device?

A suitable predicate is a device that was legally marketed in the U.S. and has the same intended use and similar technological characteristics as your new device. The goal is to prove your device is "at least as safe and effective" as the predicate.

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  Same Intended Use: This is non-negotiable. The Indications for Use statement for your device must be identical or very similar to the predicate's. You cannot claim a new intended use and use it as a predicate.
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  Similar Technological Characteristics: This includes design, materials, energy sources, principles of operation, and performance. Differences are acceptable, but you must prove they don't raise new questions of safety or effectiveness.
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  Legally Marketed: The device must be a Class I or II device that was cleared via a 510(k), was on the market before 1976 (preamendment), or was cleared through the De Novo pathway.

The Predicate Analysis Workflow

Step 1: Searching the FDA 510(k) Database

The FDA's Premarket Notification 510(k) database is your primary tool. You can search by device name, product code, or manufacturer. The goal is to create a list of potential candidates. Look for devices that have been cleared recently, as they reflect the FDA's current thinking.

Step 2: Acquiring Summary Documents

For each potential predicate, acquire the 510(k) Summary or Statement. These documents provide crucial details on the device's intended use and technological characteristics. This is often the first filter to rule out unsuitable candidates.

Step 3: Creating the Comparison Table

Once you have a primary candidate, you must create a detailed, side-by-side comparison table. This is the heart of your analysis. The table should compare, at minimum:

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  Indications for Use
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  Target Population and Anatomy
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  Design and Materials
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  Energy Source and Principles of Operation
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  Performance Specifications (e.g., accuracy, strength)
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  Sterilization and Biocompatibility

Step 4: Justifying the Differences

No two devices are identical. The final, critical step is to analyze the differences identified in your table. For each difference, you must provide a strong scientific rationale and, if necessary, performance data that proves it does not negatively impact safety or effectiveness. This justification is the core of your Substantial Equivalence narrative.

Common Mistakes to Avoid

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  Picking an Old Predicate: Using a device cleared 20 years ago can be a red flag, as standards and technology have changed.
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  Ignoring "Intended Use": Focusing only on technology while having a different intended use is an automatic failure.
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  Insufficient Data for Differences: Simply stating a difference is minor is not enough. You must provide evidence.

Frequently Asked Questions (FAQ)