FDA Predicate Device

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Summary

FDA predicate device identification is the foundation of your 510(k) submission, establishing substantial equivalence between your device and a legally marketed predicate device with the same intended use and technological characteristics. Your predicate device must be FDA-cleared, share the same product code, and demonstrate similar safety and effectiveness. Proper predicate selection determines your regulatory pathway, required testing, and likelihood of FDA clearance.

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Why is FDA Predicate Device Important?

Predicate device selection is critical for 510(k) success because it establishes the regulatory framework for demonstrating substantial equivalence. The FDA evaluates your device against your chosen predicate, not against absolute safety standards. A well-chosen predicate with similar intended use, technology, and performance characteristics streamlines your submission and reduces testing requirements. Poor predicate selection can result in additional testing requests, clinical study requirements, or outright rejection of your 510(k) submission. Your predicate also influences your labeling, indications for use, and post-market obligations.

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Regulatory Context

Under 21 CFR 807.87 and 21 CFR 807.92:

• Predicate device must be legally marketed in the US (510(k)-cleared or PMA-approved)
• Must have same intended use and same product code as your device
• Substantial equivalence requires similar safety and effectiveness
• Multiple predicates may be used if no single device provides adequate comparison

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Guide

Start with the FDA Product Classification Database to identify devices with your product code and intended use. Search by product code, device name, or 510(k) number to find potential predicates. Focus on devices cleared within the last 10 years, as older devices may not reflect current FDA expectations.

Evaluate intended use alignment carefully. Your predicate must have the same intended use as your device. Minor differences in patient population, clinical application, or use environment may be acceptable, but fundamental differences in medical purpose will disqualify a predicate. Document how your intended use aligns with your predicate’s cleared indications.

Assess technological characteristics systematically. Compare your device’s design, materials, energy source, operating principle, and performance specifications with potential predicates. Differences are acceptable if they don’t raise new safety or effectiveness questions. New technological characteristics may require additional testing or clinical data to demonstrate substantial equivalence.

Review predicate performance data thoroughly. Examine your predicate’s 510(k) summary, labeling, and any FDA correspondence to understand cleared performance specifications, testing requirements, and special controls. Your device should meet or exceed predicate performance while maintaining similar risk profile.

Consider multiple predicates strategically. If no single device provides adequate comparison, you may use multiple predicates to address different aspects of your device. For example, one predicate for hardware design and another for software functionality. Document the rationale for each predicate selection.

Evaluate predicate regulatory history. Check for FDA recalls, safety communications, or post-market issues that might affect your predicate’s suitability. Avoid predicates with significant safety concerns or regulatory problems that could complicate your submission.

Document your predicate justification comprehensively. Explain why your chosen predicate is appropriate, how your device compares technologically, and what testing demonstrates substantial equivalence. Address any differences and explain why they don’t raise new safety or effectiveness questions.

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Example

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Complete FDA Predicate Device Document

FDA Predicate Device

ID: PRED-2024-001

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1. Purpose

The purpose of this document is to define the predicate devices to be used for substantial equivalence to CardioWatch Pro.

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2. Scope

This document covers predicate and potential reference devices related to CardioWatch Pro for submission to the U.S. Food and Drug Administration.

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3. Predicate Device Information

Predicate Device Trade Name: AliveCor KardiaMobile 6L

Predicate Submission Number: K193869

Product Code: MYN - Electrocardiograph, Single Channel

Product Code Name: Electrocardiograph, Single Channel

Predicate Device Intended Use: The AliveCor KardiaMobile 6L is a single-channel electrocardiograph intended for use by healthcare professionals and patients for recording, storing, transferring, and displaying single-channel electrocardiogram (ECG) rhythms. The device is intended for patients 18 years of age and over. The device is not intended to be used on patients who have implanted pacemakers or defibrillators.

Substantial Equivalence Justification: CardioWatch Pro demonstrates substantial equivalence to the AliveCor KardiaMobile 6L based on the following comparison:

Intended Use Comparison:

• Same: Both devices are intended for ECG recording and monitoring in adults 18+ years
• Same: Both devices are intended for healthcare professional and patient use
• Same: Both devices record, store, and display single-channel ECG data
• Same: Both devices are contraindicated for patients with implanted cardiac devices
• Similar: CardioWatch Pro adds continuous monitoring capability while maintaining the same core ECG recording function

Technological Characteristics:

• Same: Single-channel ECG recording using dry electrodes
• Same: Digital signal processing and R-wave detection algorithms
• Same: Bluetooth connectivity for data transmission to mobile devices
• Same: Mobile application for data visualization and storage
• Different: CardioWatch Pro uses wearable form factor vs. handheld device - this difference does not raise new safety or effectiveness questions as both contact intact skin with dry electrodes
• Different: CardioWatch Pro provides continuous monitoring vs. spot recordings - this enhances functionality without introducing new risks

Performance Characteristics:

• Same: ECG signal acquisition and processing capabilities
• Same: Heart rate detection and rhythm analysis
• Same: Data storage and transmission protocols
• Enhanced: Continuous monitoring provides more comprehensive data collection
• Same: Mobile application interface and cloud connectivity

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4. Reference Device Information

Reference Device Rationale:

• Zio XT Patch: Provides precedent for continuous ECG monitoring in ambulatory settings, supporting CardioWatch Pro’s extended monitoring capability
• Apple Watch Series 4: Demonstrates FDA acceptance of wearable ECG devices with consumer accessibility, supporting CardioWatch Pro’s wearable design and patient use

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Q&A