Question 1

What is predicate intelligence software?

Accepted Answer

Predicate intelligence software helps medical device teams identify, compare, and document predicate devices for a 510(k) submission. A predicate is a legally marketed device (cleared via 510(k) or grandfathered pre-1976) that the sponsor claims substantial equivalence to in order to gain FDA clearance. The software supports predicate search across the FDA 510(k) database, side-by-side comparison of intended use, technological characteristics, performance testing, labeling, and the documentation of substantial-equivalence rationale that FDA reviewers will evaluate.

Question 2

Why do 510(k) submissions need predicate software?

Accepted Answer

Predicate strategy is the single highest-leverage decision in a 510(k) filing. A weak predicate selection turns what should be a 90-day review into a 200-day cycle with multiple Additional Information requests, and can force a switch to a De Novo pathway mid-cycle. Most teams run predicate research in Excel or Word across 20+ FDA database queries, then compile comparisons manually. Dedicated software reduces the error rate on predicate selection and gives the RA team a reviewable evidence trail for the SE determination.

Question 3

Does Assyro search the FDA 510(k) database directly?

Accepted Answer

Yes. Assyro queries the FDA 510(k) clearance database in real time, indexing the full clearance letter text, summary of safety and effectiveness (SSED), product code, regulation number, panel, and device classification. Searches run across indication, technological characteristics, and free text. Results include the K-number, clearance date, applicant, and link back to the original FDA record so teams can verify anything the platform surfaces against the primary source.

Question 4

How does Assyro handle multiple predicates?

Accepted Answer

FDA permits reliance on one primary predicate plus reference predicates, with specific constraints on how each can be used. Assyro structures the comparison so the primary predicate drives the overall SE claim, and reference predicates support specific technological or performance characteristics. The comparison matrix makes clear which evidence comes from which predicate, which is how FDA reviewers evaluate multi-predicate strategies. This avoids the common mistake of blurring predicates in a way that weakens the overall SE argument.

Question 5

Can Assyro help with split predicate strategy?

Accepted Answer

Yes. Split predicate is the pattern where different aspects of substantial equivalence (intended use, technological characteristics) are drawn from different predicates, but it's not a formally supported FDA approach and FDA guidance explicitly cautions against it. Assyro flags split predicate patterns early so the team can evaluate whether to strengthen the primary predicate choice or accept the risk of additional review friction. The flag is a signal, not a block; the team still makes the strategic call.

Question 6

How does predicate intelligence connect to eSTAR?

Accepted Answer

eSTAR, the FDA's interactive 510(k) submission form, has specific sections for predicate information, substantial equivalence comparison, and performance testing that reference the predicate. Assyro's predicate data flows into the eSTAR form directly: K-numbers, comparison tables, performance bridging data, and labeling comparisons populate without manual retyping. This is where the end-to-end 510(k) workflow in Assyro compounds: predicate work done in the intelligence module saves time in eSTAR authoring.

Question 7

What about 510(k) exemptions and predicate requirements?

Accepted Answer

Some Class I and II devices are 510(k)-exempt under 21 CFR 862-892, meaning no premarket notification is required as long as the device meets the exemption's limitations. Exempt devices do not need predicate analysis. Class II devices that exceed the exemption limitations still require a full 510(k) with predicate. Assyro's classification tool flags exemption status based on product code and intended use so teams avoid running unnecessary predicate work on truly exempt devices.

Question 8

Can predicate intelligence support De Novo submissions?

Accepted Answer

De Novo is the pathway for novel low-to-moderate risk devices with no valid predicate. While De Novo does not require a predicate comparison, the De Novo submission must demonstrate reasonable assurance of safety and effectiveness through general and special controls. Assyro supports the classification work (is there truly no predicate?) and the general/special controls rationale documentation, which is adjacent to predicate work even though it doesn't use the same comparison framework.

Predicate Intelligence Software

How Predicate Intelligence Fits the Submission Workflow

Search 200,000+ Cleared Devices in the FDA 510(k) Database

Build Side-by-Side SE Comparison Tables Automatically

Surface SE Gaps Before They Surface in the Review

Keep Predicate Rationale Linked to the Package Section It Supports

Controls and Traceability for Predicate Intelligence

Keep Predicate Intelligence Audit-Ready

Scale Across Programs Without Adding Complexity

Questions About Predicate Intelligence

See Predicate Intelligence in a Live Submission Workflow.