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cyntrica

Gov Data MCP

by cyntrica

fda_device_510k

Read-only

Search FDA 510(k) premarket clearance decisions to verify if a medical device is substantially equivalent and legally marketed since 1976.

Instructions

Search 510(k) premarket clearance decisions (174K+ since 1976). A 510(k) demonstrates a device is substantially equivalent to a legally marketed device.

Example searches:

  • 'advisory_committee:cv' — cardiovascular devices

  • 'openfda.regulation_number:868.5895' — by regulation number

  • 'device_name:"pacemaker"' — by device name

  • 'applicant:"Medtronic"' — by company

Count fields: country_code, advisory_committee, clearance_type.exact, decision_code

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
limitNoMax results (default 10, max 100)
searchNoOpenFDA search query. Examples: 'field:value', 'field:"Exact Phrase"', 'field:[20200101+TO+20231231]', '_exists_:field'. Combine with '+AND+', '+OR+', '+NOT+'.
Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already declare readOnlyHint=true, establishing the safe read-only nature. The description adds valuable behavioral context: dataset size (174K+), the meaning of 510(k), example query syntax, and count fields for aggregation. This goes beyond the annotation and helps the agent understand scope and functionality.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The description is well-structured with an opening statement, a brief explanation of 510(k), bulleted examples, and a count fields section. Every section adds value, though it is slightly longer than necessary—hence 4 rather than 5.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

For a search tool with two well-documented parameters and readOnlyHint annotation, the description provides essential context: what data is searched, example queries, and count fields. It could be more complete by describing the response format, but given the generic search schema and absence of output schema, it covers the key aspects.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters4/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 100%, so baseline is 3. The description adds domain-specific parameter semantics by showing real field names and values usable in the 'search' parameter (e.g., advisory_committee:cv, device_name:"pacemaker"). It also lists count fields, which clarify how the 'search' parameter can be used for aggregation-like queries.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description clearly states 'Search 510(k) premarket clearance decisions' with a specific verb and resource. It distinguishes itself from sibling FDA tools (e.g., fda_device_pma, fda_device_classification) by explicitly naming the 510(k) program and providing domain-specific examples.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines4/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The description provides clear context for when to use this tool—when searching 510(k) premarket clearance decisions—and includes example searches that convey typical use cases. However, it does not explicitly mention alternatives or exclusions, keeping it a notch below a perfect score.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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