FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a summary of safety and effectiveness for a medical device submitted in 1997. It describes a Flow Directed Thermodilution / Infusion Balloon Catheter and compares it to a similar device by Nova Medical Specialties, Inc.

The document does not provide the level of detail requested in the prompt for AI/software-based medical devices. It's focused on the physical characteristics and basic functional equivalence of two catheters. Therefore, many of the requested fields cannot be filled.

Here's an attempt to answer the questions based only on the provided text, with many N/A or "Not Provided" answers:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Functionality	Provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output.
Material Strength	Materials used in both catheters exceed the strength required.
Bond Joint Strength	Bond joints will withstand tensile pressures in excess of that required for safety and effectiveness.
Balloon Burst Strength	Test results showed "little of significance" (implying adequate performance, but not quantified).
Injection Rate	Test results showed "little of significance" (implying adequate performance, but not quantified).
Safety	Present an acceptable level of safety when properly used by a trained physician. Hazards identified in instruction sheet.

Study Details

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided. The text mentions "tests" but not how many units were tested.
- Data Provenance: Not provided. It describes "engineering tests" but not where or when they were conducted, or if they involved human subjects/patient data. It's likely internal manufacturer testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided. The document mentions "Engineering tests" and implies assessment by "trained physician[s]" for proper use, but not for establishing ground truth for the device's technical specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is typically relevant for subjective assessments, which isn't the primary focus of these physical device tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This document predates the widespread use of AI in medical devices and describes a physical catheter, not an AI algorithm.
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the physical characteristics (material strength, bond strength), the ground truth would be based on engineering standards and physical test measurements (e.g., tensile strength in pounds per square inch, burst pressure in psi). For functionality, it would be direct measurement of pressure readings and cardiac output obtained.
The sample size for the training set
- Not applicable/Not provided. This concept is relevant for machine learning models, not for engineering tests of a physical catheter.
How the ground truth for the training set was established
- Not applicable/Not provided.

Summary

Regulation Number and Section

§ 870.1240 Flow-directed catheter.

(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).