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The NAVIPORT is a sterile, single use only, dual lumen, deflectable tip, guiding catheter with various curve reach configurations. NAVIPORT device is torquable and has a steering mechanism (control knob) in the handle. The control knob allows the catheter tip to be curved or to be straightened while the NAVIPORT is being routed to the desired location. The control knob is connected to an anchor ring located at the distal tip of the guiding catheter by a stainless steel pull wire. The pull wire runs from the control knob through a small closed lumen which terminates at the anchor ring. The anchor ring function is to allow the tip of the catheter to be deflected from the handle. A large central continuous lumen with a female luer at the proximal end and the deflectable tip at the distal end serves as a conduit for medical devices to the cardiovascular system.

AI/ML Overview

This document describes a 510(k) premarket notification for the Cardima NAVIPORT™ Deflectable Tip Guiding Catheter, which primarily relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints. Therefore, many of the requested elements for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of submission.

However, I can extract and infer information about the evaluation process.

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing equivalence and safety through various types of testing, rather than reporting quantifiable performance metrics against specific "acceptance criteria" in the way a clinical trial would for performance claims. The "acceptance criteria" here are largely implied by compliance with existing guidance documents and successful completion of the described tests.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with relevant ISO standards and FDA guidance	Testing conducted; results found acceptable.
Reliability	Durability and consistent function over intended use cycles	Testing conducted; results found acceptable.
Mechanical Properties	Strength, flexibility, deflection mechanism functionality, etc.	Testing conducted; results found acceptable for intended use.
Sterilization	Sterility Assurance Level (SAL) per ANSI/AAMI/ISO 11137	Sterilized at minimum 25 kGy gamma radiation; validated process.
Packaging	Maintenance of sterility and physical integrity	Uses same validated materials and process as cleared predicate (VENAPORT).
Functionality (Animal Study)	Ability to access cardiovascular system and deliver devices without trauma	Performance acceptable when placed into heart chambers.
Substantial Equivalence	Similarities in intended use, design, and physical characteristics to predicate devices.	Determined to be substantially equivalent to Medtronic's Marinr™ Steerable Intracardiac Electrode Catheter (K931794) and Sherpa Guiding Catheter (K955651).

Study Details

Given this is a 510(k) submission and not a traditional clinical trial comparing performance against specific numerical endpoints for a device with novel performance claims, the requested study details are largely absent or not applicable in the way they would be for a direct performance study.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set: Not explicitly stated as a separate "test set" for performance evaluation in a clinical sense. The "testing" involved biocompatibility, reliability, mechanical, and animal studies.
- Animal Studies: The number of animals or specific procedures is not detailed.
- Bench Testing: The number of units tested for mechanical properties, reliability, etc., is not provided.
Data Provenance: Not specified, but generally, 510(k) bench and animal studies are conducted internally by the manufacturer or by contract research organizations (CROs) in the country of origin (implied to be the USA for Cardima, Inc., based on the address). These are prospective tests performed specifically for the submission.

2. 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)

Not applicable. Ground truth in this context would be defined by the inherent properties of the materials and device design (for bench testing) or by veterinary assessment of animal health and trauma (for animal studies). No human expert "ground truth" was established for a clinical test set in this submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or multi-reader assessment requiring adjudication.

4. 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

Not applicable. This device is a guiding catheter, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Bench Testing: Physical measurements, engineering specifications, material properties, and comparison against established industry standards.
For Animal Studies: Direct observation of access, device delivery, and assessment of trauma by trained veterinary personnel or researchers.

7. The sample size for the training set

Not applicable. There is no machine learning or AI component requiring a training set described in this 510(k) submission.

8. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, no ground truth establishment method for it is relevant.

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