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510(k) Data Aggregation
(30 days)
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.
The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.
The provided text is a 510(k) summary for the Nanostim Introducer Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic efficacy in the way an AI or diagnostic imaging device would.
Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size of test set, ground truth experts, MRMC studies, standalone performance) are not applicable here. This document primarily describes engineering verification and biocompatibility testing.
Here's the information extracted from the document that is relevant to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual test | Not explicitly stated (implied to meet visual standards) | All pre-determined acceptance criteria were met. |
| Dimensional measurement test | Not explicitly stated (implied to meet specifications) | All pre-determined acceptance criteria were met. |
| Tensile Strength | Not explicitly stated (implied to meet specifications) | All pre-determined acceptance criteria were met. |
| Torsional Strength | Not explicitly stated (implied to meet specifications) | All pre-determined acceptance criteria were met. |
| Liquid Leak | Not explicitly stated (implied to prevent leaks) | All pre-determined acceptance criteria were met. |
| Simulated Use | Not explicitly stated (implied to function as intended) | All pre-determined acceptance criteria were met. |
| Biocompatibility: Cytotoxicity | In accordance with ISO 10993-1:2009 for an external communicating device with limited exposure (<24 hours contact with circulating blood) | Completed in accordance with the standard. |
| Biocompatibility: Chemical Characterization | In accordance with ISO 10993-1:2009 for an external communicating device with limited exposure (<24 hours contact with circulating blood) | Completed in accordance with the standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the non-clinical (design verification) tests. These are typically engineering tests performed on a limited number of devices, not clinical subject data.
The data provenance is from internal testing conducted by St. Jude Medical, Inc. It is non-clinical/engineering test data, not patient data (retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., expert consensus on images, pathology results) is not relevant for these engineering verification tests. The "ground truth" here is the adherence to design specifications and performance standards as determined by engineers and laboratory testing.
4. Adjudication Method for the Test Set
Not applicable. As these are engineering verification tests, "adjudication" in the sense of resolving discrepancies between expert readings is not relevant. The results of the tests were compared against pre-determined acceptance criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done, and is not applicable for this type of device (an introducer kit) seeking 510(k) clearance based on substantial equivalence to a predicate, especially when focused on engineering design changes. This device is not an AI or diagnostic imaging device; it's an interventional accessory.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an introducer kit, not an algorithm.
7. The type of ground truth used
For the non-clinical (engineering) testing, the "ground truth" would be the established engineering specifications and performance standards for the device. For biocompatibility, the ground truth is adherence to the ISO 10993-1:2009 standard.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set. The "ground truth" for the non-clinical tests was established by predefined engineering specifications and international standards (ISO 10993-1:2009).
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