(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 guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M 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 one size (18F) and two lengths (30cm and 50cm).
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 length and packaging of the current device. 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 describes a 510(k) premarket notification for a medical device called the Nanostim Introducer Kit. This document is a submission to the FDA seeking to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | Visual test | All pre-determined acceptance criteria were met. |
| Dimensional measurement test | All pre-determined acceptance criteria were met. | |
| Torsional Strength | All pre-determined acceptance criteria were met. | |
| Simulated use/kink test | All pre-determined acceptance criteria were met. | |
| Functional Equivalence | Same indication for use as predicate | Yes |
| Same fundamental scientific technology as predicate | Yes | |
| Same technological characteristics as predicate | Yes | |
| Same materials as predicate | Yes | |
| Same principles of operation as predicate | Yes | |
| Same basic introducer design and sterilization process | Yes | |
| Safety and Effectiveness | Changes do not affect intended use or clinical effect | Yes |
| Differences raise no new issues of safety or effectiveness. | Yes |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, torsional, simulated use/kink). It generally refers to "Design verification testing."
- Test Set Sample Size: Not specified for individual tests.
- Data Provenance: The study is reported as "Design verification testing," which implies it was conducted by the manufacturer (St. Jude Medical, Inc.) to verify their modified product. The origin of the data (e.g., country) is not specified beyond being generated by the applicant. It is a retrospective study in the sense that the testing was performed on the manufactured device, not as part of a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission. The tests conducted are non-clinical, design verification tests, not clinical evaluations relying on expert interpretation of medical data (like imaging or pathology). The "ground truth" for these engineering tests would be established by objective measurements and defined specifications, not expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are non-clinical, objective measurements against pre-defined specifications determine success or failure. There is no human variability in interpreting results that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation is not required for this device." This type of study is typically performed for AI/image analysis devices where human reader performance is a key metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument (an introducer kit), not an AI algorithm or software device.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests would be based on engineering specifications and industry standards for medical device performance. For example:
- Visual test: Conformance to manufacturing standards, absence of defects.
- Dimensional measurement test: Conformance to specified dimensions (e.g., diameter, length).
- Torsional Strength: Ability to withstand a specified torsional force without breaking or deforming.
- Simulated use/kink test: Ability to perform as intended under simulated use conditions without kinking or failure.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and prior iterations, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. There is no training set for this device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).