(143 days)
The Steerable Intracardiac Catheter Introducer Kit is intended to introduce various catheters into the heart, including the left side of the heart through the interatrial septum.
The proposed device includes Steerable Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. The Steerable Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right and left side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
The Steerable Intracardiac Catheter Introducer Kit includes three components, which are (1) steerable sheath introducer, (2) dilator and (3) guidewire. The steerable sheath introduced into a body vessel, along with the dilator, over the guidewire, it is available in variable specification and curve configuration: Dilator is assembled with the sheath introduced into a body vessel over the guidewire. It is used to provide support to sheath and ensure smooth advancement; the guidewire is percutaneous placed into the body vessel to function as a guide for the introduction into the chambers of the heart.
The handle of Steerable Intracardiac Catheter Introducer is equipped with the rotation collar, turn the collar in clockwise, the tip can be stered from 0 to 180 degree(s), while turn the collar in counterclockwise, the tip can be steered from 0 to 90 degree(s) on the other side.
The transseptal needle includes two components, which are (1) stylet. The needle is used to puncture the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle lumen intact during handling and facilitate the needle advancement within the dilator.
The kit and the transseptal needle are provided sterilized. They are subject to Ethylene Oxide sterilization prior to release. The Sterility Assurance Level (SAL) is 10-6.
The shelf life of the proposed device is three (3) years.
This document is a 510(k) premarket notification for a medical device called the "Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle". It seeks to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria through a clinical study with an AI component. Therefore, much of the requested information regarding AI study details cannot be extracted from this document.
However, I can provide information based on the non-clinical tests performed to demonstrate substantial equivalence.
1. Acceptance Criteria and Reported Device Performance
The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. The acceptance criteria for these non-clinical tests are implicitly defined by compliance with the listed international and ASTM standards. The "reported device performance" is the conclusion that the device complied with these standards.
| Acceptance Criteria Category | Specific Standard / Requirement | Reported Device Performance |
|---|---|---|
| Sterility | ISO 11070-2014: Sterile single-use intravascular catheter introducer | Proposed device complies with ISO 11070-2014 |
| Ethylene Oxide sterilization residuals | Proposed device complies with ISO 10993-7:2008 | |
| Biocompatibility | In Vitro cytotoxicity | Proposed device complies with ISO 10993-5:2009 |
| Systemic toxicity | Proposed device complies with ISO 10993-11:2006 | |
| Irritation and skin sensitization | Proposed device complies with ISO 10993-10:2010 | |
| Interactions with blood (hemolytic properties) | Proposed device complies with ISO 10993-4:2002 and ASTM F 756-08 | |
| General Biocompatibility | Proposed device complies with ISO 10993-1 | |
| Packaging & Shelf Life | Seal Strength of Flexible Barrier Materials | Proposed device complies with ASTM F88/F88M-09 |
| Internal Pressurization Failure Resistance | Proposed device complies with ASTM F1140-07 (Reapproved 2012) | |
| Performance (general) | ISO 11070-1998 (related to catheter introducer performance) | Proposed device complies with ISO 11070-1998 |
| Shelf Life | (Implicitly tested to justify 3-year claim) | 3 years (Identical to predicate) |
2. Sample Size and Data Provenance
This document describes non-clinical bench testing and biocompatibility testing, not a clinical study involving patient data. Therefore, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The samples used would be units of the manufactured device for the specific tests.
3. Number of Experts and their Qualifications for Ground Truth
Not applicable. This is a submission for a physical medical device, not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" for the non-clinical tests is derived from the objective measurements and defined parameters within the standardized test methods.
4. Adjudication Method
Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human readers/interpreters to resolve discrepancies in assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical study is included in this submission." Also, the device is a physical medical instrument (catheter introducer), not an AI system. Therefore, a study comparing human readers with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical medical instrument and does not involve an algorithm with standalone performance.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria and measurable parameters established within the referenced international and ASTM standards (e.g., specific sterility assurance levels, cytotoxicity assays, seal strength measurements, etc.).
8. Sample Size for the Training Set
Not applicable. This document does not describe the development or evaluation of an AI algorithm; there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI algorithm or training set discussed in this document.
§ 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).