(344 days)
Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart. Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
The proposed device includes Intracardiac Catheter Introducer Kit as well as its accessory, Transseptal Needle. Intracardiac Catheter Introducer Kit is intended for introducing various cardiovascular catheters into heart, including both right side. When left side of heart is accessed, Transseptal Needle is intended for puncture the interatrial septum during a transseptal catheterization procedure.
The Intracardiac Catheter Introducer Kit includes three components, which are (1) sheath introducer, (2) dilator and (3) guidewire. The 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 introducer and 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 transseptal needle includes two components, which are (1) needle and (2) stylet. The needle is used to puncture the the interatrial septum during a transseptal catheterization procedure; the stylet is used to keep the needle luman intact during handling and facilitate the needle advancement within the dilator.
This document describes a medical device, the Intracardiac Catheter Introducer Kit and Transseptal Needle, and its substantial equivalence determination by the FDA. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML or Diagnostic device.
The acceptance criteria and study described here are for a traditional medical device (catheter introducer and needle) aiming to demonstrate equivalence to a predicate device, rather than proving a diagnostic performance metric.
Therefore, many of the requested fields are not applicable to the information provided in this document.
Here's the closest possible interpretation of the requested information based on the provided text, primarily focusing on "non-clinical tests" as the "study" substitute:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standards/Tests Met) | Reported Device Performance |
|---|---|
| ISO 11070-1998 (Sterile single-use intravascular catheter introducer) | Complies with the standard |
| ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | Complies with the standard |
| ISO 10993-11:2006 (Tests for systemic toxicity) | Complies with the standard |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies with the standard |
| ISO 10993-4:2002 (Selection of tests for interactions with blood) | Complies with the standard |
| ASTM F88/F88M-09 (Seal Strength of Flexible Barrier Materials) | Complies with the standard |
| ASTM F1140-07 (Reapproved 2012) (Internal Pressurization Failure Resistance of Unrestrained Packages) | Complies with the standard |
| Simulated Use Testing | Performed |
| Anti-kink Testing | Performed |
| Torque Strength Testing | Performed |
| Torqueability Testing | Performed |
| Tip Flexibility Testing | Performed |
| Flow Rate Testing | Performed |
| Coating Integrity | Performed |
| Particulate Evaluation | Performed |
| Biocompatibility (Comply with ISO 10993-1) | Complies with ISO 10993-1 (as stated in comparison table) |
| Performance (Comply with ISO 11070-1998) | Complies with ISO 11070-1998 (as stated in comparison table) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes for the individual non-clinical tests. The tests were conducted to verify design specifications and substantial equivalence, implying they were performed on samples of the manufactured device. The manufacturer is Synaptic Medical Limited, located in Beijing, PR China, which can be considered the country of origin for the device and likely where these tests were performed. These appear to be prospective tests on newly manufactured devices.
3. 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. The tests are engineering and biological evaluations against established standards, not expert-derived ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for expert review of data, not for engineering or biological testing.
5. 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 is a traditional medical device, not an AI/ML-driven diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for an AI/ML algorithm, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here is compliance with established international and ASTM standards (e.g., ISO 11070, ISO 10993, ASTM F88, ASTM F1140), and verification of specific performance characteristics (e.g., anti-kink, torque strength). These are objective measurements against defined criteria.
8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML model.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.