(225 days)
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.
The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.
The provided text is a 510(k) summary for the Fast-Cath™ Intra-Cardiac Introducer. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies showcasing acceptance criteria. As such, the document does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for novel therapeutic or diagnostic devices.
The document states that the new indication for use is supported by demonstrating that "All technological characteristics of the Fast-Cath™ Intra-Cardiac Introducer with new indication for use are identical to the predicate device including product design, packaging, sterilization, and labeling (with the exception of the new indications)." and by referencing "Clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy may reduce the complications associated with this procedure." and "Similar commercially available catheter introducers have been successfully used for introducing various cardiovascular catheters and biopsy devices into the heart."
Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this 510(k) summary.
However, I can provide what is available based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria or report device performance data. The basis of the submission is substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in this document as part of a performance study. | Not reported in this document as part of a performance study. The device's performance is assumed to be equivalent to the predicate device due to identical technological characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new performance study with a test set is described in this 510(k) summary. The submission relies on the substantial equivalence to a predicate device and existing clinical literature concerning introducers in general.
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. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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 medical device (catheter introducer), not an AI/software device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter introducer), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no new performance study described in this 510(k) summary to generate ground truth. The basis for safety and effectiveness is substantial equivalence to an existing predicate device and general clinical literature.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not a machine learning model.
§ 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).