(86 days)
The Fast-Cath™ Intra-Cardiac Introducer is intended 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 sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc.
Based on the provided 510(k) summary, there is no detailed study described that establishes specific acceptance criteria and demonstrates the device's performance against those criteria in a quantitative manner. This 510(k) relies on substantial equivalence to a predicate device rather than presenting new performance data from an independent study.
Here's a breakdown of why many of the requested points cannot be answered from the provided text:
- No specific acceptance criteria are stated. The submission focuses on asserting 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 contraindications and instructions for use)." This implies the acceptance criteria are met by virtue of being identical to a device already deemed safe and effective.
- No detailed study is mentioned. The submission references "clinical literature" and the successful use of "similar commercially available catheter introducers" and the predicate device (Daig's Fast-Cath™ Transseptal Catheter Introducers) as evidence of safety and effectiveness, but it does not describe a specific study conducted for this particular 510(k) submission with a test set, ground truth, or expert review.
However, based on the information provided, we can infer some aspects and explicitly state what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (product design, packaging, sterilization, labeling - excl. contraindications/IFU) | "All technological characteristics... are identical to the predicate device." |
| Safety and efficacy for introducing cardiovascular catheters or biopsy devices into the heart | Supported by "clinical literature" and successful historical use of similar devices and the predicate device. |
| Minimization of blood loss during catheter introduction/exchange (via hemostasis valve) | Device described as having a "hemostasis valve to minimize blood loss." |
| Capability for air aspiration, fluid infusion, blood sampling (via sideport with stopcock) | Device described as having a "sideport with a Three-way stopcock is provided for air aspiration, fluid infusion, blood sampling, etc." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No dedicated test set described.
- Data Provenance: Not applicable. The "support" is based on existing clinical literature and historical use of predicate and similar devices, not a new dataset created for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established as part of this submission. The "ground truth" for the predicate device's safety and effectiveness would have been established through its own historical use and regulatory pathway, which is not detailed here.
4. Adjudication method for the test set
- Not applicable. No test set was 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
- No. This device is a medical introducer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a medical introducer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k), the "ground truth" for demonstrating substantial equivalence relies on the established safety and effectiveness of the predicate device and the broader category of similar introducer devices as evidenced by "clinical literature" and successful market use. There is no new, explicitly defined ground truth established for this specific submission's performance claims.
8. The sample size for the training set
- Not applicable. No "training set" in the context of an algorithm or AI is described.
9. How the ground truth for the training set was established
- Not applicable. No "training set" or explicit ground truth for such a set is described.
In summary, this 510(k) submission primarily relies on the argument of substantial equivalence to an already legally marketed device rather than presenting a de novo study with explicit acceptance criteria and corresponding performance data. The support for substantial equivalence comes from:
- Identical technological characteristics to the predicate device.
- The general understanding and "clinical literature" demonstrating the safety and utility of similar introducer devices for cardiac procedures.
- The successful historical use of the predicate device (Fast-Cath™ Intra-Cardiac Catheter Introducer) and similar devices (Daig's Fast-Cath™ Transseptal Catheter Introducers).
§ 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).