(29 days)
Ultimum EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.
The Ultimum™ EV Hemostasis Introducer consists of a polyethylene introducer and dilator with a radiopaque marker band at the distal end. The introducer is fitted with a hemostasis valve for use during catheter introduction and/or exchange over a guidewire. The hub is located on the proximal end of the introducer, where a sideport with a three-way stopcock is provided for aspiration, fluid infusion, blood sampling, and pressure monitoring. The dilator is tapered at the distal tip with an internal lumen designed to accept guidewires that have a maximum diameter of 0.035" (0.889 mm).
The provided information describes a medical device, the Ultimum™ EV Hemostasis Introducer, and its regulatory submission (K140327). This submission focuses on modifications to an existing predicate device and demonstrates substantial equivalence through non-clinical testing. It does not describe an AI/ML-driven device or a clinical study involving human readers. Therefore, many of the requested categories related to AI performance, human reader improvement, and ground truth for deep learning models are not applicable or cannot be extracted from this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | Sheath Configuration; Device Outer Diameter (OD); Effective Sheath Length; Dilator Configuration; Dilator Sheath ID; Hemostasis Maintenance; Introducer Assembly Clot Management; Flushing Assembly (Kink Resistance); Insertion (Kink Resistance); Functional Use During Procedure; Tip Integrity; Suture Ring Seal Performance; Device Exchange; Device Integrity (Hemostasis Sheath Break Force); Device Integrity (Dilator Sheath Break Force); Device Integrity (Hemostasis Hub and Aspiration Tube Break Force); Device Integrity (Hub and Cap Break Force); Dilator Flushing; Device Compatibility (Sheath Hub); Device Compatibility (Dilator Hub ID) | All pre-determined acceptance criteria were met. |
| Biocompatibility Testing | Cytotoxicity; Sensitization; Intracutaneous Reactivity; Systemic Toxicity (Acute); Pyrogenicity; Hemocompatibility; Chemical Characterization. (Performed in accordance with ISO 10993-1). | All pre-determined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical bench and biocompatibility testing. It does not involve a "test set" in the context of AI/ML or a clinical study with human patients. Thus, there is no information on sample size for a test set or data provenance related to country of origin or retrospective/prospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for device performance in this context would be defined by engineering specifications, safety standards, and physiological limits demonstrated through bench and biocompatibility testing. There's no indication of clinical experts establishing ground truth for a test set in the traditional sense of diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This is not a study involving expert adjudication for diagnostic tasks.
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 not an AI-driven device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established through adherence to pre-determined engineering specifications, design requirements, and international standards (e.g., ISO 10993-1 for biocompatibility). Performance metrics are objectively measured in bench tests (e.g., break force, dimensions, hemostasis maintenance).
8. The Sample Size for the Training Set
Not applicable. This is not an AI-driven device. No training set was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI-driven device. No training set was used, and therefore, no ground truth for a training set was established.
§ 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).