(30 days)
The HeartSpan® Steerable Sheath Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The HeartSpan® Steerable Sheath Introducer consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities. The HeartSpan® Steerable Sheath Introducer has three configurations; Small, Medium, and Large Curl (differing curve radii). The steerable sheath introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheath introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection ≥180° with a radius of 16.4 - 50 mm nominal (measured at 180° deflection). The steerable sheath introducer also includes distal holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the outer surface. The dilator is designed to mate to the inner diameter of the sheath, and has a tapered tip. The guide wire is super-stiff with PTFE coating and J-tip. The guide wire maintains a percutaneous path through the skin and tissue over which the sheath/dilator assembly is tracked. The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the sheath introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
The provided text describes a 510(k) premarket notification for a medical device, the HeartSpan® Steerable Sheath Introducer. It details the device's characteristics, indications for use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
However, the document does not contain the specific information required to address the request fully, particularly regarding a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop system. The provided text is for a physical medical device (a steerable sheath introducer), not an AI algorithm or an imaging device whose performance is measured in terms of reader improvements or AI standalone performance. Therefore, many of the requested fields are not applicable to the submitted content.
Based on the provided text, I can extract information related to the acceptance criteria and performance of the physical device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted on the HeartSpan® Steerable Sheath Introducer, which serve as the acceptance criteria for its physical and functional attributes. The general statement about performance is that "The results of the testing demonstrated that the subject HeartSpan® Steerable Sheath Introducer met the predetermined acceptance criteria applicable to the safety and efficacy of the device." Specific quantitative results are not provided in this summary.
| Acceptance Criteria (Performance Testing - Bench) | Reported Device Performance |
|---|---|
| Sheath & Dilator Tube Radiopacity | Met predetermined criteria |
| Sheath Tube Flexural & Torsional Rigidity | Met predetermined criteria |
| Sheath Tube O.D., I.D. & Free Length | Met predetermined criteria |
| Sheath Curl Diameter | Met predetermined criteria |
| Sheath Hemostasis / Air Leak Resistance | Met predetermined criteria |
| Dilator Extension Length | Met predetermined criteria |
| Sheath Neutral Position Tactile Indicator | Met predetermined criteria |
| Sheath and Dilator Tip Integrity | Met predetermined criteria |
| Sheath Bonded Joints Leak Resistance | Met predetermined criteria |
| Sheath Valve Housing / Sideport Tube Joint Pull Force | Met predetermined criteria |
| Sheath Tube Joint Pull Forces | Met predetermined criteria |
| Dilator Hub & Tip I.D. | Met predetermined criteria |
| Dilator Tip Wall Thickness | Met predetermined criteria |
| Safety & Dilator Free & Overall Length | Met predetermined criteria |
| Transseptal Needle Protrusion from Dilator Tip & from Dilator Hub Performance | Met predetermined criteria |
| Dilator Hub Mark Adherence | Met predetermined criteria |
| Sheath/Dilator Attachment & Detachment Force | Met predetermined criteria |
| Dilator Hub Luer Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, and Resistance to Overriding Dilator Hub Luer Stress Cracking | Met predetermined criteria |
| Dilator Tip Integrity | Met predetermined criteria |
| Dilator Hub/Tube Joint Pull Force | Met predetermined criteria |
| Package Integrity | Met predetermined criteria |
| Sheath, Dilator & Guidewire Visual Appearance after Transit Simulation | Met predetermined criteria |
Biocompatibility Testing:
| Acceptance Criteria (Biocompatibility Testing) | Reported Device Performance |
|---|---|
| Cytotoxicity | Met predetermined criteria |
| Sensitization | Met predetermined criteria |
| Irritation / Intracutaneous | Met predetermined criteria |
| Acute Systemic Toxicity | Met predetermined criteria |
| Pyrogenicity | Met predetermined criteria |
| Hemolysis | Met predetermined criteria |
| Thrombogenicity | Met predetermined criteria |
| Complement Activation | Met predetermined criteria |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The document discusses testing for a physical medical device, not an AI model that uses a "test set" in the context of image analysis. The tests mentioned are bench tests and biocompatibility tests on the device itself. Sample sizes for these types of engineering and biological tests are not specified in this summary document.
- Data Provenance: Not applicable in the context of clinical data for AI, but for the physical device, the tests are performed in a lab setting by the manufacturer (Merit Medical Systems, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This pertains to clinical data labeling for AI models. This document describes a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: This pertains to clinical data labeling for AI models.
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 is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device, not an AI algorithm. Its performance is inherent to its design and material properties, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical device, the "ground truth" for acceptance criteria is based on engineered specifications, validated test methods, and compliance with recognized international standards (e.g., ISO, ASTM, USP, AAMI). For biocompatibility, it's established by the outcomes of standard biological tests.
8. The sample size for the training set:
- Not Applicable: This pertains to AI model training, not a physical device.
9. How the ground truth for the training set was established:
- Not Applicable: This pertains to AI model training.
In summary, the provided document is a 510(k) summary for a physical medical device (HeartSpan® Steerable Sheath Introducer) and outlines the engineering and biological testing performed to demonstrate its safety and effectiveness for substantial equivalence. It does not provide the type of information typically associated with the development and validation of an AI-powered diagnostic or assistive tool.
§ 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).