(67 days)
The HeartSpan™ Steerable Introducer Kit is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The HeartSpan™ Steerable Introducer set 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 steerable 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 introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection >180° with a radius of 10 - 56 mm (measured at 180° deflection) . The steerable 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 inner and outer surfaces. The dilator is designed to conform to the inner diameter of the sheath, and has a tapered tip.
The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
The provided text describes a Special 510(k) submission for the HeartSpan™ Steerable Introducer Kit. This type of submission generally refers to modifications to a device that has already received 510(k) clearance, and often relies heavily on comparison to the predicate device and established performance standards rather than extensive de novo clinical studies.
Therefore, the study supporting the device's acceptance primarily focuses on bench testing (performance testing) and adherence to international standards to demonstrate substantial equivalence to the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner for most items. Instead, it describes general assurance measures and categories of testing. However, it does list specific technical characteristics of the modified device which are implicitly accepted if they are equivalent or superior to the predicate.
For the purpose of this response, I will interpret "acceptance criteria" as the required performance areas and "reported device performance" as the confirmation that the device "meets the predetermined acceptance criteria." Quantitative values are only available for a few specific technical characteristics.
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance / Assessment |
|---|---|---|
| Safety & Performance Tests | Tip articulation | Meets predetermined acceptance criteria |
| Leak resistance | Meets predetermined acceptance criteria | |
| Kink resistance | Meets predetermined acceptance criteria | |
| Length | Meets predetermined acceptance criteria | |
| Inner/Outer diameter | Meets predetermined acceptance criteria | |
| Curve radius | Meets predetermined acceptance criteria | |
| Marker band location | Meets predetermined acceptance criteria | |
| Tip/tube detachment force | Meets predetermined acceptance criteria | |
| Side hole diameter and location | Meets predetermined acceptance criteria | |
| Biocompatibility | Biological Evaluation | Meets predetermined acceptance criteria (per ISO 10993 standards) |
| Sterilization | Ethylene oxide sterilization validation | Meets predetermined acceptance criteria (per ISO 11135-1) |
| Packaging | Packaged-Products Testing | Meets predetermined acceptance criteria (per ISTA P2A) |
| Technical Characteristics Comparison | Hemostasis valve provided | Yes (Equivalent to Predicate) |
| Dilator to Guide wire Compatibility | up to 0.038" (Equivalent to Predicate) | |
| Guide wire Design / Dimensions | Super-Stiff with PTFE, 0.032" x 180cm (Modified - assumed acceptable) | |
| Compatibility with Standard Transseptal Needle | Yes (Equivalent to Predicate) | |
| Length | 74 cm (Equivalent to Predicate) | |
| French size | 8.6F (Equivalent to Predicate) | |
| Bi-Directional Curving | Yes ≥180° in both directions (Equivalent to Predicate) | |
| One-Handed Operation of Curving Mechanism | Yes (Equivalent to Predicate) | |
| Wire braid reinforcement completely encapsulated | Yes (Equivalent to Predicate) | |
| Radiopaque tip or marker | Yes (Equivalent to Predicate) | |
| Soft Atraumatic Tip | Yes (Equivalent to Predicate) | |
| Side port for infusion and contrast injection | Yes (Equivalent to Predicate) |
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 size for the test sets used for performance testing (bench testing).
The data provenance is from bench testing conducted by Merit Medical Systems, Inc. (location: Malvern, PA, USA) and involves verification of product specifications and user requirements. This would be considered prospective testing in a controlled laboratory environment. No clinical data or patient data is mentioned; therefore, there is no country of origin for patient data.
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)
This section is not applicable as the study described is purely bench testing and does not involve human expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study described is purely bench testing and does not involve human adjudication. The results are from physical measurements and tests against pre-defined engineering and performance specifications.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a steerable introducer kit, a physical medical device, not an AI or imaging diagnostic tool. Therefore, the concept of human readers or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing was based on pre-determined product specifications, user requirements, and compliance with international standards (e.g., ISO 10993, ISO 11070, ISO 11135-1, ISTA P2A). These standards and specifications define the acceptable performance limits and characteristics for the device.
8. The sample size for the training set
The document describes a Special 510(k) for a modified physical device. There is no mention of a training set as this is not an AI or machine learning product. The design and manufacturing processes are likely informed by prior engineering knowledge and the predicate device's design, but this is not formally described as a "training set" in the context of this submission.
9. How the ground truth for the training set was established
Since there is no training set mentioned or applicable for this physical medical device, the establishment of "ground truth for the training set" is not applicable.
§ 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).