(219 days)
The ArtVentive Endoluminal Occlusion System (EOS) is intended for arterial and venous embolization in the peripheral vasculature.
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The AVMG EOS™ is intended for single use only.
Like the parent ArtVentive Endoluminal Occlusion System - EOS, the proposed 11mm size of the device is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability. The implant itself and the catheter's distal end are visible under fluoroscopy.
The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The tip of the guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.
This document is a 510(k) Pre-Market Notification from the FDA regarding the ArtVentive Medical Group's Endoluminal Occlusion System (EOS). It primarily establishes substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria in the typical sense of a diagnostic or accuracy study.
However, based on the provided text, we can piece together what functioned as "acceptance criteria" through performance data and a comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | The 11mm size of the delivery catheter/implant and 7.5 Fr size of the guide catheter of the ArtVentive Endoluminal Occlusion System – EOS™ are substantially equivalent to the predicate device when used according to its intended use. This equivalence was based on information demonstrating shared technological characteristics, mechanism of action, intended use, and physical characteristics. |
| Performance as Intended: | Bench studies indicate that the ArtVentive Endoluminal Occlusion System with the 11mm size of the delivery catheter/implant and 7.5mm size of the guide catheter as well as with minor design modifications made to the 5mm and 8mm parent devices perform as intended. |
| Verification & Validation for Added Sizes (11mm) and Modifications (5mm, 8mm): | The following testing was repeated for the additional sizes of the device (11mm diameter): dimensional and functional design verification/validation, MRI compatibility, corrosion, and radial strength. |
The design verification and validation testing was repeated as necessary for the minor design modifications to the cleared 5mm and 8mm delivery catheter/implant and the 6 Fr guide catheter. |
| Material Equivalence: Nitinol coil with an ePTFE polymeric cover | The device uses a Nitinol coil with an ePTFE polymeric cover, which is the same as the predicate device. |
| Design Features Equivalence: Flexibility, low profile, immediate/acute occlusion, ePTFE cover, retrievability, two-stage deployment handle, stiff proximal/flexible distal catheter sections, side port for flushing/pre-expansion. | The device is described with flexible, low profile for immediate, acute occlusion, incorporates an ePTFE cover, is retrievable, has a two-stage deployment handle, a stiff proximal section for pushability and a flexible distal section for trackability, and a side port to accommodate syringe attachment to flush and pre-expand the ePTFE membrane. These features are directly compared and found to be the same as the predicate device. |
| Mechanical Detachment Method Equivalence: Mechanical in nature | The detachment mechanism is mechanical in nature, same as the predicate device. |
| Treatment Method Equivalence: Permanent Implant | The treatment method is described as a permanent implant, same as the predicate device. |
| Application Method Equivalence: Via delivery catheter through guide catheter to target vessel | The device is applied via a delivery catheter through a guide catheter to the target vessel, same as the predicate device. |
2. Sample size used for the test set and the data provenance
The document explicitly states "Bench studies" and "design verification and validation testing." This indicates in-vitro or laboratory testing rather than testing on human or animal subjects. Therefore, human test set sample size and provenance information is not applicable. The data provenance would be from internal laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes bench testing and design verification/validation, not a study requiring expert clinical assessment for ground truth. The "ground truth" here would be defined by engineering specifications and predicate device performance characteristics.
4. Adjudication method for the test set
This is not applicable as the document describes bench testing and design verification/validation, not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench studies and design verification/validation directly comparing the device characteristics to a predicate, not a study involving human readers' performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a device, not an algorithm. Therefore, an algorithm-only standalone performance study is not applicable. The device's performance was evaluated in bench studies (standalone performance relative to engineering specifications and predicate device).
7. The type of ground truth used
The ground truth used for this submission is implicitly based on:
- Engineering specifications and design requirements: The device's physical dimensions, material properties, and functional capabilities (e.g., radial strength, trackability) were measured and compared against established requirements.
- Predicate device characteristics: The device was compared feature-by-feature (technological characteristics, mechanism of action, intended use, physical characteristics, materials, detachment method, application method) to a legally marketed predicate device (K133924 ArtVentive Medical Group, Inc./EOS).
- Performance "as intended": Demonstrating that the device performs according to its designed function in bench tests.
8. The sample size for the training set
This document describes a 510(k) submission focused on proving substantial equivalence based on bench testing and design verification. It details the device's characteristics and compares them to a predicate. There is no mention of a "training set" in the context of machine learning or AI, as this is a medical device approval based on physical and functional characteristics.
9. How the ground truth for the training set was established
As there is no mention of a "training set", this question is not applicable.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).