FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Nester® and Tornado® Embolization Coils are constructed from coiled platinum wire and synthetic fibers. The wire forms primary coil diameters that can be delivered through catheters with end hole diameters of 0.018, 0.035, and 0.038 inch. For the Nester® Embolization Coils, the extended embolus lengths range from 3 to 20 cm, and upon deployment the coiled embolus diameters range from 2 to 20 mm. For the Tornado Embolization Coils, the extended embolus lengths range from 2 to 14.2 cm, and upon deployment the coiled embolus tapering diameters range from 3/2 to 10/5 mm.

AI/ML Overview

This document describes K153778, an FDA 510(k) premarket notification for the Nester® and Tornado® Embolization Coils. It focuses on demonstrating substantial equivalence to a predicate device. The information provided is primarily related to benchtop performance, biocompatibility, and animal testing rather than AI/algorithm performance. Therefore, many of the requested criteria are not applicable.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing (Implantable Embolization Coils)	All tests results met the acceptance criteria or demonstrated that the device is biocompatible.	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility, and Pyrogenicity tests were performed. All tests results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible.
Biocompatibility Testing (Loading Stylet & Cartridge)	All tests results met the acceptance criteria or demonstrated that the device is biocompatible.	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Hemocompatibility tests were performed. All tests results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible.
Wire Tensile Testing	Peak load value ≥ minimum tensile strength requirements.	Testing shows the raw wire has a peak load value greater than or equal to the minimum tensile strength requirements. The predetermined acceptance criteria were met.
Coil Tensile Testing	(Not explicitly stated, but implied to characterize strength)	Testing characterized the embolization coils' uniaxial tensile strength. (No specific numerical acceptance criteria mentioned, but assumed to be adequate for safe use).
Rotations to Failure Testing	(Not explicitly stated, but implied to characterize strength)	Testing characterized the embolization coils' torque strength. (No specific numerical acceptance criteria mentioned, but assumed to be adequate for safe use).
Delivery Friction Testing	Embolization coils fully deploy into the portion of the target artery in an anatomical model.	Testing shows that the embolization coils fully deploy into the portion of the target artery in an anatomical model. The predetermined acceptance criteria were met.
Delivery Fatigue Testing	No visual defect after delivery.	Testing shows that the embolization coils do not have any visual defect after delivery. The predetermined acceptance criteria were met.
Fiber Security Testing	An entire fiber is not released from the coils during simulated delivery conditions.	Testing shows that an entire fiber is not released from the coils during simulated delivery conditions. The predetermined acceptance criteria were met.
MRI Testing	Compatible within specified magnetic field interactions, artifact, and RF-induced heating.	MRI compatibility was assessed by evaluating magnetic field interactions (displacement force and torque), artifact, and RF-induced heating in accordance with FDA guidance. (Stated as MR Conditional).
Animal Testing (Safety)	Target arteries do not indicate a substantially adverse biological response.	One-month, three-month, and six-month safety evaluations in swine were performed on platinum embolization coils. Testing shows that the target arteries do not indicate a substantially adverse biological response. The predetermined acceptance criteria were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: This document does not specify exact sample sizes for each bench test. For animal testing, it mentions "One-month, three-month, and six-month safety evaluations in swine," implying multiple animals, but the exact number is not stated.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a 510(k) submission for a medical device by Cook Incorporated (based in Bloomington, Indiana, USA), the testing would typically be conducted by or for the manufacturer, likely within the US or by certified labs globally. The nature of bench and animal testing is prospective in design for the purpose of demonstrating device performance and safety.

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):

Not Applicable. This document describes a medical device (embolization coils) and its performance through bench and animal testing. It does not involve interpretation of medical images or data by experts to establish a "ground truth" in the way an AI algorithm might require. The "ground truth" here is the physical and biological performance as measured by the predetermined acceptance criteria in the various tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. As mentioned above, this is not an AI/diagnostic algorithm study requiring human adjudication of ground truth. Performance is determined by meeting objective engineering and biological criteria.

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-assisted diagnostic study. It's a submission for a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established through:
- Objective engineering specifications and measurements: For tests like wire tensile strength, coil tensile strength, rotations to failure, delivery friction, delivery fatigue, and fiber security.
- Established biological and toxicological standards: For biocompatibility testing (e.g., ISO 10993 series).
- Pathological assessment (implied for animal studies): For the animal safety evaluations, although not explicitly stated, the assessment of "substantially adverse biological response" would typically involve histological examination (pathology) of the target arteries by qualified veterinary pathologists.
- Regulatory guidance: MRI compatibility assessment followed FDA guidance.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device. Therefore, there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/machine learning device.

Summary

Regulation Number and Section

§ 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).