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The Nitinol Enhanced Device (NED) is intended for arterial and venous embolization in the peripheral vasculature. This device is not intended for neurovascular use.

The NED system is comprised of polymer-based occlusion devices intended for embolization procedures in 3-6 mm vessels of the peripheral vasculature. It is intended to be used with 0.027" labeled microcatheters. The NED consists of three components: the NED implants (framing and packing), the delivery system, which is supplied engaged with the implant, and the transfer/removal tool.

The NED framing and packing implants are permanently implanted and include a 0.016" diameter polymer filament which compacts upon delivery. The implants work together to obstruct blood flow in the vessel. The framing implant is deployed first to form the initial pack and create a backing for additional implants to be deployed in accordance with physician discretion. The deployment of the framing implant is followed by the deployment of packing implants, the quantity of which is determined by the physician based on vessel size and occlusion. The physician also has the option to finish the implant pack with another framing implant. The UHMWPE braid on the implants and the nylon 6,6 tails on the packing implant provide a scaffold for thrombus to form and attach. The combination of the mechanical obstruction of blood flow and the formation of thrombus result in vessel occlusion.

The delivery system is comprised of two components: the implant pusher and the introducer. The NED delivery system comes with the NED implant pre-loaded in its package, sterile and ready for use. The pusher is a 180 cm long 0.022" diameter single super-elastic nitinol wire with a 30 cm PTFE jacket and a platinum/iridium radiopaque marker near its distal end. The nitinol pusher coupler is located on the distal end of the pusher, which as described above, serves to engage with the coupler on the implant's proximal end. The NED pusher allows the physician to reposition the NED to ensure preferred vessel positioning prior to detachment. Further, the detachment mechanism provides the physician the ability to completely withdraw the NED before detachment, should a condition result that necessitates its removal. The introducer is a PTFE tube used to protect the implant and maintain coupling between the implant and pusher prior to use (as described in Section 2.1). Once the implant and pusher are transferred into the delivery microcatheter, the introducer is discarded.

The transfer/removal tool is a disposable accessory included with the device that attaches to the hub of the delivery microcatheter prior to inserting the implant. The purpose of the transfer/removal tool is to facilitate the transfer of the implant from the device introducer into the delivery microcatheter hub and to facilitate the removal of the implant from the delivery microcatheter if necessary. The transfer/removal tool is designed to fit 0.027" labeled microcatheters. The tool is comprised of an ABS and PC Luer adapter assembly bonded with medical grade Dymax 1162-M UV adhesive. The tool utilizes a spring-loaded 300 series stainless steel tube to form the lumen.

This FDA 510(k) clearance letter pertains to a physical medical device, the Nitinol Enhanced Device (NED), not a device that relies on algorithms/AI in a way that necessitates the detailed criteria requested. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing for a vascular embolization device. It does not involve AI or software-driven performance assessment, and thus lacks information on acceptance criteria for AI performance, human expert evaluation, MRMC studies, or training/test set specifics for algorithms.

However, I can extract the relevant non-clinical performance data and the study details that were provided to demonstrate the device meets its requirements for substantial equivalence.

Acceptance Criteria and Study for Nitinol Enhanced Device (NED)

The Nitinol Enhanced Device (NED) is a physical medical device, specifically a vascular embolization device. The provided FDA 510(k) clearance letter does not describe an AI/software-driven device, therefore, many of the typical acceptance criteria and study details associated with such devices (e.g., AI performance metrics, expert adjudication, training/test set sizes for algorithms) are not applicable to this submission.

Instead, the device's acceptance criteria are met through a series of non-clinical performance tests designed to demonstrate the device's safety, functionality, and substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device without explicit AI performance metrics, the "acceptance criteria" are generally implied by successful completion of various engineering, biocompatibility, and functional tests according to established standards. The "reported device performance" refers to the successful outcome of these tests.

2. Sample Size Used for the Test Set and Data Provenance

This information is not detailed in the provided 510(k) summary. For physical device testing, sample sizes are typically determined based on statistical requirements for each specific test (e.g., number of units tested for tensile strength, number of animals in GLP studies). The document only states that the device "passed all testing."

• Test Set Sample Size: Not specified for individual tests.
• Data Provenance: The GLP Safety Study (Acute Ovine Study) and GLP Subchronic Ovine Product Validation Study were conducted using ovine (sheep) models. Details on the origin of the animals or whether these were prospective studies are not provided, but GLP (Good Laboratory Practice) studies are inherently prospective and controlled. The in-vitro and bench testing would have been conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This device is not an AI/software device requiring human expert ground truth for image interpretation or similar tasks. The "ground truth" for this device's performance is established by objective measurements against engineering specifications, biological responses in animal models, and adherence to established standards.

4. Adjudication Method for the Test Set

Not Applicable. There was no human expert adjudication of results as there were no subjective clinical assessments of AI performance or image interpretation involved. Performance was assessed through objective measurements and compliance with standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic or interpretative devices. The NED is a physical embolization device.

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

Not Applicable. The NED is a physical medical device; there is no 'algorithm only' component to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Successful completion and meeting pre-defined requirements for mechanical properties (e.g., tensile strength, detachment force), delivery characteristics, and material compatibility.
• Established Standards: Adherence to national and international standards (e.g., ASTM, ISO 10993-1) for material properties (corrosion, biocompatibility) and functional tests.
• Biological Outcomes: In vivo studies (Acute Ovine Study, Subchronic Ovine Product Validation Study) provided ground truth on the biological response to the implanted device, including safety and product validation in a living system.

8. The Sample Size for the Training Set

Not Applicable. There is no 'training set' as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no 'training set' or associated ground truth establishment process for this type of device.

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The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System is intended to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for coronary or neurovascular use.

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable non-fibered embolic coil. The EMBOLD™ Soft coil can be delivered to challenging peripheral anatomy, and the EMBOLD™ Packing coil is highly conformable to enable dense packing. The device is compatible with 0.027-inch microcatheters. In addition, the device features a mechanical detachment mechanism consisting of an inner pull wire connecting the coil and delivery wire coupler arms, activated by the user through a proximal laser-etched outer wire perforation. The delivery wire design allows the coil to be fully advanced, retracted, and deployed prior to final placement. The EMBOLD™ Soft and EMBOLD™ Packing Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.

Here's an analysis of the provided FDA 510(k) summary for the EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System, focusing on the requested information regarding acceptance criteria and the supporting study:

The provided document is a 510(k) summary, which is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. It does not describe acceptance criteria for a diagnostic algorithm or a study proving that a device meets such criteria in terms of accuracy or clinical performance (e.g., sensitivity, specificity). Instead, it focuses on the performance of a medical device (embolic coils) in terms of its physical and functional characteristics.

Therefore, many of the requested fields cannot be directly answered from this document, as they pertain to clinical performance studies for diagnostic or AI-driven devices, which is not the subject of this 510(k).

However, I can extract the relevant information regarding the performance data and equivalence testing for this specific type of device.

Acceptance Criteria and Device Performance (as interpreted for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

For an embolic coil system, "acceptance criteria" and "reported device performance" are geared towards physical and functional specifications to ensure safety and effectiveness, rather than diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical images or patient data. For physical device testing (bench, animal), specific numbers of coils, devices, or animals tested are not provided in this summary.
• Data Provenance: Not applicable in the context of image data. The testing is for the physical device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts & Qualifications: Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for this type of device and study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI-driven diagnostic tool where human reader performance would be a factor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For this type of device, the "ground truth" for performance is generally defined by engineering specifications, validated test methods (e.g., ISO standards), and a comparison to the established performance of a predicate device. It's not a clinical "ground truth" like pathology or outcomes data in the usual sense for a diagnostic device.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable. There is no training set for this device.

Summary of Device and its Assessment - As per the K230706 Document:

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System are physical vascular embolization devices. The FDA clearance (K230706) is based on demonstrating substantial equivalence to a previously cleared predicate device (EMBOLD™ Fibered Detachable Coil System, K213398).

The evidence provided to the FDA for this substantial equivalence included:

• Bench Testing: To assess mechanical properties, design, and material characteristics.
• Animal Testing: Likely to evaluate in-vivo performance, deliverability, and deployment.
• Biocompatibility Testing: In accordance with ISO 10993 standards to ensure the materials are safe for human contact.

The conclusion of the submission states that the proposed device is "as safe and effective as the predicate" because:

• It has the same intended use.
• It incorporates "substantially equivalent device materials and design, fundamental technology, manufacturing processes, sterilization process."
• Differences in technological characteristics (packing coil shape, non-fibered coil) do not raise new questions of safety and effectiveness, supported by the results of the aforementioned testing.

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