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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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Penumbra Coil 400:

• Intracranial aneurysms.
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature.

Ruby Coil System:

• Arterial and venous embolizations in the peripheral vasculature.

POD System (For POD Coils with nominal sizes ≤ 6 mm):

• Intracranial aneurysms.
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature.

POD System (For POD Coils with nominal sizes > 6 mm):

• Arterial and venous embolizations in the peripheral vasculature.

The subject devices (Penumbra Coil System and POD System) are designed for embolization in the neuro and/or peripheral vasculature. This is achieved by using coils to exclude the intended treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. The subject devices consist of a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. The devices should only be used by physicians who have received appropriate training in interventional techniques.

The subject devices consist of the following components:

• Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
• Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
• Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
• Detachment Handle: The Detachment Handle is packaged separately. It is intended for use in multiple coil detachments performed during a single procedure.

This document, a 510(k) Premarket Notification for the Penumbra Coil System and POD System, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance, especially concerning Artificial Intelligence (AI) or software-based diagnostics.

Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), and training set information are not applicable to this type of submission. This document describes a medical device (embolization coils) that is a physical product, not an AI/software device.

Here's an attempt to extract relevant information and note where the requested information is not present:

Device: Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System); POD System
Device Type: Neurovascular Embolization Device

Acceptance Criteria and Reported Device Performance (Non-AI/Software Context)

For this physical device, "acceptance criteria" are typically defined by engineering specifications and performance benchmarks, proven through bench-top (laboratory) and biocompatibility testing. The "performance" is the passing of these tests, demonstrating that the device functions as intended and is safe.

Here's a table based on the provided "Bench-Top Testing" and "Biocompatibility Testing" sections:

Information Not Applicable or Not Provided for This Type of Submission (AI/Software-Specific Questions)

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

   • N/A. This is a physical device, and the "test set" here refers to the number of units or biological samples used in bench-top and biocompatibility testing, not a clinical data set for an AI model. The document does not specify the number of units tested for each bench-top criterion. Biocompatibility tests followed ISO and CFR guidelines.

2. 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):

   • N/A. Ground truth establishment by experts is relevant for AI/diagnostic software. For a physical device, ground truth is established by objective measurements against engineering specifications and biological material reactions.

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

   • N/A. Adjudication is for resolving discrepancies in expert interpretations, not for physical device testing.

4. 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:

   • N/A. This applies to AI-assisted diagnostic tools, not physical embolization coils.

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

   • N/A. This applies to AI/software.

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

   • For this device, "ground truth" related to performance is based on engineering specifications, direct physical measurements, and well-established biological response criteria (e.g., cell viability, immune response markers) in a laboratory setting, as well as adherence to recognized standards like ASTM and ISO. There is no "expert consensus" on ground truth for the physical and biological properties being tested here in the way there would be for a diagnostic image.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/machine learning device.

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

   • N/A. There is no "training set" or AI model.

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