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The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

The Concerto Versa™ Detachable Coil is an embolization coil indicated for arterial and venous embolization in the peripheral vasculature. It consists of a platinum-tungsten embolization implant coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately. The Concerto Versa™ Detachable Coil is for single use and provided sterile.

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The Tembo Embolic System is a gelatin agent intended for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.

The Tembo Embolic System consists of biocompatible, dry resorbable particles of porcine gelatin in a 10 mL syringe with a non-vented luer lock cap.

The Tembo Embolic System is a gelatin agent and a sterile, single use, medical device intended for the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. The Tembo Embolic System particles are hydrated using commercially available contrast media or contrast mixed with saline. Once hydrated, the material is injected into the target blood vessels via a commercially available microcatheter for occlusion of target vasculature. The dry Tembo Embolic System gelatin particles are between 85 µm and 255 µm and the hydrated gelatin particles are between 150 µm and 450 µm.

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Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Detachable Coils are indicated for endovascular embolization of:

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

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target 360 Ultra, Target 360 Soft, Target 360 Standard, Target Helical Nano, Target Helical Ultra, Target 3D, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra.

Target Detachable Coils are stretch resistant, electrolytically detachable coils consisting of a platinum-tungsten alloy coil attached to a stainless steel delivery wire.

Target Detachable Coils are specifically designed for use with Stryker Neurovascular's InZone® Detachment System (sold separately).

Target Detachable Coils are compatible with Stryker Neurovascular 2-tip marker microcatheters; refer to Instructions for Use (IFU) for the compatible microcatheter sizes.

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The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:

• Hypervascular tumors
• Blood vessels to occlude blood flow for controlling bleeding/hemostasis in the peripheral vasculature

The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood vessel to block blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.

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The InZone IST Detachment System is intended for use with all versions of Stryker Neurovascular embolization devices in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Stryker Neurovascular's InZone IST Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular embolization devices. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

Stryker Neurovascular's IZDS Connecting Cable is a 180 cm cable intended for use with the InZone IST Detachment System in the detachment of monopolar embolization devices. The cable completes the connection between the InZone IST unit and a patient return electrode (a 20 or 22 gauge uncoated stainless-steel hypodermic needle) inserted subcutaneously at the patient's groin.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

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Polyvinyl Alcohol Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

The subject device polyvinyl alcohol embolic microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. The embolic microspheres consist of a macromer derived from polyvinyl alcohol (PVA) and are hydrophilic, non-resorbable. The preservation solution is 0.9% sodium chloride solution.

The polyvinyl alcohol embolic microspheres available in dyed (blue) and clear (undyed with natural color). The subject device available in particle sizes from 75-1200μm and supplied sterile in sterile sealed glass vials which contain 1 mL, 2 mL, or 3 mL of microspheres suspended in 7mL, 7mL, or 6 mL of 0.9% sodium chloride solution, respectively.

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The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature.

The HARBOR Occlusion Device is a self-expanding braided nitinol arterial embolization implant (Figure 1) supplied with components used for implantation (Figure 2). The Device has a radiopaque marker band attached to the proximal end of the implant. The implant is packaged collapsed within an Introducer sheath and attached to a Delivery System provided within a hoop dispenser.

The provided FDA 510(k) clearance letter and summary for the HARBOR Occlusion Device outlines the device's technical specifications and the testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study establishing performance criteria in relation to human interpretation or outcomes. Therefore, several requested sections (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness) are not applicable to the information provided.

However, the document does detail the acceptance criteria (implicitly, "Pass" for each test) and the studies (bench and animal) that prove the device meets these criteria in the context of its substantial equivalence submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly "Pass" for each test listed, indicating that the device must perform acceptably in those areas to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:

• Bench Tests: Not explicitly stated for each test, but implied to be sufficient for meeting ISO and ASTM standards.
• Animal Study: Not explicitly stated, but the study was described as "GLP Animal Study."

Data Provenance: Not explicitly stated. The document refers to "pre-clinical testing" and "GLP animal study," which are typically conducted in a controlled laboratory environment but the country of origin is not specified. The studies are prospective in nature, as they were conducted specifically for this device's submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes the technical and biological performance of a medical device (an occlusion device) rather than an AI/CADe system or a diagnostic imaging device that would typically involve expert readers for establishing ground truth on image interpretation. The "acceptance criteria" here relate to the device's physical and biological functioning.

4. Adjudication method for the test set

Not applicable. As above, this is not a study assessing observer performance or diagnostic accuracy.

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. This document does not describe an AI-enabled device or an MRMC study. It pertains to a physical medical device.

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

Not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests is established by:

• Engineering specifications and standards: For bench testing (e.g., specific tensile strength values, radial force, dimensions, nickel ion release limits).
• Biological responses: For biocompatibility tests (e.g., absence of cytotoxicity, irritation, sensitization, pyrogenicity, hemolysis, complement activation as per ISO 10993 standards).
• Physiological and pathological observations in an animal model: For the GLP animal study (e.g., direct observation of delivery, acute complications, vessel recanalization, foreign body reactions, device migration, and effectiveness of occlusion).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or system that requires a "training set."

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

Not applicable. No training set exists for this type of device.

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The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.

The Prestige Coil System is intended for use in the peripheral vasculature to endovascularly obstruct or occlude blood flow in vascular abnormalities of the peripheral vessels.

The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be permanently placed in the peripheral vessels to create blood stasis, reducing flow into the anomaly, and thrombosing the target site.

The provided FDA 510(k) Clearance Letter for the Prestige Coil System (Prestige Packing Coil Line Extension) does not describe a study involving an AI/Machine Learning device, human readers, or image interpretation. Instead, it describes a vascular embolization device and its mechanical and physical performance testing.

Therefore, many of the requested points in your prompt are not applicable to this document, as they relate to studies of AI performance or human reader studies in diagnostic imaging, which is not the subject of this 510(k) clearance.

However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the performance testing conducted.

Here's the breakdown based on the provided document:

Device: Prestige Coil System (Prestige Packing Coil Line Extension)

Type: Vascular Embolization Device (mechanical medical device)
Purpose: Arterial and venous embolizations in the peripheral vasculature.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document repeatedly mentions "test samples" but does not specify the exact number of samples used for each test (Visual Inspection, Dimensional Inspection, Resistance Check, and Simulated Use).
• Data Provenance: Not applicable in the context of clinical data. This refers to bench testing involving physical device samples. No specific country of origin or retrospective/prospective data collection is mentioned as this relates to device manufacturing and testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. "Ground truth" in this context refers to the defined engineering specifications and performance characteristics of the device. These are established through design controls, manufacturing standards, and engineering principles, not through expert consensus on medical image interpretation. The "experts" would be engineers and quality control personnel involved in the device's design and testing.

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

• Not Applicable. This is a concept related to consensus building among human readers (e.g., radiologists) for establishing ground truth in image-based studies. For physical device bench testing, the "adjudication" is based on objective measurements against pre-defined engineering specifications and Pass/Fail criteria. No multi-reader adjudication method applies here.

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 document describes a vascular embolization device, not an AI/Machine Learning diagnostic device. Therefore, no MRMC study or AI assistance was involved.

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

• Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the device's inherent functional capabilities as demonstrated in the bench tests, which are independent of a human operator's actions beyond following the instructions for use during the test.

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

• The "ground truth" for this device's performance testing is based on pre-established engineering specifications, design requirements, and manufacturing tolerances for the physical device. The device passes if its measured physical and functional characteristics meet these objective, pre-defined criteria. There is no biological "ground truth" (like pathology or outcomes data) in this specific submission, as it focuses on demonstrating the substantial equivalence of a modified mechanical device through bench testing.

8. The sample size for the training set

• Not Applicable. This applies to AI/Machine Learning models, not physical medical devices undergoing bench testing. The device itself is not "trained."

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

• Not Applicable. As above, this applies to AI/Machine Learning models.

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Embosphere Microspheres are indicated for use in the embolization of:

• Hypervascular tumors, including symptomatic uterine fibroids
• Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH)
• Arteriovenous malformations
• Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature

Embosphere Microspheres are small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and non-pyrogenic in a vial or in a syringe.

The product is provided in seven size ranges to allow physicians to choose the appropriate size necessary for the vessel being embolized. The size ranges available are:
• 50-100 microns
• 40-120 microns
• 100-300 microns
• 300-500 microns
• 500-700 microns
• 700-900 microns
• 900-1200 microns

The principles of operation for the subject device Embosphere Microspheres are the same as the predicate device Embosphere Microspheres (K181300). Embosphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. All indications for Embosphere Microspheres; uterine arteries, arteriovenous malformations, hypervascular tumors and prostate arteries all involve arterial embolization. The procedure of arterial embolization is similar for all arteries. Appropriately sized microspheres for target vessel occlusion are chosen by the trained interventional radiologist. The delivery procedure involves arterial access through an artery, using a guidewire and microcatheter under fluoroscopic guidance. Once the catheter tip is placed in the artery(ies) supplying the targeted tissue, Embosphere Microspheres mixed with a non-ionic contrast agent are delivered in a controlled manner under visualization to occlude the feeding vessel(s) to interrupt artery blood flow to the targeted area. The device is intended for single use.

I am sorry, but the provided text is an FDA 510(k) Clearance Letter for a medical device (Embosphere Microspheres). It details the regulatory clearance process, the device's intended use, and its equivalence to a predicate device.

This document does NOT contain information about any AI/ML model, its acceptance criteria, or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot extract the information required to answer your request regarding the acceptance criteria and the study proving the device meets them, as it pertains to an AI model. The provided text describes a physical medical device and its regulatory review, not a software or AI-driven diagnostic tool.

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