(190 days)
The CEREPAK™ Uniform, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indication of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arterial and arterial and venous embolizations in the peripheral vasculature.
The CEREPAK™ Freeform XtraSoft Detachable Coil System is indication of intracranial aneurysms.
CEREPAK™ is a platform delivery system that aids in the delivery of embolic coils (or "microcoils") using standard endovascular methods to treat hemorrhagic conditions. It consists of two main components, the CEREPAK™ Detachable Coils, and the CEREPAK™ Detacher. These components will be provided sterile and sold separately. The CEREPAK™ Detachable Coils are comprised of an embolic coil implant (microcoil) attached to a delivery system. The CEREPAK™ Detacher is a mechanical accessory that aids in the detachment of the CEREPAK™ Detachable Coils.
The delivery system of the CEREPAK™ Detachable Coils consists of a long, thin hypotube (delivery tube) shaft with an attachment interface to secure the microcoil at its distal end until deployment is required. Microcoil designs are based on the microcoils present in the predicate device. The delivery tube is advanced with the microcoil through a compatible microcatheter using standard endovascular techniques until the microcoil is placed at the target lesion.
The CEREPAK™ Detacher interacts with the delivery system to detach the microcoils. Upon finger actuation, the Detacher translates (slides) a component within the delivery tube that aided in securing the microcoil. This detaches the microcoil from the delivery tube. Once the microcoil is detached at the desired location, the delivery tube can be removed and discarded.
The provided document is a 510(k) Premarket Notification for a medical device (CEREPAK™ Detachable Coil Systems), not an AI/ML device. Therefore, the questions regarding acceptance criteria and study design for AI/ML performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.
The document describes non-clinical bench testing and an animal study to demonstrate substantial equivalence to a predicate device, focusing on the physical and functional performance of the embolization coils and their delivery system.
Here's an attempt to answer the applicable parts based on the document's content, focusing on what is provided:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Performance Testing Summary" (Table 5) and "Biocompatibility Test Summary" (Table 6). For all tests listed, the acceptance criteria are generally implied by the "Objective" of the test, and the reported performance is consistently a categorical "PASS." Specific quantitative acceptance criteria or detailed numerical results are not provided in this summary.
Table: Acceptance Criteria (Implied) and Reported Device Performance
| Test | Implied Acceptance Criteria (Objective) | Reported Device Performance |
|---|---|---|
| CEREPAK™ Detachable Coils - Design Verification | ||
| Manual Break Joint Integrity After Transit | Ensure that the manual break joint is not kinked or separated after transit. | PASS |
| Crimp Integrity After Transit | Ensure that the proximal inner tube does not accidentally translate prematurely after transit. | PASS |
| Track Force (Delivery) | Evaluate the force necessary to deliver the proposed device through a microcatheter in a simulated tortuous anatomy model. | PASS |
| Microcatheter Pullback | Measure the distance the microcatheter retracts comparing the tip position from prior to coil delivery to when the entire embolic coil is exposed out of the distal tip of the microcatheter. | PASS |
| Microcatheter Tip Deflection | Measure the deflection angle at the microcatheter tip as the device is advanced to the detachment position. | PASS |
| Overall Length | Measure the overall length of the delivery tube shaft of the CEREPAK™ delivery system. | PASS |
| Fluorosaver Location | Verify the location of the fluorosaver marker relative to the distal end of the microcoil. | PASS |
| Fluorosaver Marker Durability | Verify that the fluorosaver marker remains visible on the delivery system after 6 delivery and 5 withdrawal cycles. | PASS |
| Delivery System Outer Diameter | Measure the overall outer diameter of the CEREPAK™ delivery system. | PASS |
| Marker Band Location | Verify the location of the radiopaque marker relative to the distal end of the delivery tube. | PASS |
| Detachment Zone Strength | Measure the tensile strength of the detachment zone to prevent premature separation of the microcoil from the detachment system. | PASS |
| Delivery System Weld Strength | Measure the break load required to separate the overall delivery system. | PASS |
| Key to Coil Weld Strength | Measure the force required to separate the proximal key from the microcoil wire. | PASS |
| Durability (Pull Wire Position) | Verify the pull wire position relative to the proximal key shoulders after durability simulation (6 advancements and 5 withdrawals) to evaluate any movement. | PASS |
| Detachment Reliability with Detacher | Verify microcoil separation from the delivery tube and inner tube translation after using the Detacher to detach the microcoil. | PASS |
| Inner Tube/Pull Wire Joint Strength | Measure the strength of the joint between the pull wire and the proximal inner tube. | PASS |
| Inner Tube Outer Diameter | Measure the outer diameter of the proximal inner tube. | PASS |
| Inner Tube Length | Measure the overall length of the proximal inner tube and the length of the proximal inner tube that is exposed outside the main delivery tube. | PASS |
| Detachment Reliability with Manual Break | Verify microcoil separation from the delivery tube after using the manual break method to detach the microcoil. | PASS |
| Manual Break Feature Buckling | Measure the force required to buckle the delivery system using the manual break feature. | PASS |
| Particulate Evaluation | Measure particulates generated during simulated use with the CEREPAK™ Detachable Coils. | PASS |
| Manual Break Markers Location | Measure the spacing between the 2 manual break indicators, the distance between the manual break and each indicator, and the distance from the manual break to the proximal end of the main delivery tube. | PASS |
| Detachment Kickback | Measure the distance the delivery system retracts after detachment. | PASS |
| Microcoil Secondary Shape | Verify the secondary shape of the microcoil. | PASS |
| Microcoil Secondary Diameter | Measure the secondary shape diameter of the microcoil. | PASS |
| Microcoil Length | Measure the length of the microcoil. | PASS |
| Atraumatic 2 Terminal Ends | Verify that the two terminal ends of the microcoil have rounded edges and no sharp features. | PASS |
| Stretch Resistance of Suture | Evaluate the force at which the stretch resistant suture (SRS) fails to resist stretching. | PASS |
| Introducer Secured After Transit | Ensure that the introducer is within the packaging hoop in the correct location and the microcoil is not exposed out of the introducer after transit. | PASS |
| Introducer Dimensions | Verify the introducer length, outer diameter, taper angle and inner diameter. | PASS |
| Introducer Purge Holes Dimensions | Verify the introducer purge hole diameter and distance from the introducer tip to the purge hole. | PASS |
| Introducer Re-Sheathing | Confirm that the introducer can be re-sheathed successfully without damage to the microcoil or delivery system. | PASS |
| MRI Testing | Determine the safety in the magnetic resonance (MR) environment and the appropriate parameters for MR conditional labeling. | PASS |
| CEREPAK™ Detacher - Design Verification | ||
| Integrity after Transit | Ensure the nose cone and housing assembly of the Detacher are intact to maintain product performance. | PASS |
| Max User Input Force | Measure the maximum user input force required to actuate the slider on the detacher. | PASS |
| Slider Travel Distance and Min Input Force | Measure the distance of slider travel and user input force required to begin the detachment motion. Confirm that the spring returns the components to their initial position after use. | PASS |
| Multiple Cycle Durability | Measure the distance the Detacher translates the inner tube after 20 detachment cycles and to ensure the delivery system encounters a hard stop in the Detacher after 20 cycles. | PASS |
| Nose Cone Insert Hard Stop and Clearance | Measure the diameter of the nose cone insert proximal hole where the delivery tube will encounter a hard stop upon insertion into the Detacher. | PASS |
| Insertion Max Force | Measure the maximum force exerted on the Detacher during insertion of the proximal end of the delivery system. | PASS |
| Printed Logo and Name Verification | Ensure that the logo is printed on the CEREPAK™ Detacher. | PASS |
| CEREPAK™ Detachable Coils and Detacher - Design Validation | ||
| In-Vitro Usability Study | Evaluate various aspects of product performance under simulated use conditions utilizing a silicone arterial model which simulates clinically relevant anatomy. | PASS |
| Biocompatibility Testing | ||
| Cytotoxicity | Non-cytotoxic | PASS |
| Sensitization | Non-sensitizing | PASS |
| Irritation or Intracutaneous Reactivity | Non-irritating | PASS |
| (Acute) Systemic Toxicity | Negative | PASS |
| Genotoxicity | Non-genotoxic | PASS |
| Hemocompatibility (ASTM Hemolysis) | Non-hemolytic | PASS |
| Hemocompatibility (SC5b-9 Complement Activation Assay) | Not a potential activator of complement system (for coils), Not a potential activator of complement system (for delivery system) | PASS |
| In Vivo Thromboresistance Study (delivery system component) | Thromboresistant | PASS |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: The document states that "All testing was conducted using sampling methods as required by internal procedure," but it does not specify the exact sample sizes for each bench test. For the "In-Vitro Usability Study," it mentions it was conducted with "skilled users" using a "silicone arterial model." For the "Animal Study," it mentions it was conducted "in a porcine model," again without specifying the number of animals.
- Data Provenance (Country of Origin and Retrospective/Prospective): The document does not specify the country of origin for the data or whether the data was retrospective or prospective. Given these are non-clinical bench and animal studies to support a 510(k) submission, they would inherently be prospective studies conducted by the manufacturer (Medos International, SARL). The manufacturer is based in Switzerland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI/ML model for this type of device (embolization coil system). The performance tests are largely engineering and material science evaluations against predefined specifications. The "skilled users" mentioned in the usability/animal studies would be medical professionals (e.g., interventional neuroradiologists) demonstrating the use of the device, but not establishing a "ground truth" in the sense of diagnostic interpretation for an AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no diagnostic "test set" requiring adjudication by multiple experts.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm. The device's performance is inherently tied to its physical interaction with the human body and the user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's acceptance is based on predefined engineering specifications, material properties, and functional performance requirements of the device, derived from established standards and comparison to a legally marketed predicate device. For biocompatibility, it's based on International Standard ISO 10993-1 and FDA Guidance. For physical performance, it's based on successful operation within simulated environments and animal models ("PASS" results on specific functional tests).
8. The sample size for the training set:
Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML training set.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).