(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.
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July 14, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medos International, SARL Michael Liao Regulatory Affairs Manager Chemin-Blanc 38 Le Locle, 2400 Switzerland
Re: K220040
Trade/Device Name: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG. KRD Dated: June 15, 2022 Received: June 16, 2022
Dear Michael Liao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220040
Device Name
CEREPAKTM Uniform, Uniform XL, Uniform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freetorm, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Submitter Medos International, SARL Chemin-Blanc 38 2400 Le Locle, Switzerland
Contact Person: Michael Liao Tel: (925) 999-8646 Email: mliao7@its.jnj.com Date Prepared: July 14, 2022
II. Device
Information
| Table 1: Device Information | |
|---|---|
| Device Proprietary Name | CEREPAKTM Uniform, Uniform XL, Uniform 3D, Heliform Soft, HeliformXtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, andFreeform XtraSoft Detachable Coil Systems |
| Common or Usual Name | Device, Neurovascular Embolization & Device, Vascular, For PromotingEmbolization |
| Classification Name | Device, Neurovascular Embolization, Class II, 21 CFR 882.5950 & Vascular,For Promoting Embolization, Class II 21 CFR 870.3300 |
| Regulatory Classification | II |
| Product Codes | HCG, KRD |
| Review Panel | Neurology, Cardiovascular |
III. Predicate and Reference Devices
The predicate device is provided in Table 2 below.
| Table 2. Primary Predicate Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer* |
| K150319 | 6/12/2015 | MICRUSFRAME, DELTAFILL, DELTAXSFT,GALAXY G3, and GALAXY G3 XSFT MicrocoilDelivery Systems (this grouping is branded asCERENOVUS SPECTRA™ Family of Coils) | MedosInternational,SARL |
| * The manufacturer at time of clearance was Codman & Shurtleff, Inc. The current manufacturer is provided above. |
In addition, the following reference device is used in this 510(k) submission to support certain design elements.
| Table 3. Reference Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer* |
| K171862 | 9/25/2017 | GALAXY G3 Mini Microcoil Delivery System | MedosInternational,SARL |
| *The manufacturer at time of clearance was Codman & Shurtleff, Inc. The current manufacturer is provided above. |
There have been no prior submissions for the subject CEREPAK™ Detachable Coil Systems.
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IV. Device CEREPAK™ is a platform delivery system that aids in the delivery of embolic coils (or Description "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 CEREPAKTM Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform V. Indications for Use XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature.
The CEREPAK™ Freeform XtraSoft Detachable Coil System is indicated for embolization of intracranial aneurysms.
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Endovascular coil embolization is the technological principle for both the subject and VI. Predicate Comparison predicate devices. A comparison of the similarities and differences between the CEREPAKTM Detachable Coil Systems and the predicate and reference devices is presented in Table 4.
| Table 4. Subject, Predicate and Reference Device Comparison Summary | |||
|---|---|---|---|
| Description | Predicate Device: MICRUSFRAME, DELTAFILL,DELTAXSFT, GALAXY G3, and GALAXY G3XSFT Microcoil Delivery Systems (K150319) | Reference Device:GALAXY G3 Mini MicrocoilDelivery System (K171862) | This Submission (K220040):CEREPAKTM Uniform, Uniform XL, Uniform 3DHeliform Soft, Heliform XtraSoft, Heliform XL,Heliform XtraSoft XL, Freeform, Freeform Mini,and Freeform XtraSoft Detachable Coil Systems |
| Indications forUse | MICRUSFRAME, DELTAFILL, and DELTAXSFTMicrocoil Delivery Systems are intended forendovascular embolization of intracranialaneurysms, other neurovascular abnormalities suchas arteriovenous malformations and arteriovenousfistulae, and are also intended for arterial and venousembolizations in the peripheral vasculature.The GALAXY G3 Microcoil Delivery System isintended for endovascular embolization ofintracranial aneurysms, other neurovascularabnormalities such as arteriovenous malformationsand arteriovenous fistulae, and is also intended forarterial and venous embolizations in the peripheralvasculature.The GALAXY G3 XSFT Microcoil Delivery Systemis intended for endovascular embolization ofintracranial aneurysms. | The GALAXY G3 MiniMicrocoil Delivery System isintended for endovascularembolization of intracranialaneurysms, other neurovascularabnormalities such asarteriovenous malformationsand arteriovenous fistulae, andis also intended for arterial andvenous embolizations in theperipheral vasculature. | The CEREPAKTM Uniform, Uniform XL, Uniform3D, Heliform Soft, Heliform XtraSoft, Heliform XL,Heliform XtraSoft XL, Freeform, and Freeform MiniDetachable Coil Systems are indicated forembolization of intracranial aneurysms,neurovascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae, and arterialand venous embolizations in the peripheralvasculature.The CEREPAKTM Freeform XtraSoft DetachableCoil System is indicated for embolization ofintracranial aneurysms. |
| Classification | Class II, 21 CFR 882.5950 & 870.3300 | Same as predicate | |
| Product Code | HCG, KRD | Same as predicate | |
| Microcoil* | |||
| MicrocoilMaterial | Platinum/Tungsten | Platinum/Tungsten | Same as predicate |
| MicrocoilPrimary Wind | Triangular or Cylindrical | Cylindrical | Same as predicate |
| MicrocoilSecondary Shape | Complex, Helical, or Spherical | Complex | Same as predicate |
| MicrocoilStretch-ResistantSuture | PGA=Polyglycolic Acid SuturePP= Polypropylene Suture | PP= Polypropylene Suture | PP= Polypropylene Suture |
| ProximalInterface | Soldered socket ring attaches to delivery system | Welded key head attaches to delivery system | |
| Primary CoilWind OuterDiameter | 0.010"-0.015" | 0.009" | 0.009"-0.015" |
| SecondaryShape OuterDiameterRanges | 1.5mm - 24mm | 1mm - 3mm | 1mm - 24mm |
| MicrocoilLength Ranges | 1cm - 60cm | 1cm - 8cm | 1cm - 60cm |
| MicrocatheterCompatibility | 0.0165" to 0.021" inner lumen diameter | 0.0165" to 0.017" inner lumendiameter | 0.0165" to 0.021" inner lumen diameter |
| *CEREPAKTM includes microcoil configurations equivalent in size and shape to the predicate (K150319) and reference (K171862) devices. The predicate (K150319)includes most of the microcoil configurations that are equivalent to the CEREPAKTM. The reference device (K171862) is added to complete the range of equivalentmicrocoil offerings in the CEREPAKTM catalog. Therefore the range of microcoil sizes is the combination of the predicate and reference devices. |
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| Table 4. Subject, Predicate and Reference Device Comparison Summary, continued | |||
|---|---|---|---|
| Description | Predicate Device:MICRUSFRAME, DELTAFILL, DELTAXSFT,GALAXY G3, and GALAXY G3 XSFT MicrocoilDelivery Systems (K150319) | Reference Device:GALAXY G3 Mini MicrocoilDelivery System (K171862) | This Submission (K220040):CEREPAKTM Uniform, Uniform XL,Uniform 3D, Heliform Soft, HeliformXtraSoft, Heliform XL, Heliform XtraSoftXL, Freeform, Freeform Mini, and FreeformXtraSoft Detachable Coil Systems |
| Delivery System (K150319 and K171862 have the same Delivery System) | |||
| Delivery SystemType | Wire Shaft with radiopaque marker | Hypotube with arrangement of wires andradiopaque marker | |
| RadiopaqueMarkerLocation | 3cm from distal tip | Same as predicate | |
| IntroducerSheath Material | HDPE | Same as predicate | |
| Introducer TipFlush Ports | 3 flush ports | Same as predicate | |
| Delivery SystemLength | 190cm ± 5cm | Same nominal, tighter tolerances:190 cm ± 2cm | |
| Fluoro SaverMarkers | Five Markers Located at the Proximal End | Same as predicate | |
| Fluoro SaverMarkerMicrocatheterCompatibility | 150cm Length | Same as predicate | |
| DetachmentInterfaceMaterial | Polyolefin Elastomer | Nitinol loop wire and 304 SS pull wire coated withPTFE | |
| Delivery SystemOuter Diameter | 0.0159" Max | 0.0156" Max | |
| Other Materials/ Components | Various | Various - different from predicate** | |
| Mechanism ofDetachment | Connection to Microcoil System hub using Connecting Cable or EnPOWER ControlCable | Connection to accessory CEREPAKTMDetacher via slip fit with the proximal innertube | |
| Detachment | Detachment: Thermo-Mechanical System uses the EnPOWER Detachment Control Box(DCB) with EnPOWER Control Cable or Connecting Cable | Detachment: Mechanical finger actuation ofthe CEREPAKTM Detacher or manual breakcause translation of the pull wire and release ofthe microcoil. | |
| **Materials and components differ between subject and predicate devices however they have the same function and raise no new or different questions of safety andeffectiveness. The test methods provide comparison to the predicate and are adequate to evaluate safety and effectiveness of the subject device.Additionally, biological safety is demonstrated based on applicable standards. | |||
| Sterilization and Shelf Life | |||
| SterilizationMethod | E-Beam or Ethylene Oxide | Ethylene Oxide | |
| SterilityAssurance Level | 10-6 | Same as predicate | |
| Shelf Life | 3 years | 1 year | |
| Packaging | Packaged in a plastic hoop and enclosed in a pouch with Tyvek sealed to Nylon orPolyester. Placed inside carton. | Packaged in a plastic hoop and enclosed in apouch with Tyvek sealed to Nylon. Placedinside carton. |
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VII. Non-Clinical Testing Summary
Performance Testing - Bench
Appropriate testing was identified based on the design, risk analyses and the intended use of the CEREPAK™ Detachable Coil Systems to demonstrate that the device is substantially equivalent to the legally marketed predicate device. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by internal procedure. The bench testing included the following tests:
| Table 5. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification: CEREPAKTM Detachable Coils | ||
| Manual Break Joint IntegrityAfter Transit | The objective of this test is to ensure that the manualbreak joint is not kinked or separated after transit. | PASS: Samples metestablished acceptancecriteria |
| Crimp Integrity After Transit | The objective of this test is to ensure that the proximalinner tube does not accidentally translate prematurelyafter transit. | PASS: Samples metestablished acceptancecriteria |
| Track Force (Delivery) | The objective of this test is to evaluate the force necessaryto deliver the proposed device through a microcatheter ina simulated tortuous anatomy model. | PASS: Samples metestablished acceptancecriteria |
| Microcatheter Pullback | The objective of this test is to measure the distance themicrocatheter retracts comparing the tip position fromprior to coil delivery to when the entire embolic coil isexposed out of the distal tip of the microcatheter. | PASS: Samples metestablished acceptancecriteria |
| Microcatheter Tip Deflection | The objective of this test is to measure the deflectionangle at the microcatheter tip as the device is advancedto the detachment position. | PASS: Samples metestablished acceptancecriteria |
| Overall Length | The objective of this test is to measure the overall lengthof the delivery tube shaft of the CEREPAKTM deliverysystem. | PASS: Samples metestablished acceptancecriteria |
| Fluorosaver Location | The objective of this test is to verify the location of thefluorosaver marker relative to the distal end of themicrocoil. | PASS: Samples metestablished acceptancecriteria |
| Fluorosaver MarkerDurability | The objective of this test is to verify that thefluorosaver marker remains visible on the deliverysystem after 6 delivery and 5 withdrawal cycles. | PASS: Samples metestablished acceptancecriteria |
| Delivery System OuterDiameter | The objective of this test is to measure the overall outerdiameter of the CEREPAKTM delivery system. | PASS: Samples metestablished acceptancecriteria |
| Marker Band Location | The objective of this test is to verify the location of theradiopaque marker relative to the distal end of thedelivery tube. | PASS: Samples metestablished acceptancecriteria |
| Detachment Zone Strength | The objective of this test is to measure the tensilestrength of the detachment zone to prevent prematureseparation of the microcoil from the detachment system. | PASS: Samples metestablished acceptancecriteria |
| Delivery System WeldStrength | The objective of this test is to measure the break loadrequired to separate the overall delivery system. | PASS: Samples metestablished acceptancecriteria |
| Key to Coil Weld Strength | The objective of this test is to measure the force requiredto separate the proximal key from the microcoil wire. | PASS: Samples metestablished acceptancecriteria |
| Durability (Pull WirePosition) | The objective of this test is to verify the pull wireposition relative to the proximal key shoulders afterdurability simulation (6 advancements and 5withdrawals) to evaluate any movement. | PASS: Samples metestablished acceptancecriteria |
| Detachment Reliability withDetacher | The objective of this test is to verify microcoilseparation from the delivery tube and inner tubetranslation after using the Detacher to detach themicrocoil. | PASS: Samples metestablished acceptancecriteria |
| Inner Tube/Pull Wire JointStrength | The objective of this test is to measure the strength ofthe joint between the pull wire and the proximal innertube. | PASS: Samples metestablished acceptancecriteria |
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VII. Non-Clinical Testing Summary, continued
| Table 5. Performance Testing Summary, continued | ||||
|---|---|---|---|---|
| Test | Test Summary | Result | ||
| Design Verification: CEREPAKTM Detachable Coils | ||||
| Inner Tube Outer Diameter | The objective of this test is to measure the outerdiameter of the proximal inner tube. | PASS: Samples metestablished acceptancecriteria | ||
| Inner Tube Length | The objective of this test is to measure the overalllength of the proximal inner tube and the length of theproximal inner tube that is exposed outside the maindelivery tube. | PASS: Samples metestablished acceptancecriteria | ||
| Detachment Reliability withManual Break | The objective of this test is to verify microcoil separationfrom the delivery tube after using the manual breakmethod to detach the microcoil. | PASS: Samples metestablished acceptancecriteria | ||
| Manual Break FeatureBuckling | The objective of this test is to measure the force requiredto buckle the delivery system using the manual breakfeature. | PASS: Samples metestablished acceptancecriteria | ||
| Particulate Evaluation | The objective of this test is to measure particulatesgenerated during simulated use with the CEREPAK™Detachable Coils. | PASS: Samples metestablished acceptancecriteria | ||
| Manual Break MarkersLocation | The objective of this test is to measure the spacingbetween the 2 manual break indicators, the distancebetween the manual break and each indicator, and thedistance from the manual break to the proximal end ofthe main delivery tube. | PASS: Samples metestablished acceptancecriteria | ||
| Detachment Kickback | The objective of this test is to measure the distance thedelivery system retracts after detachment. | PASS: Samples metestablished acceptancecriteria | ||
| Microcoil Secondary Shape | The objective of this test is to verify the secondary shapeof the microcoil. | PASS: Samples metestablished acceptancecriteria | ||
| Microcoil SecondaryDiameter | The objective of this test is to measure the secondaryshape diameter of the microcoil. | PASS: Samples metestablished acceptancecriteria | ||
| Microcoil Length | The objective of this test is to measure the length of themicrocoil. | PASS: Samples metestablished acceptancecriteria | ||
| Atraumatic 2 Terminal Ends | The objective of this test is to verify that the twoterminal ends of the microcoil have rounded edges andno sharp features. | PASS: Samples metestablished acceptancecriteria | ||
| Stretch Resistance of Suture | The objective of this test is to evaluate the force atwhich the stretch resistant suture (SRS) fails to resiststretching. | PASS: Samples metestablished acceptancecriteria | ||
| Introducer Secured AfterTransit | The objective of this test is to ensure that the introduceris within the packaging hoop in the correct location andthe microcoil is not exposed out of the introducer aftertransit. | PASS: Samples metestablished acceptancecriteria | ||
| Introducer Dimensions | The objective of this test is to verify the introducerlength, outer diameter, taper angle and inner diameter. | PASS: Samples metestablished acceptancecriteria | ||
| Introducer Purge HolesDimensions | The objective of this test is to verify the introducer purgehole diameter and distance from the introducer tip to thepurge hole. | PASS: Samples metestablished acceptancecriteria | ||
| Introducer Re-Sheathing | The objective of this test is to confirm that the introducercan be re-sheathed successfully without damage to themicrocoil or delivery system. | PASS: Samples metestablished acceptancecriteria | ||
| MRI Testing | The objective of MRI testing was to determine the safetyin the magnetic resonance (MR) environment and theappropriate parameters for MR conditional labeling. | PASS: Samples metestablished acceptancecriteria |
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VII. Non-Clinical Testing Summary, continued
| Test | Test Summary | Result |
|---|---|---|
| Design Verification: CEREPAK™ Detacher | ||
| Integrity after Transit | The objective of this test is to ensure the nose cone and housing assembly of the Detacher are intact to maintain product performance. | PASS: Samples met established acceptance criteria |
| Max User Input Force | The objective of this test is to measure the maximum user input force required to actuate the slider on the detacher. | PASS: Samples met established acceptance criteria |
| Slider Travel Distance and Min Input Force | The objectives of this test are to measure the distance of slider travel and user input force required to begin the detachment motion. The test will also confirm that the spring returns the components to their initial position after use. | PASS: Samples met established acceptance criteria |
| Multiple Cycle Durability | The objective of this test is to 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: Samples met established acceptance criteria |
| Nose Cone Insert Hard Stop and Clearance | The objective of this test is to 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: Samples met established acceptance criteria |
| Insertion Max Force | The objective of this test is to measure the maximum force exerted on the Detacher during insertion of the proximal end of the delivery system. | PASS: Samples met established acceptance criteria |
| Printed Logo and Name Verification | The objective of this test is to ensure that the logo is printed on the CEREPAK™ Detacher. | PASS: Samples met established acceptance criteria |
| Design Validation: CEREPAK™ Detachable Coils and Detacher | ||
| In-Vitro Usability Study | The in-vitro design validation was conducted with skilled users to evaluate various aspects of product performance under simulated use conditions utilizing a silicone arterial model which simulates clinically relevant anatomy. | PASS: Samples met established acceptance criteria |
Animal Study
An in-vivo design validation was conducted with skilled users to demonstrate various points of product performance usability under simulated use conditions utilized in a porcine model.
Clinical Testing
A clinical study was not required, because appropriate verification and validation of the subject device was achieved considering the similarities of the proposed device to the predicate device and based on the results of the bench testing.
Shelf-Life Testing
One year accelerated aging was successfully performed on the CEREPAK™ Detachable Coils and Detacher. Through review of package integrity testing and previous testing with sterile packages made of the same material combinations, the sterile pouches are confirmed to have a shelf life of three years. However, based on the lesser shelf life currently validated for the product and packaging, the shelf life of the CEREPAKTM Detachable Coil Systems, including both the Detachable Coils and Detacher components, is established as one year.
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VII. Non-Clinical Testing Summary, continued
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part I: Evaluation of Testing Within a Risk Management Process," and FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process'." Since the duration of contact is classified differently for the microcoil and the delivery system, biocompatibility testing was performed separately. The following testing was performed:
| Test | Results | Conclusion | |
|---|---|---|---|
| Table 6. Biocompatibility Test Summary | |||
| CEREPAKTM Detachable Coils – microcoil component | |||
| 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 |
| SC5b-9 Complement Activation Assay | Not a potential activator ofcomplement system | PASS | |
| CEREPAKTM Detachable Coils – delivery system component | |||
| Cytotoxicity | Non-cytotoxic | PASS | |
| Sensitization | Non-sensitizing | PASS | |
| Irritation or Intracutaneous Reactivity | Non-irritating | PASS | |
| (Acute) Systemic Toxicity | Negative | PASS | |
| Hemocompatibility | ASTM Hemolysis | Non-hemolytic | PASS |
| SC5b-9 Complement Activation Assay | Not a potential activator ofcomplement system | PASS | |
| In Vivo Thromboresistance Study | Thromboresistant | PASS |
The embolic coils are implants with permanent (> 30 days) contact with blood. The Delivery System (within introducer component) is an externally communicating device with limited (≤ 24 hours) contact with circulating blood. Based on the passing results of the aforementioned tests, the CEREPAK™ Detachable Coils (embolic coils and delivery system) have demonstrated acceptable biocompatibility in compliance with ISO 10993-1 and applicable regulatory requirements and are considered biologically safe for their intended use.
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| VII. Non-ClinicalTestingSummary,continued | SterilizationThe CEREPAK™ Detachable Coils and CEREPAK™ Detacher are sterilizedusing a validated 100% ethylene oxide (EO) sterilization process by means of theoverkill approach to ensure sterility assurance level (SAL) of 10-6 in accordancewith ISO 11135-1, “Sterilization of health care products - Ethylene Oxide - Part 1:Requirements for development, validation and routine control of a sterilizationprocess for medical devices.” The CEREPAK™ Detachable Coils (embolic coilsand delivery system) meet EO and ethylene chlorohydrin (ECH) residual limits perEN ISO 10993-7. The CEREPAK™ Detachable Coils and CEREPAK™ Detacherare for single use only. |
|---|---|
| VIII. Conclusion | Based upon the intended use, design, materials, function, side-by-side in-vitrotesting and animal testing, it is concluded that the subject device, CEREPAKTMUniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, HeliformXL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoftDetachable Coil Systems, are substantially equivalent to the predicate device,MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXYG3 XSFT Microcoil Delivery Systems (branded as the CERENOVUSSPECTRA™ Family of Coils), K150319, cleared on June 12, 2015. Riskassessment and verification and validation testing confirmed that the technologicaldifferences do not raise new questions of safety and effectiveness for the subjectdevice. The subject device, as designed, manufactured, packaged and sterilized, issubstantially equivalent to the predicate device. |
§ 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).