(190 days)
No
The description focuses on the mechanical components and delivery system of embolic coils, with no mention of AI or ML capabilities for image analysis, diagnosis, or treatment planning.
Yes.
The device is used for treating intracranial aneurysms and neurovascular abnormalities, indicating a therapeutic purpose.
No
The device is an embolic coil system used to treat hemorrhagic conditions like aneurysms and malformations. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components: detachable coils (implants and delivery system) and a mechanical detacher. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral vasculature. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device description details a delivery system for embolic coils that are implanted into the body. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The CEREPAK™ system is clearly a medical device used for interventional procedures within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular, arterial, venous, peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Manual Break Joint Integrity After Transit: The objective of this test is to ensure that the manual break joint is not kinked or separated after transit. Result: PASS: Samples met established acceptance criteria.
- Crimp Integrity After Transit: The objective of this test is to ensure that the proximal inner tube does not accidentally translate prematurely after transit. Result: PASS: Samples met established acceptance criteria.
- Track Force (Delivery): The objective of this test is to evaluate the force necessary to deliver the proposed device through a microcatheter in a simulated tortuous anatomy model. Result: PASS: Samples met established acceptance criteria.
- Microcatheter Pullback: The objective of this test is to 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. Result: PASS: Samples met established acceptance criteria.
- Microcatheter Tip Deflection: The objective of this test is to measure the deflection angle at the microcatheter tip as the device is advanced to the detachment position. Result: PASS: Samples met established acceptance criteria.
- Overall Length: The objective of this test is to measure the overall length of the delivery tube shaft of the CEREPAKTM delivery system. Result: PASS: Samples met established acceptance criteria.
- Fluorosaver Location: The objective of this test is to verify the location of the fluorosaver marker relative to the distal end of the microcoil. Result: PASS: Samples met established acceptance criteria.
- Fluorosaver Marker Durability: The objective of this test is to verify that the fluorosaver marker remains visible on the delivery system after 6 delivery and 5 withdrawal cycles. Result: PASS: Samples met established acceptance criteria.
- Delivery System Outer Diameter: The objective of this test is to measure the overall outer diameter of the CEREPAKTM delivery system. Result: PASS: Samples met established acceptance criteria.
- Marker Band Location: The objective of this test is to verify the location of the radiopaque marker relative to the distal end of the delivery tube. Result: PASS: Samples met established acceptance criteria.
- Detachment Zone Strength: The objective of this test is to measure the tensile strength of the detachment zone to prevent premature separation of the microcoil from the detachment system. Result: PASS: Samples met established acceptance criteria.
- Delivery System Weld Strength: The objective of this test is to measure the break load required to separate the overall delivery system. Result: PASS: Samples met established acceptance criteria.
- Key to Coil Weld Strength: The objective of this test is to measure the force required to separate the proximal key from the microcoil wire. Result: PASS: Samples met established acceptance criteria.
- Durability (Pull Wire Position): The objective of this test is to verify the pull wire position relative to the proximal key shoulders after durability simulation (6 advancements and 5 withdrawals) to evaluate any movement. Result: PASS: Samples met established acceptance criteria.
- Detachment Reliability with Detacher: The objective of this test is to verify microcoil separation from the delivery tube and inner tube translation after using the Detacher to detach the microcoil. Result: PASS: Samples met established acceptance criteria.
- Inner Tube/Pull Wire Joint Strength: The objective of this test is to measure the strength of the joint between the pull wire and the proximal inner tube. Result: PASS: Samples met established acceptance criteria.
- Inner Tube Outer Diameter: The objective of this test is to measure the outer diameter of the proximal inner tube. Result: PASS: Samples met established acceptance criteria.
- Inner Tube Length: The objective of this test is to 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. Result: PASS: Samples met established acceptance criteria.
- Detachment Reliability with Manual Break: The objective of this test is to verify microcoil separation from the delivery tube after using the manual break method to detach the microcoil. Result: PASS: Samples met established acceptance criteria.
- Manual Break Feature Buckling: The objective of this test is to measure the force required to buckle the delivery system using the manual break feature. Result: PASS: Samples met established acceptance criteria.
- Particulate Evaluation: The objective of this test is to measure particulates generated during simulated use with the CEREPAK™ Detachable Coils. Result: PASS: Samples met established acceptance criteria.
- Manual Break Markers Location: The objective of this test is to 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. Result: PASS: Samples met established acceptance criteria.
- Detachment Kickback: The objective of this test is to measure the distance the delivery system retracts after detachment. Result: PASS: Samples met established acceptance criteria.
- Microcoil Secondary Shape: The objective of this test is to verify the secondary shape of the microcoil. Result: PASS: Samples met established acceptance criteria.
- Microcoil Secondary Diameter: The objective of this test is to measure the secondary shape diameter of the microcoil. Result: PASS: Samples met established acceptance criteria.
- Microcoil Length: The objective of this test is to measure the length of the microcoil. Result: PASS: Samples met established acceptance criteria.
- Atraumatic 2 Terminal Ends: The objective of this test is to verify that the two terminal ends of the microcoil have rounded edges and no sharp features. Result: PASS: Samples met established acceptance criteria.
- Stretch Resistance of Suture: The objective of this test is to evaluate the force at which the stretch resistant suture (SRS) fails to resist stretching. Result: PASS: Samples met established acceptance criteria.
- Introducer Secured After Transit: The objective of this test is to 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. Result: PASS: Samples met established acceptance criteria.
- Introducer Dimensions: The objective of this test is to verify the introducer length, outer diameter, taper angle and inner diameter. Result: PASS: Samples met established acceptance criteria.
- Introducer Purge Holes Dimensions: The objective of this test is to verify the introducer purge hole diameter and distance from the introducer tip to the purge hole. Result: PASS: Samples met established acceptance criteria.
- Introducer Re-Sheathing: The objective of this test is to confirm that the introducer can be re-sheathed successfully without damage to the microcoil or delivery system. Result: PASS: Samples met established acceptance criteria.
- MRI Testing: The objective of MRI testing was to determine the safety in the magnetic resonance (MR) environment and the appropriate parameters for MR conditional labeling. Result: PASS: Samples met established acceptance criteria.
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. Result: 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. Result: 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. Result: 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. Result: 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. Result: 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. Result: 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. Result: 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. Result: 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.
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:
- 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)
- Hemocompatibility (SC5b-9 Complement Activation Assay): Not a potential activator of complement 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)
- Hemocompatibility (SC5b-9 Complement Activation Assay): Not a potential activator of complement 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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, Heliform |
| XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and | |
| Freeform XtraSoft Detachable Coil Systems | |
| Common or Usual Name | Device, Neurovascular Embolization & Device, Vascular, For Promoting |
| Embolization | |
| 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 Microcoil | |||
| Delivery Systems (this grouping is branded as | |||
| CERENOVUS SPECTRA™ Family of Coils) | Medos | ||
| International, | |||
| 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 | Medos |
| International, | |||
| 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.
4
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.
5
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 G3 | |||
| XSFT Microcoil Delivery Systems (K150319) | Reference Device: | ||
| GALAXY G3 Mini Microcoil | |||
| Delivery System (K171862) | This Submission (K220040): | ||
| CEREPAKTM Uniform, Uniform XL, Uniform 3D | |||
| Heliform Soft, Heliform XtraSoft, Heliform XL, | |||
| Heliform XtraSoft XL, Freeform, Freeform Mini, | |||
| and Freeform XtraSoft Detachable Coil Systems | |||
| Indications for | |||
| Use | MICRUSFRAME, DELTAFILL, and DELTAXSFT | ||
| Microcoil Delivery Systems are intended for | |||
| endovascular embolization of intracranial | |||
| aneurysms, other neurovascular abnormalities such | |||
| as arteriovenous malformations and arteriovenous | |||
| fistulae, and are also intended for arterial and venous | |||
| embolizations in the peripheral vasculature. | |||
| The GALAXY G3 Microcoil Delivery System is | |||
| intended for endovascular embolization of | |||
| intracranial aneurysms, other neurovascular | |||
| abnormalities such as arteriovenous malformations | |||
| and arteriovenous fistulae, and is also intended for | |||
| arterial and venous embolizations in the peripheral | |||
| vasculature. | |||
| The GALAXY G3 XSFT Microcoil Delivery System | |||
| is intended for endovascular embolization of | |||
| intracranial aneurysms. | The GALAXY G3 Mini | ||
| Microcoil Delivery System is | |||
| intended for endovascular | |||
| embolization of intracranial | |||
| aneurysms, other neurovascular | |||
| abnormalities such as | |||
| arteriovenous malformations | |||
| and arteriovenous fistulae, and | |||
| is also intended for arterial and | |||
| venous embolizations in the | |||
| peripheral vasculature. | The CEREPAKTM Uniform, Uniform XL, Uniform | ||
| 3D, Heliform Soft, Heliform 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 CEREPAKTM Freeform XtraSoft Detachable | |||
| Coil System is indicated for embolization of | |||
| intracranial aneurysms. | |||
| Classification | Class II, 21 CFR 882.5950 & 870.3300 | Same as predicate | |
| Product Code | HCG, KRD | Same as predicate | |
| Microcoil* | |||
| Microcoil | |||
| Material | Platinum/Tungsten | Platinum/Tungsten | Same as predicate |
| Microcoil | |||
| Primary Wind | Triangular or Cylindrical | Cylindrical | Same as predicate |
| Microcoil | |||
| Secondary Shape | Complex, Helical, or Spherical | Complex | Same as predicate |
| Microcoil | |||
| Stretch- | |||
| Resistant | |||
| Suture | PGA=Polyglycolic Acid Suture | ||
| PP= Polypropylene Suture | PP= Polypropylene Suture | PP= Polypropylene Suture | |
| Proximal | |||
| Interface | Soldered socket ring attaches to delivery system | Welded key head attaches to delivery system | |
| Primary Coil | |||
| Wind Outer | |||
| Diameter | 0.010"-0.015" | 0.009" | 0.009"-0.015" |
| Secondary | |||
| Shape Outer | |||
| Diameter | |||
| Ranges | 1.5mm - 24mm | 1mm - 3mm | 1mm - 24mm |
| Microcoil | |||
| Length Ranges | 1cm - 60cm | 1cm - 8cm | 1cm - 60cm |
| Microcatheter | |||
| Compatibility | 0.0165" to 0.021" inner lumen diameter | 0.0165" to 0.017" inner lumen | |
| diameter | 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 equivalent | |||
| microcoil offerings in the CEREPAKTM catalog. Therefore the range of microcoil sizes is the combination of the predicate and reference devices. |
6
| Table 4. Subject, Predicate and Reference Device Comparison Summary, continued | |||
|---|---|---|---|
| Description | Predicate Device: | ||
| MICRUSFRAME, DELTAFILL, DELTAXSFT, | |||
| GALAXY G3, and GALAXY G3 XSFT Microcoil | |||
| Delivery Systems (K150319) | Reference Device: | ||
| GALAXY G3 Mini Microcoil | |||
| Delivery System (K171862) | This Submission (K220040): | ||
| CEREPAKTM Uniform, Uniform XL, | |||
| Uniform 3D, Heliform Soft, Heliform | |||
| XtraSoft, Heliform XL, Heliform XtraSoft | |||
| XL, Freeform, Freeform Mini, and Freeform | |||
| XtraSoft Detachable Coil Systems | |||
| Delivery System (K150319 and K171862 have the same Delivery System) | |||
| Delivery System | |||
| Type | Wire Shaft with radiopaque marker | Hypotube with arrangement of wires and | |
| radiopaque marker | |||
| Radiopaque | |||
| Marker | |||
| Location | 3cm from distal tip | Same as predicate | |
| Introducer | |||
| Sheath Material | HDPE | Same as predicate | |
| Introducer Tip | |||
| Flush Ports | 3 flush ports | Same as predicate | |
| Delivery System | |||
| Length | 190cm ± 5cm | Same nominal, tighter tolerances: | |
| 190 cm ± 2cm | |||
| Fluoro Saver | |||
| Markers | Five Markers Located at the Proximal End | Same as predicate | |
| Fluoro Saver | |||
| Marker | |||
| Microcatheter | |||
| Compatibility | 150cm Length | Same as predicate | |
| Detachment | |||
| Interface | |||
| Material | Polyolefin Elastomer | Nitinol loop wire and 304 SS pull wire coated with | |
| PTFE | |||
| Delivery System | |||
| Outer Diameter | 0.0159" Max | 0.0156" Max | |
| Other Materials | |||
| / Components | Various | Various - different from predicate** | |
| Mechanism of | |||
| Detachment | Connection to Microcoil System hub using Connecting Cable or EnPOWER Control | ||
| Cable | Connection to accessory CEREPAKTM | ||
| Detacher via slip fit with the proximal inner | |||
| tube | |||
| Detachment | Detachment: Thermo-Mechanical System uses the EnPOWER Detachment Control Box | ||
| (DCB) with EnPOWER Control Cable or Connecting Cable | Detachment: Mechanical finger actuation of | ||
| the CEREPAKTM Detacher or manual break | |||
| cause translation of the pull wire and release of | |||
| the 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 and | |||
| effectiveness. 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 | |||
| Sterilization | |||
| Method | E-Beam or Ethylene Oxide | Ethylene Oxide | |
| Sterility | |||
| Assurance 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 or | ||
| Polyester. Placed inside carton. | Packaged in a plastic hoop and enclosed in a | ||
| pouch with Tyvek sealed to Nylon. Placed | |||
| inside carton. |
7
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 Integrity | ||
| After Transit | The objective of this test is to ensure that the manual | |
| break joint is not kinked or separated after transit. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Crimp Integrity After Transit | The objective of this test is to ensure that the proximal | |
| inner tube does not accidentally translate prematurely | ||
| after transit. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Track Force (Delivery) | The objective of this test is to evaluate the force necessary | |
| to deliver the proposed device through a microcatheter in | ||
| a simulated tortuous anatomy model. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Microcatheter Pullback | The objective of this test is to 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: Samples met | |
| established acceptance | ||
| criteria | ||
| Microcatheter Tip Deflection | The objective of this test is to measure the deflection | |
| angle at the microcatheter tip as the device is advanced | ||
| to the detachment position. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Overall Length | The objective of this test is to measure the overall length | |
| of the delivery tube shaft of the CEREPAKTM delivery | ||
| system. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Fluorosaver Location | The objective of this test is to verify the location of the | |
| fluorosaver marker relative to the distal end of the | ||
| microcoil. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Fluorosaver Marker | ||
| Durability | The objective of this test is to verify that the | |
| fluorosaver marker remains visible on the delivery | ||
| system after 6 delivery and 5 withdrawal cycles. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Delivery System Outer | ||
| Diameter | The objective of this test is to measure the overall outer | |
| diameter of the CEREPAKTM delivery system. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Marker Band Location | The objective of this test is to verify the location of the | |
| radiopaque marker relative to the distal end of the | ||
| delivery tube. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Detachment Zone Strength | The objective of this test is to measure the tensile | |
| strength of the detachment zone to prevent premature | ||
| separation of the microcoil from the detachment system. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Delivery System Weld | ||
| Strength | The objective of this test is to measure the break load | |
| required to separate the overall delivery system. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Key to Coil Weld Strength | The objective of this test is to measure the force required | |
| to separate the proximal key from the microcoil wire. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Durability (Pull Wire | ||
| Position) | The objective of this test is to verify the pull wire | |
| position relative to the proximal key shoulders after | ||
| durability simulation (6 advancements and 5 | ||
| withdrawals) to evaluate any movement. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Detachment Reliability with | ||
| Detacher | The objective of this test is to verify microcoil | |
| separation from the delivery tube and inner tube | ||
| translation after using the Detacher to detach the | ||
| microcoil. | PASS: Samples met | |
| established acceptance | ||
| criteria | ||
| Inner Tube/Pull Wire Joint | ||
| Strength | The objective of this test is to measure the strength of | |
| the joint between the pull wire and the proximal inner | ||
| tube. | PASS: Samples met | |
| established acceptance | ||
| criteria |
8
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 outer | |||
| diameter of the proximal inner tube. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Inner Tube Length | The objective of this test is to 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: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Detachment Reliability with | ||||
| Manual Break | The objective of this test is to verify microcoil separation | |||
| from the delivery tube after using the manual break | ||||
| method to detach the microcoil. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Manual Break Feature | ||||
| Buckling | The objective of this test is to measure the force required | |||
| to buckle the delivery system using the manual break | ||||
| feature. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Particulate Evaluation | The objective of this test is to measure particulates | |||
| generated during simulated use with the CEREPAK™ | ||||
| Detachable Coils. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Manual Break Markers | ||||
| Location | The objective of this test is to 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: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Detachment Kickback | The objective of this test is to measure the distance the | |||
| delivery system retracts after detachment. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Microcoil Secondary Shape | The objective of this test is to verify the secondary shape | |||
| of the microcoil. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Microcoil Secondary | ||||
| Diameter | The objective of this test is to measure the secondary | |||
| shape diameter of the microcoil. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Microcoil Length | The objective of this test is to measure the length of the | |||
| microcoil. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Atraumatic 2 Terminal Ends | The objective of this test is to verify that the two | |||
| terminal ends of the microcoil have rounded edges and | ||||
| no sharp features. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Stretch Resistance of Suture | The objective of this test is to evaluate the force at | |||
| which the stretch resistant suture (SRS) fails to resist | ||||
| stretching. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Introducer Secured After | ||||
| Transit | The objective of this test is to 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: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Introducer Dimensions | The objective of this test is to verify the introducer | |||
| length, outer diameter, taper angle and inner diameter. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Introducer Purge Holes | ||||
| Dimensions | The objective of this test is to verify the introducer purge | |||
| hole diameter and distance from the introducer tip to the | ||||
| purge hole. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| Introducer Re-Sheathing | The objective of this test is to confirm that the introducer | |||
| can be re-sheathed successfully without damage to the | ||||
| microcoil or delivery system. | PASS: Samples met | |||
| established acceptance | ||||
| criteria | ||||
| MRI Testing | The objective of MRI testing was to determine the safety | |||
| in the magnetic resonance (MR) environment and the | ||||
| appropriate parameters for MR conditional labeling. | PASS: Samples met | |||
| established acceptance | ||||
| criteria |
9
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.
10
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 | |
| Hemocom | |||
| patibility | ASTM Hemolysis | Non-hemolytic | PASS |
| SC5b-9 Complement Activation Assay | Not a potential activator of | ||
| complement 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 of | ||
| complement 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.
11
| VII. Non-
Clinical
Testing
Summary,
continued | Sterilization
The CEREPAK™ Detachable Coils and CEREPAK™ Detacher are sterilized
using a validated 100% ethylene oxide (EO) sterilization process by means of the
overkill approach to ensure sterility assurance level (SAL) of 10-6 in accordance
with ISO 11135-1, “Sterilization of health care products - Ethylene Oxide - Part 1:
Requirements for development, validation and routine control of a sterilization
process for medical devices.” The CEREPAK™ Detachable Coils (embolic coils
and delivery system) meet EO and ethylene chlorohydrin (ECH) residual limits per
EN ISO 10993-7. The CEREPAK™ Detachable Coils and CEREPAK™ Detacher
are for single use only. |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VIII. Conclusion | Based upon the intended use, design, materials, function, side-by-side in-vitro
testing and animal testing, it is concluded that the subject device, CEREPAKTM
Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform
XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft
Detachable Coil Systems, are substantially equivalent to the predicate device,
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY
G3 XSFT Microcoil Delivery Systems (branded as the CERENOVUS
SPECTRA™ Family of Coils), K150319, cleared on June 12, 2015. Risk
assessment and verification and validation testing confirmed that the technological
differences do not raise new questions of safety and effectiveness for the subject
device. The subject device, as designed, manufactured, packaged and sterilized, is
substantially equivalent to the predicate device. |