CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
Device Facts
| Record ID | K220040 |
|---|---|
| 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 |
| Applicant | Medos International SARL |
| Product Code | HCG · Neurology |
| Decision Date | Jul 14, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Platform delivery system for embolic microcoils; used in endovascular procedures to treat hemorrhagic conditions. Components: CEREPAK Detachable Coils (microcoil attached to delivery shaft) and CEREPAK Detacher (mechanical accessory). Physician advances delivery tube with microcoil through microcatheter to target lesion using standard endovascular techniques. Detachment occurs via mechanical finger actuation of Detacher, which translates internal pull wire to release microcoil. Once detached, delivery tube is removed. System enables precise placement of embolic coils to occlude aneurysms or vascular abnormalities. Benefits include minimally invasive treatment of neurovascular lesions.
Clinical Evidence
No clinical data. Evidence consists of bench testing (design verification, mechanical integrity, simulated use, MRI compatibility) and in-vivo porcine animal study. Biocompatibility testing performed per ISO 10993-1.
Technological Characteristics
Microcoils: Platinum/Tungsten, secondary shapes (complex, helical, spherical). Delivery system: Hypotube shaft with Nitinol loop wire and PTFE-coated 304 SS pull wire. Detachment: Mechanical finger-actuated slider. Sterilization: Ethylene Oxide (EO) per ISO 11135-1. Shelf life: 1 year. Connectivity: None.
Indications for Use
Indicated for embolization of intracranial aneurysms, neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and peripheral arterial/venous embolizations. Freeform XtraSoft is indicated for intracranial aneurysms only.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems (K150319)
Reference Devices
- GALAXY G3 Mini Microcoil Delivery System (K171862)
Related Devices
- K050954 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) · MicroVention, Inc. · Jun 28, 2005
- K133310 — AXIUM DETACHABLE COIL SYSTEM · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 10, 2014
- K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System · Codman & Shurtleff, Inc. · Jul 14, 2017
- K081465 — AXIUM DETACHABLE COIL SYSTEM · Micro Therapeutics, Inc. · Aug 19, 2008
- K173614 — Penumbra Coil 400, Ruby Coil System, POD System · Penumbra, Inc. · Apr 17, 2018
Submission Summary (Full Text)
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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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <label> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </label> </span> </div> |
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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, Heliform<br>XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and<br>Freeform XtraSoft Detachable Coil Systems |
| Common or Usual Name | Device, Neurovascular Embolization & Device, Vascular, For Promoting<br>Embolization |
| Classification Name | Device, Neurovascular Embolization, Class II, 21 CFR 882.5950 & Vascular,<br>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,<br>GALAXY G3, and GALAXY G3 XSFT Microcoil<br>Delivery Systems (this grouping is branded as<br>CERENOVUS SPECTRA™ Family of Coils) | Medos<br>International,<br>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<br>International,<br>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,<br>DELTAXSFT, GALAXY G3, and GALAXY G3<br>XSFT Microcoil Delivery Systems (K150319) | Reference Device:<br>GALAXY G3 Mini Microcoil<br>Delivery System (K171862) | This Submission (K220040):<br>CEREPAKTM Uniform, Uniform XL, Uniform 3D<br>Heliform Soft, Heliform XtraSoft, Heliform XL,<br>Heliform XtraSoft XL, Freeform, Freeform Mini,<br>and Freeform XtraSoft Detachable Coil Systems |
| Indications for<br>Use | MICRUSFRAME, DELTAFILL, and DELTAXSFT<br>Microcoil Delivery Systems are intended for<br>endovascular embolization of intracranial<br>aneurysms, other neurovascular abnormalities such<br>as arteriovenous malformations and arteriovenous<br>fistulae, and are also intended for arterial and venous<br>embolizations in the peripheral vasculature.<br>The GALAXY G3 Microcoil Delivery System is<br>intended for endovascular embolization of<br>intracranial aneurysms, other neurovascular<br>abnormalities such as arteriovenous malformations<br>and arteriovenous fistulae, and is also intended for<br>arterial and venous embolizations in the peripheral<br>vasculature.<br>The GALAXY G3 XSFT Microcoil Delivery System<br>is intended for endovascular embolization of<br>intracranial aneurysms. | The GALAXY G3 Mini<br>Microcoil Delivery System is<br>intended for endovascular<br>embolization of intracranial<br>aneurysms, other neurovascular<br>abnormalities such as<br>arteriovenous malformations<br>and arteriovenous fistulae, and<br>is also intended for arterial and<br>venous embolizations in the<br>peripheral vasculature. | The CEREPAKTM Uniform, Uniform XL, Uniform<br>3D, Heliform Soft, Heliform XtraSoft, Heliform XL,<br>Heliform XtraSoft XL, Freeform, and Freeform Mini<br>Detachable Coil Systems are indicated for<br>embolization of intracranial aneurysms,<br>neurovascular abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae, and arterial<br>and venous embolizations in the peripheral<br>vasculature.<br>The CEREPAKTM Freeform XtraSoft Detachable<br>Coil System is indicated for embolization of<br>intracranial aneurysms. |
| Classification | Class II, 21 CFR 882.5950 & 870.3300 | | Same as predicate |
| Product Code | HCG, KRD | | Same as predicate |
| | | Microcoil* | |
| Microcoil<br>Material | Platinum/Tungsten | Platinum/Tungsten | Same as predicate |
| Microcoil<br>Primary Wind | Triangular or Cylindrical | Cylindrical | Same as predicate |
| Microcoil<br>Secondary Shape | Complex, Helical, or Spherical | Complex | Same as predicate |
| Microcoil<br>Stretch-<br>Resistant<br>Suture | PGA=Polyglycolic Acid Suture<br>PP= Polypropylene Suture | PP= Polypropylene Suture | PP= Polypropylene Suture |
| Proximal<br>Interface | Soldered socket ring attaches to delivery system | | Welded key head attaches to delivery system |
| Primary Coil<br>Wind Outer<br>Diameter | 0.010"-0.015" | 0.009" | 0.009"-0.015" |
| Secondary<br>Shape Outer<br>Diameter<br>Ranges | 1.5mm - 24mm | 1mm - 3mm | 1mm - 24mm |
| Microcoil<br>Length Ranges | 1cm - 60cm | 1cm - 8cm | 1cm - 60cm |
| Microcatheter<br>Compatibility | 0.0165" to 0.021" inner lumen diameter | 0.0165" to 0.017" inner lumen<br>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)<br>includes most of the microcoil configurations that are equivalent to the CEREPAKTM. The reference device (K171862) is added to complete the range of equivalent<br>microcoil 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:<br>MICRUSFRAME, DELTAFILL, DELTAXSFT,<br>GALAXY G3, and GALAXY G3 XSFT Microcoil<br>Delivery Systems (K150319) | Reference Device:<br>GALAXY G3 Mini Microcoil<br>Delivery System (K171862) | This Submission (K220040):<br>CEREPAKTM Uniform, Uniform XL,<br>Uniform 3D, Heliform Soft, Heliform<br>XtraSoft, Heliform XL, Heliform XtraSoft<br>XL, Freeform, Freeform Mini, and Freeform<br>XtraSoft Detachable Coil Systems |
| | Delivery System (K150319 and K171862 have the same Delivery System) | | |
| Delivery System<br>Type | Wire Shaft with radiopaque marker | | Hypotube with arrangement of wires and<br>radiopaque marker |
| Radiopaque<br>Marker<br>Location | 3cm from distal tip | | Same as predicate |
| Introducer<br>Sheath Material | HDPE | | Same as predicate |
| Introducer Tip<br>Flush Ports | 3 flush ports | | Same as predicate |
| Delivery System<br>Length | 190cm ± 5cm | | Same nominal, tighter tolerances:<br>190 cm ± 2cm |
| Fluoro Saver<br>Markers | Five Markers Located at the Proximal End | | Same as predicate |
| Fluoro Saver<br>Marker<br>Microcatheter<br>Compatibility | 150cm Length | | Same as predicate |
| Detachment<br>Interface<br>Material | Polyolefin Elastomer | | Nitinol loop wire and 304 SS pull wire coated with<br>PTFE |
| Delivery System<br>Outer Diameter | 0.0159" Max | | 0.0156" Max |
| Other Materials<br>/ Components | Various | | Various - different from predicate** |
| Mechanism of<br>Detachment | Connection to Microcoil System hub using Connecting Cable or EnPOWER Control<br>Cable | | Connection to accessory CEREPAKTM<br>Detacher via slip fit with the proximal inner<br>tube |
| Detachment | Detachment: Thermo-Mechanical System uses the EnPOWER Detachment Control Box<br>(DCB) with EnPOWER Control Cable or Connecting Cable | | Detachment: Mechanical finger actuation of<br>the CEREPAKTM Detacher or manual break<br>cause translation of the pull wire and release of<br>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<br>effectiveness. The test methods provide comparison to the predicate and are adequate to evaluate safety and effectiveness of the subject device.<br>Additionally, biological safety is demonstrated based on applicable standards. | | | |
| Sterilization and Shelf Life | | | |
| Sterilization<br>Method | E-Beam or Ethylene Oxide | | Ethylene Oxide |
| Sterility<br>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<br>Polyester. Placed inside carton. | | Packaged in a plastic hoop and enclosed in a<br>pouch with Tyvek sealed to Nylon. Placed<br>inside 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 Integrity<br>After Transit | The objective of this test is to ensure that the manual<br>break joint is not kinked or separated after transit. | PASS: Samples met<br>established acceptance<br>criteria |
| Crimp Integrity After Transit | The objective of this test is to ensure that the proximal<br>inner tube does not accidentally translate prematurely<br>after transit. | PASS: Samples met<br>established acceptance<br>criteria |
| Track Force (Delivery) | The objective of this test is to evaluate the force necessary<br>to deliver the proposed device through a microcatheter in<br>a simulated tortuous anatomy model. | PASS: Samples met<br>established acceptance<br>criteria |
| Microcatheter Pullback | The objective of this test is to measure the distance the<br>microcatheter retracts comparing the tip position from<br>prior to coil delivery to when the entire embolic coil is<br>exposed out of the distal tip of the microcatheter. | PASS: Samples met<br>established acceptance<br>criteria |
| Microcatheter Tip Deflection | The objective of this test is to measure the deflection<br>angle at the microcatheter tip as the device is advanced<br>to the detachment position. | PASS: Samples met<br>established acceptance<br>criteria |
| Overall Length | The objective of this test is to measure the overall length<br>of the delivery tube shaft of the CEREPAKTM delivery<br>system. | PASS: Samples met<br>established acceptance<br>criteria |
| Fluorosaver Location | The objective of this test is to verify the location of the<br>fluorosaver marker relative to the distal end of the<br>microcoil. | PASS: Samples met<br>established acceptance<br>criteria |
| Fluorosaver Marker<br>Durability | The objective of this test is to verify that the<br>fluorosaver marker remains visible on the delivery<br>system after 6 delivery and 5 withdrawal cycles. | PASS: Samples met<br>established acceptance<br>criteria |
| Delivery System Outer<br>Diameter | The objective of this test is to measure the overall outer<br>diameter of the CEREPAKTM delivery system. | PASS: Samples met<br>established acceptance<br>criteria |
| Marker Band Location | The objective of this test is to verify the location of the<br>radiopaque marker relative to the distal end of the<br>delivery tube. | PASS: Samples met<br>established acceptance<br>criteria |
| Detachment Zone Strength | The objective of this test is to measure the tensile<br>strength of the detachment zone to prevent premature<br>separation of the microcoil from the detachment system. | PASS: Samples met<br>established acceptance<br>criteria |
| Delivery System Weld<br>Strength | The objective of this test is to measure the break load<br>required to separate the overall delivery system. | PASS: Samples met<br>established acceptance<br>criteria |
| Key to Coil Weld Strength | The objective of this test is to measure the force required<br>to separate the proximal key from the microcoil wire. | PASS: Samples met<br>established acceptance<br>criteria |
| Durability (Pull Wire<br>Position) | The objective of this test is to verify the pull wire<br>position relative to the proximal key shoulders after<br>durability simulation (6 advancements and 5<br>withdrawals) to evaluate any movement. | PASS: Samples met<br>established acceptance<br>criteria |
| Detachment Reliability with<br>Detacher | The objective of this test is to verify microcoil<br>separation from the delivery tube and inner tube<br>translation after using the Detacher to detach the<br>microcoil. | PASS: Samples met<br>established acceptance<br>criteria |
| Inner Tube/Pull Wire Joint<br>Strength | The objective of this test is to measure the strength of<br>the joint between the pull wire and the proximal inner<br>tube. | PASS: Samples met<br>established acceptance<br>criteria |
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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 outer<br>diameter of the proximal inner tube. | PASS: Samples met<br>established acceptance<br>criteria | | |
| Inner Tube Length | The objective of this test is to measure the overall<br>length of the proximal inner tube and the length of the<br>proximal inner tube that is exposed outside the main<br>delivery tube. | PASS: Samples met<br>established acceptance<br>criteria | | |
| Detachment Reliability with<br>Manual Break | The objective of this test is to verify microcoil separation<br>from the delivery tube after using the manual break<br>method to detach the microcoil. | PASS: Samples met<br>established acceptance<br>criteria | | |
| Manual Break Feature<br>Buckling | The objective of this test is to measure the force required<br>to buckle the delivery system using the manual break<br>feature.…
