(60 days)
No
The summary describes a physical medical device (embolization coils and delivery system) with modifications to size and material indicators. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for the "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities," which directly treats a medical condition.
No.
The device, the Axium™ Detachable Coil System, is indicated for endovascular embolization of aneurysms and other neurovascular abnormalities, meaning it is a therapeutic device used for treatment, not diagnosis.
No
The device description clearly outlines physical components like platinum/tungsten embolization coils, a composite implant delivery pusher, and a hand-held detacher. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, as well as arterial and venous embolizations in the peripheral vasculature. This describes a therapeutic procedure performed within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical implant (coil) delivered into the body using a pusher and detacher. This is consistent with a therapeutic medical device, not an IVD which typically involves reagents, instruments for analysis, and controls for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or diagnostic results. The performance studies focus on the physical and mechanical properties of the device.
Therefore, the Axium™ Detachable Coil System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Axium™ Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The Axium™ Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately.
This submission expands the size offerings of the Axium™ Detachable Coil (subject device) by adding thirty-five (35) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers are a line extension of the currently sold predicate device and range in size from 1mm diameter x 1cm length to 3.5mm diameter x 10cm length. All thirtv-five (35) new SKUs have a smaller primary wire diameter than the predicate device. This line extension includes six (6) coils having a 1mm diameter which is outside of the currently cleared Axium size range of 1.5mm diameter x 1cm length to 25mm diameter x 50cm length.
The second modification features a change to the Implant Delivery Pusher by replacing the PET material of the Positive Load Indicator (PLI) and Hypotube Break Indicator (BI) with a laser mark.
These modifications to the currently cleared predicate device were made solely to accommodate the new smaller implant coil size of the subject line extension. All other aspects of the subject device (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, peripheral vasculature (arterial and venous)
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 Data:
The following bench tests were performed to support the addition of new sizes to the Axium coil line and to establish substantial equivalence to predicate Axium™ Detachable Coil System :
● Dimensions - Coil, Sheath, Implant Delivery Pusher
● Visual Inspections - Coil, Sheath, Implant Delivery Pusher
● Friction
● Force Transfer
● Coil Deformation
● Fatigue and Knotting
● Coil Tensile – Polypropylene
● Coil Tensile - Implant/Weld (Implant Coil to Coil Shell Weld)
● Labeling verification
The following testing was adopted from existing test data for currently cleared Axium™ coil sizes:
● Torque Response
● Coil Tensile - Assembly
● Pusher Dimensions
● Marker Radiopacity
● Tip Buckling
● Detachment Zone Stiffness
● Kink Resistance
● Hypotube and Weld Tensile Strength
● Pusher Elongation
● MRI Compatibility
Sterilization, biocompatibility and aging data were also adopted from the predicate device as there is no change to the manufacturing process or packaging for the addition of these new SKUs.
In addition, no clinical or animal testing was performed as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device.
In addition, there is no change in the indications for use or the fundamental scientific technology of the device that would require more extensive testing.
Conclusion: The thirty-five (35) new Axium™ Detachable Coil System size offerings are substantially equivalent to the currently cleared Axium™ Detachable Coil System based on the successful completion of nonclinical testing; a thorough assessment of existing test data; as well as identical materials of coil implant construction, principles of operation, packaging and indications for use.
Sterilization and Shelf Life:
The subject device was adopted into the EO sterilization cycle originally cleared under K060747 for the predicate device. The manufacturing process and packaging are identical to the predicate device. The smaller dimensions and the replacement of the PET shrink tubing with laser marking for the PLI and BI indicators on the Implant Delivery Pusher result in a reduction of mass/material.
EO residual testing for the subject device was adopted, as the materials of construction of the implant coil and the manufacturing process are identical to the currently cleared predicate device. In addition, the smaller dimensions and the replacement of the PET shrink tubing with laser marking for the PLI and BI indicators on the Implant Delivery Pusher result in a reduction of mass/material.
Aging and packaging studies for the predicate device have established the product and packaging remain functional and maintain sterility for 3 years. Aging studies for packaging integrity (per ASTM F2096-11) and conditioning (ASTM-4169, ISTA-2A) and device functionality were adopted from the predicate device and met all acceptance criteria. The materials of implant coil construction, manufacturing process, and packaging of the new smaller sized models of the subject device are identical to the predicate device.
Biocompatibility:
Biocompatibility data for the subject device has been adopted from the predicate device. Physicochemical and cytotoxicity testing were performed on the laser marks of the Implant Delivery Pusher for reference only. Passing results provide confirmation that the laser marks do not impact the safety of the device and add justification for adopting previous biocompatibility studies conducted for the Axium coil predicate device.
Performance Data – Bench:
Visual and Dimensional Inspection:
• Coil
• Sheath
• Implant Delivery Pusher
Test Method: Dimensions (ID, OD, length) were measured and key characteristic were inspected of the implant coil, sheath and coupler tube. Conclusion: All devices met acceptance criteria.
Softness and Conformability:
• Coil Deformation
Test Method: The first loop of the coil is advanced until it exits the sheath and is compressed to a deformation distance that is a percentage of the coil's loop OD. The peak force is recorded. Conclusion: All devices met acceptance criteria.
Ease of Deliverability:
• Force Transfer
• Friction Testing
• Fatigue and Knotting
Test Method:
• Peak delivery force was measured through a representative tortuous anatomical model.
• The proximal end of the device is advanced until the distal force exceeds a specified value. The force transfer is calculated.
• The device is placed inside the microcatheter and advanced until the coil is deployed completely inside the aneurysm model. The device is retracted and the cycle is repeated. After the required number of cycles the device is inspected.
Conclusion: All devices met acceptance criteria.
Detachment:
• Coil Tensile – Polypropylene
• Coil Tensile – Implant/Weld (Implant Coil to Coil Shell Weld)
Test Method:
• The coil is stretched until the stretch resistant member breaks. The peak force result was recorded
• The primary wire of the coil is stretched until the coil-coil shell weld breaks. The peak force result was recorded
Conclusion: All devices met acceptance criteria.
Labeling Verification:
Test Method: Text and format of drawings were visually compared to labeling and packaging product specifications. Conclusion: All devices met acceptance criteria.
Physician Usability Testing:
Test Method: The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess coil softness, conformability, ease of delivery and biomechanical stability. Conclusion: All test results met the acceptance criteria.
Performance Data – Animal:
No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.
Performance Testing - Clinical:
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in black and are arranged to create a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Patricia Casing Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K151447
Trade/Device Name: Axium™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: June 30, 2015 Received: Julv 1, 2015
Dear Ms. Casing:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena நி/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151447
Device Name Axium Detachable Coil System
Indications for Use (Describe)
The Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
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
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Patricia Casing
Regulatory Affairs Specialist
Telephone: (949) 680 - 1307
E-mail: patricia.casing@covidien.com | |
| Date Summary
Prepared: | June 30, 2015 | |
| Trade Name of
Device: | Axium™ Detachable Coil System | |
| Common Name of
Device: | Neurovascular Embolization Device | |
| Classification of
Device: | 21 CFR 882.5950 - Class II | |
| Product Code | HCG and KRD | |
| Predicate Device: | Axium™ Detachable Coil System:
K133310, cleared January 10, 2014
●
K081465, cleared August 19, 2008
●
K060747, cleared April 24, 2007
● | |
| Performance Data: | The following bench tests were performed to support the addition of
new sizes to the Axium coil line and to establish substantial
equivalence to predicate Axium™ Detachable Coil System : | |
| | Dimensions - Coil, Sheath, Implant Delivery Pusher
●
Visual Inspections - Coil, Sheath, Implant Delivery
●
Pusher
Friction
●
Force Transfer
●
Coil Deformation
●
Fatigue and Knotting
●
Coil Tensile – Polypropylene
●
Coil Tensile - Implant/Weld (Implant Coil to Coil
●
Shell Weld)
Labeling verification
●
The following testing was adopted from existing test data for currently
cleared Axium™ coil sizes: | |
| | Torque Response
●
Coil Tensile - Assembly
● | |
- Pusher Dimensions
- Marker Radiopacity ●
- Tip Buckling
- . Detachment Zone Stiffness
4
- Kink Resistance ●
- Hypotube and Weld Tensile Strength ●
- Pusher Elongation ●
- MRI Compatibility
Sterilization, biocompatibility and aging data were also adopted from the predicate device as there is no change to the manufacturing process or packaging for the addition of these new SKUs.
In addition, no clinical or animal testing was performed as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device.
In addition, there is no change in the indications for use or the fundamental scientific technology of the device that would require more extensive testing.
- Conclusion: The thirty-five (35) new Axium™ Detachable Coil System size offerings are substantially equivalent to the currently cleared Axium™ Detachable Coil System based on the successful completion of nonclinical testing; a thorough assessment of existing test data; as well as identical materials of coil implant construction, principles of operation, packaging and indications for use.
Device Description:
The Axium™ Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately.
This submission expands the size offerings of the Axium™ Detachable Coil (subject device) by adding thirty-five (35) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers are a line extension of the currently sold predicate device and range in size from 1mm diameter x 1cm length to 3.5mm diameter x 10cm length. All thirtv-five (35) new SKUs have a smaller primary wire diameter than the predicate device. This line extension includes six (6) coils having a 1mm diameter which is outside of the currently cleared Axium size range of 1.5mm diameter x 1cm length to 25mm diameter x 50cm length.
The second modification features a change to the Implant Delivery Pusher by replacing the PET material of the Positive Load Indicator (PLI) and Hypotube Break Indicator (BI) with a laser mark.
These modifications to the currently cleared predicate device were made solely to accommodate the new smaller implant coil size of the subject line extension. All other aspects of the subject device (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.
5
Indications for Use:
The Axium™ Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
Device Comparison:
The table below provides a comparison of the technological characteristics of the subject Axium device line extension and the currently cleared predicate Axium device line.
| Characteristics | Predicate Device | Subject Device | Rationale for
Difference (if
applicable) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Axium™ (K133310, (K081465,
K060747) | Axium Line Extension | N/A |
| | The Axium Detachable Coil
System is indicated for the
endovascular embolization of
intracranial aneurysms and other
neurovascular abnormalities,
such as arteriovenous
malformations and arteriovenous
fistulae. The Axium Detachable
Coils are also indicated for
arterial and venous
embolizations in the peripheral
vasculature. | Same | |
| Method of Supply | Stored within dispenser coil,
Tyvek pouch, & shipping carton | Same | N/A |
| Sterilization Method | Ethylene Oxide | Same | N/A |
| Device Size Range
(Coil Diameter x Coil
Length) | 1.5mm x 1cm – 25mm x 50cm | 1mm x 1cm - 3.5mm x
10cm | Difference in size is
due to the smaller
diameter primary
wire. Bench testing
has demonstrated that
the smaller
dimensions do not
affect the safety and
effectiveness of the
device. |
| Materials
(Implant Coil) | | | |
| Characteristics | Predicate Device | Subject Device | Rationale for
Difference (if
applicable) |
| Implant Coil Wire | Axium™ (K133310, (K081465,
K060747) | Axium Line Extension | N/A |
| | Pt (92%)/W (8%) | Same | |
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| Stretch Resistant Member | Axium™ (K133310, (K081465, K060747) | Axium Line Extension | N/A |
| Coil Shell | Pt (92%)/ W (8%) | Same | N/A |
| Detach Subassembly | SS 316LVM | Same | N/A |
| Materials
(Implant Delivery Pusher) | | | |
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| Unibody | Axium™ (K133310, K081465, K060747) | Axium Line Extension | N/A |
| Outer Jacket | SS 304 | Same | N/A |
| Marker Coil | PTFE | Same | N/A |
| Lumen Stop | Pt (92%)/ W (8%) | Same | N/A |
| Inner Liner | SS 304 | Same | N/A |
| Coupler Tube | PTFE | Same | N/A |
| Actuator Interface | SS 304 | Same | N/A |
| Release Wire | SS 304 | Same | N/A |
| Retainer Ring | SS 304 | Same | N/A |
| Break Indicator | SS 304 | Same | N/A |
| Positive Load Indicator | PET shrink tubing | Laser mark | Bench testing confirmed that the change in indicator design does not affect the safety and effectiveness of the device |
| | PET shrink tubing | Laser mark | Bench testing confirmed that the change in indicator design does not affect the safety and effectiveness of the device |
| Materials
(Introducer sheath) | | | |
| Introducer sheath | Polypropylene/HDPE | Same | N/A |
6
Sterilization and Shelf Life
The subject device was adopted into the EO sterilization cycle originally cleared under K060747 for the predicate device. The manufacturing process and packaging are identical to the predicate device. The smaller dimensions and the replacement of the PET shrink
7
tubing with laser marking for the PLI and BI indicators on the Implant Delivery Pusher result in a reduction of mass/material.
EO residual testing for the subject device was adopted, as the materials of construction of the implant coil and the manufacturing process are identical to the currently cleared predicate device. In addition, the smaller dimensions and the replacement of the PET shrink tubing with laser marking for the PLI and BI indicators on the Implant Delivery Pusher result in a reduction of mass/material.
Aging and packaging studies for the predicate device have established the product and packaging remain functional and maintain sterility for 3 years. Aging studies for packaging integrity (per ASTM F2096-11) and conditioning (ASTM-4169, ISTA-2A) and device functionality were adopted from the predicate device and met all acceptance criteria. The materials of implant coil construction, manufacturing process, and packaging of the new smaller sized models of the subject device are identical to the predicate device.
Biocompatibility
Biocompatibility data for the subject device has been adopted from the predicate device. Physicochemical and cytotoxicity testing were performed on the laser marks of the Implant Delivery Pusher for reference only. Passing results provide confirmation that the laser marks do not impact the safety of the device and add justification for adopting previous biocompatibility studies conducted for the Axium coil predicate device.
Performance Data – Bench
A summary of the non-clinical bench testing performed for the subject device is presented in the table below:
| Test | Test Method | Conclusion |
|---|---|---|
| Visual and Dimensional | ||
| Inspection: | ||
| • Coil | ||
| • Sheath | ||
| • Implant Delivery Pusher | Dimensions (ID, OD, length) were | |
| measured and key characteristic | ||
| were inspected of the implant coil, | ||
| sheath and coupler tube | All devices met | |
| acceptance criteria. | ||
| Softness and Conformability | ||
| • Coil Deformation | The first loop of the coil is advanced | |
| until it exits the sheath and is | ||
| compressed to a deformation | ||
| distance that is a percentage of the | ||
| coil's loop OD. The peak force is | ||
| recorded. | All devices met | |
| acceptance criteria. | ||
| Ease of Deliverability | ||
| • Force Transfer | ||
| • Friction Testing | ||
| • Fatigue and Knotting | • Peak delivery force was | |
| measured through a | ||
| representative tortuous | ||
| anatomical model. | ||
| • The proximal end of the device | ||
| is advanced until the distal force | All devices met | |
| acceptance criteria. |
8
| Test | Test Method | Conclusion |
|---|---|---|
| exceeds a specified value. The | ||
| force transfer is calculated. | ||
| • The device is placed inside the | ||
| microcatheter and advanced | ||
| until the coil is deployed | ||
| completely inside the aneurysm | ||
| model. The device is retracted | ||
| and the cycle is repeated. After | ||
| the required number of cycles | ||
| the device is inspected. | ||
| Detachment | ||
| • Coil Tensile – | ||
| Polypropylene | ||
| • Coil Tensile – | ||
| Implant/Weld (Implant | ||
| Coil to Coil Shell Weld) | • The coil is stretched until the | |
| stretch resistant member breaks. | ||
| The peak force result was | ||
| recorded | ||
| • The primary wire of the coil is | ||
| stretched until the coil-coil shell | ||
| weld breaks. The peak force | ||
| result was recorded | All devices met | |
| acceptance criteria. | ||
| Labeling Verification | Text and format of drawings were | |
| visually compared to labeling and | ||
| packaging product specifications. | All devices met | |
| acceptance criteria. | ||
| Physician Usability Testing | The device was navigated through a | |
| tortuous benchtop model and | ||
| deployed into a simulated silicone | ||
| aneurysm in order to assess coil | ||
| softness, conformability, ease of | ||
| delivery and biomechanical | ||
| stability | All test results met the | |
| acceptance criteria. |
Performance Data – Animal
No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.
Performance Testing - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.