(74 days)
Not Found
No
The summary describes a physical medical device (detachable coil system) and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are based on bench testing of physical properties.
Yes.
The device is used for endovascular embolization of various vascular abnormalities, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is used for embolization (treatment) of intracranial aneurysms and other neurovascular abnormalities, not for diagnosis.
No
The device description explicitly details physical components: an implantable coil, an implant delivery pusher, and an instant detacher. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Axium™ Detachable Coil System is an implantable device used for the endovascular embolization of aneurysms and other vascular abnormalities. This is a therapeutic procedure performed within the body, not a diagnostic test performed on a specimen outside the body.
- Lack of Diagnostic Function: The device's function is to physically block blood flow in specific areas, not to analyze biological samples for diagnostic purposes.
Therefore, based on the provided information, 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 coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Axium™ Detachable Coil System consists of three (3) components: 1 -- Implantable Coil 2 - Implant Delivery Pusher 3 - Instant Detacher. The Instant Detacher is packaged and sold separately. Axium™ coil configurations include bare platinum, PGLA enlaced platinum and Nylon enlaced platinum coils. Bare configuration coils are non-fiber-enlaced, whereas PGLA and Nylon are enlaced with PGLA and Nylon fibers respectively. This submission expands the size offerings of the Axium™ Detachable Coil System by adding one (1) new model number to the Axium bare product portfolio with a new diameter and coil length combination (SKU QC-1.5-1-Helix). Currently cleared sizes for Axium™ bare under K081465 already include a coil diameter of 1.5mm and a coil length of 1cm; however, not in combination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, 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)
Bench Testing: There were no material, design, sterilization, packaging or manufacturing process changes that resulted from the introduction of the new SKU (QC-1.5-1-Helix). The following testing was adopted from existing test data for currently cleared Axium™ coil sizes: Dimensions - 1st Loop Outer Diameter, Dimensions - Length, Coil Deformation, Friction, Fatigue After Knotting and Reliability Detachment, Torque Response, Force Transfer - Implant, Coil Tensile - Polypropylene, Coil Tensile - Implant/Weld (Implant Coil to Coil Shell Weld), Coil Tensile - Assembly, Particulate, Pusher Dimensions, Marker Radiopacity, Tip Buckling, Detachment Zone Stiffness, Kink Resistance, Hypotube and Weld Tensile Strength, Force Transfer - Pusher, Pusher Elongation, MRI Compatibility. In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the 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.
Axium™ Detachable Coil System (K081465)
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).
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0133310 JAN 1 0 2014
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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: | Angela Lamprey
Regulatory Affairs Specialist
Telephone: (949) 297-9611
E-mail: angela.lamprey@covidien.com |
| Date Summary
Prepared: | 09 December 2013 |
| Trade Name of
Device: | Axium™ Detachable Coil System |
| Common Name of
Device: | Neurovascular Embolization Device |
| Classification of
Device: | 21 CFR 882.5950-Class II |
| Predicate Device: | Axium™ Detachable Coil System (K081465)
Cleared 08/19/2008 |
| Device Description: | The Axium™ Detachable Coil System consists of a platinum coil secured
to a composite delivery wire and is compatible with a 2-marker band
micro catheter and a mechanical detachment system. The
Axium™ Detachable Coil System consists of three (3) components: |
| | 1 -- Implantable Coil
2 - Implant Delivery Pusher
3 - Instant Detacher. The Instant Detacher is packaged and sold
separately. |
| | Axium™ coil configurations include bare platinum, PGLA enlaced
platinum and Nylon enlaced platinum coils. Bare configuration coils
are non-fiber-enlaced, whereas PGLA and Nylon are enlaced with
PGLA and Nylon fibers respectively. |
| | This submission expands the size offerings of the Axium™ Detachable
Coil System by adding one (1) new model number to the Axium bare
product portfolio with a new diameter and coil length combination (SKU
QC-1.5-1-Helix). Currently cleared sizes for Axium™ bare under
K081465 already include a coil diameter of 1.5mm and a coil length of
1cm; however, not in combination. |
| | |
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| Intended 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. |
|---|---|
| Performance Data: | The following test(s) was performed to support the addition of the new size offering: |
| Non-Clinical | |
| Bench Testing: | |
| There were no material, design, sterilization, packaging or manufacturing process changes that resulted from the introduction of the new SKU (QC-1.5-1-Helix). The following testing was adopted from existing test data for currently cleared Axium™ coil sizes: | |
| Dimensions - 1st Loop Outer DiameterDimensions - LengthCoil DeformationFrictionFatigue After Knotting and Reliability DetachmentTorque ResponseForce Transfer - ImplantCoil Tensile - PolypropyleneCoil Tensile - Implant/Weld (Implant Coil to Coil Shell Weld)Coil Tensile - AssemblyParticulatePusher DimensionsMarker RadiopacityTip BucklingDetachment Zone StiffnessKink ResistanceHypotube and Weld Tensile StrengthForce Transfer - PusherPusher ElongationMRI Compatibility | |
| In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device. | |
| Conclusion: | The new Axium™ Detachable Coil System size offering (QC-1.5-1-Helix) is substantially equivalent to the currently cleared Axium™ Detachable Coil System based on the successful completion of non-clinical testing; a thorough assessment of existing test data; as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular c/o Ms. Angela Lamprey Regulatory Affairs Special 9775 Toledo Way Irvine, CA 92618
Re: K133310
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: December 9, 2013 Received: December 11, 2013
Dear Ms. Lamprey:
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 or any I 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Angela Lamprey
forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133310
Device Name: Axium™ Detachable Coil System
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.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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