(226 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of the embolization coils, with no mention of AI or ML.
Yes
The device is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention.
No
The device description and intended use clearly state that it is an embolization coil used for therapeutic purposes (embolization), not for diagnostic imaging or analysis.
No
The device description clearly states it consists of a platinum embolization coil, a composite implant delivery pusher, and a hand-held Instant Detacher, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "endovascular embolization of intracranial aneurysms" and other neurovascular abnormalities. This is a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "platinum embolization coil attached to a composite implant delivery pusher." This is a physical implant designed to block blood flow, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a medical device used for a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
Axium™ Detachable Coil:
Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil (Model Numbers APB-X-Y-3D/HX-ES/SS):
The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil (Model Numbers FC-X-Y-3D):
The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG, KRD
Device Description
The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.
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)
Non-clinical bench testing was conducted to evaluate the performance of Axium™ Detachable Coil and Axium™ Prime Detachable Coil in a clinically representative access model.
Design Verification Test: Ease of Delivery – Friction. Test Method Summary: Device navigated through tortuous bench top model in order to assess friction. Results: All test results met acceptance criteria.
Design Validation Test: Ease of Delivery. Test Method Summary: Device navigated through tortuous bench top model in order to assess deliverability. Results: All test results met acceptance criteria.
Design Validation Test: Detachment Reliability and Retractability. Test Method Summary: Cycle the coil (manipulate within the embolic target) without premature detachment. Results: All test results met acceptance criteria.
Design Validation Test: Detachment Reliability and Retractability. Test Method Summary: Detach the coil successfully in 3 or fewer attempts. Results: All test results met acceptance criteria.
Design Validation Test: Retrieval. Test Method Summary: Retrieve the pusher through the microcatheter after detachment. Results: All test results met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 7, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized eagle with the words "DEPARTMENT OF HEALTH" written vertically along the left side of the symbol. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Bhavika Patel Senior Specialist, Regulatory Affairs 5290 California Avenue Irvine, California 92617
Re: K203432
Trade/Device Name: Axium Detachable Coil and Axium Prime Detachable Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: June 3, 2021 Received: June 4, 2021
Dear Bhavika Patel:
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 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
1
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 mediation-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,
Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203432
Device Name Axium™ Detachable Coil Axium™ Prime Detachable Coil
Indications for Use (Describe)
Axium™ Detachable Coil:
Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil (Model Numbers APB-X-Y-3D/HX-ES/SS):
The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil (Model Numbers FC-X-Y-3D):
The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended 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
K203432 510(k) Summary
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bhavika Patel
Senior Regulatory Affairs Specialist
Telephone: (949) 434-5030
Email: bhavika.patel@medtronic.com |
| Date Summary Prepared: | 06 July 2021 |
|---|---|
| Trade Name of Device: | Axium™ Detachable Coil |
| Axium™ Prime Detachable Coil | |
| Common Name of Device: | Neurovascular Embolization Device |
| Review Panel: | Neurology |
| Product Code: | HCG , KRD |
| Regulation Number: | 21 CFR 882.5950 |
| Regulation Name: | Neurovascular Embolization Device |
| Device Classification | Class II |
| Predicate Device: | K133310 Axium™ Detachable Coil System |
| K151447 Axium™ Detachable Coil System | |
| K162704 Axium™ Prime Detachable Coil System |
Device Description:
The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.
Indication for Use Statement:
The Axium™ device family product model numbers and associated indications for use are outlined in the table below. The model numbers are formatted to summarize sizes available, where X is the coil loop outer diameter in mm and Y is the implant length in cm.
| Axium™ Device Family Indications for Use | ||
|---|---|---|
| Model Numbers | Trade Name | Indications for Use |
| QC-X-Y-HELIX | Axium™ | Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. |
| QC-X-Y-3D | Detachable | |
| NC-X-Y-HELIX | Coil | |
| PC-X-Y-HELIX | ||
| PC-X-Y-3D | ||
| APB-X-Y-3D-ES | Axium™ | The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. |
| APB-X-Y-3D-SS | Prime | |
| APB-X-Y-HX-ES | Detachable | |
| APB-X-Y-HX-SS | Coil |
4
| Axium™ Device Family Indications for Use | ||
|---|---|---|
| Model Numbers | Trade Name | Indications for Use |
| FC-X-Y-3D | Axium™ | |
| Prime | ||
| Detachable | ||
| Coil | The Axium™ Prime Detachable Coil is intended for the endovascular | |
| embolization of intracranial aneurysms and other neurovascular abnormalities, | ||
| such as arteriovenous malformations and arteriovenous fistulae. The Axium™ | ||
| Prime Detachable Coils are also intended for arterial and venous embolizations | ||
| in the peripheral vasculature. |
Proposed Change:
Medtronic requests clearance of Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as the "Axium™ device family") for revised labeling that includes changes to the directions for use to modify the accessory sheath required to perform a procedure, from femoral sheath to arterial sheath. The proposed change will allow the physician to use radial artery route during access as an alternative to femoral artery for the introduction of the device during a procedure if deemed appropriate. Axium™ Detachable Coil and Axium™ Prime Detachable Coil revised labeling also includes removal of the indication "The Axium™ [Prime] Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature" for Axium™ Detachable Coil and Axium™ Prime Detachable Coil (excludes Model Numbers FC-X-Y-3D).
Device Comparison:
| Design Feature | Predicate:
Axium™ Detachable Coil System
(K133310, K151447)
Axium™ Prime Detachable Coil System
(K162704) | Subject:
Axium™ Detachable Coil
Axium™ Prime Detachable Coil |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
for Axium™
Detachable Coil | 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. | Axium™ Detachable Coils are intended
for the endovascular embolization of
intracranial aneurysms. Axium™
Detachable Coils are also intended for the
embolization of other neuro vascular
abnormalities such as arteriovenous
malformations and arteriovenous fistulae. |
| Indications for Use
for Axium™ Prime
Detachable Coil
(Model Numbers
APB-X-Y-3D/HX-
ES/SS) | 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. | The Axium™ Prime Detachable Coils are
intended for the endovascular
embolization of intracranial aneurysms.
The Axium™ Prime Detachable Coils are
also intended for the embolization of
other neuro vascular abnormalities such as
arteriovenous malformations and
arteriovenous fistulae. |
| Indications for Use
for Axium™ Prime
Detachable Coil
(Model Numbers
FC-X-Y-3D) | The Axium™ Prime 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™ Prime
Detachable Coils are also indicated for
arterial and venous embolizations in the
peripheral vasculature. | The Axium™ Prime Detachable Coil is
intended for the endovascular
embolization of intracranial aneurysms
and other neurovascular abnormalities,
such as arteriovenous malformations and
arteriovenous fistulae. The Axium™
Prime Detachable Coils are also intended |
| Design Feature | Predicate: | Subject: |
| | Axium™ Detachable Coil System
(K133310, K151447) | Axium™ Detachable Coil |
| | Axium™ Prime Detachable Coil System
(K162704) | Axium™ Prime Detachable Coil |
| | | for arterial and venous embolizations in |
| | | the peripheral vasculature. |
| Dimensions | | |
| Device Size Range | Axium™ Bare Helix:
1.5-20 mm – Loop OD
1-50 cm - Length
Axium™ Bare 3D:
2-25 mm - Loop OD
2-50 cm - Length
Axium™ Nylon 3D:
2-4 mm – Loop OD
1-10 cm - Length
Axium™ PGLA Helix:
2-10 mm – Loop OD
1-30 cm - Length
Axium™ PGLA 3D:
2-18 mm – Loop OD
2-40 cm - Length
Axium™ Prime 3D
1-6 mm – Loop OD
2-20 cm – Length
Axium™ Prime Helix
1-6 mm – Loop OD
1-20 cm - Length
Axium™ Prime 3D
3-25 mm - Loop OD
6-50 cm - Length | Same |
| Coil Shape | Helical and 3D | Same |
| Compatible Accessories | | |
| Catheter
Compatibility | Axium™ detachable coils (Bare) should be
delivered through microcatheters with
minimum ID of 0.0165".
Axium™ detachable coils (Nylon and
PGLA) should be delivered through
microcatheters with minimum ID of 0.0165"
- 0.020".
Axium™ Prime detachable coils should
only be delivered through a microcatheter
with a minimum inside diameter of
0.0165"-0.017" with two marker bands | Same |
| Design Feature | Predicate: | Subject: |
| | AxiumTM Detachable Coil System
(K133310, K151447) | AxiumTM Detachable Coil |
| | AxiumTM Prime Detachable Coil System
(K162704) | AxiumTM Prime Detachable Coil |
| | | |
| | | |
| Guide Catheter
Compatibility | 6-8F | Same |
| Method of Coil
Detachment | Instant Detacher – standalone hand-held
mechanical unit that, when connected to the
proximal end of the pusher, pulls the release
element inside of the pusher, resulting in
release of the implant from the distal end of
the delivery pusher | Same |
| Sterilization | | |
| | | |
| Method of Supply | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide (EO) | Same |
| Stability | | |
| | | |
| Shelf Life | 3 years | Same |
| Magnetic Resonance Imaging | | |
| MRI Compatibility | MR Conditional | Same |
5
6
Biocompatibility:
There is no change to the biocompatibility of the products associated with the proposed changes.
Performance Data – Bench:
Non-clinical bench testing was conducted to evaluate the performance of Axium™ Detachable Coil and Axium™ Prime Detachable Coil in a clinically representative access model.
The following non-clinical bench tests were conducted:
| Design Verification | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Ease of Delivery – Friction | Device navigated through tortuous | |
| bench top model in order to assess | ||
| friction | All test results met acceptance | |
| criteria |
| Design Validation | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Ease of Delivery | Device navigated through tortuous | |
| bench top model in order to assess | ||
| deliverability | All test results met acceptance | |
| criteria | ||
| Detachment Reliability and | ||
| Retractability | Cycle the coil (manipulate within | |
| the embolic target) without | ||
| premature detachment | All test results met acceptance | |
| criteria | ||
| Detachment Reliability and | ||
| Retractability | Detach the coil successfully in 3 or | |
| fewer attempts | All test results met acceptance | |
| criteria | ||
| Retrieval | Retrieve the pusher through the | |
| microcatheter after detachment | All test results met acceptance | |
| criteria |
7
Performance Data - Animal:
The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction.
Performance Data - Clinical:
The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction.
Conclusion:
Axium™ Detachable Coil and Axium™ Prime Detachable Coil revised labeling includes changes to the directions for use to modify the accessory sheath required to perform a procedure, from femoral sheath. Axium™ Detachable Coil and Axium™ Prime Detachable Coil revised labeling also includes removal of the indication "The Axium™ [Prime] Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature" for Axium™ Detachable Coil and Axium™ Prime Detachable Coil (excludes Model Numbers FC-X-Y-3D). The proposed changes do not alter the intended use, design, materials, or fundamental scientific technology. The successful results of the performance evaluation verify that the proposed changes do not raise new questions of safety and efficacy. Therefore, Axium™ Detachable Coil and Axium™ Prime Detachable Coil are substantially equivalent to the predicate devices.