Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the physical components and function of embolization coils, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is described as being intended for "endovascular embolization of intracranial aneurysms" and "embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae," which are medical treatments.

Diagnostic

No

The device is an embolization coil used for therapeutic treatment of vascular abnormalities, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device consists of a platinum embolization coil, a composite implant delivery pusher, a radiopaque positioning marker, and a hand-held Instant Detacher (I.D.). These are all physical hardware components, not software.

IVD (In Vitro Diagnostic)

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 Axium™ Detachable Coils are for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities. This is a therapeutic procedure performed within the body to block blood flow.
Device Description: The device is described as a platinum embolization coil attached to a delivery system. This is a physical implant used for a therapeutic purpose.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such testing.

The device is a medical device used for a therapeutic intervention, not a diagnostic test performed outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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:
(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)
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.

Axium™ Prime Detachable Coil:
(Models: FC-X-Y-3D)
The Axium™ Prime Detachable Col 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 (comma separated list FDA assigned to the subject device)

HCG, KRD

Device Description

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil consist 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 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, Neurovascular, 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)

Non-clinical bench testing was conducted to evaluate the performance of Axium™ Detachable Coil and Axium™ Prime Detachable Coil in a clinically representative neurovascular access model. The successful results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate devices.

The following non-clinical bench tests were conducted:
Visual Inspection, Marker Dimensional (Marker Position and Total Marker Length) Inspection, Corrosion Resistance, Fluorosafe Marker Visibility.

Results:
Axium™ Detachable Coil and Axium™ Prime Detachable Coil met the acceptance criteria for visual inspection.
Axium™ Detachable Coil and Axium™ Prime Detachable Coil met the acceptance criteria for marker dimensional inspection.
Axium™ Detachable Coil and Axium™ Prime Detachable Coil met the acceptance criteria for corrosion resistance.
The devices met the user needs for which it was designed and tested.

No clinical data or animal study were deemed necessary to support the subject device submission.

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.

K203432

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

Regulation Number and Section

§ 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).

Summary

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November 7, 2023

Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Lekshmi Pillai, MS Senior Regulatory Affairs Specialist 5290 California Avenue Irvine, California 92617

Re: K233420

Trade/Device Name: Axium Detachable Coil; Axium Prime Detachable Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: October 9, 2023 Received: October 10, 2023

Dear Lekshmi Pillai:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Naira Muradyan -S

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 Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K233420

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:

(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)

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.

Axium™ Prime Detachable Coil:

(Models: FC-X-Y-3D)

The Axium™ Prime Detachable Col 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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K233420 510(k) Summary

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618, USA
Establishment Registration: 2029214 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lekshmi Pillai
Senior Regulatory Affairs Specialist
Telephone: (917) 291-3810
Email : lekshmiajaykumar.pillai@medtronic.com |

| Date Summary

Prepared:	06 November 2023
Trade Name of Device:	Axium™ Detachable Coil
Axium™ Prime Detachable Coil
Common Name of
Device:	Neurovascular Embolization Device, Vascular Embolization Device
Review Panel:	Neurology, Cardiovascular
Product Code:	HCG, KRD
Regulation Number:	21 CFR 882.5950; 21 CFR 870.3300
Regulation Name:	Neurovascular Embolization Device, Vascular Embolization Device
Device Classification	Class II
Predicate Device:	K203432
Axium™ Detachable Coil
Axium™ Prime Detachable Coil

Device Description:

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil consist 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 I.D. is sold separately.

Indications for Use Statement:

Axium™ Detachable Coil and Axium Prime Detachable Coil Indications for Use
Model Numbers	Trade Name	Indications for Use
QC-X-Y-HELIX
QC-X-Y-3D	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.
NC-X-Y-HELIX
PC-X-Y-HELIX
PC-X-Y-3D

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Axium™ Detachable Coil and Axium Prime Detachable Coil Indications for Use
Model Numbers	Trade Name	Indications for Use
APB-X-Y-3D-ES	Axium™
Prime
Detachable
Coil	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
APB-X-Y-HX-ES
APB-X-Y-HX-SS
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.

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.

Proposed Change:

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular requests clearance for the Axium™ Detachable Coil and Axium™ Prime Detachable Coil with addition of fluorosafe markers on the proximal end of the coil delivery pusher.

Device Comparison:

| Design Feature | Predicate Devices (K203432):
Axium™ Detachable Coil;
Axium™ Prime Detachable Coil | Subject Devices:
Axium™ Detachable
Coil;
Axium™ Prime
Detachable Coil |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 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 (APB-X-Y-3D-ES, APB-X-Y-3D-SS,
APB-X-Y-HX-ES, APB-X-Y-HX-SS):
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.

Axium™ Prime Detachable Coil (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 | Same |
| Design Feature | Predicate Devices (K203432):
Axium™ Detachable Coil;
Axium™ Prime Detachable Coil | Subject Devices:
Axium™ Detachable
Coil;
Axium™ Prime
Detachable Coil |
| | intended for arterial and venous embolizations in the peripheral
vasculature. | |
| Visual Markers | None | Fluorosafe
markers |
| 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". | Same
Same |
| | Axium™ Prime Detachable Coils should be delivered through
microcatheters with minimum ID of 0.0165"-0.017". | Axium™ Prime
Detachable Coils
should be delivered
through |
| Design Feature | Predicate Devices (K203432):
Axium™ Detachable Coil;
Axium™ Prime Detachable Coil | Subject Devices:
Axium™ Detachable Coil;
Axium™ Prime
Detachable Coil
microcatheters with
minimum ID of
0.0165". |
| 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 |
| Material of Construction | | |
| Main Coil | Platinum/Tungsten alloy | Same |
| Tension Safe/
Stretch Resistant
Filament | Polypropylene | Same |
| Delivery System | Pusher: Composite hypotube stainless steel with PTFE outer jacket and liner and PET & Pt/w alignment marker | Same |
| Introducer Sheath | Polypropylene and HDPE | Same |
| Sterilization | | |
| Method of Supply | Sterile and single use | Same |
| Sterilization
Method | Ethylene Oxide (EO) | Same |
| Packaging | | |
| Pouch Material | For PC-X-Y-HELIX and PC-X-Y-3D:
PLK235/Uncoated 2FS Tyvek

For all other models:
PET/Tyvek | Same

For all other models:
Nylon/Tyvek |
| Pouch Dimensions | For PC-X-Y-HELIX and PC-X-Y-3D:
17" X 9.8" (pre-sterilization)

For all other models:
10 1/8" X 10.838" | Same

5

6

7

Biocompatibility:

The fluorosafe marker (subject to this submission) added onto the proximal end of the delivery pusher is considered external communicating device having indirect blood contact via the fluid path, as it is only in contact with the delivery catheter and does not have direct exposure to circulating blood. The distal end of the delivery pusher is categorized as external communicating device with limited exposure duration (د 24 hrs.) with circulating blood. The embolization coil is considered an implant with long-term (> 30 days) direct contact with circulating blood. There are no material or contact duration changes to the components of the device that directly contact circulating blood in the current submission. Therefore, prior hemocompatibility (complement activation, direct hemolysis, and thrombogenicity) tests demonstrate the biocompatibility of the unmodified regions and components of the subject device that contact blood directly.

To assess the addition of fluorosafe markers on the proximal end of the delivery pusher, the following biocompatibility tests were performed on the final, finished delivery pusher subassemblies incorporating the fluorosafe marker.

Test Description	Study Method	Results
Cytotoxicity	Axium™ Detachable Coil and Axium™ Prime
Detachable Coil were evaluated per ISO 10993-
5: 2009, using the MEM elution method.	The Axium™ Detachable Coil and
Axium™ Prime Detachable Coil did
not induce cytotoxicity.
Sensitization	Axium™ Detachable Coil and Axium™ Prime
Detachable Coil were evaluated per ISO 10993-
10:2021, using a guinea pig maximization test.	The Axium™ Detachable Coil and
Axium™ Prime Detachable Coil
were not considered a sensitizer.
Irritation	Axium™ Detachable Coil and Axium™ Prime
Detachable Coil were evaluated per ISO 10993-
23:2021, using a rabbit intracutaneous reactivity
test.	The Axium™ Detachable Coil and
Axium™ Prime Detachable Coil are
considered non-irritant.
Acute
Systemic
Toxicity	Axium™ Detachable Coil and Axium™ Prime
Detachable Coil were evaluated per ISO 10993-
11:2017, using an acute systemic injection test
in mice.	The Axium™ Detachable Coil and
Axium™ Prime Detachable Coil
showed no mortality or evidence of
acute systemic toxicity.
Indirect
(extract)
Hemolysis	Axium™ Detachable Coil and Axium™ Prime
Detachable Coil were evaluated per ISO 10993-
4:2017, using ASTM hemolysis study.	The Axium™ Detachable Coil and
Axium™ Prime Detachable Coil are
considered non-hemolytic.
Material-Mediated
Pyrogenicity	Axium™ Detachable Coil and Axium™ Prime
Detachable Coil were evaluated per USP 151
(2020), using USP rabbit pyrogen test -
material-mediated.	The Axium™ Detachable Coil and
Axium™ Prime Detachable Coil met
the requirements and were found
to be non-pyrogenic.

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil have been evaluated to meet requirements specified in FDA guidance, "Use of International Standard ISO 10993-1, "Biocompatibility Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", " issued

8

on September 8, 2023.

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 neurovascular access model. The successful results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate devices.

The following non-clinical bench tests were conducted:

Design Verification
Test	Test Method Summary	Results
Visual Inspection	Visual inspection verified for the
darkness of the etch mark of
fluorosafe markers and the 360°
etch mark around the delivery
pusher.	Axium™ Detachable Coil and
Axium™ Prime Detachable Coil
met the acceptance criteria for
visual inspection.
Marker Dimensional (Marker
Position and Total Marker
Length) Inspection	Marker dimensional inspection
verified the total length of the
fluorosafe markers and their
position on the delivery pusher.	Axium™ Detachable Coil and
Axium™ Prime Detachable Coil
met the acceptance criteria for
marker dimensional inspection.
Corrosion Resistance	The test verified the corrosion
resistance on the delivery pusher
using the method of soaking the
devices in saline followed
by
immersion in boiling water per the
method specified in Annex A of ISO
10555-1.	Axium™ Detachable Coil and
Axium™ Prime Detachable Coil
met the acceptance criteria for
corrosion resistance.

Design Validation
Test	Test Method Summary	Results
Fluorosafe Marker Visibility	The clinical users evaluated the
devices
under simulated
use
conditions and rated fluorosafe
marker visibility.	The devices met the user needs
for which it was designed and
tested.

Performance Data – Animal and Clinical:

The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the indications for use statement, fundamental scientific technology, principles of operation or materials of construction except for the addition of fluorosafe markers. No clinical data or animal study were deemed necessary to support the subject device submission.

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Conclusion:

There is no change to the indications for use statement, fundamental scientific technology or principle of operation of the Axium™ Detachable Coils and Axium™ Prime Detachable Coils in comparison to the predicate devices. The addition of fluorosafe markers on the proximal end of the embolization coil delivery pusher does not raise new questions of safety and effectiveness and is supported by non-clinical bench testing using well-established acceptable scientific methods. The information provided in this submission supports a determination of substantial equivalence for Axium™ Detachable Coils and Axium™ Prime Detachable Coils to the predicate devices.