(84 days)
Not Found
No
The summary describes a mechanical device for embolization and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention.
No
The device is described as a system for endovascular embolization, which is a treatment procedure, rather than a device used for diagnosis.
No
The device description clearly outlines physical components including a platinum coil, delivery wire, and a mechanical detachment system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, as well as arterial and venous embolizations in the peripheral vasculature. This involves direct intervention within the body.
- Device Description: The device is described as a coil system with a delivery wire and detachment system, designed to be implanted within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is clearly designed for therapeutic intervention inside the body.
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
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™ coil configurations include bare platinum, PGLA laced platinum and Nylon laced platinum coils.
The AXIUM™ DETACHABLE COIL SYSTEM consists of three components:
- l Implantable Coil,
- 2- Implant Delivery Pusher,
3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.
This submission expands the indications for use statement to include arterial and venous embolizations in the peripheral vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, Neurovascular, 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
Bench data were generated to support the original FX Detachable Coil System (K060747), and are valid as the subject of this submission is an expanded indication and there is no change to the fundamental scientific technology of the device. Subsequent to the submission of K060747, additional bench and animal testing was performed for the AXIUM™ DETACHABLE COUL SYSTEM. A summary of the bench data are presented in Section 18 and the animal data are presented in Section 19 of this submission.
The risk assessment documentation for the AXIUM™ DETACHABLE COL SYSTEM was reviewed to assess any new or unique risks posed by the peripheral vascular indication. No new risks were identified.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).
0
Ev3® Inc. 23 May, 2008
5 510(K) SUMMARY
| Applicant: | ev3® Inc.
9775 Toledo Way
Irvine, CA 92618
USA
Phone: +1-949-837-3700
Fax: +1-949-837-2044 | AUG 19 2008 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Date: | May 22, 2008 | |
| Contact Person: | Neelu Medhekar
Director, Global Regulatory Affairs | |
| Proprietary Device Name: | AXIUMTM DETACHABLE COIL SYSTEM | |
| Common Device Name: | Neurovascular Embolization Device
(21CFR 882.5950, Product Code HCG) | |
| Classification: | Class II | |
| Predicate Devices: | Micro Therapeutics, Inc. FX Detachable Coil System
(K060747) cleared 04/24/07 – marketed as the ev3® AXIUMTM
DETACHABLE COIL SYSTEM
Micrus® Microcoil Delivery System (K073442) 02/26/2008
Boston Scientific/Target Therapeutics, Guglielmi Detachable
Coil (K962503) cleared 09/20/1996 | |
| Manufacturer: | ev3® Neurovascular a division of ev3® Inc.
9775 Toledo Way
Irvine, CA 92618
USA | |
Note: Micro Theraputics Inc., does business as ev3ª Neurovascular, which is a division of ev38 Inc. To simplify the product identification for the purposes of this submission, references will only be made to ev3 Inc.
5.1 Substantially Equivalent To:
The AXIUM™ DETACHABLE COIL SYSTEM is substantially equivalent to the Micro Therapeutics, Inc. FX Detachable Coil System (K060747) -- marketed as the ev3 AXIUM™ DETACHABLE COL SYSTEM, Microcoil Delivery System (K073442), and the Boston Scientific/Target
1
Ev30 Inc. 23 May, 2008
Traditional 510(k) – Axium™ Detachable Coil System of 154 CONFIDENTIAL
Therapeutics, Guglielmi Detachable Coil (K962503) in terms of intended use, design, specifications, and materials. These systems are all indicated for use in the embolization of aneurysms. The predicate devices, Microcoil Delivery System (K073442), and the Boston Scientific/Target Therapeutics, Guglielmi Detachable Coil (K962503) are indicated for neurovascular embolizations as well as embolizations in the peripheral vasculature.
The AXIUM™ DETACHABLE COL SYSTEM uses the same design, methods and materials in construction, packaging and sterilization as its predicates. The modification to the indications use statement has not altered the fundamental scientific technology of the AXIUM™ devices.
5.2 Description of the Device Subject to Premarket Notification:
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™ coil configurations include bare platinum, PGLA laced platinum and Nylon laced platinum coils.
The AXIUM™ DETACHABLE COIL SYSTEM consists of three components:
- l Implantable Coil,
- 2- Implant Delivery Pusher,
3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.
This submission expands the indications for use statement to include arterial and venous embolizations in the peripheral vasculature. This indication is discussed further in Section 10.
Indications for Use: 5.3
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: 5.4
Bench data were generated to support the original FX Detachable Coil System (K060747), and are valid as the subject of this submission is an expanded indication and there is no change to the fundamental scientific technology of the device. Subsequent to the submission of K060747, additional bench and animal testing was performed for the AXIUM™ DETACHABLE COUL SYSTEM. A summary of the bench data are presented in Section 18 and the animal data are presented in Section 19 of this submission.
The risk assessment documentation for the AXIUM™ DETACHABLE COL SYSTEM was reviewed to assess any new or unique risks posed by the peripheral vascular indication. No new risks were identified.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a winding snake around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2008
EV3® Inc. c/o Ms. Neelu Medhekar Director, Global Regulatory Affairs 9775 Toledo Way Irvine, CA 92618
Re: K081465 Axium™ Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: May 23, 2008 Reccived: May 27, 2008
Dear Ms. Medhckar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 - Ms. Neelu Medhekar
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ev30 Inc. 23 May, 2008
INDICATIONS FOR USE STATEMENT র্ব
510(k) No (if known): K081465
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 V (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 CDRH, Office of Device Evaluation (ODE)
echmel
Page 1 of 1
of Cardiovascular Devices
510(k) Number_ KOBILES