(400 days)
Not Found
No
The summary describes a physical medical device (embolization coils and delivery system) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is intended for the "endovascular embolization of intracranial aneurysms" and "other neuro vascular abnormalities," which are therapeutic interventions aimed at treating a disease or condition.
No
The device is an embolization coil used for treating medical conditions like aneurysms and arteriovenous malformations, rather than diagnosing them.
No
The device description clearly outlines physical components including platinum coils, a delivery pusher, and a mechanical detachment actuator, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The provided text describes a device (FX Detachable Coils) that is physically implanted inside the body to treat neurovascular abnormalities. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test.
Therefore, based on the provided information, the FX Detachable Coils are a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The FX Detachable Coil System consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a handheld mechanical FX detachment actuator which facilities the release of the coil from the delivery pusher tip. The Nexus version of the FX Detachable coil is enlaced with absorbable polymer microfilaments. The FX Detachment Actuator is sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms)
other neuro vascular (abnormalities, such as, arteriovenous malformations and arteriovenous fistulae)
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 was performed and met established criteria for:
- Dimensional & Visual Analysis
- Force Transfer
- Ease of Delivery/Coil Frictional Characteristics
- Reliability After Fatigue & Premature Detachment
- Tensile Strength of Delivery Pusher
- Tensile Strength at Detachment Zone
- Particulate Generation - Adjusted Particles / 1 mL
- Delivery Pusher Distal Tip Buckling
- Delivery Pusher Distal Stiffness Profile
- Packaging Integrity
- Detachment Actuator Life Cycle and Reliability
- Time and Reliability of Detachment
- Radiopacity
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.
K041649, K050543, K051425, K051560
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
| Trade Name: | FX Detachable Coil System | |
|---|---|---|
| Generic Name: | Neurovascular Embolization Device | APR 24 2007 |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | Micro Therapeutics, Inc. | |
| DBA ev3 Neurovascular | ||
| 2 Goodyear | ||
| Irvine, California 92618 | ||
| Contact: | Florin Truuvert |
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K041649 | Sapphire NXT Detachable | ||
| Coil System | FX Detachable Coil System | July 16, 2004 | |
| K050543 | |||
| K051425 | |||
| K051560 | Nexus Detachable Coil | ||
| System | FX Detachable Coil System | April 27, 2005 | |
| June 22, 2005 | |||
| June 28, 2005 |
Device Description
The FX Detachable Coil System consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a handheld mechanical FX detachment actuator which facilities the release of the coil from the delivery pusher tip. The Nexus version of the FX Detachable coil is enlaced with absorbable polymer microfilaments. The FX Detachment Actuator is sold separately.
Indication For Use
The FX Detachable Coils are intended for embolization of those intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neurovascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
510(k) Summarv
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1
2/2
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Dimensional & Visual Analysis | Met established criteria |
| Force Transfer | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | Met established criteria |
| Reliability After Fatigue & Premature Detachment | Met established criteria |
| Tensile Strength of Delivery Pusher | Met established criteria |
| Tensile Strength at Detachment Zone | Met established criteria |
| Particulate Generation - Adjusted Particles / 1 mL | Met established criteria |
| Delivery Pusher Distal Tip Buckling | Met established criteria |
| Delivery Pusher Distal Stiffness Profile | Met established criteria |
| Packaging Integrity | Met established criteria |
| Detachment Actuator Life Cycle and Reliability | Met established criteria |
| Time and Reliability of Detachment | Met established criteria |
| Radiopacity | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the FX detachable coil system compared with the predicate device NXT and Nexus detachable coil system.
The devices,
- Have the same intended use, .
- Use the same operating principle, .
- Incorporate the same basic design, .
- Use similar construction and material, .
- Are packaged and sterilized using same processes. .
In summary, the FX Detachable Coil System described in this submission is, in our opinion, substantially equivalent to the predicate device.
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 eagle with its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micro Therapeutics, Inc., DBA ev3 Neurovascular % Mr. Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine, California 92618
APR 2 4 2007
Rc: K060747
Trade/Device Name: FX Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: March 30, 2007 Received: April 2, 2007
Dear Mr. Daughters:
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Tom Daughters
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N. Melkerson
Director
Division of General, Restorative
DEP DIR
4/24/07
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: FX Detachable Coil System
Indications For Use:
The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of1
510(k) Number 16060747