(171 days)
Not Found
No
The device description and intended use focus on the physical characteristics and delivery system of embolization coils. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is intended for embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention to treat a medical condition.
No
The device is described as an implantable coil system intended for the embolization of intracranial aneurysms and other neuro-vascular abnormalities, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components including implantable coils, a delivery pusher, and an introducer sheath, indicating it is a hardware-based medical device.
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 embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The device is described as an implantable coil attached to a delivery system. This is consistent with a device used for therapeutic intervention within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a therapeutic implant.
Therefore, the MicroPlex Coil System (MCS) is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The MicroVention MicroPlex Coil System (MCS) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the implantable coil into the microcatheter.
The MCS-CC is a platinum complex coil that establishes the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC is a platinum helical coil that provides additional filling once the initial framework has been established by one or more complex coils. The complex and helical coils are provided in a number of diameters and lengths. The MCS-HCP is a platinum helical coil with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS-CC complex coils.
The MCS-CC and MCS-HC are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters. The MCS-HCP is available in 14-compatible systems and may be delivered through 14-type micro-catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms), neuro-vascular (abnormalities), peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating neurosurgical team
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)
Performance testing including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices.
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.
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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Section 2 - Summary of Safety and Effectiveness
Company Information (1)
MicroVention, Inc. 72 Argonaut Aliso Viejo, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 www.microvent.com
Contact Information (2)
Vincent Cutarelli Telephone: (949) 768-1184 ext. 105 Fax: (949) 768-0464 E-mail: vinc@microvent.com
(3) Device Name
| Classification Name: | Device, Artificial Embolization |
|---|---|
| Trade/Proprietary Name: | MicroPlex™ Coil System (MCS) |
| Common/Usual Name: | Embolization Coil |
(4) Device Description
The MicroVention MicroPlex Coil System (MCS) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the implantable coil into the microcatheter.
The MCS-CC is a platinum complex coil that establishes the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC is a platinum helical coil that provides additional filling once the initial framework has been established by one or more complex coils. The complex and helical coils are provided in a number of diameters and lengths. The MCS-HCP is a platinum helical coil with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS-CC complex coils.
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The MCS-CC and MCS-HC are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters. The MCS-HCP is available in 14-compatible systems and may be delivered through 14-type micro-catheters.
Indications for Use (5)
The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
Name of Predicate or Legally Marketed Device (0)
The MicroPlex Coil System (MCS) with the expanded indications for use and the additional model numbers is substantially equivalent to the Guglielmi Detachable Coil (GDC) that was determined to be substantially equivalent on January 21, 2000 (reference K993417), the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29, 2001 (reference K012145) and the Matrix Detachable Coil System that was determined to be substantially equivalent on February 1, 2001 (reference K012985).
(7) Technological Characteristics and Substantial Equivalence
The MicroPlex Coil System (MCS) is substantially equivalent in operating principle, method of application, indications for use, design, packaging and sterilization to the predicate devices.
Performance Data Summary
(8)
Performance testing including tensile strength, coil detachment, simulated use, biocompatibility and animal testing demonstrated that the MicroPlex Coil System (MCS) has equivalent performance to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
MicroVention, Inc. Vincent Cutarelli 72 Argonaut Aliso Viejo, California 92656
Re: K020434
Trade Name: MicroPlex™ Coil System (MCS) Regulation Number: 887.5950 Regulation Name: Artificial Embolization Device : 2002 Regulatory Class: III Product Code: HCG Dated: May 17, 2002 Received: May 20, 2002
Dear Mr. Cutarelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.
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Page 2 - Mr. Vincent Cutarelli
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
for Mark N. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: MicroPlex™ Coil System (MCS)
Indications for Use: The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE):
for Mark N. Milkersen
Division Sign-Off) Division of General. Restorative and Neurological Devic
510(k) Number K020434
Prescription Use: X (Per 21 CFR 801.109)