(28 days)
Not Found
No
The description focuses on the physical components and function of the coil system for embolization, with no mention of AI or ML technologies.
Yes
The device is intended for embolization of intracranial aneurysms, which falls under the definition of treating or alleviating a disease or injury, thus qualifying it as a therapeutic device.
No
The device description clearly states "The MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms", indicating it is a therapeutic device designed to treat a condition, not diagnose it.
No
The device description clearly outlines physical components including implantable coils, a delivery pusher (variable stiffness tube, retention sleeve), and a peel-away introducer sheath. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of intracranial aneurysms. This is a therapeutic procedure performed directly on the patient's body to treat a medical condition.
- Device Description: The device is an implantable coil delivered via a system to the site of the aneurysm. This is a physical implant used for treatment.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
The device is a medical device used for a therapeutic intervention, not for in vitro diagnostic testing.
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.
Product codes
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 MicroPlex Coil System (MCS) is provided in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide 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 complex and helical coils 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
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 and simulated use demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device.
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
K021914 (p. 1 of 2)
มมเลิ 9 2002
Section 2 - Summary of Safety and Effectiveness
Company Information (1)
MicroVention, Inc. 72 Argonaut Aliso Vieio, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 www.microvent.com
(2) Contact Information
Vincent Cutarelli Telephone: (949) 768-1184 ext. 105 Fax: (949) 768-0464 E-mail: vinc@microvent.com
(3) Device Name
| Trade/Proprietary Name: | MicroPlex™ Coil System (MCS) with the MCS-HC-SX Helical Coil |
|---|---|
| Common/Usual Name: | Embolization Coil |
| Classification Name: | Device, Artificial Embolization |
(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 MicroPlex Coil System (MCS) is provided in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide 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.
1
K021914 (P.2 of 2)
The complex and helical coils 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.
(5) 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.
Name of Predicate or Legally Marketed Device (6)
The MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil is substantially equivalent to the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29, 2001 (reference K012145).
(7) Technological Characteristics and Substantial Equivalence
The MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil is substantially equivalent in operating principle, method of applications for use, design, packaging and sterilization to the predicate device.
(8) Performance Data Summary
Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vincent Cutarelli ´´ Vice President, Regulatory Affairs Ouality Assurance and Clinical Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656
Re: K021914
Trade/Device Name: MicroPlex™ Coil System (MCS) Regulation Number: 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: June 7, 2002 Received: June 11, 2002
JUL - 9 2002?
Dear Mr. Cutarelli:
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 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.
3
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,
Net Rr oglen
Z. Colin McWhirter, Ph.D., M.D.
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
4
Indications For Use
510(k) Number: K021914
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
Concurrence of CDRH, Office of Device Evaluation (ODE):
NKA Lormer
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use: _ X (Per 21 CFR 801.109)