(61 days)
No
The device description and performance studies focus on the physical components and mechanical performance of embolic coils and their delivery system, with no mention of AI or ML technologies.
Yes
The device is intended for endovascular embolization and vascular occlusion to permanently obstruct blood flow to treat neurovascular abnormalities and other vascular malformations, which are direct therapeutic interventions.
No
The device is an implantable coil system intended for the endovascular embolization and vascular occlusion of aneurysms and vascular malformations, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like implantable coils, delivery pushers, tubing, and syringes, 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 describes a device used for the endovascular embolization and vascular occlusion of blood vessels within the body. This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device description details an implantable coil and a delivery system used to place the coil within blood vessels. This is consistent with an interventional device, not a device used to examine specimens in vitro (outside of a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (like blood, urine, tissue, etc.) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG
Device Description
The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) consist of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heat-shrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to treatment site on the delivery pusher through standard neuro-interventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the MCS and HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms), neurovascular system (blood vessels), 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)
Performance testing documented in K012145, K021914 and K020434, including tensile strength, coil detachment, simulated use and animal testing, has demonstrated that the MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are equivalent in performance to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
OCT 2 2 2003
K032590
P/2
Section 2 - Summary of Safety and Effectiveness
Company Information (1)
MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 www.microvention.com
Contact Information (2)
Vincent Cutarelli Telephone: (949) 768-1184 ext. 105 Fax: (949) 768-0464 E-mail: vinc@microvention.com
Device Name (3)
| Classification Name: | Device, Artificial Embolization |
|---|---|
| Trade/Proprietary Name: | MicroPlex™ Coil System (MCS) |
| HydroCoil® Embolic System (HES) | |
| Common/Usual Name: | Embolization Coil |
Device Description (4)
The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) consist of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heat-shrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to treatment site on the delivery pusher through standard neuro-interventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the MCS and HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.
1
K032590
P2/2
(5) Indications for Use
The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
(6) Name of Predicate or Legally Marketed Device
The MicroVention MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are substantially equivalent to the MicroPlex™ Coil System that was determined to be substantially equivalent on July 29, 2002 (reference K020434) and the MicroCoil System that was determined to be substantially equivalent on August 1, 2003 (reference K031578).
Technological Characteristics and Substantial Equivalence (7)
The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are 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 documented in K012145, K021914 and K020434, including tensile strength, coil detachment, simulated use and animal testing, has demonstrated that the MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are equivalent in performance to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
OCT 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vincent Cutarelli Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656
Re: K032590
Trade/Device Name: MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 19, 2003 Received: August 22, 2003
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 (OS) 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), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N Millkan
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
K 032590
Indications For Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES)
Indications for Use: The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE):
for Mark N. Melkner
vision Sign-Off) Division of General, Restorative nd Neurological Devices
Prescription Use: __ X_ (Per 21 CFR 801.109)