(37 days)
Not Found
No
The summary describes a mechanical device (coils and delivery system) and its intended use for embolization. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making component. The performance studies are bench tests evaluating physical properties and simulated use, not algorithmic performance.
Yes.
The device is intended for "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and "vascular occlusion of blood vessels," indicating a therapeutic purpose to treat diseases or conditions.
No
Explanation: The device is described as an implantable coil system used for the endovascular embolization and occlusion of intracranial aneurysms and other neurovascular abnormalities, which are therapeutic interventions rather than diagnostic processes.
No
The device description explicitly states that the device consists of implantable coils made of platinum alloy and a delivery pusher, which are physical hardware components. It also mentions a hand-held battery-powered detachment controller.
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 endovascular embolization and vascular occlusion of blood vessels. This is a therapeutic procedure performed within the body to treat conditions like aneurysms and vascular malformations.
- Device Description: The device is described as an implantable coil and a delivery system. This is consistent with a therapeutic device used for embolization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the MicroPlex Coil System and HydroCoil Embolic System are therapeutic devices, not IVDs.
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 MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular system, peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Test Summary:
- Test: Visual Inspection; Test Method: Using a microscope, inspect per product drawings; Results: All test samples met the acceptance criteria and passed testing.
- Test: Pusher Resistance; Test Method: Measure the pusher resistance using a digital multi-meter; Results: All test samples met the acceptance criteria and passed testing.
- Test: Simulated Use; Test Method: Using cerebrovascular benchtop model, conduct the following assessments on each test sample: Introduction, Tracking inside microcatheter, Deployment, Microcatheter Movement, Detachment; Results: All test samples met the acceptance criteria and passed testing.
Key Metrics
Not Found
Predicate Device(s)
MicroPlex Coil System (MCS) - K132952, HydroCoil Embolic System (HES) - K132952
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
MicroVention, Inc. Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780
Re: K153594
Trade/Device Name: MicroPlex Coil System (MCS), HydroCoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: December 21, 2015 Received: December 23, 2015
Dear Ms. Pangelina:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -SFD/△
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153594
Device Name
MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for MicroVention, a company that specializes in neurovascular products. The logo features a stylized graphic to the left of the company name. Below the company name is the word "TERUMO", which is likely the parent company of MicroVention. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
510(K) SUMMARY
(Prepared December 01, 2015)
| Trade Name: | MicroPlex Coil System (MCS), HydroCoil Embolic System (HES) |
|---|---|
| Generic Name: | Neurovascular Embolization Device |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California 92780 | |
| U.S.A. | |
| Contact: | Laraine Pangelina |
| Sr. Regulatory Affairs Project Manager | |
| MicroVention, Inc. | |
| Predicate Device: | MicroPlex Coil System (MCS) - K132952 |
| HydroCoil Embolic System (HES) - K132952 | |
| 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. | |
| Device Description: | The MCS devices consist of an implantable coil made of platinum alloy |
| (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is | |
| attached to a V-Trak delivery pusher via a polymer filament. The | |
| proximal end of the pusher is inserted into a hand held battery powered | |
| V-Grip Detachment Controller (sold separately). The implant segment | |
| detaches upon activation of the Detachment Controller. |
Bench Test Summary:
| Test | Test Method | Results |
|---|---|---|
| Visual Inspection | Using a microscope, inspect per product drawings | All test samples met the acceptance |
| criteria and passed testing. | ||
| Pusher Resistance | Measure the pusher resistance using a digital multi- | |
| meter | All test samples met the acceptance | |
| criteria and passed testing. | ||
| Simulated Use | Using cerebrovascular benchtop model, conduct the | |
| following assessments on each test sample: | ||
| • Introduction | ||
| • Tracking inside microcatheter | ||
| • Deployment | ||
| • Microcatheter Movement | ||
| • Detachment | All test samples met the acceptance | |
| criteria and passed testing. |
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Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized graphic to the left of the text. The text "MicroVention" is in a larger, bolder font, and "TERUMO" is in a smaller font below it.
Predicate / Subject
Technological Comparison:
| Design Feature | Predicate Devices | Subject Devices |
|---|---|---|
| Implant Coil Shape | Helical or 3D | Same |
| Implant Coil Wire material | Platinum/Tungsten (92/8 %) alloy | Same |
| Implant Hydrogel material | MCS - None | |
| HES - Hydrophilic acrylic copolymer | Same | |
| Implant Coil-to-Pusher Coupler material | Platinum (90%) / iridium (10%) | Same |
| Implant to Pusher filament / SR member | ||
| material | Polyolefin elastomer or PET | Same |
| Adhesive material | Ultraviolet curing adhesive (DYMAX 1128- | |
| AM-VT) | Same | |
| Delivery Pusher Overall Construction | Variable stiffness stainless steel hypotube | |
| with platinum and stainless steel coils at | ||
| the distal end. | Same | |
| Delivery Pusher Proximal Connector | ||
| Construction | • 3 gold connectors (Ø.016") over | |
| mandrel | ||
| • Middle gold connector is welded to | ||
| mandrel | ||
| • Distal gold connector is welded to | ||
| hypotube | ||
| • Annealed section of hypotube distal of | ||
| gold connector | ||
| • Polyimide tube used for insulation | ||
| • 1 solder joint visible, 1 solder joint not | ||
| visible (inside hypotube) | • Gold plated hypotube used for one | |
| connector (Ø.014") | ||
| • 2 gold connectors (Ø.016") over | ||
| hypotube | ||
| • Polyimide tube used for insulation | ||
| • 2 solder joints visible | ||
| Delivery Pusher Length | 185 cm | 195cm |
Risk Analysis:
The MCS and HES products are designed, developed and tested in accordance with the MicroVention Design and Development procedure and with the MicroVention internal quality system procedure for risk management. Possible hazards and associated risk related to the device modification and clinical usage of the device were identified, examined and found to be acceptable after the implementation of the mitigation measures such as physician training program, labeling warnings and instructions for use.
The devices that are the subject of this submission are substantially Summary of Substantial equivalent to the predicate device with regard to intended use, Equivalence: patient population, device design, materials, processes, and operating principal.