(91 days)
Not Found
No
The device description focuses on the physical components and detachment mechanism of embolization coils, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench and biocompatibility tests, not studies evaluating algorithmic performance.
Yes
The device is intended for the "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and for "vascular occlusion...to permanently obstruct blood flow," which are therapeutic interventions.
No
This device is described as an implantable coil system used for the embolization and occlusion of blood vessels, treating conditions like aneurysms and arteriovenous malformations. It is a therapeutic device designed for treatment, not for diagnosing medical conditions.
No
The device description clearly details physical components including implantable coils, a delivery pusher, and a 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 is for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, as well as vascular occlusion in the peripheral vasculature. This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition.
- Device Description: The device is an implantable coil used to physically obstruct blood flow. This is a medical device used for treatment, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from a patient to help diagnose or monitor a condition. This device is used to directly treat a condition within the patient's body.
N/A
Intended Use / Indications for Use
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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, KRD
Device Description
Treatment of cerebral aneurysms can be performed either by surgical clipping or endovascular techniques (e.g., embolization coils). Endovascular methods to embolize intracranial aneurysms with implantable platinum embolization coils were developed in the 1970s. Embolization coils including the MicroVention MCS and HES products are now widely used to treat all aneurysms.
The MCS consists of an implantable coil made of bare platinum alloy (Platinum/Tungsten), and the HES consists of an implantable coil made of the same platinum alloy with a hydrogel inner core. The coil is attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment. The V-Grip is packaged and sold separately.
The modified MCS and HES devices are substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
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
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
Pre-Clinical Testing:
Design Verification and Validation Bench Test Summary included tests for:
- Visual Inspection: Acceptance Criteria - Per product drawing. Result - Pass, Met established criteria. (Same as predicate: Y)
- Simulated Use: The test simulates a neurointerventional embolization procedure to assess deployment, repositioning, and detachment in an aneurysm. Acceptance Criteria - All performance ratings shall be >= 3. Result - Pass, Met established criteria. (Same as predicate: Y)
- Pusher Resistance: Using a digital multimeter, measure the resistance through a microcatheter. Acceptance Criteria - 36.7-53.0 Ohm. Result - Pass, Met established criteria. (Same as predicate: Y)
- Detachment Zone Tensile: Using an Instron tester, measure the breakforce at the detachment zone. Acceptance Criteria - >= 0.08 lbf. Result - Pass, Met established criteria. (Same as predicate: Y)
Biocompatibility Test Summary - HES Coil Implant included tests for:
- MEM Elution (ISO 10993-5) - Passed
- ISO Cell Culture Agar Overlay (100 10993-2) - Passed
- Sensitization-Guinea Pig Maximization (ISO 10993-10) - Passed
- ISO Intracutaneous Reactivity Evaluation (ISO 10993-10) - Passed
- Hemolysis (ISO 10993-4) - Passed
- Prothrombin Time Assay - ISO (ISO 10993-4) - Passed
- Systemic toxicity (IV injection) (ISO 10993-11) - Passed
- Rabbit Pyrogen Test (material mediated) (ISO 10993-11) - Passed
- Bacteria Reverse Mutation Assay (Ames) (180 10993-3) - Passed
- 7-day Muscle Implantation (180 10993-6) - Passed
- 13-week Intramuscular Implantation Test (ISO 10993-6) - Passed
- 26-week Intramuscular Implantation Test (ISO 10993-6) - Passed
Biocompatibility Test Summary - MCS Coil Implant included tests for:
- MEM Elution (ISO 10993-5) - Passed
- ISO Cell Culture Agar Overlay (ISO 10993-5) - Passed
- Sensitization-Guinea Pig Maximization (ISO 10993-10) - Passed
- ISO Intracutaneous Reactivity Evaluation (ISO 10993-10) - Passed
- Hemolysis (ISO 10993-4) - Passed
- Prothrombin Time Assay - ISO (ISO 10993-4) - Passed
- Systemic toxicity (IV injection) (ISO 10993-11) - Passed
- Rabbit Pyrogen Test (material mediated) (ISO 10993-11) - Passed
- Bacteria Reverse Mutation Assay (Ames) (SO 10993-3) - Passed
- 7-day Muscle Implantation (ISO 10993-6) - Passed
- 90-day Intramuscular Implantation Test (ISO 10993-6) - Passed
- 100-day Intramuscular Implantation Test (ISO 10993-6) - Passed
Biocompatibility Test Summary - Delivery Pusher included tests for:
- MEM Elution (ISO 10993-5) - Passed
- ISO Cell Culture Agar Overlay (ISO 10993-5) - Passed
- Sensitization-Guinea Pig Maximization (ISO 10993-10) - Passed
- ISO Intracutaneous Reactivity Evaluation (ISO 10993-10) - Passed
- Hemolysis (ISO 10993-4) - Passed
- Prothrombin Time Assay - ISO (ISO 10993-4) - Passed
- Systemic toxicity (IV injection) (ISO 10993-11) - Passed
- Rabbit Pyrogen Test (material mediated) (ISO 10993-11) - Passed
Key Results: The results of the bench testing demonstrate that the subject device is safe and effective when used according to the instructions for use and performs equivalent to the predicate device. The testing was used in support of the risk analysis documentation for the subject device.
Key Metrics
Not Found
Predicate Device(s)
K103758, K091641, K111451, K103758, K08241, K093919, K090891, K093358, K102365, K091641, K103758, K113457, K112226, K120908, K090357, K100454, K091641, K080666
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
DEC 1 9 2013
510(K) SUMMARY
(Prepared November 12, 2013)
MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)
Laraine Pangelina, Sr. Regulatory Affairs Project Manager
Trade Name:
Generic Name: Neurovascular Embolization Device
Class II, 21 CFR 882.5950 Classification:
Submitted By: MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780 U.S.A.
Contact:
Predicate Devices:
MicroPlex Coil System (MCS) (K103758, K091641, K111451, K103758, K08241, K093919, K090891, K093358, K102365) HydroCoil Embolic System (HES) (K091641, K103758, K113457, K112226, K120908, K090357, K100454, K091641, K080666)
Intended for the endovascular embolization of Indications for Use: intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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.
Treatment of cerebral aneurysms can be performed Device Description: either by surgical clipping or endovascular techniques (e.g., embolization coils). Endovascular methods to
embolize intracranial aneurysms with implantable platinum embolization coils were developed in the 1970s. Embolization coils including the MicroVention MCS and HES products are now widely used to treat all aneurysms.
The MCS consists of an implantable coil made of bare platinum alloy (Platinum/Tungsten), and the HES consists of an implantable coil made of the same platinum alloy with a hydrogel inner core. The coil is attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment. The V-Grip is packaged and sold separately.
The modified MCS and HES devices are substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
1
MicroVention : ﺗ
Pre-Clinical Testing:
| Design Verification and Validation Bench Test Summary | |||
|---|---|---|---|
| Test / Test Description | Acceptance Criteria | Test & Acceptance | |
| Criteria same as | |||
| predicate device? | |||
| Y/N | Result | ||
| Visual Inspection | |||
| Perform visual inspection | |||
| and measurements using | |||
| device drawing | Per product drawing | Y | Pass |
| Met established | |||
| criteria | |||
| Simulated Use | |||
| The test simulates a | |||
| neurointerventional | |||
| embolization procedure to | |||
| assess deployment, | |||
| repositioning, and | |||
| detachment in an | |||
| aneurysm. | All performance ratings | ||
| shall be ≥ 3 | Y | Pass | |
| Met established | |||
| criteria | |||
| Pusher Resistance | |||
| Using a digital multimeter, | |||
| measure the resistance | |||
| through a microcatheter. | 36.7-53.0 $Ω$ | Y | Pass |
| Met established | |||
| criteria | |||
| Detachment Zone Tensile | |||
| Using an Instron tester, | |||
| measure the breakforce at | |||
| the detachment zone. | ≥0.08 lbf | Y | Pass |
| Met established | |||
| criteria |
CONCLUSION: The results of the bench testing demonstrate that the subject device is safe and
effective when used according to the instructions for use and performs equivalen device. The testing was used in support of the risk analysis documentation for the subject device.
| Biocompatibility Test Summary - HES Coil Implant | |||
|---|---|---|---|
| Test | Requirement | Result | |
| MEM Elution | 10993-5 | Passed | |
| ISO Cell Culture Agar Overlay | 100 10993-2 | Passed | |
| Sensitization-Guinea Pig Maximization | ISO 10993-10 | Passed | |
| ISO Intracutaneous Reactivity Evaluation | ISO 10993-10 | Passed | |
| Hemolysis | ISO 10993-4 | Passed | |
| Prothrombin Time Assay - ISO | ISO 10993-4 | Passed | |
| Systemic toxicity (IV injection) | ISO 10993-11 | Passed | |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Passed | |
| Bacteria Reverse Mutation Assay (Ames) | 180 10993-3 | Passed | |
| 7-day Muscle Implantation | 180 10993-6 | Passed | |
| 13-week Intramuscular Implantation Test | ISO 10993-6 | Passed | |
| 26-week Intramuscular Implantation Test | ISO 10993-6 | Passed |
2
AlleroVention
| Biocompatibility Test Summary - MCS Coil Implant | ||||
|---|---|---|---|---|
| Test | Requirement | Result | ||
| MEM Elution | ISO 10993-5 | Passed | ||
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Passed | ||
| Sensitization-Guinea Pig Maximization | ISO 10993-10 | Passed | ||
| ISO Intracutaneous Reactivity Evaluation | ISO 10993-10 | Passed | ||
| Hemolysis | ISO 10993-4 | Passed | ||
| Prothrombin Time Assay - ISO | ISO 10993-4 | Passed | ||
| Systemic toxicity (IV injection) | ISO 10993-11 | Passed | ||
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Passed | ||
| Bacteria Reverse Mutation Assay (Ames) | SO 10993-3 | Passed | ||
| 7-day Muscle Implantation | ISO 10993-6 | Passed | ||
| 90-day Intramuscular Implantation Test | ISO 10993-6 | Passed | ||
| 100-day Intramuscular Implantation Test | ISO 10993-6 | Passed | ||
| Biocompatibility Test Summary - Delivery Pusher | ||||
| Test | Requirement | Result | ||
| MEM Elution | ISO 10993-5 | Passed | ||
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Passed | ||
| Sensitization-Guinea Pig Maximization | ISO 10993-10 | Passed | ||
| ISO Intracutaneous Reactivity Evaluation | ISO 10993-10 | Passed | ||
| Hemolysis | ISO 10993-4 | Passed | ||
| Prothrombin Time Assay - ISO | ISO 10993-4 | Passed | ||
| Systemic toxicity (IV injection) | ISO 10993-11 | Passed | ||
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Passed |
Predicate / Subject Technological Comparison:
| Feature | MCS Predicate Devices | HES Predicate Devices | Subject Devices |
|---|---|---|---|
| Indications for Use | Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is 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. | Same | Same |
| Device Overview | An implantable coil attached to a delivery pusher via a polyolefin elastomer material. The delivery pusher contains radiopaque | Same | Same |
3
Special 510(k) MicroPlex Embolic System (MCS) & HydroCoil Embolic System (HES) with V-Trak Advanced Delivery Pusher
MicroVention
| TERUMO | |||
|---|---|---|---|
| positioning markers at the distal end. The | |||
| proximal end is inserted into a hand held | |||
| battery powered Detachment Controller. | |||
| When the Detachment Controller is | |||
| activated, the flow of electrical current | |||
| heats the polyolefin elastomer filament, | |||
| resulting in detachment of the implant | |||
| segment. The Detachment Controller is | |||
| packaged and sold separately. | |||
| Coil shape | Helical, 3D | Same | Same |
| Coil OD (mm) | 1-24 | 1-24 | Same |
| Restrained coil | |||
| length (cm) | 1-68 | 1-50 | Same |
| Main coil wire | |||
| material | Platinum/Tungsten (92/8%) alloy | Same | Same |
| Coupler Material | Platinum (90%)/ iridium (10%) | Same | Same |
| Adhesive Material | DYMAX 1128-AM-VT UV Adhesive | Same | Same |
| Stretch resistance | |||
| filar material | Polyolefin Elastomer or PET | PET | Same |
| Implant-to-pusher | |||
| material | Polyolefin elastomer | Same | Same |
| Delivery method | V-Trak delivery pusher | V-Trak delivery | |
| pusher | V-Trak | ||
| Advanced | |||
| delivery | |||
| pusher1 | |||
| 1 The subject device is the same as the predicate devices with the exception of the modified V- | |||
| Trak Advanced deliver pusher. Other than the colorant in the PET connector tube, the V-Trak | |||
| Advanced delivery pusher is essentially the same as the cleared V-Trak delivery pusher. The MCS | |||
| and HES devices with the V-Trak Advanced delivery pusher are the same with regard to intended | |||
| use and principal of operation. Any differences in technological characteristics do not introduce | |||
| any new issues of safety or effectiveness. Therefore, it is our conclusion that the MCS and HES | |||
| devices with the V-Trak Advanced delivery pusher is substantially equivalent to the predicate | |||
| devices. |
Summary of Substantial Equivalence:
The subject devices are the same as the predicate devices with regard to intended use and principal of operation. Any differences in technological characteristics do not introduce any new issues of safety or effectiveness. Therefore, it is our conclusion that the MCS and HES devices with the V-Trak Advanced delivery pusher is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle symbol, which is a common emblem associated with the U.S. government.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2013
MicroVention Terumo c/o Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager MicroVention, Incorporated 1311 Valencia Avenue Tustin, CA 92780
Re: K132952
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, KRD Dated: November 18, 2013 Received: November 21, 2013
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
5
Page 2 - Ms. Laraine Pangelina
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Joyce M. Whang -S
for Carlos Peña, Ph.D.
Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K132952
Device Name: _ MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)
Indications For Use:
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. 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.
Prescription Use _ كا (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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