(118 days)
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.
The MCS Vector consists of an implantable coil made of bare platinum alloy. The Vector implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroPlex Coil System - Vector:
No clinical studies are mentioned in the provided text. This 510(k) summary primarily focuses on establishing substantial equivalence through bench testing and comparison of physical properties and intended use with predicate devices. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be addressed from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit: Met same as predicate) | Reported Device Performance |
|---|---|---|
| Dimensional Measurement | Met same criteria as predicate | Met same criteria as predicate |
| Simulated Use: | Met same criteria as predicate | Met same criteria as predicate |
| - Introduction | ||
| - Tracking | ||
| - Deployment | ||
| - Frame movement | ||
| - Microcatheter movement | ||
| - Microcatheter manipulation | ||
| - Compartmentalization | ||
| - Detachment | ||
| - Overall performance | ||
| Spring Constant | Met same criteria as predicate | Met same criteria as predicate |
| Weld Tensile Strength | Met same criteria as predicate | Met same criteria as predicate |
| Detachment Zone Tensile Strength | Met same criteria as predicate | Met same criteria as predicate |
Implicit Acceptance Criteria: The document states that the MicroPlex Coil System - Vector "Met same criteria as predicate" for all listed bench tests. This implies that the acceptance criteria for each test were the established performance benchmarks of the predicate devices: MicroPlex Coil System - Cosmos 10 (K082461, K093919, K103758) and MicroPlex Coil System - Cosmos 18 (K090891, K093358). The specific numerical values or ranges for these criteria are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench tests" but does not provide details on the number of samples tested for each criterion.
- Data Provenance: The study is in-vitro bench testing, not involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes bench testing, not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document describes bench testing, not a study requiring adjudication of expert opinions on patient data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. No MRMC or human-in-the-loop study was described. This is a medical device for embolization, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device for embolization, not an algorithm. Bench testing evaluates the physical and functional performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Physical Benchmarks/Engineering Specifications: The "ground truth" for the bench tests would have been the established engineering specifications and performance characteristics of the predicate devices, which the new device aimed to match or exceed.
8. The sample size for the training set
- Not Applicable. This is a medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
In summary: The provided 510(k) summary for the MicroPlex Coil System - Vector demonstrates the device meets acceptance criteria through bench testing, specifically by showing that its physical properties and simulated use performance "met same criteria as predicate" devices. The document does not contain information about clinical trials, human data, AI performance, or expert adjudication, as it relies on substantial equivalence to previously cleared devices based on non-clinical performance data.
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K///451
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | MicroPlex Coil System - Vector | SEP 2 0 2011 |
|---|---|---|
| Generic Name: | Neurovascular Embolization Device | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California 92780 U.S.A. | |
| Contact: | Laraine Pangelina | |
| Predicate Device: | MicroPlex Coil System - Cosmos 10 (K082461, K093919, K103758)MicroPlex Coil System - Cosmos 18 (K090891, K093358) |
Device Description:
The MCS Vector consists of an implantable coil made of bare platinum alloy. The Vector implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
The table below provides information about the physical properties of the MCS Vector with a comparison to the predicate devices.
| Feature | MCS - Cosmos 10 | MCS - Cosmos 18 | MCS - Vector |
|---|---|---|---|
| Coil shape | 3D | Same | Same |
| Coil implant diameter | 2-12mm | 6-24mm | 3-15mm |
| Coil restrained length | 2-45cm | 17-68cm | 6-60cm |
| Deliver pusher length | 185cm | Same | Same |
| Main coil wire material | Platinum/Tungstenalloy | Same | Same |
| Coupler material | Platinum/Iridium | Same | Same |
| Adhesive material | Utraviolet cure | Same | Same |
| Implant to pusher material | Polyolefin elastomer | Same | Same |
| Stretch resistant filarmaterial | Polyolefin elastomer | Same | Same |
| MRI compatibility | Yes | Yes | Yes |
| Method of supply | Sterile, single use | Same | Same |
| Packaging configuration | Dispenser coil;pouch, shippingcarton | Same | Same |
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្រុក
| Indications for Use: | Intended for the endovascular embolization of intracranialaneurysms and other neurovascular abnormalities such asarteriovenous malformations and artiovenous fistula. The MCSis also intended for vascular occlusion of blood vessels withinthe neurovascular system to permanently obstruct blood flow toan aneurysm or other vascular malformation and for arterial andvenous embolization in the peripheral vasculature. | |
|---|---|---|
| Bench Test Summary: | Test | Result |
| Dimensional Measurement | Met same criteria as predicate | |
| Simulated Use:Introduction, Tracking,Deployment, Frame movement,Microcatheter movement,Microcatheter manipulation,Compartmentalization,Detachment, Overall performance | Met same criteria as predicate | |
| Spring Constant | Met same criteria as predicate | |
| Weld Tensile Strength | Met same criteria as predicate | |
| Detachment Zone Tensile Strength | Met same criteria as predicate |
.
.
Summary of Substantial Equivalence:
The MCS Vector is substantially equivalent to the predicate devices with regard to intended use, patient population, device design, materials, processes, and operating principal.
・ - -
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11:00:22 Ad: 0 10963 New Hampsince Acenne Documents online Room Welodsono Silver Spring, MD 20003-0000
Microvention, Inc. c/o Ms. Laraine Pangelina 1311 Valencia Ave Tustin. CA 92780
SEP 2 0 2011
Re: K111451
Trade/Device Name: Microplex Coil System-Vector Regulation Number: 21 CFR 882.5950 Regulation Name: Device. Neurovascular embolization Regulatory Class: Class II Product Code: HCG Dated: August 9, 2011 Received: August 10. 2011
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. Ilisting 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 -
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device-related 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 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Pari 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.lda.gov/MedicalDevices/Safetv/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eaton m. f.
Malvina B. Eydelman M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
KIII45|
MicroPlex Coil System - Vector
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.
Prescription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jeffrey Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111451
§ 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).