(30 days)
The MicroPlex Coil System is 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 Cosmos consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Trak™ MCS delivery pusher via a polymer filament. 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. The implant segment detaches upon activation of the Detachment Controller.
The MicroPlex Coil System - Cosmos (K093919) is a neurovascular embolization device. The provided document is a 510(k) summary, which indicates that the device's acceptance criteria and performance are typically evaluated through substantial equivalence to a predicate device, rather than a clinical study with detailed statistical endpoints.
Based on the provided information, here's a breakdown of the acceptance criteria and the "study" (bench testing) that demonstrates the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MicroPlex Coil System - Cosmos are defined by the predicate device's established performance and design specifications. The "reported device performance" in this context refers to the results of bench tests conducted to demonstrate that the new device meets these pre-established criteria. The document states that all listed tests "Met established criteria," implying satisfactory performance against predefined internal specifications or industry standards.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Conformance to visual design specifications | Met established criteria |
| Dimensional Measurement | Conformance to specified dimensions | Met established criteria |
| Simulated Use | Functionality and performance in simulated use conditions | Met established criteria |
| Detachment Test | Reliable and controlled detachment of the coil | Met established criteria |
| Detachment Zone Tensile | Sufficient tensile strength at the detachment zone | Met established criteria |
| Advancement/Retraction Force | Acceptable forces for device manipulation | Met established criteria |
| Coil to Coupler Weld Tensile | Sufficient strength of the weld | Met established criteria |
| Spring Constant | Conformance to specified mechanical properties | Met established criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the submission is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" and that the "Cosmos Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal."
This indicates that the primary "study" proving the device meets acceptance criteria is bench testing to demonstrate performance similar to the predicate device. The document does not specify the sample size used for each of the listed bench tests.
Regarding data provenance:
- Country of Origin: The submitting company, MicroVention, Inc., is based in Tustin, California, U.S.A. Therefore, the bench testing was likely conducted in the USA.
- Retrospective or Prospective: Bench testing, by its nature, is a prospective evaluation where tests are designed and performed to assess the device's characteristics. It is not based on historical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a 510(k) for a device demonstrated through substantial equivalence and bench testing, there is no mention of experts involved in establishing ground truth for a test set in the clinical sense. Ground truth for bench testing would typically be engineering specifications, established scientific principles, or comparison to the predicate device's known performance. These are not typically established by clinical experts in the same way as, for example, a radiologist establishing ground truth for an imaging AI algorithm.
4. Adjudication Method for the Test Set
As there is no clinical test set or human expert review described for establishing ground truth, there is no adjudication method mentioned. The "acceptance criteria" are likely engineering specifications or performance metrics derived from the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned in this 510(k) summary. This type of study is common for evaluating the effectiveness of AI-assisted diagnostic tools, which is not the nature of this device (a physical neurovascular embolization coil).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria for this device is based on:
- Engineering Specifications: Pre-defined technical requirements for the device's visual, dimensional, and mechanical properties.
- Performance of the Predicate Device: The MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891) serves as the benchmark against which the new device (Cosmos) is compared for substantial equivalence. The predicate device's established safety and effectiveness dictate the expected performance of the new device.
There is no mention of pathology, outcomes data, or expert consensus in a clinical setting establishing "ground truth" for these bench tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this device.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 1 2010
| Trade Name: | MicroPlex Coil System - Cosmos |
|---|---|
| Generic Name: | Neurovascular Embolization Device, accessory |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California 92780U.S.A. |
| Contact: | Laraine Pangelina |
| Predicate Device: | MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891) |
| Device Description: | The Cosmos consist of an implant coil made of platinum alloy.The coils are designed in 3D spherical structure in various loopsizes and lengths. The coil is attached to a V-Trak™ MCSdelivery pusher via a polymer filament. The delivery pushercontains radiopaque positioning markers at the distal end. Theproximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. The implant segment detachesupon activation of the Detachment Controller. |
| Indications for Use: | The Cosmos is a member of the MicroPlex Coil System (MCS).The intended use as stated in the product labeling is as follows:The MicroPlex Coil System is intended for the endovascularembolization of intracranial aneurysms and other neurovascularabnormalities such as arteriovenous malformations andarteriovenous fistulae. The MCS is also intended for vascularocclusion of blood vessels within the neurovascular system topermanently obstruct blood flow to an aneurysm or other vascularmalformation and for arterial and venous embolizations in theperipheral vasculature. |
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Bench
1
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| Test | Result |
|---|---|
| Visual Inspection | Met established criteria |
| Dimensional Measurement | Met established criteria |
| Simulated Use | Met established criteria |
| Detachment Test | Met established criteria |
| Detachment Zone Tensile | Met established criteria |
| Advancement/Retraction Force | Met established criteria |
| Coil to Coupler Weld Tensile | Met established criteria |
| Spring Constant | Met established criteria |
Summary of Substantial Equivalence:
The Cosmos Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MicroVention Terumo c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Ave. Tustin, CA 92780
JAN 2 1 2010
Re: K093919
Trade/Device Name: MicroPlex Coil System - Cosmos, Models: 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, and 101245CSSR-V
Regulation Number: 21 CFR 882.5950
Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: December 21, 2009 Received: December 22, 2009
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.
:
If your device is classified (see above) into either elass 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 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 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling.regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm 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.fda.gov/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Eydelman, M.D.
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): | K093919 |
|---|---|
| Device Name: | MicroPlex Coil System (MCS) - Cosmos |
| Indications for Use: | The MicroPlex Coil System is intended for the endovascularembolization of intracranial aneurysms and otherneurovascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae. The MCS is alsointended for vascular occlusion of blood vessels within theneurovascular system to permanently obstruct blood flow to ananeurysm or other vascular malformation and for arterial andvenous 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 K093919
§ 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).