(126 days)
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES 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 embolization in the peripheral vasculature.
The MCS Cosmos 10 consists of an implantable coil made of bare platinum alloy. The HES HydroFrame 10 consists of implantable coil made of platinum alloy with a biologically inert and stable inner hydrogel core. Both the Cosmos 10 and the HydroFrame 10 coils are available in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the delivery pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implantable coil detaches upon activation of the Detachment Controller.
Both the Cosmos 10 and the HydroFrame 10 coil implants have a PET member within the primary coil to provide stretch resistance properties. Both feature a 3-dimensional shape that creates a frame when placed within an aneurysm.
The HydroFrame 10 also has a hydrogel core member that runs parallel with the stretch resistant member within the coil. The expansion properties of the hydrogel allow for improved filling properties of the implanted coil.
The provided text describes a 510(k) submission for MicroPlex Coil System – Cosmos 10 and HydroCoil Embolic System - HydroFrame 10, which are neurovascular embolization devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against new, specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted in the way typically expected for a clinical performance study. The submission primarily relies on bench test comparisons to establish equivalence, implying that if the new devices perform similarly to the predicate devices in these tests, they meet the same implicit acceptance criteria as the legally marketed predicates.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) addressing a line extension, explicit "acceptance criteria" for clinical performance are not stated in the provided documents. Instead, the "performance" is demonstrated by showing equivalence to the predicate devices through bench testing. The acceptance criterion for each test is implicitly "Met same criteria as predicate."
| Test (Implicit Acceptance Criteria: Met same criteria as predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Visual Inspection | Met same criteria as predicate |
| Dimensional Measurement | Met same criteria as predicate |
| Simulated Use: | |
| - Introduction | Met same criteria as predicate |
| - Tracking | Met same criteria as predicate |
| - Deployment | Met same criteria as predicate |
| - Frame tumbling | Met same criteria as predicate |
| - Microcatheter movement | Met same criteria as predicate |
| - Microcatheter manipulation | Met same criteria as predicate |
| - Compartmentalization | Met same criteria as predicate |
| - Periphery fill | Met same criteria as predicate |
| - Basket formation | Met same criteria as predicate |
| - Shape retention | Met same criteria as predicate |
| - Overall performance | Met same criteria as predicate |
| Spring Constant | Met same criteria as predicate |
| Gel Expansion (HES only) | Met same criteria as predicate |
| Weld Tensile | Met same criteria as predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document does not specify exact sample sizes for each bench test. These are typically performed on a statistically significant number of units according to internal quality standards, but the specific numbers are not provided in this summary.
- Data Provenance: The data is based on bench testing performed by MicroVention, Inc. (Tustin, California, U.S.A.). It is by nature prospective as it involves testing newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to the provided document. The "tests" described are bench tests of physical and mechanical properties, not clinical evaluations requiring expert interpretation of images or patient outcomes. The "ground truth" for these tests would be established by objective measurements and comparisons against engineering specifications and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies for interpreting ambiguous clinical data or images. Bench tests rely on objective measurement and comparison.
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:
This information is not applicable. The device is a physical embolization coil, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical embolization coil, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" is derived from:
- Engineering specifications and design parameters.
- Measured physical and mechanical properties that demonstrate equivalence to the predicate devices.
- Pre-established performance characteristics of the predicate devices.
8. The sample size for the training set:
This refers to a training set for an algorithm, which is not applicable in this context. The devices are physical medical devices, not algorithms requiring a training set.
9. How the ground truth for the training set was established:
This question is not applicable as there is no algorithm or "training set" for this physical medical device.
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t
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | MicroPlex Coil System – Cosmos 10HydroCoil Embolic System - HydroFrame 10 | |
|---|---|---|
| Generic Name: | Neurovascular Embolization Device, accessory | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California 92780 U.S.A.714-247-8000 | |
| Contact: | Laraine Pangelina | |
| Date Prepared: | April 20, 2011 | |
| Predicate Device: | MicroPlex Coil System, Cosmos 10 (K093919)HydroCoil Embolic System, HydroFrame 10 (K090357) | |
| Indications for Use: | Intended for the endovascular embolization of intracranialaneurysms and other neurovascular abnormalities such asarteriovenous malformations and artiovenous fistula. The MCS andHES are also intended for vascular occlusion of blood vesselswithin the neurovascular system to permanently obstruct blood flowto an aneurysm or other vascular malformation and for arterial andvenous embolization in the peripheral vasculature. | |
| Device Description: | The MCS Cosmos 10 consists of an implantable coil made of bareplatinum alloy. The HES HydroFrame 10 consists of implantable coilmade of platinum alloy with a biologically inert and stable inner hydrogelcore. Both the Cosmos 10 and the HydroFrame 10 coils are available invarious loop sizes and lengths. The coil is attached to a V-Trak deliverypusher. The proximal end of the delivery pusher is inserted into a handheld battery powered V-Grip Detachment Controller (sold separately). Theimplantable coil detaches upon activation of the Detachment Controller.Both the Cosmos 10 and the HydroFrame 10 coil implants have a PETmember within the primary coil to provide stretch resistance properties.Both feature a 3-dimensional shape that creates a frame when placedwithin an aneurysm.The HydroFrame 10 also has a hydrogel core member that runs parallelwith the stretch resistant member within the coil. The expansionproperties of the hydrogel allow for improved filling properties of theimplanted coil.The table below provides information about the physical properties of theCosmos 10 and HydroFrame 10, with a comparison to their respectivepredicate devices. | |
| MCS Cosmos 10 | ||
| Feature | Predicate Device | Subject Device |
| Coil shape | 3D - spherical | Same |
| Coil implant diameter | 3-12mm | 2.0-2.5mm |
| Coil restrained length | 6-45cm | 2-4cm |
| Deliver pusher length | 185cm | Same |
| Main coil wire material | Platinum/Tungsten alloy | Same |
| Coupler material | Platinum/Iridium | Same |
| Adhesive material | Utraviolet cure | Same |
| Implant to pusher material | Polyolefin elastomer | Same |
| Stretch resistant filar material | Polyolefin elastomer | PET |
| MRI compatibility | Yes | Same |
| Method of supply | Sterile, single use | Same |
| Packaging configuration | Dispenser coil, pouch, carton | Same |
| HES HydroFrame 10 | ||
| Feature | Predicate Device | Subject Device |
| Coil shape | 3D - spherical | Same |
| Coil implant diameter | 3-12mm | 2.0-2.5mm |
| Coil restrained length | 6-43cm | 2.4cm |
| Deliver pusher length | 185cm | Same |
| Main coil wire material | Platinum/Tungsten alloy | Same |
| Coupler material | Platinum/Iridium | Same |
| Adhesive material | Utraviolet cure | Same |
| Implant to pusher material | Polyolefin elastomer | Same |
| Stretch resistant filar material | Polyolefin elastomer | PET |
| Gel | Hydrophilic acrylic copolymer | Same |
| MRI compatibility | Yes | Same |
| Method of supply | Sterile, single use | Same |
| Packaging configuration | Dispenser coil, pouch, carton | Same |
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MicroVention, Inc. Special 510(k) – MCS & HES Line Extension
t
| Bench Test Summary: | Test | Result |
|---|---|---|
| Visual Inspection | Met same criteria as predicate | |
| Dimensional Measurement | Met same criteria as predicate | |
| Simulated Use:Introduction, Tracking, Deployment, Frame tumbling,Microcatheter movement, Microcatheter manipulation,Compartmentalization, Periphery fill, Basket formation,Shape retention, Overall performance | Met same criteria as predicate | |
| Spring Constant | Met same criteria as predicate | |
| Gel Expansion (HES only) | Met same criteria as predicate | |
| Weld Tensile | Met same criteria as predicate |
Summary of Substantial Equivalence:
The Cosmos 10 and HydroFrame 10 coils that are the subject of this submission 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 seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Microention, Inc. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
APR 2 8 2011
Re: K103758
Trade/Device Name: Microplex Coil System-Cosmos 10 and, Hydrocoil System-Hydroframe 10 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: March 25, 2011 Received: March 29, 2011
Dear Ms. Pangelina
We have reviewed your Section 510(k) premarket notification of intent to market the device m & re review 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 I ou may, mereleve, mains 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 addition. Vie 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.
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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 100-1050,
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/CDRH/CDRHOffices/ucm1 1 5809.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/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 inte (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Rick Remmers
Malvina B. Eydelman, M 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): K103758
Device Name: MicroPlex Coil System (MCS) - Cosmos 10 HydroCoil Embolic System (HES) - HydroFrame 10 ·
Indications For Use:
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES 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 embolization in the peripheral vasculature.
Prescription Use × (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 CDRH, Office of Device Evaluation (ODE)
JEFFREY Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K103758
§ 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).