(126 days)
The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The 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 embolizations in the peripheral vasculature.
The MicroVention HydroCol® Embolic System (HES) consists of an implantable coil attached to a delivery system called a V-Trak® delivery pusher. The HES coils are platinum coils augmented with a hydrophilic polymer. The V-Trak delivery pusher is powered by a V-Grip® detachment controller, which is provided separately.
The HES is available in several coil types based on the coil primary diameter and configuration. Each coil type must be delivered only through a wire-reinforced microcatheter with the minimum inner diameter specified. Within each coil type is a broad range of coil secondary (loop) diameters and lengths.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the HydroCoil® Embolic System (HES), a neurovascular embolization device.
This document primarily focuses on:
- Device Description: What the HydroCoil Embolic System is.
- Indications for Use: The medical conditions and procedures for which the device is intended.
- Substantial Equivalence: A claim that the updated device (with modified product labeling) is substantially equivalent to a previously cleared predicate device, based on a clinical trial.
Crucially, this document is not a study report and does not contain the specific information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or human-in-the-loop studies for AI algorithms.
The text mentions the "HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) trial" as the basis for updating the labeling and demonstrating substantial equivalence. However, it does not provide any details about the design, results, or specific acceptance criteria met by the device in that trial. It only states that the purpose of the submission is to "update the labeling with the additional device experience from the HELPS trial."
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.
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DEC - 1 2011 K112181
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | HydroCoil® Embolic System (HES) |
|---|---|
| Generic Name: | Neurovascular Embolization Device |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California 92780 U.S.A. |
| Contact: | Vin Cutarelli714-247-8181vin.cutarelli@microvention.com |
| Predicate Device: | HydroCoil® Embolic System (HES) K100454 |
Device Description:
The MicroVention HydroCol® Embolic System (HES) consists of an implantable coil attached to a delivery system called a V-Trak® delivery pusher. The HES coils are platinum coils augmented with a hydrophilic polymer. The V-Trak delivery pusher is powered by a V-Grip® detachment controller, which is provided separately.
The HES is available in several coil types based on the coil primary diameter and configuration. Each coil type must be delivered only through a wire-reinforced microcatheter with the minimum inner diameter specified. Within each coil type is a broad range of coil secondary (loop) diameters and lengths.
Indications for Use:
The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The 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 embolizations in the peripheral vasculature.
The device should only be used by physicians who have undergone pre-clinical training in all aspects of HES procedures as prescribed by MicroVention.
Substantial Equivalence:
The purpose of this submission is to update the labeling with the additional device experience from the HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) trial. The HydroCoil Embolic System (HES) with the modified product labeling is substantially equivalent to the predicate device with regard to intended use, operating principle, device design, materials, manufacturing processes and patient population.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
DEC - 1 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MicroVention, Inc. c/o Mr. Vin Cutarelli Senior Vice President, Regulatory Affairs and Quality Assurance 1311 Valencia Ave.
Re: K112181
Tustin, CA 92780
Trade/Device Name: HydroCoil® Embolic System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 3, 2011 Received: November 4, 2011
Dear Mr. Cutarelli:
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.
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Page 2 - Mr. Vin Cutarelli
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.
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/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/MedicalDevices/Safety/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melvin R. Felder
Malvina B. Eydelman, b 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:
HydroCoil Embolic System
The HydroCoil Embolic System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The 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 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
KILLI81 510(k) Number_
§ 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).