(30 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the coil and delivery system, with no mention of AI/ML.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, as well as for vascular occlusion to obstruct blood flow, which are therapeutic interventions.
No
The HES is an implantable coil designed for the endovascular embolization and occlusion of blood vessels, treating conditions like intracranial aneurysms and arteriovenous malformations. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it consists of an implantable coil made of platinum alloy with an inner hydrogel core, a delivery pusher, and a battery-powered detachment controller, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for endovascular embolization and vascular occlusion within the body (intracranial, neurovascular system, peripheral vasculature). This is a therapeutic procedure performed directly on the patient.
- Device Description: The device is an implantable coil designed to be placed within blood vessels. This is an in-vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, this device falls under the category of an implantable medical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes
HCG, KRD
Device Description
The HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher 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 modified HES is 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
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Test Summary:
Visual Inspection: Met same criteria as predicate
Dimensional Measurement: Met same criteria as predicate
Simulated Use (Introduction, Tracking, Reposition / Deployment, Detachment, Overall Performance): Met same criteria as predicate
Spring Constant: Met same criteria as predicate
Gel Expansion: Met same criteria as predicate
Weld Tensile: Met same criteria as predicate
Advancement / Retraction Force: Met same criteria as predicate
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K120908
APR 2 5 2012
MicroVention. Inc. Special 510(k) HydroCoil Embolic System (HES) -- Modification to HydroFill (formerly HydroSoft Plus)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
HydroCoil Embolic System (HES) Trade Name: Neurovascular Embolization Device, accessory Generic Name: Class II, 21 CFR 882.5950 Classification: MicroVention, Inc Submitted By: 1311 Valencia Avenue Tustin, California 92780 U.S.A. Laraine Pangelina Contact: HydroCoil Embolic System (HES) (K112226, K113457) Predicate Device: Indications for Use: The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula. 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 embolization in the peripheral vasculature. The HES consists of implantable coil made of platinum alloy with inner Device Description: hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher 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 modified HES is 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, Inc.
Special 510(k)
Special Jro(K)
HydroCoil Embolic System (HES) – Modification to HydroFill (formerly HydroSoft Plus)
| Bench Test Summary: | |
|---|---|
| -- | --------------------- |
| Test | Result |
|---|---|
| Visual Inspection | Met same criteria as predicate |
| Dimensional Measurement | Met same criteria as predicate |
| Simulated Use | |
| • Introduction | |
| • Tracking | |
| • Reposition / Deployment | |
| • Detachment | |
| • Overall Performance | Met same criteria as predicate |
| Spring Constant | Met same criteria as predicate |
| Gel Expansion | Met same criteria as predicate |
| Weld Tensile | Met same criteria as predicate |
| Advancement / Retraction Force | Met same criteria as predicate |
Predicate / Subject Device Comparison:
| Feature | Predicate Device | Subject Device |
|---|---|---|
| Coil shape | Helical | Same |
| Implant diameter | 2 mm - 24 mm | Same |
| Implant restrained length | 2 cm - 50 cm | Same |
| Deliver pusher length | 185 cm | Same |
| Main coil wire material | Platinum/Tungsten | |
| (92/8 %) alloy | Same | |
| Coupler material | Platinum (90%) / | |
| iridium (10%) | Same | |
| Adhesive material | Dymax 1128-AM- | |
| VT | Same | |
| Implant to pusher material | Polyolefin | |
| Elastomer | Same | |
| Stretch resistant filar | ||
| material | Polyolefin | |
| Elastomer | PET | |
| Gel material | Hydrophilic | |
| Copolymer | Same | |
| MRI compatibility | Yes | Yes |
| Method of supply | Sterile, single use | Same |
| Packaging configuration | Dispenser, pouch, | |
| carton | Same |
Summary of Substantial Equivalence:
The HES coils that are the subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient equivalent to the productions as terrals, processes, and operating principal.
.
1
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol, possibly an eagle, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 5 2012
MicroVention c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K120908
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: March 23, 2012 Received: March 26, 2012
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.
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Page 2 - Ms. Laraine Pangelina
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/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 vours.
Kesia Alexander
Image /page/3/Picture/8 description: The image shows a stylized signature in black ink. The signature appears to be a cursive "f" connected to another letter, possibly an "r" or a similar character. The overall impression is that of a quick, flowing signature.
Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MicroVention, Inc. Special 510(k) BydroCoil Embolic System (HES) – Modification to HydroFill (formerly HydroSoft Plus)
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
HydroCoil Embolic System (HES)
The 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.
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 K120908