(64 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the embolic coils and delivery system, with no mention of AI or ML.
Yes
The device is intended to treat intracranial aneurysms and other neurovascular abnormalities by permanently obstructing blood flow, which is a therapeutic intervention.
No
The device description indicates it is an embolic coil system used for the physical obstruction of blood flow to treat aneurysms and vascular malformations, not for diagnostic purposes.
No
The device description clearly outlines hardware components including platinum alloy coils, a polymer filament, a delivery pusher with radiopaque markers, and a battery-powered detachment controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The HydroCoil Embolic System is described as an implantable device (coils made of platinum alloy with a hydrogel core) delivered endovascularly (within blood vessels) to treat conditions like aneurysms and vascular malformations.
- Intended Use: The intended use clearly states the device is for "endovascular embolization" and "vascular occlusion of blood vessels," which are procedures performed inside the body.
The device is a therapeutic medical device used for interventional procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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 artiovenous 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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The HydroFrame coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-TrakTM 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-GripTM Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
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
Not Found
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:
Test: Visual Inspection; Result: Met same specifications as predicate
Test: Dimensional Measurement; Result: Met same specifications as predicate
Test: Simulated Use: Introduction, Tracking, Deployment, Frame tumbling, Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, Basket formation, Shape retention, Overall performance; Result: Met same specifications as predicate
Test: Advancement/Retraction; Result: Met same specifications as predicate
Test: Spring Constant; Result: Met same specifications as predicate
Test: Gel Expansion; Result: Met same specifications as predicate
Test: Weld Tensile; Result: Met same specifications as predicate
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HydroCoil Embolic System, HydroFrame (K090357)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K(w454
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Special 510(k), HydroCoil Embolic System - HydroFrame
510(IK) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | HydroCoil Embolic System, HydroFrame | APR 22 201 |
|---|---|---|
| Generic Name: | Neurovascular Embolization Device, accessory | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc | |
| 1311 Valencia Avenue | ||
| Tustin, California 92780 | ||
| U.S.A. | ||
| Contact: | Laraine Pangelina | |
| Predicate Device: | HydroCoil Embolic System, HydroFrame (K090357) | |
| Device Description: | The HydroFrame coils consist of implant coil made of platinum alloy with | |
| inner hydrogel core. The coils are designed in 3D spherical structure in | ||
| various loop sizes and lengths. The coil is attached to a V-TrakTM | ||
| 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-GripTM Detachment | ||
| Controller (sold separately). The implant segment detaches upon | ||
| activation of the Detachment Controller. | ||
| 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 artiovenous 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. | ||
| Bench Test Summary: | Test | |
| Result |
| Test | Result |
|---|---|
| Visual Inspection | Met same specifications as predicate |
| Dimensional Measurement | Met same specifications as predicate |
| Simulated Use: | |
| Introduction, Tracking, Deployment, | |
| Frame tumbling, Microcatheter | |
| movement, Microcatheter manipulation, | |
| Compartmentalization, Periphery fill, | |
| Basket formation, Shape retention, | |
| Overall performance | Met same specifications as predicate |
| Advancement/Retraction | Met same specifications as predicate |
| Spring Constant | Met same specifications as predicate |
| Gel Expansion | Met same specifications as predicate |
| Weld Tensile | Met same specifications as predicate |
1
MicroVention, Inc.
Technological comparison, subject and predicate device:
subject and predicate device.
| Features | Predicate Device | 510(k) Subject Device |
|---|---|---|
| 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 | ||
| artiovenous 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. | Same | |
| Design Attributes | ||
| Coil Shape | 3D - Spherical | Same |
| Primary Coil Wind | ||
| OD (inch) | 0.0120-0.0125 | 0.0125 - .0150 |
| 3D Coil OD (mm) | 3 - 8 | 6 - 24 |
| Restrained Coil | ||
| Length (cm) | 6 - 33 | 19 - 50 |
| Pusher Length | 185 cm | Same |
| Materials | ||
| Main Coil Wire | Platinum/Tungsten alloy | |
| (92/8) | Same | |
| Coil-to-Pusher | ||
| Coupler | Platinum / Iridium (90/10) | Same |
| Adhesive | UV cure adhesive | |
| (DYMAX 1128-AM-VT) | Same | |
| Implant to the pusher | Polyolefin Elastomer | Same |
| Stretch Resistant | ||
| Filament | Polyolefin Elastomer | Same |
| Hydrogel | Hydrophilic acrylic | |
| copolymer | Same | |
| General | ||
| Catheter | ||
| Compatibility | Compatible with | |
| microcatheters having an | ||
| ID of ≥ .015". | Compatible with | |
| microcatheters having an | ||
| ID of ≥ .015" (HydroFrame |
- and ≥ .0165"
(HydroFrame 18) |
| Method of Supply | Sterile, single use | Same |
| Package
Configuration | Dispenser coil, pouch &
shipping carton | Same |
: . .
.
Summary of Substantial Equivalence:
Equivalence:
The HydroFrame Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the edge. In the center of the seal is a stylized image of an eagle or bird-like figure with its wings spread. The image is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR 2 2 2010
MicroVention. Inc. c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K100454
Trade/Device Name: HydroCoil Embolic System (HES) - HydroFrame Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: March 19, 2010 Received: March 23, 2010
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 indives 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, Dr to 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, into not 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 truthing music might might might might might ding.
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 offecting 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 Rigister.
3
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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
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): | K100454 |
|---|---|
| Device Name: | HydroCoil Embolic System, HydroFrame |
| 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 artiovenous 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. |
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)
Kristen Bowsher
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_k100 454