(57 days)
No
The summary describes a physical medical device (embolic coils and delivery system) and its intended use for embolization. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are bench tests of physical properties.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a treatment for a disease or condition.
No
The device description clearly states its purpose as an embolic system for endovascular embolization and vascular occlusion, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly details physical components such as platinum alloy coils, a delivery pusher, and a battery-powered detachment controller, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and "vascular occlusion of blood vessels." This describes a therapeutic procedure performed within the body to treat a medical condition.
- Device Description: The device is described as an "implant coil made of platinum alloy with inner hydrogel core" and a "delivery pusher." This is a physical implant and delivery system used for a surgical or interventional procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens or analysis of samples.
Therefore, the HydroFrame HydroCoil Embolic System is a therapeutic medical device, not an in vitro diagnostic device.
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 various values va
Product codes
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 with miller hydroget core. he a V-Trak™ MCS delivery pusher via a polymer fillament. 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 proximal end is niscreed into nell onecry powered. Controller 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
Bench Testing: 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; Gel Expansion Met established criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K090357 /P1/2
510(k) Summary
APR ] 0 2009
| Trade Name: | HydroFrame - HydroCoil Embolic System (HES) | ||
|---|---|---|---|
| Generic Name: | Neurovascular Embolization Device | ||
| Classification: | Class II, 21 CFR 882.5950 | ||
| Submitter Name | |||
| and Address | MicroVention, Inc | ||
| 75 Columbia | |||
| Aliso Viejo, California U.S.A. | |||
| Contact Name: | Florin Truuvert | ||
| Senior Director, Worldwide Regulatory Affairs | |||
| Phone: (949) 951-0516 | |||
| Fax: (949) 349-1360 | |||
| florin.truuvert@microvention.com | |||
| Predicate Device: | 510(k) | ||
| K082461 | |||
| K080666 | Description | ||
| MicroVention, Bare Platinum Framing Coils | |||
| MicroVention, HydroSoft (HES) | Clearance Date | ||
| Oct 2, 2008 | |||
| July 11, 2008 |
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 with miller hydroget core. he a V-Trak™ MCS delivery pusher via a polymer fillament. 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 proximal end is niscreed into nell onecry powered.
Costroller Controller.
Indication 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 various values va
1
P.2/2
Verification and Test Summary Table
| Bench Testing | 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 |
| Gel Expansion | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the HydroFrame coils when compared with the predicate device MicroVention Inc., Bare Platinum Framing Coils (K082461) and the HydroSoft coils (K08066).
The devices,
،
- . Have the same intended use,
- . Use the same operating principle,
- . Incorporate the same basic design,
- . Use similar construction and material,
- Are packaged and sterilized using same material and processes. .
In summary, the HydroFrame coils described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic that resembles a bird in flight, composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention, Inc. c/o Florin Truuvert Senior Director, Worldwide Regulatory Affairs 75 Columbia. Suite A Aliso Viejo, CA 92656
APR 1 0 2009
Re: K090357
Trade/Device Name: HydroFrame Hydrocoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulatory Class: Class II Product Code: HCG, KRD Dated: February 10, 2009 Received: February 12, 2009
Dear Ms. Truuvert:
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 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
R. le. Mean, MD k
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090357
HydroFrame Hydrocoil Embolic System (HES) Device Name:
Indications For Use:
The HydroFrame 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 (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)
J.M.S.
(Division Si Division of Ophthalmic and Ear. Nose and Throat Devices
510(k) Number KC090357
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