(98 days)
Not Found
No
The description focuses on the mechanical and electrical components of the device and its detachment mechanism, with no mention of AI or ML.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which are therapeutic interventions.
No
The device is an embolic system intended for the endovascular embolization and vascular occlusion of blood vessels, which are interventional treatments, not diagnostic procedures.
No
The device description clearly details physical components like coils, delivery systems, pushers, wires, tubing, and a 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:
- 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.
- Device Function: The HydroCoil® Embolic System (HES) is an implantable medical device used for the physical embolization (blocking) of blood vessels. It is delivered directly into the body to treat conditions like aneurysms and vascular malformations.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device's function is mechanical and electrical, not diagnostic testing of bodily fluids or tissues.
Therefore, the HES falls under the category of an implantable therapeutic 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 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 HydroCoil® Embolic System (HES) is based on electrical coil detachment. The HES consist of an implantable coil attached to a delivery system called a V-TRAK™ Delivery Pusher. The Delivery Pusher is a variable stiffness, stainless steel and tapered mandrel. Two silver electrical leads run along the outside of the mandrel from the proximal to the distal end. Platinum and stainless steel wires are wound around the distal end of the mandrel to form the electrical heater and provide kink-resistance. Two outer layers of PET tubing cover the distal end of the pusher assembly. A layer of polyimide tubing covers the proximal end. The proximal end of the HES coils incorporates a platinum coupler for attachment to the Delivery Pusher. A polyolefin elastomer filament is attached to the proximal end of the coil. This filament runs through the inner lumen of the coil coupler and is attached to the distal end of the Delivery Pusher.
The Delivery Pusher is powered by a hand-held, battery-powered V-GRIP™ Detachment Controller designed specifically for the HES. A gold-plated stainless steel connector at the proximal end of the Delivery Pusher is used to connect it to the Detachment Controller, The Detachment Controller is provided separately. The coil is delivered to treatment site on the Delivery Pusher through standard neuro-interventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the HES into the micro-catheter. Once the coil is deployed, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the Detachment Controller is turned on, the flow of current melts the polyolefin elastomer filament at the coupler/pusher junction resulting in coil detachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms), 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)
Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is equivalent in performance to the predicate devices.
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
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).
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K07D656 page
Section 2 - Summary of Safety and Effectiveness
Company Information (1)
MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 461-3314 Fax: (949) 349-1360 www.microvention.com
JUN 1 5 2007
Contact Information (2)
Vincent Cutarelli Telephone: (949) 951-0505 Fax: (949) 349-1360 E-mail: vinc@microvention.com
(3) Device Name
| Classification Name: | Device, Artificial Embolization |
|---|---|
| Trade/Proprietary Name: | HydroCoil® Embolic System (HES) |
| Common/Usual Name: | Embolization Coil |
| Classification | Class II |
(4) Device Description
The HydroCoil® Embolic System (HES) is based on electrical coil detachment. The HES consist of an implantable coil attached to a delivery system called a V-TRAK™ Delivery Pusher. The Delivery Pusher is a variable stiffness, stainless steel and tapered mandrel. Two silver electrical leads run along the outside of the mandrel from the proximal to the distal end. Platinum and stainless steel wires are wound around the distal end of the mandrel to form the electrical heater and provide kink-resistance. Two outer layers of PET tubing cover the distal end of the pusher assembly. A layer of polyimide tubing covers the proximal end. The proximal end of the HES coils incorporates a platinum coupler for attachment to the Delivery Pusher. A polyolefin elastomer filament is attached to the proximal end of the coil. This filament runs through the inner lumen of the coil coupler and is attached to the distal end of the Delivery Pusher.
1
K070656 page 2/2
The Delivery Pusher is powered by a hand-held, battery-powered V-GRIP™ Detachment Controller designed specifically for the HES. A gold-plated stainless steel connector at the proximal end of the Delivery Pusher is used to connect it to the Detachment Controller, The Detachment Controller is provided separately. The coil is delivered to treatment site on the Delivery Pusher through standard neuro-interventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the HES into the micro-catheter. Once the coil is deployed, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the Detachment Controller is turned on, the flow of current melts the polyolefin elastomer filament at the coupler/pusher junction resulting in coil detachment.
(5) 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.
(6) Name of Predicate or Legally Marketed Device
The HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is substantially equivalent to the HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils that was determined to be substantially equivalent on December 30, 2003 (reference K033836) and the MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a Modified Detachment System that was determined to be substantially equivalent on June 28, 2005 (reference K050954).
(7) Technological Characteristics and Substantial Equivalence
The HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is substantially equivalent in operating principle, method of applications for use, design, materials, packaging and sterilization to the predicate devices.
Performance Data Summary (8)
Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is equivalent in performance to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention, Inc % Mr. Vincent Cutarelli Vice President, Regulatory Affairs and Quality Assurance 75 Columbia, Suite A Aliso Viejo, California 92677
JUN 1 5 2007
Re: K070656
Trade/Device Name: HydroCoil® Embolic System with (HES) with the HES-HC-HS (10) coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG, KRD Dated: May 30, 2007 Received: May 31, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set
3
Page 2 - Mr. Vincent Cutarelli
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/index20tm1
Sincerely yours,
Fox Po
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
ROMA DIRECT
6/14.
Radiological Health
Enclosure
4
Indications For Use
510(k) Number:
Device Name: HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils
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.
Concurrence of CDRH, Office of Device Evaluation (ODE):
N
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L67065
Prescription Use: X (Per 21 CFR 801.109)