(20 days)
Not Found
No
The device description focuses on the physical components and mechanism of action of an embolic coil system, with no mention of AI or ML technologies.
Yes
The device is described as "intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and for "permanently obstruct[ing] blood flow to an aneurysm or other vascular malformation," indicating a direct therapeutic action to treat a medical condition.
No
Explanation: The device, the HydroCoil® Embolic System (HES), is described as an embolic system intended for the endovascular embolization and occlusion of intracranial aneurysms and neurovascular abnormalities. It is a treatment device, not one used for diagnosis.
No
The device description clearly outlines physical components including implantable coils, a delivery pusher made of stainless steel and PET tubing, a luer hub, an introducer sheath, and syringes. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the HydroCoil® Embolic System (HES) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the endovascular embolization and vascular occlusion of blood vessels within the body (intracranial, neurovascular, peripheral vasculature). This is a therapeutic intervention performed in vivo (within a living organism).
- Device Description: The device description details an implantable coil and a delivery system used to place the coil within blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, while the HES is a device implanted directly into the body to treat a condition.
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
Device Description
The HydroCoil® Embolic System (HES) consists of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system dc-airing and coil detachment. The HES prominer platinum helical coils with an outer layer of a hydrophilic polymer. The polymer material is a cross-linked copolymer of acrylamide and acrylic acid. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heatshrunk over the coupler/pusher junetion in order to attach the coil to the delivery pusher. The coil is delivered to the treatment site on the delivery pusher through standard neurointerventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for 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 (blood vessels, aneurysms, other vascular malformation), 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)
Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-S (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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DEC 3 0 2003
Dafe 1 of
Section 2 - Summary of Safety and Effectiveness
Company Information (1)
MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 www.microvention.com
Contact Information (2)
Vincent Cutarelli Telephone: (949) 768-1184 ext. 105 Fax: (949) 768-0464 E-mail: vinc@microvention.com
Device Name (3)
| Classification Name: | Device, Artificial Embolization |
|---|---|
| Trade/Proprietary Name: | HydroCoil® Embolic System (HES) |
| Common/Usual Name: | Embolization Coil |
Device Description (4)
The HydroCoil® Embolic System (HES) consists of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system dc-airing and coil detachment. The HES prominer platinum helical coils with an outer layer of a hydrophilic polymer. The polymer material is a cross-linked copolymer of acrylamide and acrylic acid. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heatshrunk over the coupler/pusher junetion in order to attach the coil to the delivery pusher. The coil is delivered to the treatment site on the delivery pusher through standard neurointerventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.
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Indications for Use (5)
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.
Name of Predicate or Legally Marketed Device (6)
The HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils is substantially equivalent to the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590), the GDC-10 Stretch Resistant Guglielmi Detachable Coil that was determined to be substantially equivalent on January 21, 2000 (reference K993415) and the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil that was determined to be substantially equivalent on January 21, 2000 (reference K993418).
Technological Characteristics and Substantial Equivalence (7)
The HydroCoil® Embolic System (HES) with the HES-HC-S (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-S (10) coils is equivalent in performance to the predicate devices.
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Mr. Vincent Cutarelli Vice President, Regulatory Affairs Quality Assurance and Clinical Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656
Re: K033836
Trade/Device Name: HydroCoil® Embolic System (HES) with the HES-HC-S (10) Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: December 9, 2003 Received: December 11, 2003
Dear Mr. Cutarclli:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stared in the 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 I va may, therefore, mans 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 11 your de hee to such additional controls. Existing major regulations affecting your device can may or die Jeen 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 mcan I reaso be ac mode a determination that your device complics with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must of any I catal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct el K Fart 6077, atoomig (21 OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Vincent Cutarelli
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 premainer noticate 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033836
Device Name: HydroCoil® Embolic System (HES) with the HES-HC-S (10) Coils
Indications For Use: The HydroCoil® Embolic System (HES) is intended for the mulcations For USC." The Tryalio aneurysms and other neurovascular chuovasoular Umbolization of increations and arteriovenous fistulae.
The HES is also intended for vascular occlusion of blood vessels within the The HEO is aloo intended formanently obstruct blood flow to an aneurysm or other vascular cystem and for arterial and venous embolizations in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
All ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) Division of General, Restorative and Neurological Devices
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Number K033836