(26 days)
K070656, K0509054
Not Found
No
The description focuses on the physical components and mechanical function of the embolic coil system and detachment controller. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, and vascular occlusion to permanently obstruct blood flow, which are therapeutic interventions.
No
The device description clearly states its purpose is for "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and for "vascular occlusion of blood vessels." This indicates it is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description clearly outlines hardware components including platinum alloy implants, delivery pushers, and a battery-powered detachment controller.
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, peripheral vasculature). This is a therapeutic procedure performed directly on the patient.
- 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 a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to physically obstruct blood flow.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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 HydroSoft coils consist of an implant made of plantinum alloy with an inner hydrogel core. The coils are designed in helical 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-Grip " Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
The HyperSoft coils consist of an implant coil made of platinum alloy. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-Trak 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-Grip™ Detachment Controller. 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 (aneurysms), 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 Testing | Result |
|---|---|
| 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Met established criteria
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.
K070656, K0509054
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
091641
JUN 3 0 2009
510(k) Summary
| Trade Name: | HydroCoil Embolic System - HydroSoft
MicroPlex Coil System - HyperSoft |
|-----------------|---------------------------------------------------------------------------|
| Generic Name: | Neurovascular Embolization Device |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc
75 Columbia
Aliso Viejo, California U.S.A. |
| Contact: | Naomi Gong |
Predicate Devices:
| Number | Description | Clearance Date |
|---|---|---|
| K070656 | HydroCoil Embolic System with the | |
| HES-HC-HS (10) [marketed under the | ||
| HydroSoft name] | June 15, 2007 | |
| K0509054 | MicroPlex Coil System and HydroCoil | |
| Embolic System | June 28, 2005 |
Device Description
The HydroSoft coils consist of an implant made of plantinum alloy with an inner hydrogel core. The coils are designed in helical 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-Grip " Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
The HyperSoft coils consist of an implant coil made of platinum alloy. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-Trak 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-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
1
Indications For Use
The HydroSoft and HyperSoft coils are members of the HydroCoil Embolic System (HES) and MicroPlex Coil System (MCS). The intended use as stated in the product . labeling is as follows:
The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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.
| Bench Testing | Result |
|---|---|
| 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 |
Verification and Test Summary Table
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the HydroSoft and HyperSoft coils when compared with the predicate devices (K070656 and K050954)
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 HydroSoft and HyperSoft coils described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN 3 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention, Inc. c/o Naomi Gong Regulatory Affairs Project Manager 75 Columbia Suite A Aliso Viejo, CA 92656
Re: K091641
Trade/Device Name: MicroVention HydroCoil® Embolic System (HES) - HydroSoft Coils and MicroPlex® Coil System (MCS) - HyperSoft Coils
Regulation Number: 21 CFR 882.5950
Regulation Name: Neurovascular Embolization Device
Regulatory Class: II Product Code: HCG Dated: June 3, 2009 Received: June 4, 2009
Dear Ms. Gong:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
forth in the quality systems (OS) 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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
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
4
Indications for Use
K09164
510(k) Number (if known):
Device Name:
HydroSoft Embolic System (HES) - HydroSoft Coils MicroPlex Coil System (MCS) - HyperSoft Coils
Indications For Use:
The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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 (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)
Jeff Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091641
Page 1 of 1