(24 days)
Not Found
No
The summary describes a physical medical device (embolic coil) and its delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
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, HES, is described as an implantable coil for endovascular embolization and vascular occlusion, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it consists of an "implantable coil made of platinum alloy with inner hydrogel core" and a "V-Trak delivery pusher," which are physical hardware components. It also mentions a "hand held battery powered V-Grip 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 is an implantable coil designed to be placed within blood vessels. This is an invasive medical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The purpose is to physically block blood flow.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous 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
HCG, KRD
Device Description
The HydroSoft Plus HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
With the exception of the coil dimensions (see comparison table below), the HydroSoft Plus line extension is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration and sterilization method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms, neurovascular abnormalities like arteriovenous malformations and arteriovenous fistula), 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 criteria as predicate
Test: Dimensional Measurement; Result: Met same criteria as predicate
Test: Simulated Use (Introduction, Tracking, Reposition / Deployment, Detachment, Overall Performance); Result: Met same criteria as predicate
Test: Spring Constant; Result: Met same criteria as predicate
Test: Gel Expansion; Result: Met same criteria as predicate
Test: Weld Tensile; Result: Met same criteria as predicate
Test: Advancement / Retraction Force; Result: Met same criteria 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 (HES), HydroSoft Plus (K112226)
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
MicroVention, Inc. Special 510(k) HydroCoil Embolic System (HES) – HydroSoft Plus Line Extension
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ﻣﺮﻳﻜﺎ ﺎ
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | HydroCoil Embolic System (HES), HydroSoft Plus |
|---|---|
| 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 (HES), HydroSoft Plus (K112226) |
| Indications for Use: | The HES is intended for the endovascular embolization of |
| intracranial aneurysms and other neurovascular abnormalities | |
| such as arteriovenous malformations and arteriovenous 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. | |
| Device Description: | The HydroSoft Plus HES consists of implantable coil made of platinum |
| alloy with inner hydrogel core. The helical-shaped implantable coil is | |
| available in various outer dimensions and lengths. The coil is attached | |
| to a V-Trak delivery pusher. The proximal end of the pusher is inserted | |
| into a hand held battery powered V-Grip Detachment Controller (sold | |
| separately). The implant segment detaches upon activation of the | |
| Detachment Controller. |
With the exception of the coil dimensions (see comparison table below),
the HydroSoft Plus line extension is substantially equivalent to the
cleared predicate devices with regard to intended use, principal of
operation, materials, manufacturing processes, packaging configuration
and sterilization method. |
1
MicroVention, Inc. Special 510(k) HydroCoil Embolic System (HES) - HydroSoft Plus Line Extension
| Bench Test Summary: | Test | Result | |
|---|---|---|---|
| Visual Inspection | Met same criteria as predicate | ||
| Dimensional Measurement | Met same criteria as predicate | ||
| Simulated Use | |||
| • Introduction | |||
| • Tracking | |||
| • Reposition / Deployment | |||
| • Detachment | |||
| • Overall Performance | Met same criteria as predicate | ||
| Spring Constant | Met same criteria as predicate | ||
| Gel Expansion | Met same criteria as predicate | ||
| Weld Tensile | Met same criteria as predicate | ||
| Advancement / Retraction Force | Met same criteria as predicate | ||
| Predicate / Subject | |||
| Device Comparison: | Feature | Predicate Device | Subject Device |
| Coil shape | Helical | Same | |
| Implant diameter | 2 mm - 10 mm | 5 mm - 24 mm | |
| Implant restrained length | 2 cm - 10 cm | 15 cm - 50 cm | |
| Deliver pusher length | 185 cm | Same | |
| Main coil wire material | Platinum/Tungsten | ||
| (92/8 %) alloy | Same | ||
| Coupler material | Platinum (90%) / | ||
| iridium (10%) | Same | ||
| Adhesive material | Dymax 1128-AM- | ||
| VT | Same | ||
| Implant to pusher material | Polyolefin | ||
| Elastomer | Same | ||
| Stretch resistant filar | |||
| material | Polyolefin | ||
| Elastomer | Same | ||
| Gel material | Hydrophilic | ||
| Copolymer | Same | ||
| MRI compatibility | Yes | Yes | |
| Method of supply | Sterile, single use | Same | |
| Packaging configuration | Dispenser, pouch, | ||
| carton | Same |
Predicate / Device Con
... . . . . . .
Summary of Substantial Equivalence:
The HES coils that are the subject of this submission 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 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MicroVention, Inc. c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
DEC 1 6 2011
Re: K113457
Trade/Device Name: HydroCoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 18, 2011 Received: November 22, 2011
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 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. Iisting of 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 truthful and not misleading.
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.
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/ReportaProblem/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.
Sincerely yours,
Malvina B. Eydelman, M.D.
Malvina B. Eydelman, M.I 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
| 510(k) Number (if known): | K113457 |
|---|---|
| Device Name: | HydroCoil Embolic System (HES) |
| Indications for Use: | The 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. |
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)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113457