(57 days)
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.
The 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. The RD11-006 HES is a line extension which is substantially the same as the predicate devices (K070656, K080666, K091641). The implantable coil portion of both the predicate and the subject device is constructed from platinum alloy wire. The RD11-006 implantable coil is constructed of an oval-shaped platinum alloy wire, whereas the predicate devices are constructed of a round platinum alloy wire. All other materials and design features are the same for both the predicate and subject devices.
This document describes an FDA 510(k) summary for the HydroCoil Embolic System (HES) and asserts its substantial equivalence to a predicate device. It specifically focuses on a line extension with an oval-shaped platinum alloy wire, while the predicate devices used a round wire. There is no information in the provided text about a study (clinical or otherwise) that uses human readers, ground truth, or statistical analysis in the context of device performance. The entire submission is a declaration of equivalence based on bench testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document indicates that the acceptance criteria for the subject device are the "same criteria as predicate" for all bench tests. The reported device performance is that it "Met same criteria as predicate."
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| 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 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The "Bench Test Summary" implies testing of device features, but the number of units tested is not provided.
- Data Provenance: The data is from bench testing, presumably conducted by the manufacturer, MicroVention, Inc., in the USA (Tustin, California). It is not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the provided document details a 510(k) submission for a medical device (embolic coils) where the primary evidence presented is bench testing for substantial equivalence to a predicate device. There is no mention of a performance study involving human readers or experts to establish ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
This is not applicable for the reasons stated above. The evaluation is based on objective measurements from bench tests, not expert adjudication of diagnostic images or outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is an embolic coil, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device based on the information provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this submission is related to the physical and mechanical properties of the device. The "acceptance criteria" for the bench tests effectively serve as the ground truth against which the subject device's performance is measured. This includes:
- Meeting dimensional specifications.
- Achieving established thresholds for mechanical properties (e.g., spring constant, weld tensile strength, advancement/retraction force).
- Performing as expected during simulated use (introduction, tracking, deployment, detachment).
- Exhibiting expected gel expansion characteristics.
These are objective, measurable characteristics that confirm functional equivalence to the predicate device.
8. The sample size for the training set:
This is not applicable. There is no "training set" in the context of an embolic coil device submission for bench testing. The device is not learning from data.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
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്ചു
K11226
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| SEP 2 9 2011 | |
|---|---|
| Trade Name: | HydroCoil Embolic System (HES) |
| Generic Name: | Neurovascular Embolization Device, accessory |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California 92780U.S.A. |
| Contact: | Laraine Pangelina |
| Predicate Device: | HydroCoil Embolic System (K070656, K080666, K091641) |
| Device Description: | The 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.The RD11-006 HES is a line extension which is substantially the same as the predicate devices (K070656, K080666, K091641). The implantable coil portion of both the predicate and the subject device is constructed from platinum alloy wire. The RD11-006 implantable coil is constructed of an oval-shaped platinum alloy wire, whereas the predicate devices are constructed of a round platinum alloy wire. All other materials and design features are the same for both the predicate and subject devices. |
| 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. |
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| 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 | 2 mm – 7 mm | |
| Implant restrained length | 1 cm – 30 cm | 2 cm – 10 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 |
.
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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized symbol resembling an abstract bird or wave-like form, composed of three curved lines. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Microvention, Inc. c/o Ms. Loraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
SEP 2 9 201
Re: K112226
Trade/Device Name: HydroCoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: August 02, 2011 Received: August 03, 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, listing 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.
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
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CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality svstems (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.html 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/Resourcesfor You/Industry/default.htm.
12
Sincerely yours.
Kevin Alexander
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
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INDICATIONS FOR USE
| 510(k) Number (if known): | K112226 |
|---|---|
| Device Name: | HydroCoil Embolic System (HES) |
| Indications for Use: | The HES is intended for the endovascular embolization ofintracranial aneurysms and other neurovascular abnormalitiessuch as arteriovenous malformations and arteriovenous fistulae.The HES is also intended for vascular occlusion of bloodvessels within the neurovascular system to permanentlyobstruct blood flow to an aneurysm or other vascularmalformation and for arterial and venous embolizations in theperipheral 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)
ALEX BAILEY
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112226
ಸ್ಕ
§ 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).