(64 days)
The HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous 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.
The HydroFrame coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical 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-GripTM Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
The provided text describes the HydroCoil Embolic System, HydroFrame, a neurovascular embolization device. The submission is a Special 510(k) for this device, comparing it to an existing predicate device (K090357). The acceptance criteria and supporting study are focused on demonstrating that the updated device maintains the same performance characteristics as the predicate through bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test was "Met same specifications as predicate". The reported device performance for all tests listed below was that this criterion was met.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Dimensional Measurement | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Simulated Use: Introduction, Tracking, Deployment, Frame tumbling, Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, Basket formation, Shape retention, Overall performance | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Advancement/Retraction | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Spring Constant | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Gel Expansion | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Weld Tensile | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (number of devices tested for each bench test). It also does not provide information on data provenance (country of origin or whether it was retrospective or prospective), as these were bench tests of a physical device, not an AI algorithm utilizing clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is purely bench testing of a physical medical device, not an AI algorithm requiring expert ground truth for interpretation. The ground truth for bench tests would be directly measurable physical properties and performance characteristics.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is purely bench testing of a physical medical device. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI algorithms or imaging interpretation, not for the bench testing of a physical embolization device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests was based on engineering specifications and measurable physical properties of the predicate device. The goal was to ensure the new device met the same objective specifications as the existing one.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device, not an AI algorithm that requires a training set and associated ground truth.
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Special 510(k), HydroCoil Embolic System - HydroFrame
510(IK) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | HydroCoil Embolic System, HydroFrame | APR 22 201 |
|---|---|---|
| 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, HydroFrame (K090357) | |
| Device Description: | The HydroFrame coils consist of implant coil made of platinum alloy withinner hydrogel core. The coils are designed in 3D spherical structure invarious loop sizes and lengths. The coil is attached to a V-TrakTMdelivery pusher via a polymer filament. The delivery pusher containsradiopaque positioning markers at the distal end. The proximal end isinserted into a hand held battery powered V-GripTM DetachmentController (sold separately). The implant segment detaches uponactivation of the Detachment Controller. | |
| Indications for Use: | The HydroCoil Embolic System (HES) is intended for theendovascular embolization of intracranial aneurysms and otherneurovascular abnormalities such as arteriovenousmalformations and artiovenous fistula. The HES is also intendedfor vascular occlusion of blood vessels within the neurovascularsystem to permanently obstruct blood flow to an aneurysm orother vascular malformation and for arterial and venousembolization in the peripheral vasculature. | |
| Bench Test Summary: | TestResult |
| Test | Result |
|---|---|
| Visual Inspection | Met same specifications as predicate |
| Dimensional Measurement | Met same specifications as predicate |
| Simulated Use:Introduction, Tracking, Deployment,Frame tumbling, Microcathetermovement, Microcatheter manipulation,Compartmentalization, Periphery fill,Basket formation, Shape retention,Overall performance | Met same specifications as predicate |
| Advancement/Retraction | Met same specifications as predicate |
| Spring Constant | Met same specifications as predicate |
| Gel Expansion | Met same specifications as predicate |
| Weld Tensile | Met same specifications as predicate |
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MicroVention, Inc.
Technological comparison, subject and predicate device:
subject and predicate device.
| Features | Predicate Device | 510(k) Subject Device |
|---|---|---|
| Indications for Use | The HydroCoil EmbolicSystem (HES) is intended forthe endovascularembolization of intracranialaneurysms and otherneurovascular abnormalitiessuch as arteriovenousmalformations andartiovenous fistula. The HESis also intended for vascularocclusion of blood vesselswithin the neurovascularsystem to permanentlyobstruct blood flow to ananeurysm or other vascularmalformation and for arterialand venous embolization inthe peripheral vasculature. | Same |
| Design Attributes | ||
| Coil Shape | 3D - Spherical | Same |
| Primary Coil WindOD (inch) | 0.0120-0.0125 | 0.0125 - .0150 |
| 3D Coil OD (mm) | 3 - 8 | 6 - 24 |
| Restrained CoilLength (cm) | 6 - 33 | 19 - 50 |
| Pusher Length | 185 cm | Same |
| Materials | ||
| Main Coil Wire | Platinum/Tungsten alloy(92/8) | Same |
| Coil-to-PusherCoupler | Platinum / Iridium (90/10) | Same |
| Adhesive | UV cure adhesive(DYMAX 1128-AM-VT) | Same |
| Implant to the pusher | Polyolefin Elastomer | Same |
| Stretch ResistantFilament | Polyolefin Elastomer | Same |
| Hydrogel | Hydrophilic acryliccopolymer | Same |
| General | ||
| CatheterCompatibility | Compatible withmicrocatheters having anID of ≥ .015". | Compatible withmicrocatheters having anID of ≥ .015" (HydroFrame10) and ≥ .0165"(HydroFrame 18) |
| Method of Supply | Sterile, single use | Same |
| PackageConfiguration | Dispenser coil, pouch &shipping carton | Same |
: . .
.
Summary of Substantial Equivalence:
Equivalence:
The HydroFrame Coils 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 is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the edge. In the center of the seal is a stylized image of an eagle or bird-like figure with its wings spread. The image is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR 2 2 2010
MicroVention. Inc. c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K100454
Trade/Device Name: HydroCoil Embolic System (HES) - HydroFrame Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: March 19, 2010 Received: March 23, 2010
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 indives 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, Dr to 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, into not 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 truthing music might might might might might ding.
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 offecting 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 Rigister.
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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/ReportalProblem/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
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): | K100454 |
|---|---|
| Device Name: | HydroCoil Embolic System, HydroFrame |
| 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 artiovenous 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. |
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)
Kristen Bowsher
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_k100 454
§ 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).