(24 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 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.
This document describes the 510(k) summary for MicroVention, Inc.'s HydroCoil Embolic System (HES) - HydroSoft Plus Line Extension. This submission is for a medical device (neurovascular embolization device), not an AI/ML powered device, so many of the requested categories are not applicable.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study (bench testing) performed:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Visual Inspection | Met same criteria as predicate |
| Dimensional Measurement | Met same criteria as predicate |
| Simulated Use | Met same criteria as predicate |
| - Introduction | Met same criteria as predicate |
| - Tracking | Met same criteria as predicate |
| - Reposition / Deployment | Met same criteria as predicate |
| - Detachment | Met same criteria as predicate |
| - 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:
This table highlights the specific device characteristics that define the acceptance criteria for a "substantially equivalent" device:
| Feature | Predicate Device (K112226) | Subject Device (HydroSoft Plus Line Extension) | Acceptance Criteria Met? |
|---|---|---|---|
| Coil shape | Helical | Same | Yes |
| Implant diameter | 2 mm - 10 mm | 5 mm - 24 mm | Difference |
| Implant restrained length | 2 cm - 10 cm | 15 cm - 50 cm | Difference |
| Deliver pusher length | 185 cm | Same | Yes |
| Main coil wire material | Platinum/Tungsten (92/8 %) alloy | Same | Yes |
| Coupler material | Platinum (90%) / iridium (10%) | Same | Yes |
| Adhesive material | Dymax 1128-AM-VT | Same | Yes |
| Implant to pusher material | Polyolefin Elastomer | Same | Yes |
| Stretch resistant filar material | Polyolefin Elastomer | Same | Yes |
| Gel material | Hydrophilic Copolymer | Same | Yes |
| MRI compatibility | Yes | Yes | Yes |
| Method of supply | Sterile, single use | Same | Yes |
| Packaging configuration | Dispenser, pouch, carton | Same | Yes |
Note on Differences: The "Implant diameter" and "Implant restrained length" are explicitly different between the predicate and subject devices. The core of this 510(k) submission is to demonstrate that despite these dimensional differences (which represent the "line extension"), the new device is still substantially equivalent in terms of safety and effectiveness, performing to "the same criteria as predicate" in the bench tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes for each bench test conducted (e.g., how many coils were subjected to "Weld Tensile" testing). It only states that the tests were performed and "Met same criteria as predicate."
- Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin of data or whether it was retrospective or prospective, as these terms typically apply to clinical studies involving human or animal subjects, which is not the case for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device 510(k) submission based on bench testing of physical properties and performance, not diagnostic imaging or AI assessment that requires expert ground truth labeling. The "ground truth" for these tests is defined by established engineering and material science standards and the performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical trials or studies where subjective assessments or discrepancies in expert interpretations require resolution. Bench tests involve objective measurements against predefined specifications.
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
Not applicable. This submission is for a physical medical device (coil embolization system), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. The testing described is performance testing of a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests is the performance specifications and established criteria of the predicate device (K112226), along with general engineering and material science standards applicable to such devices. The new HydroSoft Plus line extension is considered to meet the acceptance criteria if its performance in these tests is "the same" as or equivalent to the predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for physical device bench testing.
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MicroVention, Inc. Special 510(k) HydroCoil Embolic System (HES) – HydroSoft Plus Line Extension
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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, Inc1311 Valencia AvenueTustin, California 92780U.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 ofintracranial aneurysms and other neurovascular abnormalitiessuch as arteriovenous malformations and arteriovenous fistula.The HES is also intended for vascular occlusion of blood vesselswithin the neurovascular system to permanently obstruct bloodflow to an aneurysm or other vascular malformation and forarterial and venous embolization in the peripheral vasculature. |
| Device Description: | The HydroSoft Plus HES consists of implantable coil made of platinumalloy with inner hydrogel core. The helical-shaped implantable coil isavailable in various outer dimensions and lengths. The coil is attachedto a V-Trak delivery pusher. The proximal end of the pusher is insertedinto a hand held battery powered V-Grip Detachment Controller (soldseparately). The implant segment detaches upon activation of theDetachment Controller.With the exception of the coil dimensions (see comparison table below),the HydroSoft Plus line extension is substantially equivalent to thecleared predicate devices with regard to intended use, principal ofoperation, materials, manufacturing processes, packaging configurationand sterilization method. |
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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 / SubjectDevice 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 | PolyolefinElastomer | Same | |
| Stretch resistant filarmaterial | PolyolefinElastomer | Same | |
| Gel material | HydrophilicCopolymer | 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.
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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.
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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/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
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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
§ 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).