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.

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 modified HES is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

AI/ML Overview

The provided text describes a Special 510(k) submission for a modification to the HydroCoil Embolic System (HES), specifically to the HydroFill component. This is a submission demonstrating substantial equivalence to a predicate device, not a de novo clearance or a novel device submission. Therefore, the "acceptance criteria" discussed are primarily related to bench testing demonstrating that the modified device performs similarly to the predicate device, rather than clinical efficacy endpoints. The study described is a series of bench tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this Special 510(k), the "acceptance criteria" are implied by demonstrating that the modified device met the same criteria as the predicate device in a series of bench tests. The reported performance is that all tests met these implied criteria.

Test	Acceptance Criteria (Implied)	Reported Device Performance (Subject Device)
Visual Inspection	Match predicate device's visual characteristics	Met same criteria as predicate
Dimensional Measurement	Match predicate device's dimensional specifications	Met same criteria as predicate
Simulated Use	Perform similarly to predicate in:	Met same criteria as predicate
• Introduction	• Introduction	• Introduction
• Tracking	• Tracking	• Tracking
• Reposition / Deployment	• Reposition / Deployment	• Reposition / Deployment
• Detachment	• Detachment	• Detachment
• Overall Performance	• Overall Performance	• Overall Performance
Spring Constant	Match predicate device's spring constant	Met same criteria as predicate
Gel Expansion	Match predicate device's gel expansion properties	Met same criteria as predicate
Weld Tensile	Match predicate device's weld tensile strength	Met same criteria as predicate
Advancement / Retraction Force	Match predicate device's forces	Met same criteria as predicate

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes (number of devices or tests performed) for each bench test. It only states that the modified device "Met same criteria as predicate." The data provenance is internal to MicroVention, Inc., and is derived from bench testing (presumably in a laboratory setting). It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. For bench tests demonstrating substantial equivalence, ground truth is established by engineering specifications, material properties, and performance benchmarks against the predicate device, not by expert clinical consensus.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is required to establish ground truth or resolve discrepancies. Bench tests rely on objective measurement and predefined engineering criteria.

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 is a submission for a modification to a medical device (embolic coils), not an AI-powered diagnostic or therapeutic system. An MRMC study is not relevant to this type of device and submission.

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.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests effectively consisted of the established performance and material specifications of the predicate device. The goal was to demonstrate that the modified device performed equivalently to these known specifications. This is an engineering/performance-based "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The data presented is from verification and validation bench testing of the physical device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, there is no training set for this type of device.

Summary

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K120908

APR 2 5 2012

MicroVention. Inc. Special 510(k) HydroCoil Embolic System (HES) -- Modification to HydroFill (formerly HydroSoft Plus)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

HydroCoil Embolic System (HES) Trade Name: Neurovascular Embolization Device, accessory Generic Name: Class II, 21 CFR 882.5950 Classification: MicroVention, Inc Submitted By: 1311 Valencia Avenue Tustin, California 92780 U.S.A. Laraine Pangelina Contact: HydroCoil Embolic System (HES) (K112226, K113457) Predicate Device: 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. The HES consists of implantable coil made of platinum alloy with inner Device Description: 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 modified HES is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.

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MicroVention, Inc.

Special 510(k)

Special Jro(K)
HydroCoil Embolic System (HES) – Modification to HydroFill (formerly HydroSoft Plus)

	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 - 24 mm	Same
Implant restrained length	2 cm - 50 cm	Same
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	PET
Gel material	HydrophilicCopolymer	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 equivalent to the productions as terrals, processes, and operating principal.

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol, possibly an eagle, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 2 5 2012

MicroVention c/o Ms. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

Re: K120908

Trade/Device Name: HydroCoil Embolic System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 23, 2012 Received: March 26, 2012

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.

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Page 2 - Ms. Laraine Pangelina

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 vours.

Kesia Alexander

Image /page/3/Picture/8 description: The image shows a stylized signature in black ink. The signature appears to be a cursive "f" connected to another letter, possibly an "r" or a similar character. The overall impression is that of a quick, flowing signature.

Malvina B. Evdelman, 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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MicroVention, Inc. Special 510(k) BydroCoil Embolic System (HES) – Modification to HydroFill (formerly HydroSoft Plus)

INDICATIONS FOR USE

K120908

510(k) Number (if known):

Device Name:

Indications for Use:

HydroCoil Embolic System (HES)

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)

Jeffrey Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120908

Regulation Number and Section

§ 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).