The HydroCoil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS 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 HydroSoft coils consist of an implant made of plantinum alloy with an inner hydrogel core. The coils are designed in helical 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-Grip " Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

The HyperSoft coils consist of an implant coil made of platinum alloy. The coils are designed in helical structure in various loop sizes and lengths. The coil is attached to a V-Trak 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-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.

AI/ML Overview

The provided text describes a 510(k) summary for the HydroCoil Embolic System - HydroSoft and MicroPlex Coil System - HyperSoft, which are neurovascular embolization devices. The submission primarily focuses on establishing substantial equivalence to predicate devices through bench testing. There is no clinical study described in this document that would involve human subjects, data analysis for performance metrics relevant to AI/diagnostic devices, or the establishment of ground truth by medical experts.

Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and AI performance cannot be answered from the provided text. The document is essentially a regulatory filing proving that the new devices are functionally similar to existing ones based on engineering tests.

Here is an attempt to answer the questions based only on the provided information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance (Result from Bench Testing)
Simulated Use (Functionality)	Met established criteria
Detachment Test (Functionality)	Met established criteria
Detachment Zone Tensile (Strength)	Met established criteria
Advancement/Retraction Force (Handling)	Met established criteria
Coil to Coupler Weld Tensile (Strength)	Met established criteria
Spring Constant (Mechanical Property)	Met established criteria

Note: The document states "Met established criteria" for each test. The specific numerical values or ranges for these criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance
This information is not provided in the document. The tests performed are bench tests on the device itself, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. The "ground truth" in this context refers to the defined engineering specifications or performance standards for the device's mechanical properties and functionality, not medical diagnoses established by experts.

4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication typically refers to the resolution of disagreements among experts when establishing ground truth for diagnostic studies. For engineering bench tests, failure to meet a criterion is generally unambiguous.

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 information is not applicable/not provided. This document describes a medical device (coils for embolization), not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This document pertains to a physical medical device, not an algorithm or AI system.

7. The type of ground truth used
For the bench tests, the "ground truth" was likely predetermined engineering specifications, design requirements, and performance standards for the device's various mechanical and functional aspects.

8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this device's regulatory submission, as it's not an AI or machine learning product.

9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.

Summary

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091641

JUN 3 0 2009

510(k) Summary

Trade Name:	HydroCoil Embolic System - HydroSoftMicroPlex Coil System - HyperSoft
Generic Name:	Neurovascular Embolization Device
Classification:	Class II, 21 CFR 882.5950
Submitted By:	MicroVention, Inc75 ColumbiaAliso Viejo, California U.S.A.
Contact:	Naomi Gong

Predicate Devices:

Number	Description	Clearance Date
K070656	HydroCoil Embolic System with theHES-HC-HS (10) [marketed under theHydroSoft name]	June 15, 2007
K0509054	MicroPlex Coil System and HydroCoilEmbolic System	June 28, 2005

Device Description

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Indications For Use

The HydroSoft and HyperSoft coils are members of the HydroCoil Embolic System (HES) and MicroPlex Coil System (MCS). The intended use as stated in the product . labeling is as follows:

Bench Testing	Result
Simulated Use	Met established criteria
Detachment Test	Met established criteria
Detachment Zone Tensile	Met established criteria
Advancement/Retraction Force	Met established criteria
Coil to Coupler Weld Tensile	Met established criteria
Spring Constant	Met established criteria

Verification and Test Summary Table

Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the HydroSoft and HyperSoft coils when compared with the predicate devices (K070656 and K050954)

The devices,

. Have the same intended use,
Use the same operating principle, �
. Incorporate the same basic design,
. Use similar construction and material,
. Are packaged and sterilized using same material and processes.

In summary, the HydroSoft and HyperSoft coils described in this submission is, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc. c/o Naomi Gong Regulatory Affairs Project Manager 75 Columbia Suite A Aliso Viejo, CA 92656

Re: K091641

Trade/Device Name: MicroVention HydroCoil® Embolic System (HES) - HydroSoft Coils and MicroPlex® Coil System (MCS) - HyperSoft Coils

Regulation Number: 21 CFR 882.5950

Regulation Name: Neurovascular Embolization Device

Regulatory Class: II Product Code: HCG Dated: June 3, 2009 Received: June 4, 2009

Dear Ms. Gong:

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.

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 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

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forth in the quality systems (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.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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

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

K09164

510(k) Number (if known):

Device Name:

HydroSoft Embolic System (HES) - HydroSoft Coils MicroPlex Coil System (MCS) - HyperSoft Coils

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jeff Toy

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

510(k) Number K091641

Page 1 of 1

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).