The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are 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 MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. 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.

AI/ML Overview

The provided document contains information regarding the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). However, it focuses primarily on the regulatory submission and technical comparison to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly available in the provided text.

Here's an attempt to extract the information that is present and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Bench Test Summary" tables, which outline tests performed and their results. These represent acceptance criteria for the bench tests to demonstrate manufacturing quality and function. It does not provide acceptance criteria for clinical efficacy or safety, which would typically be part of a larger clinical study.

Test	Acceptance Criteria (Implied by "met acceptance criteria")	Reported Device Performance
Visual Inspection	Product drawings	All test samples met the acceptance criteria and passed testing.
Pusher Resistance	Implied standard for digital multi-meter measurement (specific values not provided)	All test samples met the acceptance criteria and passed testing.
Simulated Use	Successful: • Introduction • Tracking inside microcatheter • Deployment • Microcatheter Movement • Detachment	All test samples met the acceptance criteria and passed testing.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated for bench tests.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests are "bench tests," implying laboratory-based testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. (This would be more relevant for clinical ground truth, which is not described here).

4. Adjudication method for the test set

Adjudication Method: Not specified. Bench tests typically involve direct measurement or observation against predefined specifications, often without peer adjudication in the way clinical studies do.

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

MRMC Study: No, this document describes a regulatory submission for medical devices (coils) for neurovascular embolization, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related metrics are applicable or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable, as this is a medical device (coils) and not an algorithm.

7. The type of ground truth used

Ground Truth Type: For the bench tests, the "ground truth" seems to be defined by engineering specifications, product drawings, and functional requirements for the device. For example, for "Visual Inspection," the ground truth is "product drawings."

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document refers to physical device testing rather than machine learning algorithm training.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable.

Summary of Missing Information:

The provided document is a 510(k) summary for a neurovascular embolization device. It details the device's description, indications for use, comparison to a predicate device, and bench testing results. It does not contain information about clinical trials, AI performance, or studies involving human readers or expert-established ground truth in a clinical context. The "acceptance criteria" and "performance" discussed are limited to manufacturing and functional bench tests.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

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

January 22, 2016

MicroVention, Inc. Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

Re: K153594

Trade/Device Name: MicroPlex Coil System (MCS), HydroCoil Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: December 21, 2015 Received: December 23, 2015

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Carlos L. Pena -SFD/△

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153594

Device Name

MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for MicroVention, a company that specializes in neurovascular products. The logo features a stylized graphic to the left of the company name. Below the company name is the word "TERUMO", which is likely the parent company of MicroVention. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.

510(K) SUMMARY

(Prepared December 01, 2015)

Trade Name:	MicroPlex Coil System (MCS), HydroCoil Embolic System (HES)
Generic Name:	Neurovascular Embolization Device
Classification:	Class II, 21 CFR 882.5950
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California 92780U.S.A.
Contact:	Laraine PangelinaSr. Regulatory Affairs Project ManagerMicroVention, Inc.
Predicate Device:	MicroPlex Coil System (MCS) - K132952HydroCoil Embolic System (HES) - K132952
Indications for Use:	The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES)are intended for the endovascular embolization of intracranial aneurysmsand other neurovascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae. The MCS and HES are alsointended for vascular occlusion of blood vessels within the neurovascularsystem to permanently obstruct blood flow to an aneurysm or othervascular malformation and for arterial and venous embolizations in theperipheral vasculature.
Device Description:	The MCS devices consist of an implantable coil made of platinum alloy(MCS) or a platinum allot with an inner hydrogel core (HES). The coil isattached to a V-Trak delivery pusher via a polymer filament. Theproximal end of the pusher is inserted into a hand held battery poweredV-Grip Detachment Controller (sold separately). The implant segmentdetaches upon activation of the Detachment Controller.

Bench Test Summary:

Test	Test Method	Results
Visual Inspection	Using a microscope, inspect per product drawings	All test samples met the acceptancecriteria and passed testing.
Pusher Resistance	Measure the pusher resistance using a digital multi-meter	All test samples met the acceptancecriteria and passed testing.
Simulated Use	Using cerebrovascular benchtop model, conduct thefollowing assessments on each test sample:• Introduction• Tracking inside microcatheter• Deployment• Microcatheter Movement• Detachment	All test samples met the acceptancecriteria and passed testing.

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Image /page/4/Picture/0 description: The image contains the logo for MicroVention TERUMO. The logo features a stylized graphic to the left of the text. The text "MicroVention" is in a larger, bolder font, and "TERUMO" is in a smaller font below it.

Predicate / Subject

Technological Comparison:

Design Feature	Predicate Devices	Subject Devices
Implant Coil Shape	Helical or 3D	Same
Implant Coil Wire material	Platinum/Tungsten (92/8 %) alloy	Same
Implant Hydrogel material	MCS - NoneHES - Hydrophilic acrylic copolymer	Same
Implant Coil-to-Pusher Coupler material	Platinum (90%) / iridium (10%)	Same
Implant to Pusher filament / SR membermaterial	Polyolefin elastomer or PET	Same
Adhesive material	Ultraviolet curing adhesive (DYMAX 1128-AM-VT)	Same
Delivery Pusher Overall Construction	Variable stiffness stainless steel hypotubewith platinum and stainless steel coils atthe distal end.	Same
Delivery Pusher Proximal ConnectorConstruction	• 3 gold connectors (Ø.016") overmandrel• Middle gold connector is welded tomandrel• Distal gold connector is welded tohypotube• Annealed section of hypotube distal ofgold connector• Polyimide tube used for insulation• 1 solder joint visible, 1 solder joint notvisible (inside hypotube)	• Gold plated hypotube used for oneconnector (Ø.014")• 2 gold connectors (Ø.016") overhypotube• Polyimide tube used for insulation• 2 solder joints visible
Delivery Pusher Length	185 cm	195cm

Risk Analysis:

The MCS and HES products are designed, developed and tested in accordance with the MicroVention Design and Development procedure and with the MicroVention internal quality system procedure for risk management. Possible hazards and associated risk related to the device modification and clinical usage of the device were identified, examined and found to be acceptable after the implementation of the mitigation measures such as physician training program, labeling warnings and instructions for use.

The devices that are the subject of this submission are substantially Summary of Substantial equivalent to the predicate device with regard to intended use, Equivalence: patient population, device design, materials, processes, and operating principal.

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).