The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The 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 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

Here's an analysis of the acceptance criteria and supporting study for the MicroPlex Embolic System (MCS) Line Extension, based on the provided document:

Acceptance Criteria and Device Performance

The device, the MicroPlex Coil System (MCS) Line Extension (specifically MCS HyperSoft 3D), was subject to a series of bench tests. The acceptance criteria for these tests were established by demonstrating substantial equivalence to predicate devices (K091641 and K103758). The document explicitly states that the new device "Met the same acceptance criteria as the predicate devices" for all listed tests.

Test	Acceptance Criteria	Reported Device Performance
Visual Inspection	Same as predicate devices (K091641, K103758)	Met the same acceptance criteria as the predicate devices
Dimensional Measurement	Same as predicate devices (K091641, K103758)	Met the same acceptance criteria as the predicate devices
Simulated Use	Same as predicate devices (K091641, K103758)	Met the same acceptance criteria as the predicate devices
Detachment Test	Same as predicate devices (K091641, K103758)	Met the same acceptance criteria as the predicate devices
Coil to Coupler Weld Tensile	Same as predicate devices (K091641, K103758)	Met the same acceptance criteria as the predicate devices
Spring Constant	Same as predicate devices (K091641, K103758)	Met the same acceptance criteria as the predicate devices

Study Details for Device Performance

It's important to note that this submission is for a Special 510(k) Line Extension, which primarily focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through bench testing and technological comparison, rather than extensive clinical studies. Therefore, many of the typical clinical study parameters (like sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this type of submission.

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

Sample Size for Test Set: Not specified in the document. The testing described is bench testing of the device itself (coils and delivery system), not a study involving patient data.
Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer, MicroVention, Inc. (based in Tustin, California, U.S.A.). The data is prospective in the sense that the new coils were manufactured and then tested according to established protocols.

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

Number of Experts: Not applicable. For bench testing, "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards, rather than expert consensus on medical images or clinical outcomes.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Bench tests follow predefined protocols and acceptance criteria based on quantifiable measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This submission is for a physical medical device (coils) and its delivery system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance

Standalone Performance Done: No. This is not an algorithmic or software-only device.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this submission is based on engineering specifications, established test methods, and the performance characteristics of the legally marketed predicate devices. The new device's performance was compared to these established benchmarks to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no AI model involved that would require a training set. The "training" for this device's development would be the historical data and performance of previous iterations and predicate devices.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no AI training set. The design and validation of the new device are informed by the known and regulated performance of the predicate devices and general neurovascular device development principles.

Summary

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Special 510(k) MicroPlex Embolic System (MCS) Line Extension , MicroVention

OCT 0 4 2013

131948

510(K) SUMMARY

Trade Name:

MicroPlex Coil System (MCS)

Class II, 21 CFR 882.5950

MicroPlex Coil System (MCS)

MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780

Laraine Pangelina

Neurovascular Embolization Device

Generic Name:

Classification:

Submitted By:

Contact:

U.S.A.

Indications for Use:

Predicate Device:

Device Description:

Test	Result
Visual Inspection	Met the same acceptance criteria as the predicate devices
DimensionalMeasurement	Met the same acceptance criteria as the predicate devices
Simulated Use	Met the same acceptance criteria as the predicate devices
Detachment Test	Met the same acceptance criteria as the predicate devices
Coil to Coupler WeldTensile	Met the same acceptance criteria as the predicate devices
Spring Constant	Met the same acceptance criteria as the predicate devices

Bench Test Summary:

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MicroPlex Embolic System (MCS) Line Extension

Predicate / Subject Technological Comparison:

Design Feature	Predicate Device(K091641)	Predicate Device(K103758)	Line Extension(MCS HyperSoft 3D)
Coil shape	Helical	3D	3D
Coil Filar Size	0.00125 - 0.00150	0.00200 - 0.00225*	0.00125*
Coil Implant Diameter	1 - 8 mm	2 - 12 mm	1.0 - 1.5 mm
Coil Restrained Length	1 - 10 cm	2 - 45 cm	1.5 - 4.5 mm
Main Coil Wire Material	Platinum/Tungsten(92/8%) alloy	Same	Same
Coupler Material	Platinum (90%)/ iridium(10%)	Same	Same
Adhesive Material	DYMAX 1128-AM-VTUV Adhesive	Same	Same
Stretch Resistance FilarMaterial	PET	Polyolefin Elastomer (3-12mm coils) or PET (2.0-2.5mm coils)	PET
Implant-to-V-TrakAttachment Material	Confidential	Same	Same
Delivery Method	V-Trak delivery pusher	Same	Same
Package Configuration	Dispenser hoop, pouch,and carton	Same	Same
MRI Compatibility	Yes	Yes	Yes
Method of Supply	Sterile, single use	Same	Same

Summary of Substantial Equivalence:

Based on a comparison of technical specifications and device testing results, the MCS HyperSoft 3D devices are substantially equivalent to legally marketed predicate devices.

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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 consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

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

October 4, 2013

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

Re: K131948

Trade/Device Name: MicroPlex Coil System (MCS): MCS HyperSoft 3D Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: July 16, 2013 Received: September 6, 2013

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.

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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Page 2 - Ms. Laraine Pangelina

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 1000-1000.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFF) Pass 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,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting 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): K131948 Device Name: MicroPlex Coil System (MCS) Indications for Use: The MicroPiex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The 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.

Preseription Use X (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Victor Krauthamer	SVA
	2013.10.04 10:46:26-04'00'

(Division Sign Off)

Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number
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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).