The Capture™ LP Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Description

The Capture™ LP device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptoms onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Platinum -Iridium and Platinum-Tungsten radiopaque markers on the proximal and distal ends respectively. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

AI/ML Overview

I am sorry, but based on the provided document, the device described is not an AI/ML powered device. As such, I cannot provide a response to your request, as it specifically asks for details related to AI/ML powered devices, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance metrics.

The document details the K141516 MindFrame Capture™ LP Revascularization Device, which is a physical thrombus retriever for ischemic stroke. The performance data presented in the document pertains to bench testing (e.g., durability, tensile strength, radial force, clot retrieval in models) and animal studies (usability, effectiveness, safety in swine), not a software or AI/ML-based diagnostic or treatment device.

Therefore, the requested information regarding acceptance criteria, study details, and performance metrics in the context of AI/ML are not available in this document.

Summary

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

February 5, 2015

Micro Therapeutics, Inc., d/b/a ev3 Neurovascular Mr. Larry Boucher Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K141516 Trade/Device Name: MindFrame Capture™ LP Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: December 24, 2014 Received: January 5, 2015

Dear Mr. Boucher,

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

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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 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 - 50/0

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) K141516

Device Name

Capture™ LP Revascularization Device

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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1. 510(k) Summary

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Larry BoucherSenior Regulatory Affairs SpecialistTelephone: (949) 297-9781E-mail: larry.boucher@covidien.com
Date SummaryPrepared:	28 January 2015
Trade Name ofDevice:	Capture™ LP Revascularization Device
Common Name ofDevice:	Catheter, Thrombus Retriever
Classification ofDevice:	21 CFR 870.1250 – Class II
Predicate Device:	Solitaire™ FR Revascularization Device 510(k)#: K113455
Performance Data:	The following bench testing was performed in support of the Capture™ LP Revascularization Device:A f Temperature Testing Radial Force Testing Radiopacity Testing Kink Resistance Testing Dimensional Testing Durability Testing Delivery Force Testing Re-sheathing (withdrawal) Force Testing Component and Attachment (Tensile) Integrity Testing Torque Strength Testing Performance (Clot Retrieval) Testing Physician Usability Testing

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	Biocompatibility testing, sterilization validation, and a 2-yearaccelerated aging study were also performed. In addition, an acute and30-day and 90-day chronic animal studies were performed.
Conclusion:	The Capture™ LP device is substantially equivalent to the Solitaire™FR device based on the successful completion of non-clinical bench andanimal testing as well as similar principles of design, operation andindications for use.

Device Description:

Indications for Use:

The ev3 / Covidien Capture™ LP Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Comparison

The table below provides a comparison of the technological characteristics of the Capture™ LP Revascularization Device and the Solitaire™ FR Revascularization Device.

Characteristic	Solitaire™ FR	Capture™ LP	Rationale for Difference (If Present)
Indication for Use	The Solitaire™ FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.	The Capture™ LP Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.	N/A
Characteristic	Solitaire™ FR	Capture™ LP	Rationale for Difference (If Present)
Sizes Offered	4x15mm4x20mm6x20mm6x30mm	3x20mm3x30mm4x20mm4x30mm	The Capture™ LP device is designed to be delivered through a smaller ID (0.432 mm/0.017" inner diameter) micro catheter.
Device Design	Laser-cut stent attached to a nitinol push-wire	Laser-cut stent attached to a nitinol push-wire	N/A
Distal End Design	"Overlapping" design	Tubular design	The results of bench testing and animal testing establish the equivalency of the Capture™ LP device and the Solitaire™ FR device.
Materials
Stent	Nitinol	Nitinol	N/A
Distal Marker	90% Platinum/ 10% Iridium	92% Platinum/ 8% Tungsten	The material used for the Capture™ LP device was shown to be biocompatible per ISO 10993 testing. In addition, the Radiopacity of the material was shown to be equivalent to that of the Solitaire™ FR device through design verification testing.
Proximal Marker	90% Platinum/ 10% Iridium	90% Platinum/ 10% Iridium	N/A
Tip Attachment	Mechanical/Dymax adhesive	Laser welded	The tensile strength of the attachment zone was shown to be equivalent to Solitaire™ FR through design verification testing.
Marker Attachment	Laser weld	Solder (Gold/Tin)	The material used for the Capture™ LP device was shown to be biocompatible per ISO 10993 testing. In addition, the tensile strength of the marker attachment was shown to be equivalent to that of the Solitaire™ FR device through design verification testing.
Pusher Wire	Nitinol	Nitinol	N/A
Introduction Sheath	PTFE	HDPE	The material used for the Capture™ LP device was shown to be biocompatible per ISO 10993 testing.

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Sterilization and Shelf Life

The packaged Capture™ LP Revascularization device will be sterilized using a validated gamma irradiation sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10 ° in accordance with ISO 11137-1/-2, Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose - Method VDmax25.

Aging studies for the Capture™ LP Revascularization Device have established the product and packaging remain functional and maintain sterility for up to 2 years. Aging studies for packaging integrity (per ASTM F2096-11), seal strength and device functionality were performed and met all acceptance criteria.

Biocompatibility

Biocompatibility testing for the Capture™ LP Revascularization Device was conducted to conform with FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The table below summarizes the biocompatibility testing performed on the Capture™ LP device.

Test	Result	Conclusion
Cytotoxicity - L929MEM Elution	The test article scored a "0" (no cytotoxicreaction) at 24, 48, and 72±4 hours	Non -cytotoxic
Klingman MaximizationTest	No animal challenged with the test articleextracts were observed with a sensitizationresponse greater than "0."	Non-sensitizer
Intracutaneous InjectionTest	The differences between the mean test andcontrol scores of the extract dermalobservations were less than 1.0	Non-irritant
Acute Systemic InjectionTest – ISO	None of the animals injected with the testarticle extract show a significantly greaterbiological reaction than animals treated withthe control extract vehicle.	Not systemically toxic
Rabbit Pyrogen Test	The difference between the individualrabbit's maximum temperature andbaseline temperature was ≤0.5°C.	Non-pyrogenic
Complement ActivationC3a and SC5b-9	Test article and control devices exhibitedsimilar activation respective of thenormalized C3a and SC5b concentrationproduced by CVF	Levels of the complimentsC3a and SC5b complementswere similar for Capture LPand control device
Hemolysis: DirectContact/Extract	The blood had a plasma free hemoglobinlevel of 0.9455 mg/ml.	Non-hemolytic
In VitroHemocompatibility/Platelet and Leukocyte	The mean of the three readings for thereference material, negative control,comparison and test articles were within	No adverse effect on plateletand leukocyte counts

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Test	Result	Conclusion
Count	±25% of the respective average values	±25% of the respective average values
Partial ThromboplastinTime	The mean clotting time values for the testarticle were 90% of the negative control.	No adverse effect onprothrombin coagulationtime of human plasma.
Thrombosis (In Vivo) –2 dog	Implantation of the test and controldevices in the jugular veins resulted in noadverse effects or clinical signs	The Capture LP device andcontrol device have similarthromboresistancecharacteristics
Reverse Mutation Assay(Ames)	None of the tester strains shoes an increasein reversion rates when treated with thetest article	Non-mutagenic
In Vitro MouseLymphoma Assay withExtended Treatment	The mutant frequencies and cloningefficiencies of preparations treated withthe test article were within the limitsdefined for a negative response.	Non-mutagenic
In Vivo MouseMicronucleus Assay	There were no biologically significantincreases in mPCE production in the testarticle treated groups.	Non-mutagenic

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Performance Data – Bench

A summary of the pre-clinical bench testing performed for the Capture™ LP Revascularization device is presented in the table below.

Test	Method	Conclusions
Total Length	The total length of the devicewas measured from distal tip toproximal wire	All devices met acceptancecriteria.
Delivery and Re-sheathing ForceTesting	Delivery and re-sheathing forcewere tested during simulated usein a representative tortuousanatomical model	Delivery and re-sheathing forcetesting met acceptance criteria.Delivery and re-sheathing forcesame as predicate.
Durability Testing	Device was evaluated fordelivery and withdrawal beyondthe recommended number ofpasses and re-sheathingsrecommended in the IFU.	Devices demonstrated no damageafter delivery and withdrawal.Durability same as predicate.
Differential ScanningCalorimetry (DSC) Testing	Af Temperature measured usingDSC testing per ASTM F2004-05	The transformational temperatureis lowered as the size of thedevice increases.
Kink Resistance Testing	Device was delivered through abend in a fixture of known radiusand then inspected in-place forany kinks or poor wallapposition.	Device was resistant to kinkingaround small radii turns. Kinkradii smaller than predicate dueto smaller device size.
System Tensile Testing	Fully assembled devices weretested to failure and peak tensilestrength recorded.	System tensile testing metacceptance criteria. Systemtensile strength same aspredicate.
Markercoil Tensile StrengthTesting	Device was tested to determinethe tensile strength of the bondsof the distal radiopaque markers	The tensile strength of the distalradiopaque markers metacceptance criteria. Themarkercoil tensile strength sameas predicate.
Torque Strength Testing	Device was torqued in arepresentative tortuous model todetermine number of rotations toseparate device	Torque strength testing metacceptance criteria. Torquestrength same as predicate.
Test	Method	Conclusions
Radial Force Testing	Radial force testing performed ondevice within recommendedvessel diameters specified inIFU.	Radial force testing of theCapture™ LP device iscomparable to the predicatedevice for the recommendedvessel diameters specified inIFU.
Radiopacity	Angiography of device taken inporcine model.	Radiopacity of Capture™ LPdevice equivalent to that of thepredicate device.
Performance Test (Clot RetrievalBench Test)	Device was delivered through atortuous anatomical model toevaluate the effectiveness of thedevice to retrieve soft and hardclots of various lengths anddiameters	Capture™ LP device restoreddistal blood flow 100% of thetime. Performance testing betterthan predicate device.
Physician Usability Testing	The device was delivered in atortuous benchtop model to assessthe users' ability reliably deploy anduse the neurothrombectomy device.	Capture™ LP rated similar to thepredicate device when usedwith the Rebar-14 microcatheter.

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Performance Data - Animal

An acute animal study was performed that assessed usability, effectiveness, and safety of the Capture™ LP device as compared to the predicate device. A total of six swine were evaluated for usability effectiveness and safety. Effectiveness was measured by placing manufactured clot in the animal pharyngeal artery and assessing the ability of the device to retrieve the clot and restore blood flow to the target vessel. Safety was assessed by passing the device multiple times through the chose vessel and conducting an angiographic and histopathological evaluation. A summary of the study results is presented in the table below.

Test	Result	Conclusion
Successful Clot Retrieval	The device was deployed to retrievemanufactured clot in the pharyngealartery of porcine model.	The Capture™ LP device was ableto retrieve the manufactured clot inall test animals. Clot recovery is thesame as the predicate device.
Sustained Flow (TIMI 2 or 3) InClot Vessel	After clot retrieval, blood flow to thetarget vessel and distal vasculaturewas assessed.	Blood flow was assessed with aTIMI score of 2 or 3 for all vesselswhere the Capture™ LP device wasused to retrieve clot. Blood flowrestoration the same as that for thepredicate device.

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Average Number of Passes for Clot	The number of passes to	The number of passes for the
Retrieval	successfully retrieve clot was	Capture™ LP to successfully
	evaluated.	retrieve clot from the target vessels
		is equivalent to that of the predicate
		device.

The histological findings observed for both the Capture™ LP and the predicate devices demonstrated that the artery response to neurothrombectomy was comparable between the two devices.

30-day and 90-day chronic animal studies were performed to evaluate the usability and safety of the Capture™ LP device. In each study, the device was deployed and recovered in the vasculature of the swine test subjects and angiographic and histopathologic assessments were performed for vessel damage, thrombus formation, and vasospasm. Angiographic visualization during the procedure and just prior to subject sacrifice demonstrated that there was no wall damage or thrombus formation during the treatment. Histopathologic evaluation demonstrated that the artery response to the neurothrombectomy procedure was considered to be comparable between the Capture™ LP device and the predicate device.

Performance Testing - Clinical

Substantial equivalence of the Capture™ LP Revascularization Device has been established to the predicate device through the results of bench and animal testing. Equivalence has also been established through an evaluation of the indications for use, performance specifications, packaging, and the fundamental scientific technology. Therefore, clinical data is not required for the Capture™ LP device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).