The Solitaire™ 2 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 (IVt-PA) or fail IVt-PA therapy are candidates for treatment.

Device Description

The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom 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 Pt-Ir radiopaque markers on the proximal and distal ends.

This purpose of this application is to add one (1) new model number (SFR2-4-40) to the Solitaire™ 2 Revascularization Device family. The additional model will be identical to the currently cleared Solitaire™ 2 4x20 (SFR2-4-20) model, with the exception of a longer retriever length.

AI/ML Overview

The provided document is a 510(k) summary for the Solitaire™ 2 Revascularization Device, specifically for the addition of a new 4x40mm model (SFR2-4-40). The application aims to demonstrate substantial equivalence to previously cleared Solitaire™ devices. As such, it relies on bench and animal testing rather than a new clinical study. The concept of "acceptance criteria" and "device performance" in the context of this document refers to the results of these non-clinical tests meeting specific thresholds, often in comparison to the predicate device.

Here's the breakdown of the information requested:

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

For this device, "acceptance criteria" are implied by the conclusions that "All devices met acceptance criteria" and that performance was "same as the predicate device" or that findings were "comparable." Specific numerical acceptance criteria are not explicitly detailed in this summary, but the successful conclusions for each test imply they were met.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Total System Length	Met specified dimensions	All devices met acceptance criteria.
Distal Tip to Fluoro Safe Marker Length	Met specified dimensions	All devices met acceptance criteria.
Delivery Force	Comparable to predicate device; within acceptable thresholds	All devices met acceptance criteria. Delivery force same as the predicate device.
Retrieval Force	Comparable to predicate device; within acceptable thresholds	All devices met acceptance criteria. Retrieval force same as the predicate device.
Radial Force	Within acceptable range (measured 100% in-process)	Radial force was measured 100% in-process on DVT builds.
Durability	No irregularities, breaks, kinks, marker coil migration, glue separations, or other defects after extended use	All devices showed no irregularities, breaks, kinks, marker coil migration, glue separations, or other observed defects after all attempts. Durability same as the predicate device.
Performance (Clot Retrieval)	Successful retrieval of soft and firm clots from specified vessels	All devices successfully retrieved the soft and firm clots from the respective vessels. Performance is the same as the predicate device.
Biocompatibility	No new materials, comparable to predicate	Biocompatibility data for the Solitaire™ FR device adopted; no new materials introduced.
Sterilization & Shelf Life	Identical to predicate device validation	Adopted from the predicate device; identical materials, design, manufacturing, and packaging.
Tissue Damage (Animal Study)	Minimal or comparable tissue damage to predicate	No histological remarkable difference in the vessel in regards to tissue injury.
Hemorrhage (Animal Study)	Minimal or comparable hemorrhage to predicate	No histological remarkable difference in the vessel in regards to hemorrhagic evaluation.
Thrombogenicity (Animal Study)	Minimal or comparable thrombogenicity to predicate	No histological remarkable difference in the vessel in regards to thrombogenic evaluation.
Usability (Animal Study)	Equivalent to predicate device in delivery, positioning, deployment, repositioning, retrieval, and condition	Safe, usable, and equivalent to the predicate device based on interventionalist assessment.

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

Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., number of devices tested for delivery force). It generally states "Samples were measured" or "Samples were evaluated."
Animal Study Test Set:
- Sample Size: 12 swine. (6 for acute study, 6 for chronic 30-day study).
- Provenance: Not explicitly stated (e.g., country of origin for the animals), but it's an animal study conducted by the manufacturer/sponsor (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular) to support the device. It is a prospective study in the sense it was designed and executed for this submission.

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

Bench Testing: Not applicable. Bench tests rely on direct measurement and established engineering principles, not expert interpretation of data as ground truth for a test set in the same way clinical data would.
Animal Study: "Usability for the acute and chronic study were assessed by an interventionalist." The number of interventionalists is not specified, nor are their specific qualifications provided beyond the title "interventionalist."

4. Adjudication method for the test set

Bench Testing: Not applicable. These are objective measurements against internal specifications or predicate device performance.
Animal Study: No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the animal study. The "interventionalist" assessed usability, and histological findings were compared.

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

No MRMC study was done. This submission is for a medical device (thrombus retriever) that directly treats a condition, not an AI/imaging diagnostic tool that assists human readers.

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

Not applicable. This device is a physical medical device (thrombus retriever), not an algorithm or AI system. Its performance is evaluated through its mechanical capabilities and biological interaction, not as a standalone algorithm.

7. The type of ground truth used

Bench Testing: The "ground truth" for bench tests is the objective, physical measurement of device characteristics against pre-defined engineering specifications or direct comparison to the predicate device's measured performance.
Animal Study: The "ground truth" was established through:
- Angiographic images: Visual assessment of vessel status.
- Histopathological evaluation: Microscopic examination of tissue for damage, hemorrhage, and thrombi.
- Interventionalist assessment: Subjective (but expert-driven) assessment of usability attributes (delivery, positioning, deployment, etc.).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's evaluation, as it is not an AI/machine learning device. The 510(k) process for this type of device relies on demonstrating equivalence through non-clinical (bench and animal) testing to a predicate device, not through training a model on data.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant to this device submission.

Summary

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

October 22, 2014

Micro Therapeutics, Inc. d/b/a Ev3 Neurovascular Mr. Larry Boucher Sr. Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618

Re: K141491 Trade/Device Name: Solitaire 2 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: August 20, 2014 Received: August 21, 2014

Dear Mr. Larry 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 -SFD/A

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) K141491

Device Name Solitaire 2 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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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:	20 August 2014
Trade Name ofDevice:	Solitaire™ 2 Revascularization Device, 4x40mm
Common Name ofDevice:	Catheter, Thrombus Retriever
Classification ofDevice:	21 CFR 870.1250 – Class II
Predicate Device:	Solitaire™ 2 Revascularization Device, 510(k)#: K123378Solitaire™ FR Revascularization Device (Biocompatibility)510(k)#: K113455
Performance Data:	The following bench testing was performed in support of theSolitaire™ 2 4x40 device and to establish substantial equivalence to theSolitaire™ 2 Revascularization Device:Dimensional Testing Delivery Force Testing Retrieval Force Testing Durability Testing Performance (Clot Retrieval) Testing Radial Force (in-process) The following test data was adopted from the predicate device:Af Temperature Testing Kink Resistance Testing System Tensile Testing

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. Distal Marker Testing
Torque Response Testing
Radiopacity Testing

Biocompatibility, sterilization, and aging data were also adopted from the predicate device as there is no change to the materials of construction, design, manufacturing process, or packaging for the addition of this additional model.

Animal studies were performed to assess the safety and usability of the Solitaire™ 2 4x40 device compared to the previously cleared Solitaire™ 2 4x20 device. No clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.

Conclusion: The Solitaire™ 2 4x40 device is substantially equivalent to the currently cleared Solitaire™ 2 device based on the successful completion of non-clinical bench and animal testing as well as similar principles of design, operation and indications for use.

Device Description:

Indications for Use:

The Solitaire™ 2 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 Solitaire™ 2 4x40 model and the currently cleared Solitaire™ 2 Revascularization Device.

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	Solitaire™ 2(K123378)	Solitaire™ FR(K113455)	Solitaire™ 2 4x40	Rationale forDifference (ifapplicable)
Indication forUse	The Solitaire™ 2RevascularizationDevice is intended torestore blood flow byremoving thrombusfrom a largeintracranial vessel inpatients experiencingischemic strokewithin 8 hours ofsymptom onset.Patients who areineligible forintravenous tissueplasminogenactivator (IV t-PA) orwho fail IV t-PAtherapy arecandidates fortreatment.	Same	Same	N/A
Method ofSupply	Stored withindispenser coil, Tyvekpouch, & shippingcarton	Same	Same	N/A
SterilizationMethod	Ethylene Oxide	Same	Same	N/A
Device Sizes	4x15mm4x20mm6x20mm6x30mm	Same	4x40mm	The difference in sizeis due to the extraworking length of thedevice. Bench andanimal testing havedemonstrated that theextra working lengthdoes not affect thesafety andeffectiveness of thedevice.
Materials
Stent	Nitinol	Same	Same	N/A
Push-wire	Nitinol	Same	Same	N/A
Markers	90% Platinum/ 10%Iridium	Same	Same	N/A
Push-wire ShrinkTubing	PTFE	Same	Same	N/A
Introducer Sheath	PTFE/Grilamid	Same	Same	N/A

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Sterilization and Shelf Life

The currently cleared Solitaire™ 2 Revascularization Device into the EO sterilization cycle originally cleared under K1113455 for the Solitaire™ FR Revascularization Device. The materials of construction, design, manufacturing process, and packaging are identical to the predicate device. Therefore no additional validation testing is required.

Residual testing for the Solitaire™ 2 4x40mm device was adopted from the Solitaire™ 2 Revascularization Device as the materials of constructions and the manufacturing process are identical to the currently cleared Solitaire™ 2 device. In addition, the surface area of the Solitaire™ 2 4x40mm device is 5.2% less than the currently cleared Solitaire™ 2 6x30mm device.

Aging studies for the Solitaire™ 2 Revascularization Device have established the product and packaging remain functional and maintain sterility for 2 years. Aging studies for packaging integrity (per ASTM F2096-11), seal strength and device functionality were performed and met all acceptance criteria. The materials of construction, design, manufacturing process, and packaging of the Solitaire™ 2 4x40mm device are identical to the predicate device. Therefore the existing aging and packaging data has been adopted for the new model number.

Biocompatibility

Biocompatibility data for the Solitaire device family was tested for the Solitaire™ FR Revascularization device. The biocompatibility data for the Solitaire™ FR device has been adopted for the Solitaire™ 2 4x40mm device as no new materials have been introduced into the manufacturing process or the finished device.

Performance Data – Bench

A summary of the non-clinical bench testing performed for the Solitaire™ 2 4x40mm model is presented in the table below.

Test	Method	Conclusion
Total System Length	Samples were measured fromthe proximal tip of the push-wire to the distal-most tip ofthe finger marker coils.	All devices met acceptancecriteria.
Distal Tip to Fluoro SafeMarker Length	Samples were measured fromthe distal tip of the device tothe distal side of the proximalfluoro safe marker.	All devices met acceptancecriteria.

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Test	Method	Conclusion
Delivery Force	Peak delivery force wasmeasured through arepresentative tortuousanatomical model.	All devices met acceptancecriteria. Delivery force sameas the predicate device.
Retrieval Force	Retrieval force was measuredthrough a representativetortuous anatomical model.	All devices met acceptancecriteria. Retrieval force sameas the predicate device.
Radial Force	The radial force was measured100% in-process.	Radial force was measured100% in-process on DVTbuilds.
Durability	Samples were evaluated ontheir ability to withstanddelivery and withdrawal forcesin a representative tortuousmodel beyond therecommended number ofpasses and re-sheathingsallowed per the IFU	All devices showed noirregularities, breaks, kinks,marker coil migration, glueseparations, or other observeddefects after all attempts.Durability same as thepredicate device.
Performance	Test samples were evaluatedfor their ability to restoreblood flow and retrieve softclot from a 4mm vessel andhard clot in a 2mm vessel in arepresentative tortuous model.	All devices successfullyretrieved the soft and firmclots from the respectivevessels. Performance is thesame as the predicate device.

Performance Data - Animal

An acute and 30 day animal study was performed that assessed safety and usability of the Solitaire™ 2 4x40 device as compared to the Solitaire 2 4x20 predicate device. A total of twelve swine were evaluated with a total of 3 passes and 6 resheathings across selected sections of vessels, with six (6) swine used for the acute study and six (6) swine used for the chronic 30 day study. A total of 4 vessels per animal were treated with two (2) vessels receiving the control device and two (2) vessels treated with the test device. Safety was evaluated for tissue damage, hemorrhage, and thrombi using angiographic images and histopathological evaluation.

Histological findings of the Solitaire™ 2 4x40 and the predicate device for the acute and chronic study demonstrated that the vessel response to neurothrombectomy was comparable between the two devices with no histological remarkable difference in the vessel in regards to tissue injury, hemorrhagic evaluation and thrombogenic evaluation.

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Usability for the acute and chronic study were assessed by an interventionalist on the following attributes after each pass: delivery through catheter, ability to position stent retriever at intended target zone, ability to deploy retriever, ability to re-sheath and reposition, ability to retrieve the device through a guide catheter and device condition. The safety and usability results from the acute and 30-day animal studies suggest that the Solitaire™ 2 4x40 device is safe, usable and is equivalent to the predicate device.

Performance Testing - Clinical

No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model number. Substantial equivalence of the Solitaire™ 2 4x40 device has been established to the predicate device through the results of bench and animal testing.

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).