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 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.
The following modifications have been made to the device in support of this application:
• The attachment zone has been redesigned for greater tensile strength.
• The marker band has been redesigned to aid the crimping process.
• The pushwire now contains a fluorosafe marker.
• The Solitaire™ 2 Device uses one piece of PTFE tubing.

AI/ML Overview

This K123378 submission for the Solitaire™ 2 Revascularization Device is a medical device submission for a thrombus retriever, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Solitaire™ FR Revascularization Device) based on modifications to the device design and subsequent non-clinical bench testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical bench testing submission for a medical device modification, the "acceptance criteria" are implied by successful completion of the specified tests, demonstrating that the device modifications do not adversely affect its performance compared to the predicate. No specific numerical thresholds (e.g., sensitivity, specificity) for performance are provided as would be expected for an AI/ML diagnostic or prognostic tool.

Acceptance Criteria (Implied by Successful Testing)	Reported Device Performance (Summary)
Delivery Force within acceptable limits	Test performed to support changes
Withdrawal Force within acceptable limits	Test performed to support changes
Total System Length within specifications	Test performed to support changes
Fluoro Safe Marker Length within specifications	Test performed to support changes
Distal Tip to Fluoro Marker Length within specs	Test performed to support changes
Durability maintained	Test performed to support changes
Radiopacity maintained	Test performed to support changes
Torque Response maintained	Test performed to support changes
Torque Strength maintained	Test performed to support changes
System Tensile Strength maintained	Test performed to support changes
Performance after 1-Year Accelerated Aging Study	Delivery Force, Withdrawal Force, Durability, Torque Response, Torque Strength, System Tensile Strength maintained

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

Test set sample size: Not applicable. These were non-clinical bench tests on the device itself, not clinical data sets. The "sample" would refer to the number of devices or components tested for each parameter. This information is not detailed in the summary provided.
Data provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).

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

Not applicable. Ground truth in this context typically refers to clinical diagnosis or outcome. For bench testing, the "ground truth" is defined by the engineering specifications and established test methods for device performance parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a clinical study involving reader adjudication.

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:

Not applicable. This is not an AI/ML device. No MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this device, the "ground truth" for non-clinical testing is defined by the engineering specifications and performance standards for medical devices of this type, which are assessed through a series of defined bench tests. There is no biological or clinical "ground truth" in the AI/ML sense in this submission.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

In summary, the K123378 submission demonstrates substantial equivalence for the Solitaire™ 2 Revascularization Device primarily through extensive non-clinical bench testing, focusing on the mechanical and physical performance characteristics of the modified device components. It does not involve any AI/ML components or clinical data analyses as would be relevant for the questions posed.

Summary

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K123378

29 October 2012

NOV 3 0 2012

Solitaire™ 2 Revascularization Device

3. 510(k) Summary

ﺗ ,

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Larry BoucherSr. Regulatory Affairs SpecialistTelephone: (949) 297-9781E-mail: larry.boucher@covidien.com
Date SummaryPrepared:	27 November 2012
Trade Name ofDevice:	Solitaire™ 2 Revascularization Device
Common Name ofDevice:	Catheter, Thrombus Retriever
Classification ofDevice:	21 CFR 870.1250 - Class II
Predicate Device:	Solitaire™ FR Revascularization Device (K113455)
Device Description:	The Solitaire™ 2 device is designed to restore blood flow in subjectsexperiencing ischemic stroke due to large intracranial vessel occlusionwithin 8 hours of symptom onset. It is indicated for subjects who areineligible for intravenous tissue plasminogen activator (IV t-PA) orwho fail IV t-PA therapy. The distal nitinol portion of the devicefacilitates clot retrieval and has Pt-Ir radiopaque markers on theproximal and distal ends.The following modifications have been made to the device in support ofthis application:• The attachment zone has been redesigned for greater tensilestrength.• The marker band has been redesigned to aid the crimpingprocess.• The pushwire now contains a fluorosafe marker.• The Solitaire™ 2 Device uses one piece of PTFE tubing.
Intended Use:	The Solitaire™ 2 Revascularization Device is intended to restore bloodflow by removing thrombus from a large intracranial vessel in patientsexperiencing 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.

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29 October 2012

Performance Data:

The following tests were performed to support the changes to the Solitaire™ 2 Revascularization Device:

Non-Clinical

Bench Testing:

. Delivery Force
Withdrawal Force .
Total System Length .
Fluoro Safe Marker Length ●
. Distal Tip to Fluoro Marker Length
Durability .
. Radiopacity
Torque Response
Torque Strength .
. System Tensile

1-Year Accelerated Aging Study

Delivery Force .
◆ Withdrawal Force
Durability .
. Torque Response
Torque Strength ●
System Tensile Strength .

The following tests were not performed as they are not related to the changes being made to the Solitaire™ 2 Revascularization Device:

Bench Testing:

. Kink Resistance
Marker Coil Tensile Strength .
. Radial Force

In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.

Conclusion:

The Solitaire™ 2 device is substantially equivalent to the Solitaire™ FR Revascularization Device based on the successful completion of non-clinical testing as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 30, 2012

Micro Therapeutics DBA ev3 Neurovascular c/o Mr. Larry Boucher Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618

Re: K123378

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: October 29, 2012 Received: November 1, 2012

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.

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Page 2 - Mr. Larry Boucher in

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 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.

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/CDRH/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Quynh T. Hoang for: .

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: K123378

Device Name: Solitaire™ 2 Revascularization Device

Indications For Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quynh T. Hoang

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123378

Page 1 of 1

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).