The Solitaire™ Platinum 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™ Platinum device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the working cell length, proximal and distal ends. The Solitaire™ Platinum device is a modification to the currently cleared Solitaire™ 2 Revascularization Device to increase the working length radiopacity.

AI/ML Overview

The provided text is a 510(k) summary for the Solitaire™ Platinum Revascularization Device. It describes the device, its indications for use, and how it was deemed substantially equivalent to predicate devices. However, this document does not contain information about an AI/ML-based device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria.

The information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is specific to the development and validation of AI/ML medical devices. The Solitaire™ Platinum Revascularization Device is a physical medical device (a thrombectomy device), and its evaluation primarily involved bench testing, animal usability testing, and comparison to predicate physical devices.

Therefore, I cannot fulfill your request to create:

A table of acceptance criteria and reported device performance for an AI/ML device, as this document does not describe AI/ML device performance. The listed "performance data" refers to mechanical properties and visibility of a physical device.
Sample sizes used for the test set and data provenance related to an AI/ML model, because no AI/ML model is discussed.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
MRMC comparative effectiveness study results or effect size for human readers with/without AI assistance.
Standalone (algorithm only) performance data.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
Sample size for the training set for an AI/ML model.
How ground truth for the training set was established for an AI/ML model.

The document explicitly states: "No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device." and "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." This further confirms the absence of typical AI/ML validation studies such as those involving human readers or large datasets for model training and testing.

In summary, the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, as it pertains to a physical medical device.

Summary

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

December 23, 2015

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Phuong Chau Senior Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618

Re: K153071

Trade/Device Name: Solitaire™ Platinum Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 23, 2015 Received: November 25, 2015

Dear Ms. Phuong Chau:

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,

William J. Heetderks -S

for 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) K153071

Device Name

Solitaire™ Platinum 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 K153071

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Phuong ChauSenior Regulatory Affairs Product SpecialistTelephone: (949) 297-5487E-mail: phuong.chau@medtronic.com
Date Summary Prepared:	December 14, 2015
Trade Name of Device:	Solitaire™ Platinum Revascularization Device
Common Name of Device:	Catheter, Thrombus Retriever
Classification of Device:	21 CFR 870.1250 – Class II
Product Code	NRY
Predicate Device:	Solitaire™ 2 Revascularization Device510(k)#: K123378 and K141491
	Solitaire™ FR Revascularization Device (Biocompatibility)510(k)#: K113455
Performance Data:	The following bench testing was performed in support of theSolitaire™ Platinum device:Delivery Force Testing Re-sheathing Force Testing Multiple Re-sheathing Durability Body Finger Marker Tensile Body Markers Radiopacity Radial Force (in-process) The following test data was adopted from the predicate device: Total System Length Kink Resistance Total System Tensile

Distal Marker Coil Tensile •

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Clot Retrieval Bench and Device Recovery Durability
Torque Response
Torque Strength
Radiopacity (Distal Markers)
Fluorosafe Marker Location .

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.

An animal study to assess usability was performed. No animal testing for safety and efficacy or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.

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

Device Description:

Indication for Use:

Device Comparison

The table below provides a comparison of the technological characteristics of the Solitaire™ Platinum device and the currently cleared Solitaire™ 2 Revascularization Device.

	Solitaire FR(K113455)	Solitaire™ 2(K123378 &K141491)	Solitaire™Platinum	Rationale forDifference(if present)
Indication forUse	The Solitaire™ FRRevascularization	The Solitaire™ 2Revascularization	Same	N/A
Solitaire FR(K113455)	Solitaire™ 2(K123378 &K141491)	Solitaire™Platinum	Rationale forDifference(if present)
Device 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.	Device is intendedto restore blood flowby removingthrombus from alarge intracranialvessel in patientsexperiencingischemic strokewithin 8 hours ofsymptom onset.Patients who areineligible forintravenous tissueplasminogenactivator (IV t-PA)or who fail IV t-PAtherapy arecandidates fortreatment.	Device is intended torestore blood flow byremoving thrombusfrom a large intracranialvessel in patients experiencingischemic stroke within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) orwho fail IV t-PA therapy arecandidates for treatment.
Stored withindispenser coil, Tyvekpouch, & shippingcarton	Stored withindispenser coil,Tyvek pouch, &shipping carton	Same	N/A
Ethylene Oxide	Ethylene Oxide	Same	N/A
4x15mm4x20mm6x20mm6x30mm	4x15mm4x20mm4x40mm6x20mm6x30mm	4x20mm4x40mm6x20mm	The three sizesare within therange of sizescleared forSolitaire 2 andSolitaire FR.
Materials
Stent	Nitinol	Same	N/A
Push-wire	Nitinol	Same	N/A
Distal MarkerCoils	90% Platinum/ 10%Iridium	Same	N/A
Body MarkerFingers & Coils	N/A	90% Platinum/10% Iridium Samematerial as DistalMarker Coils aspredicate.	Markers areadded to thebody of the stentretriever toincreaseradiopacity.Bench testinghas demonstratedthat this changedoes not raisenew question onthe safety andeffectiveness ofthe device.
	Solitaire FR(K113455)	Solitaire™ 2(K123378 &K141491)	Solitaire™Platinum	Rationale forDifference(if present)
Shrink Tubing
IntroducerSheath	PTFE/Grilamid	PTFE/Grilamid	Same	N/A

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Sterilization and Shelf Life

The packaged Solitaire™ Platinum device will be sterilized using a validated Ethylene Oxide sterilization cycle. The materials of construction, design, manufacturing process, and packaging are identical to the predicate device. Therefore no additional validation testing is required.

Aging studies for the Solitaire™ 2 Revascularization Device have established the product and packaging remain functional and maintain sterility for up to 2 years. Aging studies for packaging integrity, seal strength and device functionality were performed and met all acceptance criteria. The materials of construction, design, manufacturing process, and packaging of the Solitaire™ Platinum device are identical to the predicate device. Therefore the existing aging and packaging data has been adopted for the Solitaire™ Platinum.

Biocompatibility

Biocompatibility data for the Solitaire device family was tested for the Solitaire™ FR Revascularization Device. The biocompatibility data for the Solitaire™ FR was adopted for the Solitaire™ 2 Revascularization Device. The Solitaire™ Platinum does not introduce any new materials into the finished device or the manufacturing process. Therefore the existing biocompatibility testing data has been adopted for the Solitaire™ Platinum.

Performance Data - Bench

A summary of the bench testing performed for the Solitaire™ Platinum is summarized in the table below.

Test	Method	Conclusion
Delivery Force	Peak delivery force wasmeasured through arepresentative tortuousanatomical model.	All devices met acceptancecriteria.
Re-sheathing Force	Retrieval force was measuredthrough a representativetortuous anatomical model.	All devices met acceptancecriteria.

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Test	Method	Conclusion
Multiple Re-sheathingDurability	Samples were evaluated ontheir ability to withstanddelivery and withdrawalforces in a representativetortuous model 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.All devices met acceptancecriteria.
Body Finger Marker Tensile	Markercoil tensile strengthtesting is performed to verifythe strength of the laser weldof the Pt/Ir markercoil to theNitinol distal finger of thedevice.	All devices met acceptancecriteria.
Radial Force	The radial force was measured100% in-process.	Radial force was measured100% in-process on testbuilds. All devices metacceptance criteria.
Body Markers Radiopacity	Verification analysis of bodymarkers.	All devices met acceptancecriteria.

Performance Data - Animal

Animal usability testing was performed and assessed by an interventional neurologist on the following attributes after each pass: delivery of the device through the microcatheter, the ability to deploy the retriever, the ability to resheath and redeploy the retriever, the ability to retrieve the device through the guide catheter, the device condition, and the fluoroscopic visibility of the radiopaque body markers.

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.

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).