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 subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are 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.

AI/ML Overview

The provided text describes the Solitaire™ Platinum Revascularization Device and its performance data to establish substantial equivalence with a predicate device. The information primarily focuses on bench testing and biocompatibility rather than clinical studies involving human or animal subjects for the new devices (4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The table below combines information from multiple sections of the document to present the acceptance criteria and the conclusion for each test. The "Reported Device Performance" column reflects the conclusion stated in the document, which consistently indicates that the device met the acceptance criteria and is substantially equivalent to the predicate.

Test Category / Description	Method	Acceptance Criteria	Reported Device Performance
Biocompatibility
Cytotoxicity	ISO 10993-5	Viability is ≥70%.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-5 and are substantially equivalent to the predicate device.
Sensitization	ISO 10993-10	Test article does not elicit a sensitization response.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device.
Irritation	ISO 10993-10	Differences in the mean test and control scores of the extract dermal observations are < 1.0.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device.
Acute Systemic Toxicity	ISO 10993-11	No abnormal clinical signs and weight loss in excess of 10%. Temperature rise ≥0.5°C	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-11 and are substantially equivalent to the predicate device.
Hemolysis	ISO 10993-4	No significant differences between the test article extract and negative control article results. The test article is considered non-hemolytic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Partial Thromboplastin Time	ISO 10993-4	Clotting times are similar to the negative control and the reference material (HDPE) indicating the device materials are not an activator of the intrinsic coagulation pathway.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Platelet and Leukocyte Count	ISO 10993-4	Test article does not adversely affect the platelet and leukocyte components of the blood compared to the reference material.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Complement Activation C3a and SC5b-9 Assay	ISO 10993-4	Levels of C3a and SC5b-9 are comparable and less than the positive control.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Thrombosis	ISO 10993-4	Thrombo-resistance properties are acceptable in clinical use.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
Bacterial Mutagenicity Test	ISO 10993-3	Test article is considered non-mutagenic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
In-vitro Mouse Lymphoma Assay	ISO 10993-3	Test article is considered non-mutagenic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
In-vivo Mouse Micronucleus Assay	ISO 10993-3	Test article is considered non-mutagenic.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
Bench Testing
Delivery Force	Measurement through representative tortuous anatomical model.	Stent must be below delivery force specification.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for delivery force and are substantially equivalent to the predicate device.
Re-sheathing Force	Measurement through representative tortuous anatomical model.	Stent must be below re-sheathing force specification.	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for re-sheathing force and are substantially equivalent to the predicate device.
Multiple Re-sheathing Durability	Evaluation in a representative tortuous model beyond recommended passes/re-sheathings.	The subject 4-20-05 and 6-24-06 devices must reliably deploy and resheath up to four (4) times.	The subject 4-20-05 and 6-24-06 devices showed no irregularities, breaks, kinks, body marker migration, glue separations, or other observed defects after all deployment and re-sheathing attempts. The devices met the acceptance criteria and are substantially equivalent to the predicate device.
Body Marker Tensile	Testing of laser weld strength of Platinum/Iridium markercoil to Nitinol distal finger.	Body marker should be greater than or equal to existing tensile strength specification.	The subject 4-20-05 and 6-24-06 devices met acceptance criteria for body marker tensile and are substantially equivalent to the predicate device.
Body Marker Radiopacity	Verification analysis of body markers.	The radiopaque body markers must be visible using standard catheter laboratory equipment.	The subject 4-20-05 and 6-24-06 devices met acceptance criteria for body marker radiopacity and are substantially equivalent to the predicate device.
Proximal Marker to Distal Marker	100% in-process measurement of laser cut and electro-polished stent length.	Length of stent must meet all inspection criteria.	The subject 4-20-05 and 6-24-06 devices met acceptance criteria for proximal marker to distal marker and are substantially equivalent to the predicate device.
Af Temperature	100% in-process tracking of heat set parameters.	Temperature should be less than or equal to existing Af temperature specification.	The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices met acceptance criteria for Af and are substantially equivalent to the predicate device.
Radial Force	100% in-process measurement.	Stent must be within existing radial force specification.	Radial force was measured 100% in-process. The subject 4-20-05 and 6-24-06 devices met acceptance criteria for radial force and are substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not explicitly state numerical sample sizes for most of the bench tests (e.g., how many devices were tested for delivery force). For "Multiple Re-sheathing Durability," it implies that devices were tested for "up to four (4) times" deployment and re-sheathing, but not the number of physical devices sampled. For "Proximal Marker to Distal Marker" and "Radial Force," it states "100% in-process" measurement, which implies all manufactured units were tested. For biocompatibility tests, details on sample sizes are not provided within this summary sheet.
Data Provenance: The data is from "bench testing" and "biocompatibility" studies, primarily conducted in a laboratory setting. There is no information regarding the country of origin of the data. The data is prospective as it was generated specifically for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The tests described are primarily physical/mechanical bench tests and in-vitro/in-vivo (animal for biocompatibility) biocompatibility tests. "Ground truth" in the context of expert consensus (like for medical image interpretation) is not relevant for these types of engineering and biological safety evaluations. The acceptance criteria are based on established standards (ISO) and internal specifications.

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

This is not applicable. The tests are directly measured against predefined numerical or qualitative acceptance criteria. There is no expert adjudication process for the results of these bench or biocompatibility tests mentioned.

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

An MRMC comparative effectiveness study was not done. This document pertains to the regulatory submission for a physical medical device (revascularization device) and focuses on engineering performance and biocompatibility, not on AI-assisted diagnostic or interpretative tasks typically assessed by MRMC studies.

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

A standalone performance study of an algorithm was not done. This device is a physical medical device, not a software algorithm.

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

The "ground truth" for the bench tests are the established engineering specifications and physical properties of the device, as measured by standard laboratory methods. For biocompatibility, the ground truth is based on biological safety standards (e.g., ISO 10993 series) which define acceptable biological responses. There is no "expert consensus," "pathology," or "outcomes data" specifically mentioned as ground truth for these specific validation tests of the new devices, as the focus is on physical and material properties, and the new devices are considered substantially equivalent to a predicate.

8. The sample size for the training set

This is not applicable. The document describes the performance testing of a physical medical device (Solitaire™ Platinum Revascularization Device), not a machine learning or AI algorithm that requires a "training set."

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

This is not applicable, as there is no training set for this type of device submission.

Summary

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Image /page/0/Picture/1 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 image of three human profiles facing to the right, stacked on top of each other.

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

September 21, 2016

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Mr. Ryan Kenney Product Specialist, Regulatory Affairs 9775 Toledo Way Irvine, California 92618

Re: K161879

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: August 19, 2016 Received: August 22, 2016

Dear Mr. Kenney:

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/Resourcesfor You/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.

Michael J.Hoffmann -A

for Carlos L. Peña, Ph.D., M.S. 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) K161879

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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K161879 510(k) Summary

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Ryan KenneyProduct Specialist, Regulatory AffairsTelephone: (949) 297-5489E-mail: ryan.j.kenney@medtronic.com

Date SummaryPrepared:	September 08, 2016
Trade Name ofDevice:	Solitaire™ Platinum Revascularization Device
Common Name ofDevice:	Catheter, Thrombus Retriever
Classification ofDevice:	21 CFR 870.1250 – Class II
Product Code:	NRY
Predicate Device:	Solitaire™ Platinum Revascularization Device510(k)#: K153071
Performance Data:	The following performance testing was performed to support thesubject 4-20-05 and 6-24-06 Solitaire™ Platinum RevascularizationDevices:Delivery Force Testing Re-Sheathing Force Testing Multiple Re-Sheathing Durability Body Marker Tensile Body Marker Radiopacity (in-process) Proximal Marker Band to Distal Marker Band (in-process) Af Temperature (in-process) Radial Force (in-process) The following performance testing was leveraged from the predicatedevice: Total System Length Kink Resistance Distal Finger Marker Coil and Push-wire Tensile Clot Retrieval and Device Recovery Durability Torque Response Torque Strength Radiopacity (Fluoroscopic Visualization Distal Finger Marker Coil) Fluorosafe Marker Location
	Biocompatibility Particulate
	The materials of construction, design, and packaging process for thisportfolio expansion of the subject 4-20-05 and 6-24-06 SolitaireTMPlatinum Revascularization Devices (K161879) are equivalent to thepredicate SolitaireTM Platinum Revascularization Device (K153071).
	In addition, the manufacturing process of the subject 4-20-05 and 6-24-06 SolitaireTM Platinum Revascularization Devices (K161879) isequivalent to the predicate SolitaireTM Platinum RevascularizationDevice (K153071). Therefore; no additional biocompatibility,sterilization, packaging, or shelf life validations are required.
	Non-clinical bench testing confirmed that the portfolio expansion ofthe subject 4-20-05 and 6-24-06 SolitaireTM PlatinumRevascularization Devices do not introduce new risks or increaseexisting risks.
Conclusion:	The subject 4-20-05 and 6-24-06 SolitaireTM PlatinumRevascularization Devices (K161879) are substantially equivalent tothe predicate SolitaireTM Platinum Revascularization Device(K153071) based on non-clinical bench testing, similarities indesign, principles of operation, and indications for use.

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Device Description:

Indications for Use:

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 Comparison:

The following table provides a comparative of the technological characteristics associated with the portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) and the predicate Solitaire™ Platinum Revascularization Device (K153071).

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	Predicate Device	Subject Devices	Rationale for Difference(if applicable)
	Solitaire™ PlatinumRevascularizationDevice(K153071)	4-20-05 and 6-24-06Solitaire™ PlatinumRevascularizationDevices(K161879)
Indication for Use	The Solitaire™ PlatinumRevascularizationDevice 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 as K153071.	N/A.
Method ofSupply	Stored withindispenser coil, Tyvekpouch, and shippingcarton.	Same as K153071.	N/A.
SterilizationMethod	Ethylene Oxide	Same as K153071.	N/A.
Device Size(s)	4-20-104-40-106-20-10	4-20-056-24-06	The subject devices shareidentical technologicalcharacteristics to thepredicate device. Non-clinical bench testing hasdemonstrated that thedevices do not raisequestions about the safetyand effectiveness.
Materials
	Predicate DeviceSolitaire™ PlatinumRevascularizationDevice(K153071)	Subject Devices4-20-05 and 6-24-06Solitaire™ PlatinumRevascularizationDevices(K161879)	Rationale for Difference(if applicable)
Solitaire™Platinum Non-Detachable EP	Nitinol	Same as K153071.	N/A
Push-wire	Nitinol	Same as K153071.	N/A
Proximal Coil	90% Platinum/10% Iridium	Same as K153071.	N/A
Body Marker	N/A	90% Platinum/10% Iridium.	Same material as the BodyFinger Marker Coil.
Body FingerMarker Coil	90% Platinum/10% Iridium	N/A	Not a design feature of thesubject devices.
Distal FingerMarker Coil	90% Platinum/10% Iridium	Same as K153071.	N/A
Push-wireShrink Tubing	PTFE	Same as K153071.	N/A
Dymax Glue	Dymax 1128A-M-T	Same as K153071.	N/A
Guidewire Clip	UV Curing Adhesive	Same as K153071.	N/A
Dispenser Coil	HDPE, ID Coatedwith Hydro-Sil 2000	Same as K153071.	N/A
StentIntroducerSheath	PTFE/Grilamid	Same as K153071.	N/A

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Sterilization and Shelf Life:

The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device. The materials of construction, design, manufacturing process, sterilization load configuration and packaging process for this portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are equivalent to the predicate Solitaire™ Platinum Revascularization Device. The packaging of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices remains functional and maintain sterility for up to two (2) years. Therefore, no additional sterilization or shelf life validation testing is required for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.

Biocompatibility:

The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not introduce any new materials into the finished device or the manufacturing process. The material of construction for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are identical to the predicate Solitaire™ Platinum

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Revascularization Device. Biocompatibility was leveraged from the predicate Solitaire™ Platinum Revascularization Device in support of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. A summary of the biocompatibility testing leveraged for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below.

TestCategory	TestDescription	Method	AcceptanceCriteria	Conclusion
Cytotoxicity	L929 MTTCytotoxicity	ISO 10993-5	Viability is ≥70%.	The subject 4-20-05and 6-24-06 devicesmet the acceptancecriteria for ISO10993-5 and aresubstantiallyequivalent to thepredicate device.
Sensitization	Guinea PigMaximizationSensitization	ISO 10993-10	Test article does notelicit a sensitizationresponse.	The subject 4-20-05and 6-24-06 devicesmet the acceptancecriteria for ISO10993-10 and aresubstantiallyequivalent to thepredicate device.
Irritation	IntracutaneousIrritation Test	ISO 10993-10	Differences in themean test and controlscores of the extractdermal observationsare < 1.0.	The subject 4-20-05and 6-24-06 devicesmet the acceptancecriteria for ISO10993-10 and aresubstantiallyequivalent to thepredicate device.
AcuteSystemicToxicity	Acute SystemicInjection TestMaterialsMediatedRabbit Pyrogen	ISO 10993-11	No abnormal clinicalsigns and weight lossin excess of 10%.Temperature rise≥0.5°C	The subject 4-20-05and 6-24-06 devicesmet the acceptancecriteria for ISO10993-11 and aresubstantiallyequivalent to thepredicate device.
TestCategory	TestDescription	Method	Acceptance Criteria	Conclusion
Hemo-compatibility	Hemolysis	ISO 10993-4	No significant differences between the test article extract and negative control article results. The test article is considered non-hemolytic	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device.
	Partial Thromboplastin Time		Clotting times are similar to the negative control and the reference material (HDPE) indicating the device materials are not an activator of the intrinsic coagulation pathway.
	Platelet and Leukocyte Count		Test article does not adversely affect the platelet and leukocyte components of the blood compared to the reference material.
	Complement Activation C3a and SC5b-9 Assay		Levels of C3a and SC5b-9 are comparable and less than the positive control.
	Thrombosis		Thrombo-resistance properties are acceptable in clinical use.

Genotoxicity	Bacterial Mutagenicity Test	ISO 10993-3	Test article is considered non-mutagenic	The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device.
	In-vitro Mouse Lymphoma Assay		Test article is considered non-mutagenic
	In-vivo Mouse Micronucleus Assay		Test article is considered non-mutagenic

Test Description	Method	Acceptance Criteria	Conclusion
Delivery Force	Peak delivery force wasmeasured through arepresentative tortuousanatomical model.	Stent must bebelow deliveryforce specification.	The subject 4-20-05 and 6-24-06 devices met the acceptancecriteria for delivery force andare substantially equivalent tothe predicate device.
Re-sheathingForce	Retrieval force wasmeasured through arepresentative tortuousanatomical model.	Stent must bebelow re-sheathingforce specification.	The subject 4-20-05 and 6-24-06 devices met the acceptancecriteria for re-sheathing forceand are substantiallyequivalent to the predicatedevice.
Multiple Re-sheathingDurability	Samples wereevaluated on theirability to withstanddelivery andwithdrawal forces in arepresentative tortuousmodel beyond therecommended numberof passes and re-sheathings allowed perthe Instructions for Use(IFU).	The subject 4-20-05 and 6-24-06devices mustreliably deploy andresheath up to four(4) times.	The subject 4-20-05 and 6-24-06 devices showed noirregularities, breaks, kinks,body marker migration, glueseparations, or other observeddefects after all deploymentand resheathing attempts.The subject 4-20-05 and 6-24-06 devices met the acceptancecriteria for multiple re-sheathing durability and aresubstantially equivalent to thepredicate device.
Body MarkerTensile	Body Marker tensilestrength testing isperformed to verify thestrength of the laserweld of thePlatinum/Iridiummarkercoil to theNitinol distal finger ofthe device.	Body markershould be greaterthan or equal toexisting tensilestrengthspecification.	The subject 4-20-05 and 6-24-06 devices met acceptancecriteria for body markertensile and are substantiallyequivalent to the predicatedevice.
Test Description	Method	AcceptanceCriteria	Conclusion
Body MarkerRadiopacity	Verification analysis ofbody markers.	The radiopaquebody markers mustbe visible usingstandard catheterlaboratoryequipment	The subject 4-20-05 and 6-24-06 devices met acceptancecriteria for body markerradiopacity and aresubstantially equivalent to thepredicate device.
Proximal Markerto Distal Marker	The length of the lasercut and electro-polished stents aremeasured 100% inprocess.	Length of stentmust meet allinspection criteria	The subject 4-20-05 and 6-24-06 devices met acceptancecriteria for proximal marker todistal marker and aresubstantially equivalent to thepredicate device.
A f Temperature	In-process 100%tracking of heat setparameters used to setfinal Af	Temperatureshould be less thanor equal to existingA f temperaturespecification.	The subject 4-20-05 and 6-24-06 Solitaire™ PlatinumRevascularization Devicesmet acceptance criteria for Afand are substantiallyequivalent to the predicatedevice.
Radial Force	The radial force wasmeasured 100% in-process.	Stent must bewithin existingradial forcespecification.	Radial force was measured100% in-process.The subject 4-20-05 and 6-24-06 devices met acceptancecriteria for radial force andare substantially equivalent tothe predicate device.

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Performance Data – Bench:

A summary of the bench testing performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below.

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Performance Data – Animal:

The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate Solitaire™ Platinum Revascularization Device. Therefore, no additional non-clinical animal testing was performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices.

Performance Testing - Clinical:

The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate device. The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device and do not raise new questions of the safety and effectiveness of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. Therefore, no additional clinical study was performed.

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).