Intracranial aneurysms
· Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
· Arterial and venous embolizations in the peripheral vasculature

Device Description

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano Target Helical Nano Target XL 360 Soft Target 360 Ultra Target Helical Ultra Target XL 360 Stand Target 360 Soft Target XL Helical Target 360 Standard Target 3D All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils in the 360-shape, the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops. The Stryker Neurovascular InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

AI/ML Overview

The provided document describes the verification testing conducted for the Stryker Neurovascular Target Detachable Coils, focusing on demonstrating substantial equivalence to a predicate device after minor design modifications. It does not contain information about an AI-powered device or a study involving human readers and AI assistance. Therefore, it is not possible to answer all categories of your request comprehensively. However, I can extract the relevant information from the document as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of an algorithm or AI model development. Instead, it describes various engineering and material tests performed on the physical device. The sample sizes for each specific test (e.g., number of coils for tensile strength, number of detachment tests) are not explicitly stated. The data provenance is related to in-house testing by Stryker Neurovascular.

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

This information is not applicable as the document describes validation of a physical medical device, not an AI-powered diagnostic or decision-support system. Ground truth in this context refers to established engineering standards and performance targets.

4. Adjudication method for the test set

Not applicable. The testing described involves objective measurements and adherence to specified criteria rather than expert adjudication of interpretations.

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 document pertains to the regulatory submission for a physical neurovascular embolization device, not an AI-powered medical device or software.

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

Not applicable. This document is about a physical medical device.

7. The type of ground truth used

For the engineering tests (tensile strength, buckling, detachment, packaging, simulated use), the "ground truth" or reference for acceptance was meeting the same criteria as the predicate device, implying adherence to established performance specifications for such devices.

For biocompatibility, the ground truth was meeting established criteria for biocompatibility tests (MEM Elution Cytotoxicity, Hemolysis, USP Physicochemical, FTIR, Natural Rubber Latex, ELISA Inhibition Assay).

For MRI testing, the ground truth was meeting the criteria specified in the referenced ASTM standards (F2052, F2213, F2182, F2119) and demonstrating performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary

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

May 19, 2016

Stryker Neurovascular Ms. Kate Taylor Sr. Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K153658

Trade/Device Name: Target Detachable Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 13, 2016 Received: May 16, 2016

Dear Ms. Taylor:

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,

Carlos L. Pena -S

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) K153658

Device Name Target Detachable Coils

Indications for Use (Describe)

Target Detachable Coils are indicated for endovascular embolization of:
· Intracranial aneurysms
· Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
· Arterial and venous embolizations in the peripheral vasculature

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Neurovascular

510(k) Summary

Summary Date:	May 19, 2016
Submitter Name and Address: Stryker Neurovascular	47900 Bayside ParkwayFremont, CA. 94538
Contact Person:	Kate TaylorSr. Regulatory Affairs SpecialistPhone: 510 413-2175Email: kate.taylor@stryker.com
Trade Name:	Target® Detachable Coils
Common Name:	Occlusion Coil, Vascular Occlusion Coil, Neurovascular OcclusionCoil
Classification Name:	Target Detachable Coils are classed as vascular and neurovascularembolization devices under 21 CFR 870.3300 (KRD) and 21 CFR882.5950 (HCG), respectively, and are Class II devices (specialcontrols).
	The special control for the devices is FDA's guidance document,Class II Special Controls Guidance Document: Vascular andNeurovascular Embolization Devices (issued 29 Dec 2004).
Legally MarketedPredicate Devices:	Primary PredicateK123377, Target Detachable Coils (cleared 30 November 2012)
	Reference DevicesK093142 Target Detachable Coils (cleared 04 Feb 2010)K102672 Target Detachable Coils (cleared 15 October 2010)K112385 Target Detachable Coils (cleared 15 September 2011)K113412 Target Detachable Coils (cleared 13 December 2012)

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Device Description:	Stryker Neurovascular Target Detachable Coils are comprised of the following coil types:Target 360 Nano Target Helical Nano Target XL 360 SoftTarget 360 Ultra Target Helical Ultra Target XL 360 StandTarget 360 Soft Target XL HelicalTarget 360 Standard Target 3DAll Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately).Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils in the 360-shape, the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.The Stryker Neurovascular InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Comparison to the Predicate Device:	Target Detachable CoilsThe modifications described within this 510(k) include minor dimensional changes to the components in the Target Coil design, which when used with the updated InZone Detachment System, result in shorter detachment time. Additional changes include modifications to the Target Detachable Coils carton, packaging hoop and Directions for Use.The modified Stryker Neurovascular Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils.The modifications to the Target Detachable Coils do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices.Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971:2012. Stryker Neurovascular has determined the modifications to the predicate devices raise no new questions of safety or effectiveness.

Device Description:

Stryker Neurovascular Target Detachable Coils are comprised of the following coil types:Target 360 Nano Target Helical Nano Target XL 360 SoftTarget 360 Ultra Target Helical Ultra Target XL 360 StandTarget 360 Soft Target XL HelicalTarget 360 Standard Target 3DAll Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately).Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coils in the 360-shape, the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.The Stryker Neurovascular InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Comparison to the Predicate Device:

Target Detachable CoilsThe modifications described within this 510(k) include minor dimensional changes to the components in the Target Coil design, which when used with the updated InZone Detachment System, result in shorter detachment time. Additional changes include modifications to the Target Detachable Coils carton, packaging hoop and Directions for Use.The modified Stryker Neurovascular Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils.The modifications to the Target Detachable Coils do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices.Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971:2012. Stryker Neurovascular has determined the modifications to the predicate devices raise no new questions of safety or effectiveness.

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Verification Testing:

Verification testing of the modified Target Detachable Coil consisted of the following:

Test	Test Method Summary/Purpose	Results
Delivery WireTensile Strength	Determine the force at break at bondjoints for delivery wire via tensiletesting.	Met the same criteria asthe predicate device.
Proximal ContactBuckling	Determine the maximum bucklingforce to kink the proximal contact.	Met the same criteria asthe predicate device.
Proximal ContactTensile Strength	Determine the maximum tensile forceto break the proximal contact joint.	Met the same criteria asthe predicate device.
Coil Detachment	Measure coil detachment time inbovine serum using the InZoneDetachment System.	Met the same criteria asthe predicate device.
Biocompatibility	• MEM Elution Cytotoxicity• Hemolysis Direct/Extract Contact• USP Physicochemical USP <661>• FTIR• Natural Rubber Latex• ELISA Inhibition Assay forAntigenic Protein ASTM D6499-12	Met the same criteria asthe predicate device.
Packaging	Assess the ability of the packagingsystem to protect the finished device.	Met the same criteria asthe predicate device.
Simulated Use	• Detachment unit compatibility withcoil• Introducer sheath frictionacceptability• Removal of coil from the packaginghoop without damaging the device	Met the same criteria asthe predicate device.

Additional MRI testing was conducted in support of updates to the Directions for Use MRI Safety Information (Peripheral Use)

Test	Test Method Summary/Purpose	Results
Magneticallyinduceddisplacement	ASTM F2052	Met the same criteria asthe predicate device.
Magneticallyinduced torque	ASTM F2213	Met the same criteria asthe predicate device.
Magneticallyinduced heatingeffect	ASTM F2182	Met the same criteria asthe predicate device.
MR inducedimage artifact	ASTM F2119	Met the same criteria asthe predicate device.

Predicate Device Testing (from K102672)

MRI testing from a previous 510(k) was used in support of updates to the Directions for Use MRI Safety Information (Neurovascular Use)

Test	Test Method Summary/Purpose	Results
Magneticallyinduceddisplacement	ASTM F2052	Met the same criteria asthe predicate device.
Magneticallyinduced torque	ASTM F2213	Met the same criteria asthe predicate device.
Magneticallyinduced heatingeffect	ASTM F2182	Met the same criteria asthe predicate device.
MR inducedimage artifact	ASTM F2119	Met the same criteria asthe predicate device.

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Accessories:

Intended Use / Indications for Use: Target Detachable Coils are not packaged with any accessories.

Intended Use

Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Indications for Use

Target Detachable Coils are indicated for endovascular embolization of:

Intracranial aneurysms
· Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
· Arterial and venous embolizations in the peripheral vasculature

Because the subject modifications do not alter the intended use or indications for use of the predicate devices, or the fundamental scientific technology of the predicate devices; and because risk assessment of the modifications and successful verification testing raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate devices.

Conclusion:

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Test	Test Method Summary/Purpose	Acceptance Criteria	Reported Device Performance
Delivery Wire Tensile Strength	Determine the force at break at bond joints for delivery wire via tensile testing.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Proximal Contact Buckling	Determine the maximum buckling force to kink the proximal contact.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Proximal Contact Tensile Strength	Determine the maximum tensile force to break the proximal contact joint.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Coil Detachment	Measure coil detachment time in bovine serum using the InZone Detachment System.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Biocompatibility	MEM Elution Cytotoxicity, Hemolysis Direct/Extract Contact, USP Physicochemical USP <661>, FTIR, Natural Rubber Latex, ELISA Inhibition Assay for Antigenic Protein ASTM D6499-12.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Packaging	Assess the ability of the packaging system to protect the finished device.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
Simulated Use	Detachment unit compatibility with coil, Introducer sheath friction acceptability, Removal of coil from the packaging hoop without damaging the device.	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - Magnetically induced displacement	ASTM F2052	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - Magnetically induced torque	ASTM F2213	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - Magnetically induced heating effect	ASTM F2182	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Peripheral Use) - MR induced image artifact	ASTM F2119	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - Magnetically induced displacement	ASTM F2052	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - Magnetically induced torque	ASTM F2213	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - Magnetically induced heating effect	ASTM F2182	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.
MRI Testing (Neurovascular Use) - MR induced image artifact	ASTM F2119	Met the same criteria as the predicate device.	Met the same criteria as the predicate device.