Who is the manufacturer of Target Detachable Coils?

Stryker Neurovascular filed the 510(k) submission for Target Detachable Coils (K153658).

What is the FDA product code for Target Detachable Coils?

HCG. It is classified under 21 CFR 882.5950 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Target Detachable Coils?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Target Detachable Coils?

Target Detachable Coils (K123377).

Who can help prepare an FDA 510(k) submission like Target Detachable Coils?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Target Detachable Coils

K153658 · Stryker Neurovascular · HCG · May 19, 2016 · Neurology

Device Facts

Record ID	K153658
Device Name	Target Detachable Coils
Applicant	Stryker Neurovascular
Product Code	HCG · Neurology
Decision Date	May 19, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5950
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Target Detachable Coils are platinum-tungsten alloy coils attached to stainless steel delivery wires; designed for endovascular embolization of intracranial aneurysms and other neuro/peripheral vascular abnormalities. Coils feature multi-strand material to resist stretching; 360-shape variants include smaller distal loops. Used with Stryker InZone Detachment System (sold separately) to achieve coil detachment. Operated by physicians in clinical settings (e.g., neuro-interventional suites). Device is navigated through vasculature to target site; detachment via InZone system occludes blood flow to treat aneurysms/malformations. Modifications in this submission include minor dimensional changes to components and updated packaging/labeling to improve detachment time. Benefit is effective, controlled occlusion of vascular abnormalities.

Clinical Evidence

Bench testing only. Verification testing included delivery wire tensile strength, proximal contact buckling/tensile strength, coil detachment time in bovine serum, and biocompatibility (MEM Elution, Hemolysis, USP <661>, FTIR, ASTM D6499-12). MRI safety testing performed per ASTM F2052, F2213, F2182, and F2119. All tests met criteria equivalent to the predicate device.

Technological Characteristics

Platinum-tungsten alloy coil; stainless steel delivery wire; multi-strand stretch-resistant core. Dimensions vary by model. Compatible with InZone Detachment System. Biocompatibility per ISO 10993 standards. MRI safety verified per ASTM F2052, F2213, F2182, F2119.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and arterial/venous embolizations in peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Target Detachable Coils (K123377)

Reference Devices

Target Detachable Coils (K093142)
Target Detachable Coils (K102672)
Target Detachable Coils (K112385)
Target Detachable Coils (K113412)

Related Devices

K123377 — TARGET DETACHABLE COIL · Stryker Neurovascular · Nov 30, 2012
K112385 — TRAGET DETACHABLE COIL · Stryker Neurovascular · Sep 15, 2011
K161429 — Target Detachable Coils · Stryker Neurovascular · Jun 22, 2016
K113412 — TARGET DETACHABLE COIL · Stryker Neurovascular · Dec 13, 2011
K160832 — Penumbra Smart Coil · Penumbra, Inc. · Apr 20, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is black and the background is white. There is a registered trademark symbol to the right of the word. Neurovascular ## 510(k) Summary | Summary Date: | May 19, 2016 | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name and Address: Stryker Neurovascular | 47900 Bayside Parkway Fremont, CA. 94538 | | Contact Person: | Kate Taylor Sr. Regulatory Affairs Specialist Phone: 510 413-2175 Email: kate.taylor@stryker.com | | Trade Name: | Target® Detachable Coils | | Common Name: | Occlusion Coil, Vascular Occlusion Coil, Neurovascular Occlusion Coil | | Classification Name: | Target Detachable Coils are classed as vascular and neurovascular embolization devices under 21 CFR 870.3300 (KRD) and 21 CFR 882.5950 (HCG), respectively, and are Class II devices (special controls). | | | The special control for the devices is FDA's guidance document, Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (issued 29 Dec 2004). | | Legally Marketed Predicate Devices: | Primary Predicate K123377, Target Detachable Coils (cleared 30 November 2012) | | | Reference Devices K093142 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) | {4}------------------------------------------------ | 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. | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison to the Predicate Device: | Target Detachable Coils The 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. | {5}------------------------------------------------ #### Verification Testing: Verification testing of the modified Target Detachable Coil consisted of the following: | Test | Test Method Summary/Purpose | Results | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | 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. | | Proximal Contact Buckling | Determine the maximum buckling force to kink the proximal contact. | 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. | | Coil Detachment | Measure coil detachment time in bovine serum using the InZone Detachment System. | 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. | | Packaging | Assess the ability of the packaging system to protect the finished 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. | 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 | |-------------------------------------------|-----------------------------|---------------------------------------------------| | Magnetically induced displacement | ASTM F2052 | Met the same criteria as the predicate device. | | Magnetically induced torque | ASTM F2213 | Met the same criteria as the predicate device. | | Magnetically induced heating effect | ASTM F2182 | Met the same criteria as the predicate device. | | MR induced image artifact | ASTM F2119 | Met the same criteria as the 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 | |-------------------------------------------|-----------------------------|---------------------------------------------------| | Magnetically induced displacement | ASTM F2052 | Met the same criteria as the predicate device. | | Magnetically induced torque | ASTM F2213 | Met the same criteria as the predicate device. | | Magnetically induced heating effect | ASTM F2182 | Met the same criteria as the predicate device. | | MR induced image artifact | ASTM F2119 | Met the same criteria as the predicate device. | {6}------------------------------------------------ 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: