Who is the manufacturer of Target Detachable Coils?

Stryker Neurovascular filed the 510(k) submission for Target Detachable Coils (K161429).

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: Special).

What are the predicate devices for Target Detachable Coils?

Target Detachable Coils (K153658); Target Detachable Coils (K123377); Target Detachable Coils (K093142); Target Detachable Coils (K102672); Target Detachable Coils (K112385); Target Detachable Coils (K113412).

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

K161429 · Stryker Neurovascular · HCG · Jun 22, 2016 · Neurology

Device Facts

Record ID	K161429
Device Name	Target Detachable Coils
Applicant	Stryker Neurovascular
Product Code	HCG · Neurology
Decision Date	Jun 22, 2016
Decision	SESE
Submission Type	Special
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. 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

Device Story

Target Detachable Coils are platinum-tungsten alloy coils with multi-strand stretch-resistant cores; attached to stainless steel delivery wires. Used for endovascular embolization of intracranial aneurysms and other vascular abnormalities. Operated by physicians in clinical settings; requires use with Stryker Neurovascular InZone Detachment System (sold separately) and compatible microcatheters. Device introduced via microcatheter to occlude blood flow in target vessels. Provides mechanical obstruction to stabilize vascular lesions. Modifications include larger primary coil OD (0.017 inches) and updated introducer sheath dimensions/pigmentation.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included dimensional analysis, visual inspection, durability (tensile strength), particulate release, friction testing, biocompatibility (MEM Elution, Hemolysis, USP <661>, FTIR), packaging integrity, and simulated use in tortuous models. All tests met criteria equivalent to predicate devices.

Technological Characteristics

Platinum-tungsten alloy coil; stainless steel delivery wire; high-density polyethylene introducer sheath. Stretch-resistant multi-strand core. Primary coil OD 0.017 inches. Compatible with microcatheters (max ID 0.48 mm/0.019 in). Sterilization process unchanged from predicate. No software or energy source.

Indications for Use

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

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 (K153658)
Target Detachable Coils (K123377)
Target Detachable Coils (K093142)
Target Detachable Coils (K102672)
Target Detachable Coils (K112385)
Target Detachable Coils (K113412)

Related Devices

K113412 — TARGET DETACHABLE COIL · Stryker Neurovascular · Dec 13, 2011
K123377 — TARGET DETACHABLE COIL · Stryker Neurovascular · Nov 30, 2012
K153658 — Target Detachable Coils · Stryker Neurovascular · May 19, 2016
K242243 — Target Detachable Coils · Stryker Neurovscular · Aug 29, 2024
K252694 — Target Detachable Coil · Stryker Neurovascular · Dec 11, 2025

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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 22, 2016 Stryker Neurovascular Ms. Kate Taylor Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538 Re: K161429 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 20, 2016 Received: May 23, 2016 Dear Ms. Kate 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) K161429 Device Name Target Detachable Coils #### Indications for Use (Describe) Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. 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 in all lowercase letters, and there is a registered trademark symbol to the right of the "r". The text is black and the background is white. Neurovascular # 510(k) Summary | Summary Date: | May 20, 2016 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name and Address: | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA. 94538 | | Contact Person: | Kate Taylor Staff 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 K153658 Target Detachable Coils (cleared 19 May 2016) Reference Predicates K123377 Target Detachable Coils (cleared 30 November 2012) | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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) | | Device Description: | Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano | {4}------------------------------------------------ | Device Description: (continued) | 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 This 510(k) requests clearance of 8 new Target Detachable Coil UPNs – Target XXL 360 Detachable Coils. The change which differentiates the Target XXL 360 Coils from the rest of the Target Detachable Coil product family is a new, larger primary coil OD (0.017 inches), as compared to current range of Target Coils primary coil ODs (0.010 - 0.014 inches). The larger primary coil OD of the Target XXL 360 Detachable Coils necessitates minor dimensional increase to the ID of the introducer sheath, which is a component of the packaging hoop and facilitates introduction into the microcatheter. The new introducer sheath is made of the same high density polyethylene material as the current introducer sheath, but uses a different pigment to color the sheath to provide differentiation from other Target Coils. The larger primary OD requires that the Target XXL Coil be used with the larger of the microcatheters recommended for all other Target Coils: maximum internal diameter 0.48 mm [0.019 in]. The new UPNs utilize the same design and materials of existing Target Coils, and the same manufacturing, packaging and sterilization processes. 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. | | | Verification testing has demonstrated the modified Target Detachable Coils are substantially equivalent to the predicate Target Detachable Coils. | {5}------------------------------------------------ ### Verification Testing: Accessories: Verification testing of the modified Target Detachable Coil consisted of the following: | Test | Test Method Summary/Purpose | Results | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Dimensions | Coil Secondary Diameter and 2D Loop Secondary Diameter are measured. | Met the same criteria as the predicate device. | | Visual | Visual confirmation that the entire coil is contained within the introducer sheath. | Met the same criteria as the predicate device. | | Durability | The coil is visually inspected for damage and Main Junction Tensile Strength is tested after simulated deployment/retraction in a tortuous model. | Met the same criteria as the predicate device. | | Particulates | Particulate release due to delivery of the coil is measured. | Met the same criteria as the predicate device. | | Friction | Frictional force through an introducer sheath and a compatible microcatheter is measured. | Met the same criteria as the predicate device. | | Biocompatibility | • MEM Elution Cytotoxicity/Part 5 • Hemolysis Direct/Extract Contact/Part 4 • USP Physicochemical USP <661> • FTIR/Part 18 • Natural Rubber Latex | 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 | • Coil conformability • Coil durability during repositioning • Microcatheter compatibility • Coil friction during delivery through the microcatheter • Introducer sheath friction acceptability • Removal of coil from the packaging hoop without damaging the device | Met the same criteria as the predicate device. | Target Detachable Coils are not packaged with any accessories. | Intended Use / Indications for Use | Intended Use/Indications for use | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. 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 | | Conclusion: | 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. |