TARGET DETACHABLE COIL

K113412 · Stryker Neurovascular · HCG · Dec 13, 2011 · Neurology

Device Facts

• Record ID: K113412
• Device Name: TARGET DETACHABLE COIL
• Applicant: Stryker Neurovascular
• Product Code: HCG · Neurology
• Decision Date: Dec 13, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Target 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 attached to stainless steel delivery wires; designed for endovascular embolization of intracranial aneurysms and vascular malformations. Coils feature multi-strand material to resist stretching; distal end of main coil includes smaller loop (75% diameter) to facilitate placement. Used with InZone Detachment System (sold separately) for detachment. Operated by physicians in clinical settings. Device is hydrated via flushing dispenser assembly prior to use. Coils are deployed endovascularly to occlude target vasculature; providing mechanical obstruction to blood flow. Modifications include smaller coil sizes (1mm and 1.5mm secondary OD) using 0.00125in platinum wire diameter.

Clinical Evidence

Bench testing only. Verification testing included functional mechanical testing (main junction tensile test, durability challenge test, coil/catheter compatibility) and design/use FMEAs to assess migration risk for smaller coil sizes.

Technological Characteristics

Platinum-tungsten alloy coil; stainless steel delivery wire. Multi-strand stretch-resistant core. 1mm and 1.5mm secondary OD sizes. 0.00125in platinum wire diameter. Used with InZone Detachment System. Packaged in flushing dispenser assembly for hydration. Class II device.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and arterial/venous embolizations in the 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 Coil and InZone® Detachment System (K093142)
• Target Detachable Coil (K102672)
• Target Detachable Coil (K112385)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Stryker Neurovascular. The word "Stryker" is in a bold, sans-serif font on the top line. Below that, the word "Neurovascular" is in a smaller, bold, sans-serif font. The logo is black and white.

v ·

KII3412

DEC 1 3 2011

| 510(k) Summary Of Safety And Effectiveness | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Date | December 12, 2011 |
| Submitter Name and<br>Address | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA. 94538 |
| Contact Person: | Rhoda M. Santos<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name: | Target® Detachable Coils |
| Common Name: | Occlusion Coil, Vascular Occlusion Coil, Neurovascular Occlusion<br>Coil |
| Classification Name: | Target Detachable Coils are classed as vascular and neurovascular<br>embolization devices under 21 CFR 870.3300 (KRD) and 21 CFR<br>882.5950 (HCG), respectively, and are Class II devices (special<br>controls).<br>The special control for the devices is FDA's guidance document,<br>Class II Special Controls Guidance Document: Vascular and<br>Neurovascular Embolization Devices (issued 29 Dec 2004). |

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# K113412

#### Legally Marketed Predicate Devices:

| Reference (Clearance Date) | Device |
|-----------------------------|---------------------------------------------------------|
| K093142 (4 February 2010) | Target Detachable Coil and InZone®<br>Detachment System |
| K102672 (15 October 2010) | Target Detachable Coil |
| K112385 (15 September 2011) | Target Detachable Coil |

#### Device Description:

Stryker Neurovascular's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. 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 Stryker Neurovascular's 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 Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils 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.

Stryker Neurovascular's 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.

The modifications described within this Special 510(k) have resulted in 12 new smaller coil sizes to be added to the currently approved Target Helical ULTRA and Target 360 ULTRA coil subtypes. These 12 new UPNs use the same processes as the current Target Detachable Coil products with the only difference being the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in.

#### Verification Testing:

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

Testing and Assessments performed for modifications that are the subject of this submission

1) Functional Testing to assess mechanical properties impacted by the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in:

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## <113412

- Main Junction Tensile Test a)
- b) Durability Challenge Test
- c) Coil / Catheter Compatibility

· 2) Assessment of coil migration of smaller coil sizes via Use and Design FMEAs

Accessories:

Indications for Use / Intended Use:

Target Detachable Coils are packaged within a flushing dispenser coil assembly. The dispenser coil is an accessory item with an attached flushport used to hydrate the coil prior to use.

Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Target 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

#### Comparison to Predicate Device:

#### Target Detachable Coils

Stryker Neurovascular's smaller coil sizes Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils.

Although the smaller coil sizes use a Platinum (Pt) coil wire diameter of 0.00125in to achieve a smaller secondary OD of 1mm and 1.5mm,

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#### 510(k) Summary Of Safety And Effectiveness (cont.)

the modifications 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 +A1:2003.

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.

Because the subject modifications do not alter the intended use or Conclusion: 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 effectivenss, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

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

Stryker Neurovascular c/o Ms. Rhoda M. Santos Senior Regulatory Affairs Specialist 47900 Bayside Parkway Freemont, CA 94538

DEC 1 3 2011

Re: K113412

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: November 17, 2011 Received: November 18, 2011

Dear Ms. Santos:

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. Ilisting 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.

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Page 2 - Ms. Rhoda M. Santos

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Melvin R. Feldman, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K113412

Device Name: Target Detachable Coils

Indications For Use:

Target Detachable Coils are indicated for the endovascular embolization of:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K1i3412

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