TRAGET DETACHABLE COIL

K112385 · Stryker Neurovascular · HCG · Sep 15, 2011 · Neurology

Device Facts

• Record ID: K112385
• Device Name: TRAGET DETACHABLE COIL
• Applicant: Stryker Neurovascular
• Product Code: HCG · Neurology
• Decision Date: Sep 15, 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 stretch-resistant, platinum-tungsten alloy coils attached to stainless steel delivery wires; designed for endovascular embolization of intracranial aneurysms and vascular malformations. Used in clinical settings by physicians; coils are deployed via catheter and detached using the InZone Detachment System (sold separately). Coils feature a multi-strand core to resist stretching; specific models include a smaller distal loop (75% diameter) to facilitate placement. Device is packaged in a flushing dispenser coil assembly for hydration prior to use. Modifications in this submission include a change in introducer sheath material (polypropylene to high-density polyethylene), a new dispenser coil clip, and updated branding/labeling. These modifications do not alter the fundamental scientific technology or intended use. The device provides a mechanical occlusion of vascular abnormalities, potentially reducing blood flow to aneurysms or malformations, thereby benefiting patients by preventing rupture or reducing symptoms.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including functional testing (coil/catheter compatibility, product removal), packaging verification, shelf-life testing, and biocompatibility testing (ISO 10993 series). Design validation was performed by a physician to assess the new introducer sheath and retention clip functionality.

Technological Characteristics

Platinum-tungsten alloy coil; stainless steel delivery wire; high-density polyethylene introducer sheath. Multi-strand core for stretch resistance. Mechanical detachment via InZone system. Biocompatibility per ISO 10993. MR Conditional (1.5T/3T).

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, 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 Coil and InZone® Detachment System (K093142)
• Target Detachable Coil (K102672)

Submission Summary (Full Text)

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KI12385

Image /page/0/Picture/1 description: The image shows the Stryker Neurovascular logo. The word "Stryker" is in a bold, sans-serif font, with a registered trademark symbol to the right of the "r". Below "Stryker" is the word "Neurovascular" in a smaller, sans-serif font.

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SEP 1 5 2011

| 510(k) Summary Of Safety And Effectiveness | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Date | September 12, 2011 |
| Submitter Name and Address | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA. 94538 |
| Contact Person: | Jim Leathley<br>Regulatory Affairs Project Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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).<br>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). |

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# KII 2385

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

# Legally Marketed

Predicate Devices:

| Reference (Clearance Date) | Device |
|----------------------------|---------------------------------------------------------|
| K093142 (4 Feb 2010) | Target Detachable Coil and InZone®<br>Detachment System |
| K102672 (15 Oct 2010) | 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.

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

Verification testing of the Target Detachable Coil consists of testing Verification Testing: as described in K093142 as well as the following:

Predicate Device Testing (from K 102672)

1) Functional testing to assess:

Main Junction Tensile Strength Delivery Wire Tensile Strength Coil Detachment Time

2) MR Compatibility testing to assess:

Magnetically induced displacement (ASTM F2052) Magnetically induced torque (ASTM 2213) Magnetically induced heating effect (in 1.5 T and 3 T MR systems - ASTM F2182) MR induced image artifact (ASTM F2119)

As a result of MR compatibility testing, the Directions for Use (DFU) for the Target Detachable Coil has been revised to include a more comprehensive MR Conditional statement describing the conditions under which the device was tested.

3) Pre-clinical testing to provide post-implant MR artifact data and to assess and compare the modified Target Detachable Coil to control coils in coiled aneurysm models.

4) Confirmatory biocompatibility testing as follows:

MEM Elution Cytotoxicity Hemolysis, Direct Contact USP Physico-Chemical <661>

5) Assessment of the new grade stainless-steel by Boston Scientific's Coporate Toxicology group.

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

Testing for modifications that are the subject of this submission (K112385)

1) Functional Testing to assess:

a) Coil / Catheter Compatibility

b) Product Removal from the Flushing Dispenser Coil (Product Removal Test Method, No Twistlock)

2) Packaging Verification testing to assess the ability of the new introducer sheath to protect the finished device

3) Shelf Life Testing, following climatic conditioning and distribution simulation. to assess the ability of the new introducer sheath to protect the finished device

4) Confirmatory biocompatibility testing as follows:

a) Cytotoxicity, MEM Elution (EN ISO 10993-5:2009) b) Sensitization, Guinea Pig Maximization (EN ISO 10993-10:2009)

c) Intracutaneous Reactivity (EN ISO 10993-10:2010)

d) Acute Systemic Injection (EN ISO 10993-11:2009)

e) Rabbit Pyrogen, Materials Medicated (EN ISO 10993-11:2009)

f) Hemolysis, Direct Contact ((EN ISO 10993-4:2009)

g) Partial Thromboplastin Time (EN ISO 10993-4:2009)

h) In Vitro Hemocompatibility (EN ISO 10993-4:2009)

i) Complement Activation (EN ISO 10993-4:2009)

i) USP Physico-Chemical <661>

k) Latex Testing (ASTM D6499-07)

5) Design Validation testing in which a physician assessed the new introducer sheath and new retention clip for the ability of the new configuration to:

a) protect the finished device

b) provide acceptable introducer sheath friction

c) provide for proper hydration of the finished devicde within the new introducer sheath

d) enable easy removal of the finished device from the dispenser coil

Physician evaluation also assessed whether the revised DFU was clear, legible and easy to read.

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

| Accessories: | Target Detachable Coils are packaged within a flushing dispenser<br>coil assembly. The dispenser coil is an accessory item with an<br>attached flushport used to hydrate the coil prior to use. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use /<br>Intended Use: | Target Detachable Coils are intended for use in the treatment of<br>intracranial aneurysms and other neuro and peripheral vascular<br>abnormalities such as arteriovenous malformations and arteriovenous<br>fistulae. |
| | Target Coils are indicated for endovascular embolization of:<br>• Intracranial aneurysms<br>• Other neurovascular abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae<br>• Arterial and venous embolizations in the peripheral vasculature |

#### Comparison to Predicate Device:

#### Target Detachable Coils

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

Although the devices incorporate modifications to the introducer sheath (i.e., a change in material from polypropylene to high density polyethylene), a new dispenser coil clip, and revised packaging and labeling (i.e., a change from Boston Scientific branding to Stryker Neurovascular branding), including revised instructions for use, 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. 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.

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

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

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Image /page/6/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Stryker Neurovascular c/o James Leathley Regulatory Affairs Project Manager 47900 Bayside Parkway Freemont, CA 94538

SEP 15 2011

Re: K112385

Trade/Device Name: Target Detachable Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: August 17. 2011 Received: August 18, 2011

Dear Mr. Leathley:

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 ffor 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

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Page 2 - James Leathley

807): labeling (21 CFR Part 801); medical device 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/CDRHOffices/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

lev.th.m.f

Malvina B. Eydelman, i 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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Special 510(k): Modification of Stryker Neurovascular's Target® Detachable Coils

Image /page/8/Picture/1 description: The image shows the Stryker Neurovascular logo. The word "Stryker" is in large, bold, black letters. Below it, in smaller letters, is the word "Neurovascular" also in black. There is a registered trademark symbol to the right of the word Stryker.

# INDICATIONS FOR USE STATEMENT

KII2385 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

and the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states o

| Prescription Use | <div style="display:inline-block;">√</div> | OR | Over The Counter Use | |
|----------------------|--------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |

JOE HUTTER

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Special 510(k), Stryker Neurovascular Modification of Target Detachable Coils

| 510(k) Number | K 112385 |
|---------------|----------|
|---------------|----------|

August 2011