TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM

K093142 · Boston Scientific Corp · HCG · Feb 4, 2010 · Neurology

Device Facts

• Record ID: K093142
• Device Name: TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: HCG · Neurology
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• 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 Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Device Story

Target Detachable Coils are platinum-tungsten alloy coils with a multi-strand core to resist stretching; used for embolization of intracranial aneurysms and vascular malformations. The InZone Detachment System is a power supply unit used to detach these coils. The system is operated by physicians in a clinical setting. The coil is delivered via a stainless steel wire; the InZone system provides the energy to trigger detachment. The healthcare provider uses the system to place coils within the target vessel to induce occlusion. This procedure benefits patients by treating aneurysms and vascular malformations, reducing risk of rupture or hemorrhage.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety testing per EN 60601-series standards and design/use failure mode and effects analysis (FMEAs).

Technological Characteristics

Coils: Platinum-tungsten alloy, stainless steel delivery wire, multi-strand stretch-resistant core. InZone System: Power supply unit, firmware-controlled. Electrical safety per EN 60601. Sterilization method not specified.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and arterial/venous embolizations in the peripheral vasculature. For use by clinicians in a prescription-only setting.

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

• GDC 10-UltraSoft® Coils (K002181)
• GDC Power Supply and Detachable Coil Connecting Cables (K021494)
• GDC 360 Detachable Coils (K042539)
• Matrix2® Detachable Coils (K050700)

Reference Devices

• GDC devices (K031049)

Submission Summary (Full Text)

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K093142

# FEB - 4 2010

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

| Summary Date | October 1, 2009 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and<br>Address | Boston Scientific Corporation<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<br>InZone Detachment System |
| Common Name: | Occlusion Coil, Vascular Occlusion Coil, Neurovascular Occlusion<br>Coil |
| | Power Supply |
| 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). |
| | 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). |
| | The InZone Detachment System is intended for use with all currently<br>marketed Boston Scientific Detachable Coils in the embolization of<br>intracranial aneurysms and other vascular malformations of the<br>neuro and peripheral vasculature. |

ﻴﺔ - ﺗﻮ

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### Legally Marketed

Predicate Devices:

| Reference (Clearance Date) | Device |
|----------------------------|---------------------------------------------------------------|
| K002181 (11 Aug 2000) | GDC 10-UltraSoft® Coils<br>(introduction of UltraSoft coils) |
| K021494 (6 June 2002) | GDC Power Supply and Detachable Coil Connecting Cables |
| K031049 (3 June 2003) | Clearance of ISAT indication for all GDC devices |
| K042539 (19 Oct 2004) | GDC 360 Detachable Coils<br>(introduction of 360 shape coils) |
| K050700 (15 April 2005) | Matrix2® Detachable Coils |

### Device Description:

Boston Scientific Corporation'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 Boston Scientific'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.

Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

. ﺍ

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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.<br>There are no accessories to the InZone Detachment System. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>Boston Scientific's InZone Detachment System is intended for use<br>with all Boston Scientific Detachable Coils in the embolization of<br>intracranial aneurysms and other vascular malformations of the<br>neuro and peripheral vasculature. |
| Comparison to Predicate Device: | |
| | Target Detachable Coils |
| | Boston Scientific Corporation's Target Detachable Coils have the<br>same intended use/indications for use as the predicate devices. |
| | Although the coils incorporate modifications in design, materials,<br>packaging, and instructions for use, the modifications do not alter the<br>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. Boston Scientific has determined the modifications to the predicate devices raise no new questions of safety or effectiveness.

Verification testing has demonstrated Target Detachable Coils are substantially equivalent to the current legally marketed predicate devices.

.

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Comparison to Predicate Device (cont.):

#### InZone Detachment System

Boston Scientific Corporation's InZone Detachment System has the same intended use and indications for use as the current legally marketed predicate device, Boston Scientific's Detachable Coil Power Supply cleared under premarket notification K021494 (cleared 6 June 2002).

Although the InZone Detachment System incorporates modifications in materials, firmware, packaging, and instructions for use, the modifications do not alter the fundamental scientific technology of the predicate device.

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. Boston Scientific has determined the modifications to the predicate device raise no new questions of safety or effectiveness.

Verification testing of the InZone Detachment System, including electrical safety testing in accordance with applicable parts of the EN 60601-series of standards, has demonstrated the devices to be substantially equivalent to the current legally marketed predicate device.

#### 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 effectivenss, Boston Scientific has determined the Target Detachable Coils and InZone Detachment System to be substantially equivalent to the current legally marketed predicate devices.

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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 stripes forming its body and wing. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

James Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, CA 94538-6515

FEB - 4 2010

Re: K093142

Trade/Device Name: Target Detachable Coils and InZone Detachment System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG and KRD Dated: January 22, 2010 Received: January 25, 2010

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 (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.

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you active oper.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

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 STATEMENT

510(k) Number: _ Ko93142_

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
Device Name: InZone Detachment System

Intended Use:

The InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the newro and oeriohenal vasculature.

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

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

______________________________________________________________________________________________________________________________________________________________________________

K 093142

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
| OR. Over The Counter Use | |

KRISTEN BOWSHER

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number