MODIFICATION TO:CONTOUR SE MICROSPHERES

K071634 · Boston Scientific Corp · HCG · Jul 12, 2007 · Neurology

Device Facts

• Record ID: K071634
• Device Name: MODIFICATION TO:CONTOUR SE MICROSPHERES
• Applicant: Boston Scientific Corp
• Product Code: HCG · Neurology
• Decision Date: Jul 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Contour SE Microspheres (Syringe) is intended to be used for the embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).

Device Story

Contour SE Microspheres are spherical polyvinyl alcohol embolic devices designed for targeted vascular occlusion or blood flow reduction. The device is supplied in a sterile syringe containing 1 mL or 2 mL of microspheres and 5 mL of saline, packaged in a sterile, peel-away barrier. It is intended for smooth delivery through infusion catheters. The device is used by clinicians to treat hypervascular tumors and AVMs. By occluding vessels, the microspheres reduce blood flow to the target site, providing a therapeutic benefit for the specified conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Spherical polyvinyl alcohol (PVA) embolic material. Delivered via sterile syringe (1 mL or 2 mL microspheres with 5 mL saline). Designed for compatibility with standard infusion catheters. Sterile, single-use device.

Indications for Use

Indicated for embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).

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

• Contour SET™ Microspheres

Submission Summary (Full Text)

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Special 510(k)
Boston Scientisco Modified CSENA

| Summary of Safety and Effectiveness | | K071634 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| General Information | Submitter: Boston Scientific Corporation<br>100 Boston Scientific Way<br>Marlborough, MA 01752<br>508-683-4234 | JUL 12 2007 |
| | Contact Person: Shilpa Prem | |
| General Provisions | Trade Name: Contour SET™ Microspheres (Syringe)<br>Classification Name: Vascular Embolization Device | |
| Name of Predicate Devices | Contour SET™ Microspheres | |
| Classification | Class II | |
| Performance Standards | Performance Standards have not been established by FDA under Section 514 of the<br>Food, Drug and Cosmetic Act | |
| Intended Use Device Description | Contour SE Microspheres (Syringe) is intended to be used for the embolization of<br>hypervascular tumors, including leiomyoma uteri and arteriovenous malformations<br>(AVMs). | |
| Device Description | Contour SE Microspheres are spherical-shaped polyvinyl alcohol embolic devices to<br>provide targeted vascular occlusion or reduction of blood flow within targeted<br>vessels. The product is packaged sterile syringe containing a 1 mL of or 2 mL of<br>Contour SE Microsphere and 5 mL of saline. Each syringe is packaged in a sterile,<br>peel-away barrier.<br><br>Contour SE Microspheres are designated for smooth delivery through a variety of<br>infusion catheters. | |
| Summary of Substantial Equivalence | The Contour SE Microspheres (Syringe) have been tested and compared to the<br>predicate devices. All data gathered demonstrate this device as substantially<br>equivalent. No new issues of safety and efficacy have been raised. | |

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation, Inc % Ms. Shilpa Prem Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752-1234

JUL 1 2 2007

Re: K071634

Trade/Device Name: Contour SE " Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG, KRD Dated: June 14, 2007 Received: June 15, 2007

Dear Ms. Prem:

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 such 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); 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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Page 2 - Ms. Shilpa Prem

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K071634

Device Name: Contour SE™ Microspheres

Indications For Use: Contour SE Microspheres are indicated for the embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).

Prescription Use (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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

**510(k) Number** /k071634