MODIFICATION TO:CONTOUR SE MICROSPHERES by BOSTON SCIENTIFIC CORP.

Contour SE Microspheres are spherical-shaped polyvinyl alcohol embolic devices to provide targeted vascular occlusion or reduction of blood flow within targeted vessels. The product is packaged sterile syringe containing a 1 mL of or 2 mL of Contour SE Microsphere and 5 mL of saline. Each syringe is packaged in a sterile, peel-away barrier.

Contour SE Microspheres are designated for smooth delivery through a variety of infusion catheters.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called Contour SET™ Microspheres (Syringe). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary states that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety and efficacy have been raised," regarding the comparison to predicate devices. However, it does not detail specific performance metrics, study designs, sample sizes, or ground truth establishment.

Therefore, I cannot provide the requested information from this document.

Summary

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Special 510(k)
Boston Scientisco Modified CSENA

Summary of Safety and Effectiveness		K071634
General Information	Submitter: Boston Scientific Corporation100 Boston Scientific WayMarlborough, MA 01752508-683-4234	JUL 12 2007
	Contact Person: Shilpa Prem
General Provisions	Trade Name: Contour SET™ Microspheres (Syringe)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 theFood, Drug and Cosmetic Act
Intended Use Device Description	Contour SE Microspheres (Syringe) is intended to be used for the embolization ofhypervascular tumors, including leiomyoma uteri and arteriovenous malformations(AVMs).
Device Description	Contour SE Microspheres are spherical-shaped polyvinyl alcohol embolic devices toprovide targeted vascular occlusion or reduction of blood flow within targetedvessels. The product is packaged sterile syringe containing a 1 mL of or 2 mL ofContour SE Microsphere and 5 mL of saline. Each syringe is packaged in a sterile,peel-away barrier.Contour SE Microspheres are designated for smooth delivery through a variety ofinfusion catheters.
Summary of Substantial Equivalence	The Contour SE Microspheres (Syringe) have been tested and compared to thepredicate devices. All data gathered demonstrate this device as substantiallyequivalent. No new issues of safety and efficacy have been raised.

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Public Health Service

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
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.(b)
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).