CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

K100663 · Boston Scientific Corporation · NAJ · Apr 16, 2010 · Cardiovascular

Device Facts

• Record ID: K100663
• Device Name: CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
• Applicant: Boston Scientific Corporation
• Product Code: NAJ · Cardiovascular
• Decision Date: Apr 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Boston Scientific's Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Device Story

Contour Embolization Particles are artificial embolization devices made of polyvinyl alcohol. They are delivered via angiographic catheter to provide vascular occlusion in peripheral hypervascular tumors and arteriovenous malformations (AVMs). The particles are supplied as dry volume in sterile vials and are available in various size ranges (45-1180 µm) to accommodate different catheter inner diameters. The device is intended for single patient use by a physician during interventional procedures. The particles physically obstruct blood flow to the target lesion, facilitating tumor devascularization or AVM management. This submission specifically updates the labeling to modify contraindications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical materials and design to the predicate device.

Technological Characteristics

Polyvinyl alcohol particles; range of sizes from 45-1180 µm; compatible with various angiographic catheters (0.53 mm to 1.12 mm ID); sterile; gamma irradiation; single-use; non-implantable.

Indications for Use

Indicated for embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Contraindicated for use of particles smaller than 355 microns in the treatment of leiomyoma uteri.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

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 § 870.1(e).

Predicate Devices

• Contour™ Embolization Particles (K030966)

Submission Summary (Full Text)

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K100663
pg. 1 of 2

# 510(k) Summary
Per 21 CFR §807.92

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| Submitter's Name and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Debbie McIntire<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | March 5, 2010 |
| Proprietary Name(s) | Contour™ Embolization Particles |
| Common Name | Contour Embolization Particles |
| Product Code | NAJ |
| Classification of Device | Class II, 21 CFR Part 870.3300 |
| Predicate Device | Contour™ Embolization Particles K030966 September 23, 2003 |
| Device Description | Contour Embolization Particles are artificial embolization devices.<br>These devices are intended to provide vascular occlusion upon selective.placement via an angiographic catheter. Contour Embolization Particles are packaged sterile by gamma irradiation. Each vial is intended for single patient use only.<br>The Contour™ Embolization particles are packaged in 1 cc dry volume per vial. The vials (glass with screw cap closure) are contained within a poly/Tyvek® pouch. The pouches are placed in boxes, in either a 2 vial/box or 5 vial/box configurations. All vials and boxes are appropriately labeled. The labels are color coded to differentiate between the different size ranges. The device is sterilized by gamma irradiation and labeled with a 26 month shelf life.<br>The Contour Embolization Particles are available in a range of sizes as tabulated below: |

:

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K100663
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Device Description (continued)

| Size | Minimum Compatible<br>Catheter ID |
|--------------|------------------------------------------------------------|
| 45-150 µm | 0.53 mm (0.021 in)<br>(e.g. Renegade™ 18, Renegade<br>STC) |
| 150-250 µm | |
| 250-355 µm | |
| 355-500 µm | |
| 500-710 µm | 0.69 mm (0.027 in)<br>(e.g. Renegade Hi-Flo) |
| 710-1000 µm | |
| 1000-1180 µm | 1.12 mm (0.044 in)<br>(e.g. Imager™ II Selective) |

The Contour Embolization Particles are made of polyvinyl alcohol, which has been used for embolization procedures since 1972.

| Intended Use of<br>Device | Boston Scientific's Contour Embolization Particles are used for the<br>embolization of peripheral hypervascular tumors, including leiomyoma<br>uteri and peripheral arteriovenous malformations (AVMs). |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics | The materials and design of the Contour Embolization Particles are<br>equivalent to the predicate Contour Embolization Particles. |
| Support of<br>Substantial<br>Equivalence | Boston Scientific Corporation considers the proposed Contour<br>Embolization Particles to be substantially equivalent to the existing<br>Contour Embolization Particles (K030966, cleared September 23, 2003).<br>This assessment is based upon identical device materials and design<br>characteristics. The only change being initiated is to the labeling. The<br>510(k) is being submitted to delete two contraindications from the<br>Directions for Use and add two new contraindications. |
| Conclusion | Based on the indications for use and the technological characteristics, the<br>Contour Embolization Particles has been shown to be equivalent in<br>intended use and is considered to be substantially equivalent to the<br>Contour Embolization Particles (K030966; cleared September 23, 2003). |

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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Ms. Debbie McIntire Senior Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place MAPLE GROVE MN 55311

### APR 1 6 2010

Re: K100663

> Trade Name: Contour™ Embolization Particles Regulation Number: 21-CFR § 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: NAJ Dated: March 5, 2010 Received: March 8, 2010

Dear Ms. McIntire:

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. 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 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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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,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use Statement

K100663 510(k) Number:

Device Name: Contour™ Embolization Particles

Indications for Use:

The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 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 Reproductive, Abdominal, and Radiological Devices 510(k) Number_

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