CONTOUR SE MICROSPHERES

K034068 · Boston Scientific Corp · KRD · Mar 26, 2004 · Cardiovascular

Device Facts

• Record ID: K034068
• Device Name: CONTOUR SE MICROSPHERES
• Applicant: Boston Scientific Corp
• Product Code: KRD · Cardiovascular
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Contour SE™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

Device Story

Contour SE™ Microspheres are artificial embolization devices used to occlude blood flow to hypervascular tumors, such as uterine leiomyomas, and arteriovenous malformations (AVMs). The device is administered by a physician via catheterization. By blocking the arterial supply to the target lesion, the microspheres induce ischemia, which can lead to tumor shrinkage or reduction of blood flow to malformations. The device is intended for clinical use in a hospital or surgical setting.

Clinical Evidence

Prospective clinical study conducted to support safety and effectiveness for the treatment of uterine fibroids. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Artificial embolization device. Materials are biocompatible per ISO 10993. No new materials introduced compared to predicate devices.

Indications for Use

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

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 SET™ Microspheres (K022427, K032707 & K032542)
• Contour™ Emboli PVA (K030966)

Submission Summary (Full Text)

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MAR 2 6 2004

Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K034068' from left to right. The characters are written in a simple, slightly rough style, with some variations in line thickness.

## Section 15

## Summary of Safety and Effectiveness

| General Provisions | Trade Name: Contour SET™ Microspheres<br>Classification Name: Artificial Embolization Device |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Contour SET™ Microspheres (K022427, K032707 & K032542)<br>Contour™ Emboli PVA (K030966) |
| Classification | Class III |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514 of<br>the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | Contour SET™ Microspheres may be used for the embolization of hypervascular<br>tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs). |
| Biocompatibility | No new materials have been introduced during this modification to the indications<br>for use statement as compared to the predicate devices. The predicate devices<br>have been tested for biocompatibility per ISO 10993. All data demonstrate this<br>device is biocompatible for its intended use. |
| Summary of<br>Substantial<br>Equivalence | The Contour SET™ Microspheres have been tested and compared to the predicate<br>device. All data gathered demonstrate this device as substantially equivalent. No<br>new issues of safety or efficacy have been raised. Clinical data were collected in a<br>prospective clinical study to support the safety and effectiveness of these devices<br>for treatment of uterine fibroids. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 26 2004

Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K034068

Trade/Device Name: UAE Contour SE™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial embolization device Regulatory Class: III Product Code: 74 KRD and 85 NAJ Dated: December 30, 2003 Received: December 31, 2003

Dear Ms. Bolton:

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 docs 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and it your be FDA finding of substantial equivalence of your device to a legally promaticated predicated. " ceresults 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 If you dosite specific at Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other or other to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. brogden.

Nancy C. Brogdon 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

510(k) Number (if known): K034068

Device Name: Contour® SE™ Microspheres

Indications For Use: Contour SE™ Microspheres may be used 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 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Choydon

(Division Sion Off) Division of Reproductive. And and Radiological Devices 510(k) Number

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