CONTOUR SE MICROSPHERES

K022427 · Boston Scientific Corp · HCG · Aug 22, 2002 · Neurology

Device Facts

• Record ID: K022427
• Device Name: CONTOUR SE MICROSPHERES
• Applicant: Boston Scientific Corp
• Product Code: HCG · Neurology
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Contour SET ™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.

Device Story

Contour SE™ Microspheres are artificial embolization devices used to occlude blood flow to hypervascular tumors and arteriovenous malformations. The device consists of microspheres delivered via catheter to the target site to induce embolization. Used in clinical settings by physicians; the device acts as a mechanical embolic agent to reduce blood supply to the target lesion, potentially benefiting patients by shrinking tumors or treating vascular malformations. No software or electronic components are involved.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Artificial embolization device; biocompatible materials tested per ISO 10993; mechanical embolic agent; no software or electronic components.

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations in patients requiring such procedures.

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® Emboli PVA
• Embosphere Microspheres
• EmboGold Microspehers

Submission Summary (Full Text)

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Special 510(k)
Contour SE™ Microspheres
July 24, 2002

# Summary of Safety and Effectiveness

AUG 2 2 2 2002

| General<br>Provisions | <b>Trade Name:</b> Contour SET ^™ Microspheres |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <b>Classification Name:</b> Artificial Embolization Device |
| Name of<br>Predicate<br>Devices | Contour ^® Emboli PVA<br>Embosphere Microspheres<br>EmboGold Microspehers |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | Contour SET ^™ Microspheres are indicated for use for the embolization of<br>hypervascular tumors and arteriovenous malformations. |
| Biocompatibility | The Contour SET ^™ Microspheres have been tested for biocompatibility per<br>ISO 10993. All data demonstrate this device is biocompatible for its intended<br>use. |
| Summary of<br>Substantial<br>Equivalence | The Contour SET ^™ Microspheres have been tested and compared to the<br>predicate device. All data gathered demonstrate this device as substantially<br>equivalent. No new issues of safety or efficacy have been raised. |

0048

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 2 2002

Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Dix Avenue Glens Falls, New York 12801-3864

Re: K022427

Trade/Device Name: Contour SE™ Microspheres Regulation Number: 882.5950 Regulation Name: Artificial embolization devices Regulatory Class: Class III Product Code: HCG Dated: July 24, 2002 Received: July 25, 2002

Dear Ms. Greenizen:

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. Jodi Lynn Greenizen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
for Mark N. Melkers

Celia M. Witten, Ph.D., M.D. 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)<br>Number<br>(if known) | Unknown |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Contour SET ^TM Microspheres |
| Indications<br>for Use | Contour SET ^TM Microspheres are indicated for use for the embolization of<br>hypervascular tumors and arteriovenous malformations. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Confidential
Boston Scientific Corporation

OR

Over-The Counter Use
(Optional Format 1-2-96)

for Mark N. Mekerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number. K022427