MODIFICATION TO CONTOUR SE MICROSPHERES

K032542 · Boston Scientific Corp · HCG · Sep 16, 2003 · Neurology

Device Facts

• Record ID: K032542
• Device Name: MODIFICATION TO CONTOUR SE MICROSPHERES
• Applicant: Boston Scientific Corp
• Product Code: HCG · Neurology
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Contour SE Microspheres are spherical embolic particles provided in sterilized glass vials. Used for embolization of hypervascular tumors and arteriovenous malformations. Device is intended for prescription use by clinicians. Particles are delivered to the target site to occlude blood flow. Benefit includes therapeutic embolization of vascular abnormalities.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Spherical embolic particles; sterilized glass vial packaging; biocompatible per ISO 10993.

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations.

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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Contour SET™ Microspheres – Sub S00 Siles
Contour SET™ Microspheres – Sub S00 Sizes
August 14, 2003

## 510(k) Summary K032542

| General<br>Provisions | Trade Name: Contour SETM Microspheres | | |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Classification Name: Artificial Embolization Device | | |
| Device<br>Description/<br>Indications for<br>Use | The Contour SE TM Microspheres are spherical embolic particles and are<br>available in a variety of particle sizes and are indicated for use for the<br>embolization of hypervascular tumors and arteriovenous malformations.<br>These particles are provided in a sterilized glass vial. | | |
| Data Summary<br>Prepared | September 15, 2003 | | |
| Contact Name/<br>Number | Jodi Lynn Greenizen<br>Regulatory Affairs Project Manager<br>Boston Scientific Corporation<br>10 Glens Falls Technical Park<br>Glens Falls, NY 12801 | | |
| Name of<br>Predicate<br>Devices | Contour® Emboli PVA<br>Embosphere Microspheres<br>EmboGold Microspehers | | |
| Classification | Class III, 21 CFR 882.5950<br>Submitted Per 21 CFR 807 | | |
| 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 SETM Microspheres are indicated for use for the embolization of<br>hypervascular tumors and arteriovenous malformations. | | |

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2/2/ 1032542

Special 510(k) Contour SE™ Microspheres - Sub 500 Sizes August 14, 2003

| Biocompatibility | The Contour SE™ Microspheres have been tested for biocompatibility per<br>ISO 10993. All data demonstrate this device is biocompatible for its intended<br>use. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

The Contour SE™ Microspheres have been tested and compared to the Summary of predicate device. All data gathered demonstrate this device as substantially Substantial Equivalence equivalent. No new issues of safety or efficacy have been raised.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Dix Avenue Glens Falls, New York 12885-3864

Re: K032542

Trade/Device Name: Contour SETM Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: August 14, 2003 Received: August 18, 2003

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), 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/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

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

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K032542

| 510(k) Number (if known) | -Unknown |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Contour SE™ Microspheres |
| Indications for Use | Contour SE™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;"><span style="text-decoration: overline;">X</span></div> | OR | Over-The Counter Use | <div style="text-align:left;"><span style="text-decoration: overline;"></span></div> |
|----------------------|---------------------------------------------------------------------------------------|----|--------------------------|--------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

*Miriam C. Provost*

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

| Boston Scientific Corporation | 510(k) Number | <div style="text-align:left;"><span style="text-decoration: overline;">K032542</span></div> |
|-------------------------------|---------------|---------------------------------------------------------------------------------------------|
|-------------------------------|---------------|---------------------------------------------------------------------------------------------|

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