CONTOUR SE MICROSPHERES (SYRINGE)

K032707 · Boston Scientific Corp · HCG · Sep 23, 2003 · Neurology

Device Facts

• Record ID: K032707
• Device Name: CONTOUR SE MICROSPHERES (SYRINGE)
• Applicant: Boston Scientific Corp
• Product Code: HCG · Neurology
• Decision Date: Sep 23, 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 a sterilized syringe. Used by physicians for embolization of hypervascular tumors and arteriovenous malformations. Particles are delivered via catheter to the target site to occlude blood flow to the lesion. Device functions as a mechanical embolic agent. Benefits include reduction of blood supply to tumors or malformations to facilitate clinical management.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards. No clinical data provided.

Technological Characteristics

Spherical embolic particles. Provided in sterilized syringe. Biocompatibility verified per ISO 10993. Class III device (21 CFR 882.5950).

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations in patients requiring therapeutic vascular occlusion.

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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SEP 2 3 2003

## 510(k) Summary K032707

| 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 syringe. |
| Data Summary<br>Prepared | September 16, 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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The Contour SETM Microspheres have been tested for biocompatibility per Biocompatibility ISO 10993. All data demonstrate this device is biocompatible for its intended use.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation Miami Technology Center 8600 N.W. 41 Street Miami, Florida 33166

Re: K032707

Trade/Device Name: Contour SETM Microspheres (Syringe) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: August 29, 2003 Received: September 2, 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 yours,

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

| | K032707 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032707

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

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