← Product Code [HCG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCG) · K032542 # MODIFICATION TO CONTOUR SE MICROSPHERES (K032542) _Boston Scientific Corp · HCG · Sep 16, 2003 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCG/K032542 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [HCG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCG.md) - **Decision Date:** Sep 16, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 882.5950 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date "SEP 16 2003" in a bold, sans-serif font. The letters and numbers are evenly spaced and aligned horizontally. The text appears to be printed or stamped onto a surface. Contour SET™ Microspheres – Sub S00 Siles Contour SET™ Microspheres – Sub S00 Sizes August 14, 2003 ## 510(k) Summary K032542 | General
Provisions | Trade Name: Contour SETM Microspheres | | | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | | Classification Name: Artificial Embolization Device | | | | Device
Description/
Indications for
Use | The Contour SE TM Microspheres are spherical embolic particles and are
available in a variety of particle sizes and are indicated for use for the
embolization of hypervascular tumors and arteriovenous malformations.
These particles are provided in a sterilized glass vial. | | | | Data Summary
Prepared | September 15, 2003 | | | | Contact Name/
Number | Jodi Lynn Greenizen
Regulatory Affairs Project Manager
Boston Scientific Corporation
10 Glens Falls Technical Park
Glens Falls, NY 12801 | | | | Name of
Predicate
Devices | Contour® Emboli PVA
Embosphere Microspheres
EmboGold Microspehers | | | | Classification | Class III, 21 CFR 882.5950
Submitted Per 21 CFR 807 | | | | Performance
Standards | Performance Standards have not been established by FDA under Section 514
of the Food, Drug and Cosmetic Act | | | | Intended Use
and Device
Description | Contour SETM Microspheres are indicated for use for the embolization of
hypervascular tumors and arteriovenous malformations. | | | . 1/2 {1}------------------------------------------------ 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
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 predicate device. All data gathered demonstrate this device as substantially Substantial Equivalence equivalent. No new issues of safety or efficacy have been raised. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines suggesting movement or progress. 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. {3}------------------------------------------------ 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ ## Indications For Use . ・・・・ 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 |
X
| OR | Over-The Counter Use |
| |----------------------|---------------------------------------------------------------------------------------|----|--------------------------|--------------------------------------------------------------------------------------| | (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 |
K032542
| |-------------------------------|---------------|---------------------------------------------------------------------------------------------| |-------------------------------|---------------|---------------------------------------------------------------------------------------------| 000066 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCG/K032542](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCG/K032542) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com