TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

K032553 · Cordis Neurovascular, Inc. · HCG · Sep 23, 2003 · Neurology

Device Facts

• Record ID: K032553
• Device Name: TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
• Applicant: Cordis Neurovascular, Inc.
• 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

The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be: very high-risk for management by traditional operative techniques 1) inoperable 2) and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Device Story

TRUFILL DCS ORBIT Detachable Coil System consists of platinum alloy coils and a delivery syringe. Device used by neurosurgeons/interventionalists in clinical settings (e.g., OR, cath lab) for endovascular embolization. Coils are delivered via catheter to target site (aneurysm/malformation) to induce thrombosis and occlude blood flow. Syringe facilitates controlled delivery/detachment. Procedure guided by fluoroscopic imaging. Output is physical occlusion of vascular defect. Benefits include minimally invasive alternative to open surgery for high-risk/inoperable patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

Platinum alloy detachable coils; delivery syringe; endovascular delivery system; fluoroscopic visualization; mechanical detachment mechanism.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, and for patients with neurovascular arteriovenous malformations or fistulae. Also indicated for peripheral arterial and venous embolizations.

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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of a bird or eagle with its wings spread.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Amarilys Machado Senior Regulatory Affairs Specialist Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes. Florida 33014

Re: K032553

Trade/Device Name: TRUFILL DCS ORBIT™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 18, 2003 Received: August 25, 2003

Dear Ms. Machado:

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. Amarilys Machado

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.

Sincerely yours,

, Mark N Millerson

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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K032\\$\\$3

Cordis Franchise Form - ( Intended Use Statement

Effective Date 11/15/00

Page 1 of 1

510(k) Number (if known):

Device Name: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe, also known as the TRUFILL DCS ORBIT™ Detachable Coil System.

## Indications for Use Statement

The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

very high-risk for management by traditional operative techniques 1)

inoperable 2)

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

(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

Mark N Millam

estorative

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