(28 days)
The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for a device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
The document states that the TRUFILL DCS ORBIT™ Detachable Coil and associated syringes have been found substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. However, it does not provide the specific performance data or the study design used to demonstrate this equivalence.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff entwined with a serpent, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Cordis Neurovascular, Inc. % Amarilys Machado Manager, Regulatory Affairs 14000 N.W. 57th Court Miami Lakes, Florida 33014
Re: K080967
Trade/Device Name: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe or TRUFILL® DCS Syringe II, also known as the TRUFILL DCS ORBIT™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: April 3, 2008 Received: April 4, 2008
Dear Amarilys 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
{1}------------------------------------------------
Page 2 – Amarilys Machado
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
//
Image /page/2/Picture/1 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, stylized font, with a registered trademark symbol next to it. Below the company name, the words "a Johnson-Johnson company" are written in a smaller, cursive font.
Page 1 of 1 CFF 20014 Only the Native File to be Used Intended Use Statement
Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe or TRUFILL® DCS Syringe II, also known as the TRUFILL DCS ORBIT™ Detachable Coil System
Indications For Use:
The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ad Neurological Devices
510(k) Number K080967
§ 882.5950 Neurovascular embolization device.
(a)
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.(b)
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).