(85 days)
The Coeur Injector Adaptor / Pressure Jacket is intended to be installed on Liebel-Flarsheim Angiomal* 6000 and Angiomat* Illumena** Contrast Delivery Systems to allow the injectors to be used with the Coeur 150mL A-Series (Angiographic andCT) Syringes (Catalog Numbers: C853-6150 and C853-6159).
The COEUR Injector Adaptor/Pressure Jacket, Model C859-6003 is an accessory intended to be installed on specific contrast delivery systems to allow the use of specific syringes.
The provided text is a 510(k) premarket notification letter from the FDA to COEUR Medical regarding their Injector Adaptor/Pressure Jacket. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain information about the acceptance criteria, study design, or performance metrics of the device as if it were an AI/software as a medical device (SaMD).
Therefore, I cannot provide the requested information as the document does not originate from a study report or clinical trial that would typically outline such details. The FDA letter confirms the device's classification and allows it to be marketed, but it does not detail performance testing against acceptance criteria in the manner described in the prompt.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2003
COEUR Medical A Division of COEUR, Inc. c/o Ms. Debra F. Manning VP, Quality & Regulatory Affairs 209 Creekside Drive P.O. Box 2125 Washington, NC 27889
K032920 Re:
The COEUR Injector Adaptor/Pressure Jacket, Model C859-6003 Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: September 15, 2003 Received: September 22, 2003
Dear Ms. Manning:
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 Codc 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
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Page 2 -- Ms. Debra F. Manning
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Her orean enterested (1); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand of ovisions (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) This lotter will and in you to ough finding of substantial equivalence of your device to a legally premated notificate 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) 594-4648. 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 yours,
Quse D, Hary Jr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K032920
Device Name: Coeur Medical, a division of Cocur, Inc., Injector Adapter / Pressure Jacket
Indications For Use:
The Coeur Injector Adaptor / Pressure Jacket is intended to be installed on Liebel-Flarsheim Angiomal* 6000 and Angiomat* Illumena** Contrast Delivery Systems to allow the injectors to be used with the Coeur 150mL A-Series (Angiographic andCT) Syringes (Catalog Numbers: C853-6150 and C853-6159).
V Prescription Use (Part 21 CFR 801 Subpart D)
-10(K) Number
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)
Kisond. Htz. C. Bramzaden
(Division Sign-off)
Division of Cardiovascular Devices
12/16/03
Page 1 of
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.