(120 days)
Syringe for injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.
The Disposable CT/MR Syringes for Nemoto Injectors are plastic, single-use, disposable syringes to be offered in 20mL, 100mL and 200mL sizes. The syringes will be offered made of polypropylene or PET - both materials, of which, are available in current legally marketed products. The Nemoto Disposable CT and MR Disposable Syringes are designed for use on Nemoto CT and MR injectors and perform similarly to predicate devices.
This document describes a 510(k) premarket notification for "Disposable CT/MR Syringes for Nemoto Injectors." This is a medical device and not a software algorithm, therefore, the requested information about acceptance criteria, study details, ground truth, and training sets is not applicable in the context of this submission.
The 510(k) process for devices like these primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria through an AI study.
Here's why many of your specific questions cannot be answered from the provided document:
- No AI or Software Component: The device is a physical, disposable syringe. It does not involve any artificial intelligence, machine learning, or software algorithms that would require a study of its diagnostic performance.
- Substantial Equivalence: The submission aims to show that the new disposable syringes are substantially equivalent to existing, legally marketed syringes, not to demonstrate superior performance through a clinical trial or AI-based assessment.
- Focus on Physical and Material Equivalence: The description focuses on physical attributes (plastic, single-use, sizes) and materials (polypropylene or PET) being similar to existing products. The intended use is also identical to predicate devices.
- No Diagnostic Claims: There are no diagnostic claims being made by the syringe itself, only that it is used for the injection of contrast media or saline for CT and MR imaging. The diagnostic performance is related to the imaging system and interpretation, not the syringe.
Therefore, I cannot provide a table of acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or information about AI-specific studies (MRMC or standalone) because the provided document relates to a physical medical device submission that does not involve these types of evaluations.
The document confirms that this device was approved for marketing based on its substantial equivalence to predicate devices, not on a performance study against acceptance criteria in the way you've outlined for AI/software.
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NOV - 2 2005
510(k) Summary
Coeur, Inc. Submitter: Name: 704 Cadet Court Address: Lebanon, TN 37087 (615) 574-7923 Phone: Debra F. Manning, VP, O & RA Contact: Date: June 30, 2005 Trade/Proprietary Name: Disposable CT/MR Syringes for Nemoto Device: 2. Iniectors Syringes for CT and MR Injections Common/Usual Name:
Classification Name:
Legally Marketed Devices to which Substantial Equivalence is claimed: Coeurlock Disposable Angiographic Syringe (K965214) - Coeur Front Load Injector Turret and 200mL FrontLoad Syringe (K960965) - Coeur Coeur 130mL Syringe (K971712) - Coeur Syringe for Nemoto 3S Injector, Unimachs Corp., Catalog # 3S Syringe (K983826) -Approved for Legal Marketing for Unimachs Corporation Medrad Stellant CT Injector System with Imaging System Interface Module (K033881) – Medrad. Inc. Medrad Microprocessor CT Injection System (K880493) – Medrad, Inc. CT 9000 Digital Injection System (K912944) – Mallinckrodt Inc., Liebel-Flarsheim Business OptiStar MR Injection System (K984088) - Mallinckrodt Inc., Liebel-Flarsheim Business E-Z-EM Percupump 1A (K864227) - E-Z-EM, Inc. Oz Power Syringe (K973334) – Cardiovascular Innovations
Angiographic Injector & Syringe
Device Description: The Disposable CT/MR Syringes for Nemoto Injectors are plastic, 4. single-use, disposable syringes to be offered in 20mL, 100mL and 200mL sizes. The syringes will be offered made of polypropylene or PET - both materials, of which, are available in current legally marketed products. The Nemoto Disposable CT and MR Disposable Syringes are designed for use on Nemoto CT and MR injectors and perform similarly to predicate devices.
The Disposable CT/MR Syringe for Nemoto Injectors is a ડ. Intended Use of Device: svringe for the injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter.
NOV - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coeur. Incorporated c/o Ms. Debra F. Manning VP, Quality & Regulatory Affairs 704 Cadet Court Lebanon, TN 37087
K051799 Re:
Disposable CT/MR Syringes for Nemoto Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II Product Code: DXT Dated: September 28, 2005 Received: September 30, 2005
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. Iisting 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.
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Page 2 - Ms. Debra F. Manning
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. 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Duna R. Vicianes
A 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
KOSI 799 510(k) Number (if known):
Device Name: Coeur, Inc. Disposable CT/MR Syringes for Nemoto Injectors
Indications For Use:
Syringe for injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.
ﮨﮯ ﮨﮯ ﮨﯿﮟ ﮨﮯ ﮐﮧ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺳﺘﻌﻤﺎﻝ ﮐﮯ ﺳﺎﺗﮫ ﺍﺳﺘﻌﻤﺎﻝ ﮐﮯ ﺳﺎﺗﮫ ﺍﺳﺘﻌﻤﺎﻝ ﮐﮯ ﺳﺎﺗﮫ ﺍﺳﺘﻌﻤﺎﻝ ﮐﮯ ﺳﺎﺗﮫ ﺍﺳﺘﻌﻤﺎﻝ ﮐﮯ ﺳﺎﺗﮫ ﺍﺳﺘﻌﻤﺎﻝ ﮐﮯ ﺳﺎﺗﮫ ﺍﺳﺘﻌﻤﺎ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DUMAS R. BUCHNER
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_K 6 51
§ 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.