DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS

K051799 · Coeur, Inc. · DXT · Nov 2, 2005 · Cardiovascular

Device Facts

• Record ID: K051799
• Device Name: DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
• Applicant: Coeur, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Nov 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

Syringe for injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.

Device Story

Disposable plastic syringes (20mL, 100mL, 200mL) designed for use with Nemoto CT and MR injectors. Syringes facilitate delivery of contrast media or saline into patient vasculature during diagnostic imaging. Operated by clinical staff in radiology settings. Device functions as a mechanical fluid delivery component; compatible with existing Nemoto injector systems. Provides sterile, single-use fluid path for imaging contrast administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, disposable plastic syringes. Materials: Polypropylene or PET. Sizes: 20mL, 100mL, 200mL. Designed for mechanical interface with Nemoto CT/MR injectors.

Indications for Use

Indicated for the injection of contrast media or saline during CT and MR imaging procedures using Nemoto injectors.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Coeurlock Disposable Angiographic Syringe (K965214)
• Coeur Front Load Injector Turret and 200mL FrontLoad Syringe (K960965)
• Coeur 130mL Syringe (K971712)
• Syringe for Nemoto 3S Injector, Unimachs Corp., Catalog # 3S Syringe (K983826)
• Medrad Stellant CT Injector System with Imaging System Interface Module (K033881)
• Medrad Microprocessor CT Injection System (K880493)
• CT 9000 Digital Injection System (K912944)
• OptiStar MR Injection System (K984088)
• E-Z-EM Percupump 1A (K864227)
• Oz Power Syringe (K973334)

Submission Summary (Full Text)

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NOV - 2 2005

## 510(k) Summary

Coeur, Inc. Submitter: Name: 704 Cadet Court Address: Lebanon, TN 37087 [phone] 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:

3.

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 [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/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.

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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

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