COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR

K133600 · Coeur, Inc. · DXT · Apr 30, 2014 · Cardiovascular

Device Facts

• Record ID: K133600
• Device Name: COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
• Applicant: Coeur, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Apr 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes

Device Story

The Front Load Adapter is a mechanical accessory designed for the Liebel-Flarsheim Optivantage DH Injector. It enables the use of Coeur Front Load Syringes with the specified power injector system. The device consists of a component that attaches to the injector ram, allowing it to interface with the plunger of the Coeur syringe. It is used in clinical settings by healthcare professionals to facilitate the injection of contrast media, saline, or other diagnostic fluids into the heart, great vessels, and coronary arteries during x-ray imaging procedures. The adapter ensures proper syringe loading, filling, and injection performance without interfering with the power injector's operation.

Clinical Evidence

No clinical data. Bench testing only. Verification of functional performance included successful installation, syringe loading, and injection of contrast/saline fluids using the Liebel-Flarsheim Optivantage DH Injector.

Technological Characteristics

Mechanical adapter for power injectors. Materials are appropriate for medical use in contact with contrast media and saline. The device is a passive mechanical component that interfaces with the injector ram to accommodate Coeur syringes. No electronic or software components.

Indications for Use

Indicated for use in adapting Liebel-Flarsheim Optivantage DH Injectors to enable the use of Coeur Front Load Syringes for the injection of contrast media, saline, or other diagnostic fluids into patients.

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

• Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors (K070798)
• Medrad Envision CT Injector System (K993728)
• Optivantage DH Injector System with Enhanced Communication (K063503)

Submission Summary (Full Text)

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# APR 3 0 2014 K133600

### Coeur, Inc. Front Load Adapter for CT Injector

ﻣﺮ ﻣ

### 510(k) Summary

| 1. | Submitter: | Name: | Coeur, Inc. |
|----|------------|----------|--------------------------------------------------------------------------------------|
| | | Address: | 100 Physicians Way, Suite 200<br>Lebanon, TN 37090<br>Owner/Operator Number: 9038672 |
| | | Phone: | [phone] (Corporate Office) |
| | | Fax: | [phone] (Corporate Fax) |
| | | Contact: | Debra F. Manning, Director, Q & RA |
| | | Date: | November 22, 2013 |

| 2. | Device: | Trade/Proprietary Name: | Front Load Adapter for CT Injector for use |
|----|---------|-------------------------|--------------------------------------------|
| | | | with Coeur Front Load Syringe |
| | | Common/Usual Name: | Adapters for Power Injectors |
| | | Classification Name: | Accessory, Injector and Syringe, |
| | | | Angiographic |

#### Legally Marketed Devices to which Substantial Equivalence is claimed: ട്.

Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors (K070798) - Coeur

Medrad Envision CT Injector System, Medrad, K993728

Optivantage DH Injector System with Enhanced Communication (K063503) - Mallickrodt Inc., Liebel-Flarsheim

- 4. Device Description: The proposed device is a Front Load Adapterfor Liebel-Flarsheim Optivantage DH Injector. As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a highpressure injector which is used to inject contrast media into the heart, great vessels. and coronary arteries to study the heart and vessels by x-ray photography. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe.
- 5. Intended Use of Device: For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes

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- Summary of Technological Characteristics As Compared to Predicate Devices: The 6. intended use, the method of use, and the materials of the proposed device are the same as those identified for the legally-marketed predicate Coeur devices as appropriate to the injector. Like the legally-marketed predicate injectors, the proposed device allows for the intended use (injecting contrast media, saline, or other diagnostic fluids into patients) and is made with materials appropriate for its function. The proposed devices position the Coeur Front Load Syringe in front of the ram for use with the injector. Any differences in syringe placement are not significant as the ram is advanced to move the plunger to the full forward position for filling, enabling use with and like the predicate device.
If Substantial Equivalence was based on an Assessment of Ferformance Data, the following information is also provided:

- Nonclinical Tests Submitted: Verification of functional performance was achieved 1. which included that the adapter can be properly installed, the syringe will properly load into the adapter, and that the syringe, with the adapter, can be filled and used to inject contrast, saline, or other diagnostic thuids into the patient without affecting the function of the power injectors.
Such testing was conducted for the design for use on the Liebel-Flarsheim Optivantage DH Injectors. The installation, the loading, and the injection were all successfully completed. The equipment performed as intended.

- 2. Clinical Tests Submitted: NA
- 3. Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions drawn from the nonclinical tests demonstrate that the device is as safe and as effective as the legally marketed predicate devices identified.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text surrounding the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenus Document Control Center - WO66-Good Silver Spring, MI) 20993-0002

April 30. 2014

Coeur, Inc. Ms. Debra Manning Director, Quality & Regulatory Alfairs 100 Physicians Way, Suite 200 Lebanon. TN 37090

રિંદ: K133600

> Trade/Device Name: Frontload Adapter for CT Injector Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Agiographic Regulatory Class: Class II Product Code: DXT Dated: April 10. 2014 Received: April 11. 2014

Dear Ms. Manning:

We have reviewed vour 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 androval 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in

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Page 2 - Ms. Debra Manning

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Bram D. Zuckerman -S

Bram D. Zuckerman, MD 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):

Device Name: Front Load Adapter for CT Injector

Indications For Use:

For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes

Prescription Use V (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)

# Bram D. Zuckerman -S 2014.04.30 06:41:48 -04'00'

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