ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS

K070798 · Coeur, Inc. · DXT · Oct 4, 2007 · Cardiovascular

Device Facts

• Record ID: K070798
• Device Name: ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
• Applicant: Coeur, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Oct 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Coeur, Inc. Adapters are for use in adapting CT and/or Angiographic power injectors for use with Coeur syringes.

Device Story

The Coeur, Inc. Adapter is a mechanical accessory designed for installation onto existing CT and/or Angiographic power injectors. It enables the use of Coeur-brand syringes with these injectors by providing a physical interface between the injector ram and the syringe plunger. The device includes steel and anodized aluminum components, o-rings, and a plastic lever mechanism. The lever allows the system to interface with specific injector features, such as a 'Used Syringe Alarm.' The adapter is mechanically affixed to the injector using bolts, screws, or pins. It does not alter the fundamental operation of the power injector, which remains responsible for the delivery of contrast, saline, or diagnostic fluids into the patient's vascular system. The device is intended for use in clinical settings where power injectors are utilized for diagnostic imaging. It benefits the patient by allowing the use of Coeur syringes with a broader range of existing power injection equipment.

Clinical Evidence

Bench testing only. Verification of functional performance was conducted to ensure proper installation, syringe loading, and fluid injection capability. No clinical data was submitted.

Technological Characteristics

Mechanical adapter consisting of steel, anodized aluminum, o-rings, and plastic components (including levers with magnets). Mechanically affixed to power injectors via bolts, screws, or pins. Non-sterile. No software or electronic components.

Indications for Use

Indicated for use in adapting CT and/or Angiographic power injectors to enable the use of Coeur syringes for the injection of contrast, saline, or other diagnostic fluids into a patient.

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 Front Load Injector Retrofit Kit (K965214)
• Front Load Injector Turret and 200ml Front Load Syringe (K960965)
• CT 8000 Digital Injection System (K912944)
• Medrad Envision CT Injection System (K993728)
• Coeur Injector Adapter/Pressure Jacket (K032920)
• Medrad MCT, MCT Plus Injector/Medrad Front Load (K924116)

Submission Summary (Full Text)

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K070798

### ് 2007 OCI A

### Coeur, Inc.

## Coeur Medical, a division of Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors

### 510(k) Summary

| 1. | Submitter: | Name: | Coeur Medical, a division of Coeur, Inc. |
|----|------------|----------|---------------------------------------------|
| | | Address: | 209 Creekside Drive<br>Washington, NC 27889 |
| | | Phone: | [phone] (Corporate Office) |
| | | Fax: | [phone] (Corporate Fax) |
| | | Contact: | Debra F. Manning, VP, Q & RA |
| | | Date: | October 2, 2007 |

2. Device: Trade/Proprietary Name: Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors Common/Usual Name: Adapter for Power Injectors Classification Name: Accessory, Injector and Syringe, Angiographic

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

Coeur Front Load Injector Retrofit Kit (K965214) - Coeur

Front Load Injector Turret and 200ml Front Load Syringe (K960965) - Coeur

CT 8000 Digital Injection System (K912944) - Mallinckrodt Group, Inc.

Medrad Envision CT Injection System (K993728) - Medrad

Coeur Injector Adapter/Pressure Jacket (K032920) - Coeur

Medrad MCT, MCT Plus Injector/Medrad Front Load (K924116) - Medrad

#### 4. Device Description:

As defined by 21 CFR 870.1650, 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. 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

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injector to adapt it to fit the plunger of the Coeur syringe. It also includes a plastic lever component that allows the injector to be used more like the existing Mallinckrodt injector and will also be sold separately as a replacement part for that injector.

- 5. Intended Use of Device: The Coeur, Inc. Adapters are for use in adapting CT and/or Angiographic power injectors for use with Coeur syringes.

| Technological<br>Characteristics | Proposed Device | Coeur<br>Devices | Medrad<br>Devices | Mallinckrodt<br>(LF) Device | Rationale for Applicable<br>Differences |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in adapting<br>power injectors for use<br>with Coeur syringes to<br>enable the intended<br>use of the power<br>injectors (injection of<br>contrast, saline, or<br>other diagnostic fluids<br>into a patient) to be<br>accomplished using<br>Coeur syringes. | Same | Syringe based<br>fluid delivery<br>systems for<br>injecting<br>contrast into<br>patient. | Injects contrast<br>into vascular<br>system for<br>angiographic<br>or CT as<br>prescribed. | NA - The proposed device does<br>not alter the intended use (injecting<br>contrast, saline, or other diagnostic<br>fluid into patient) of the power<br>injectors upon which it will be<br>installed. |
| Sterile | No | No | No | No | NA - The disposable syringe is<br>sterile, not the adapters/power<br>injectors with which they are used. |
| Components | Combinations of steel<br>and anodized<br>aluminum, o-rings and<br>plastic components<br>including levers with<br>magnets. | Steel and<br>anodized<br>aluminum<br>and o-rings<br>or plastic | Injector system<br>includes<br>hardware and<br>software | Injector system<br>including<br>hardware and<br>software | The proposed device incorporates<br>a plastic lever to enable use of the<br>syringe system similar to a feature<br>available with some Mallinckrodt<br>equipment. Otherwise, the<br>differences are not applicable as<br>the components are durable for<br>their intended use. |
| Connection<br>Method | Mechanically affixed<br>to injector in a secure<br>manner (i.e., affixed<br>with bolts, screws,<br>and/or dowel and roll<br>pins.). | Same | NA | NA | NA |
| Function | Holds disposable<br>syringe in position<br>in front of injector<br>ram. | Same | Same | Same | NA |

#### Summary of Technological Characteristics As Compared to Predicate Devices: 6.

If Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:

- 1. Non-clinical Tests Submitted: Verification of functional performance has been performed to ensure that the adapter can be properly installed, the syringe will properly load into the injector, and that the syringe can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors.

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The installation, the loading, and the injection were all successfully completed. The equipment performed as intended.

#### Clinical Tests Submitted: NA 2.

- Conclusions Drawn from Non-clinical and Clinical Tests Submitted: The 3. primary difference between the proposed Coeur devices and the currently marketed Coeur devices is that the proposed device will be used upon injectors for which it is designed to fit - the form and function will not be significantly different. The proposed design will also allow components that may be used with other power injectors, including, for example, the incorporation of a lever that allows the system with the Coeur syringe to use a "Used Syringe Alarm" feature available with the Mallinckrodt system. The lever will also be available for sale separately as a replacement component. Coeur has expanded its business to include the offering of service for power injectors in its new service division and replacement components are needed for this division. This lever is one such replacement component.
The primary difference between the proposed devices and legally marketed power injectors is that it works in conjunction with the power injectors without changing their intended use, to allow use of the Coeur syringes.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coeur Medical a division of Coeur, Inc. c/o Ms. Debra F. Manning Vice President, Quality & Regulatory Affairs 209 Creekside Drive Washington, NC 27889

2007

Re: K070798

> Trade/Device Name: Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: August 31, 2007 Received: September 4, 2007

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 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

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Page 2 - Ms. Debra F. Manning

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C

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): K070798

Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Device Name: Power Injectors

Indications For Use:

for use in adapting CT and/or Angiographic power injectors for use with Coeur 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)

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