MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE

K113133 · Medrad, Inc. · DXT · Dec 15, 2011 · Cardiovascular

Device Facts

• Record ID: K113133
• Device Name: MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Device Story

Powered injector system for angiographic procedures; delivers contrast media and flushing solutions from 150ml disposable syringes. System comprises power unit, display control unit (DCU), and injector head. User programs volume and flow rate via DCU; device executes injection. Used in clinical settings by healthcare professionals. Design includes pressure jacket, snap-on plastic seal, and drop-front cone cover. Software controls injection parameters. Benefits include precise, automated delivery of contrast agents during angiography.

Clinical Evidence

Bench testing only. Testing included pressure jacket pressure cycles, syringe insert/remove cycles, high-pressure life use cases, general use case verification, drop-front engage/disengage cycles, and software verification/validation.

Technological Characteristics

Software-controlled powered injector. Components: Power unit, Display Control Unit (DCU), injector head. Materials include plastic seals and covers. Connectivity/software: Software-controlled injection parameters. Sterilization: Not specified.

Indications for Use

Indicated for the injection of contrast medium and flushing solutions into humans undergoing angiographic studies. Prescription use only.

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

• Mark 7Arteion Injector System (K112086)

Submission Summary (Full Text)

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DEC 1 5 2011

## Section 5 – 510(k) Summary

.

| Submitter: | MEDRAD, INC.<br>One Medrad Drive<br>Indianola, PA 15051 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 15, 2011 |
| Trade Name: | MEDRAD Mark 7 Arterion Injection System |
| Classification: | 870.1650 |
| Product Code: | DXT |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K112086 Mark 7Arteion Injector System |
| Device Description: | The MEDRAD Arterion Mark 7 is a software controlled medical device<br>used to inject contrast agents from a 150ml disposable syringe. Commonly<br>referred to as a powered injector it is designed to allow a user to fill a<br>disposable syringe, and perform an injection with a preprogrammed<br>volume and flow rate. The Arterion consists of three basic components or<br>modules: a Power Unit, Display Control Unit (DCU), and an injector<br>head. |
| Intended Use: | The MEDRAD Mark 7 Arterion Injection System is intended to be used<br>specifically for the purposes of injecting contrast medium and common<br>flushing solutions into humans for angiographic studies. |
| Comparison to<br>predicate: | Design changes were made to the predicate device which included: adding<br>a plastic seal that snaps on to the pressure jacket, adding a clear plastic<br>cover designed to fit onto the drop front cone, and software modifications. |
| Performance Data: | Bench and laboratory testing was performed to support a determination of<br>substantial equivalence to the predicate device.<br>Results from the testing provide assurance that the proposed device<br>conforms to the requirements for its intended use. This included the<br>following testing:<br>• Pressure Jacket Pressure Cycle<br>• Pressure Jacket Syringe Insert/Remove Cycle<br>• Syringe High Pressure Life Use Case<br>• Disposables General Use Case<br>• Drop Front Engage/Disengage Cycle Test<br>• General Use Case Verification<br>• Software Verification/Validation |

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MEDRAD considers the Mark 7 Arterion Injection System to be Conclusion: substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indication for use, fundamental technology, and principles of operation. .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 9 2012

Medrad, Inc. c/o Mr. Mike Burnside Manager, Regulatory Affairs One Medrad Drive Indianola. PA 15051

Re: K113133

Trade/Device Name: Mark 7 Arterion™ Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II (two) Product Code: DXT Dated: November 29, 2011 Received: November 30, 2011

Dear Mr. Burnside:

This letter corrects our substantially equivalent letter of December 15, 2011.

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 (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 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 – Mr. Mike Burnside

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, 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): ___________________________________________________________________________________________________________________________________________________

Device Name: MEDRAD Mark 7 Arterion™ Injection System

## Indications for Use:

The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the The MEDKAD Mark 7 Alterior Injoction by solutions into historial into humans for angiographic studies.

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) |
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number (K113/33