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

K112086 · Medrad, Inc. · DXT · Oct 14, 2011 · Cardiovascular

Device Facts

• Record ID: K112086
• Device Name: MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Oct 14, 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 delivery of contrast media and flushing solutions during angiographic procedures. System comprises power unit, display control unit (DCU), and injector head. User programs volume and flow rate; device controls delivery from 150ml disposable syringe. Used in clinical settings by healthcare professionals. Design features front-load syringe mechanism, modernized power supply, and updated user interface. Benefits include precise fluid delivery, lighter weight, and smaller footprint compared to predecessors. Output is controlled fluid injection; assists clinicians in performing diagnostic angiography.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -11, -18), hemocompatibility, device operational characteristics, fluid delivery testing, human factors engineering, electrical design testing, mechanical design testing, and software verification/validation.

Technological Characteristics

Powered injector system. Components: Power unit, DCU, injector head. Materials: Biocompatible disposables (ISO 10993). Connectivity: Software-controlled. Sterilization: Not specified. Software: Embedded control system for flow rate and volume regulation.

Indications for Use

Indicated for the injection of contrast medium and flushing solutions into humans during angiographic studies.

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

• MEDRAD Mark V Provis Injection System (NFJ)
• MEDRAD Mark V Plus Injection System (K903390)
• MEDRAD Avanta Fluid Management System (K050456)

Submission Summary (Full Text)

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年112086

## OCT 1 4 2011

# Section 16 – 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: | September 15, 2011 |
| Trade Name: | MEDRAD Mark 7 Arterion Injection System |
| Classification: | II |
| Product Code: | DXT |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>MEDRAD Mark V Provis Injection System (NFJ)<br>K903390 MEDRAD Mark V Plus Injection System<br>K050456 MEDRAD Avanta Fluid Management System |
| Device Description: | The MEDRAD Arterion Mark 7 is a software controlled medical<br>device used to inject contrast agents from a 150ml disposable syringe.<br>Commonly referred to as a powered injector it is designed to allow a<br>user to fill a disposable syringe, and perform an injection with a<br>preprogrammed volume and flow rate. The Arterion consists of three<br>basic components or modules: a Power Unit, Display Control Unit<br>(DCU), and an injector head. |
| Intended Use: | The MEDRAD Mark 7 Arterion Injection System is intended to be<br>used specifically for the purposes of injecting contrast medium and<br>common flushing solutions into humans for angiographic studies. |
| Comparison to<br>predicate: | Design changes were made to the predicate device which included:<br>newer technology for the display/user interface encompassing<br>associated software changes or enhancements, architectural changes to<br>the injector head (front load of the syringe), and modernization of the<br>power supply. The device is lighter in weight and also has a smaller<br>imprint for ease of placement and movement. |

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#### Performance Data Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use, and that its' intended use has not changed from the predicate. This included the following testing:

- . Biocompatibility of Disposables (neat extracts)
- Cytotoxicity (ISO 10993-5) o
- Intracutaneous Reactivity (ISO 10993-10) o
- Sensitization (ISO 10993-10) o
- Acute Systemic Toxicity (ISO 10993-11) o
- O Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18) o
- Hemocompatibility o
- Device Operational Characteristics �
- Fluid Delivery Testing ●
- Human Factors Engineering .
- Electrical Design Element Testing .
- Mechanical Design Element Testing .
- Software Verification/Validation ●
- MEDRAD considers the Mark 7 Arterion Injection System to be Conclusion: substantially equivalent to the predicate devices 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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Food and Drug Administration 10903 New Flamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 4 2011

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

Re: K112086

Trade/Device Name: MEDRAD Mark 7 Arterion™ Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injection Syringe Regulatory Class: Class II Product Code: DXT Dated: September 15, 2011 Received: September 16, 2011

Dear Mr. Burnside:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four over been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession the 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 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

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Page 2 - Mr. Mike Burnside

(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 (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 requiration (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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" (21CFR 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/Resourcesfor You/Industry/default.htm.

://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Skidderey years.

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): K112086

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 purposes of injecting contrast medium and common flushing solutions 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) (Div/sion Sign-Off) Division of Cardiovascular Devices 510(k) Number