EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900

K063029 · E-Z-Em, Inc. · JAK · Nov 2, 2006 · Radiology

Device Facts

• Record ID: K063029
• Device Name: EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
• Applicant: E-Z-Em, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner. The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

Device Story

EmpowerCT/EmpowerCTA Injector Systems are motor-driven, linear-actuated syringe injectors for vascular administration of contrast and flushing media during CT scans. System components include injector, remote control, EDA, and power supply. User specifies volume (1-200 mL), flow rate (0.1-10 mL/sec), and pressure (40-300 psi) via remote control. Modification adds data/state synchronization with CT scanners via CAN-CIA DSP 425 protocol. Device uses color touch screen for protocol management (up to 50 stored protocols, 8 phases). Healthcare providers use system to automate contrast delivery; synchronization ensures timing between injection and scanner acquisition. Benefits include precise, reproducible contrast delivery and potential for extravasation detection via EDA.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparative performance analysis of the modified connectivity feature against the predicate devices.

Technological Characteristics

Syringe-type, software-controlled, venous-side, low-pressure injector. Electric motor linear-actuated syringe piston. Medical-grade switching power supply. Color touch screen interface. Connectivity via CT trigger port or CAN-CIA DSP 425 data communication. Pressure limiting functionality included. Designed for use with dedicated E-Z-EM disposables (Fast*Load CT Syringe, EDA Electrode Patch, Transfer Set).

Indications for Use

Indicated for humans undergoing CT scanning of the body requiring vascular administration of contrast and flushing media. The EDA is indicated for detecting contrast media extravasation during power injection.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• E-Z-EM EmpowerCTA Injector System (K031571)
• EmpowerCT Injector System (K011160)

Reference Devices

• EDA Device (K961845)
• EDA Device (K974621)
• Fast*Load CT Syringe (K933846)
• Empower Transfer Set (K041178)
• EmpowerCTA Connecting Tube (K031571)

Submission Summary (Full Text)

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K0630229

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## EmpowerCT/EmpowerCTA Injector System Special 510(k) Summary

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| Contact Information: | Tracey Campbell<br>E-Z-EM, Inc.<br>Director of Regulatory Affairs<br>1111 Marcus Avenue, suite LL-26<br>Lake Success, NY 11042<br>Phone: [phone], ext. 3407<br>Fax: [phone] |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV - 2 2006 |
| | Steven Hartman<br>E-Z-EM, Inc.<br>Director of Engineering<br>750 Summa Avenue<br>Westbury, NY 11590<br>Phone: [phone], ext. 2345<br>Fax: [phone] |
| Trade Name: | EmpowerCT and EmpowerCTA Injector Systems |
| Common Name: | Radiographic CT Injector for Contrast Medium, Automatic |
| Classification: | System, X-Ray, Tomography, Computed<br>Plethysmograph, Impedance<br>Cardiovascular/Radiology/Injector, Contrast medium,<br>Automatic<br>21 CFR 892.1750 (Product Code JAK)<br>21 CFR 870.2770 (Product Code DSB)<br>21 CFR 870.1650 (Product Code IZQ) |
| Currently Marketed<br>Devices: | E-Z-EM EmpowerCTA Injector System (K031571)<br>EmpowerCT Injector System (K011160) |
| New Indications for Use: | The EmpowerCTA Injector system is intended for the<br>vascular administration of contrast and flushing media and<br>the EmpowerCT Injector system is intended for vascular<br>administration of contrast. Both injector systems are used<br>in conjunction with computed tomography (CT) scanning of<br>the body with an optional interface to a CT scanner. |
| Description of<br>Modification: | The EmpowerCT and EmpowerCTA Injector Systems have<br>been modified to allow for connection to a CT scanner.<br>This connection will allow data and state information to be<br>synchronized between the scanner and injector systems.<br>The EmpowerCT and EmpowerCTA Injector Systems are<br>currently marketed as injection systems that use one or<br>two consumable syringe(s) to displace contrast media and |

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flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.

The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.

Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.

| Volume- | Volume is selectable from 1 ml to 200 ml in 1 ml increments. |
|------------|----------------------------------------------------------------------------------|
| Flow Rate- | Flow rates are selectable from 0.1 to 10 ml/sec in increments of<br>0.1ml/sec. |
| Pressure- | Maximum syringe pressure is selectable from 40-300 psi in<br>increments of 1 psi |

## Accessories:

There is no change to the accessories available with the CT or CTA Injector Systems.

- The EmpowerCT is currently available with or without the E-Z-EM EDA . Device (K961845, K974621). The EmpowerCT Injector System is designed specifically for use with the following currently approved dedicated E-Z-EM disposables:
- Fast*Load CT Syringe (K933846) .
- EDA Electrode Patch (K961845, K974621) .
- Empower Transfer Set (K041178)· .
- · The EmpowerCTA Injector System is also currently available with or without the E-Z-EM EDA device (K961845, K974621) The EmpowerCTA Injector System is designed specifically for use with the currently approved dedicated E-Z-EM disposables:
- Fast*Load CT Syringe (K933846) .
- EDA Electrode Patch (K961845, K974621) .
- Empower Transfer Set (K041178) .
- EmpowerCTA Connecting Tube (K031571) .

## Comparative Summary:

In the proposed device modification, the EmpowerCT and EmpowerCTA Injectors in addition to having a CT Trigger option, will now have a mechanism to synchronize data and state information communication between the CT Injector System and the CT Scanner. The connectivity is the only modification being made to the EmpowerCT and EmpowerCTA Injector Systems.

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A comparison between the proposed E-Z-EM EmpowerCTA and EmpowerCT Injector A companser botwoon the proposeeed Injector System devices are presented in the following tables.

| Performance (Injector) | Proposed Devices<br>E-Z-EM EmpowerCT and<br>EmpowerCTA Injector with<br>optional scanner interconnect | Currently marketed<br>devices<br>E-Z-EM EmpowerCT<br>(K011160) and<br>EmpowerCTA Injector<br>(K031571) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Design | Syringe type injector, software<br>controlled, venous side, low pressure<br>injector. | Same as Proposed |
| Anatomical Sites | Inject contrast and flushing media<br>into a peripheral vein | Same as Proposed |
| Flow Rate | 0.1 to 10 mL/sec in user specified<br>increments of 0.1 ml/sec<br>A Accuracy: ±5% of programmed<br>rate +0.1 mL/sec | Same as Proposed |
| Delivery Volume | 1 to 200 mL in user specified<br>increments of 1 mL<br>Accuracy: ±2% of programmed<br>volume +1ml) | Same as Proposed |
| Maximum Pressure | 40 to 300 psi in user specified<br>increments of 1 psi<br>Accuracy: ±10% of programmed<br>pressure limit + 10 psi | Same as proposed |
| Pressure Limiting | Yes | Yes |
| Operating Principle | Electric Motor Linear Actuated<br>Syringe Piston | Same as Proposed |
| Power Supply | Medical Grade Switching Power<br>Supply | Same as Proposed |
| Remote Start Switch | Yes | Yes |
| Air Detection | User Observed | Same as Proposed |
| Display | Color Touch screen | Same as Proposed |
| Maximum Number of Injection<br>Phases per Protocol | 8 (Contrast Only)<br>or<br>2 (1 Contrast followed by 1 Saline)<br>or<br>3 (2 Contrast followed by 1 Saline) | Same as Proposed |
| Maximum Number of Stored<br>Injection Protocols | 50 | Same as Proposed |
| Programmed Pause | Yes | Yes |
| Connectivity | Yes either via a CT Trigger port or<br>via a data communication method.<br>The data communication method<br>was developed in accordance with<br>the CAN-CIA specification DSP 425. | Yes via a CT Trigger port<br>only. |
| Target Population | Humans | Same as Proposed |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NOV - 2 2006

Ms. Tracey Campbell Director, Regulatory Affairs E-Z-EM, Inc. 750 Summa Avenue WESTBURY NY 11590

Re: K063029

Trade/Device Name: E-Z-EM Empower CT/CTA Injector System with optional EDA Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Codes: JAK, DSB and IZQ Dated: September 29, 2006 Received: October 2, 2006

Dear Ms. Campbell:

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 (Premarket Approval), 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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Protecting and Promoting Public St

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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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

| Number: | K063029 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Application: | Special 510(k) Device Modification |
| Device Name: | E-Z-EM EmpowerCT/CTA Injector System with optional EDA |
| Indications for Use: | |
| Injector: | Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner. |
| EDA: | The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector. |

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices

| 510(k) Number | K063029 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | <div> <img alt="check" src="check"/> </div> | OR | Over-the-Counter Use |
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