MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

K071378 · E-Z-Em, Inc. · JAK · Jun 13, 2007 · Radiology

Device Facts

• Record ID: K071378
• Device Name: MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
• Applicant: E-Z-Em, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jun 13, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended 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.

Device Story

EmpowerCT/CTA Injector Systems are syringe-type, software-controlled, venous-side, low-pressure injectors; used in clinical settings for vascular administration of contrast and flushing media during CT scans. Operation involves electric motor linear-actuated syringe pistons; controlled via color touch screen. Systems feature pressure limiting, remote start, and optional CT scanner interface. New modification adds optional GFR calculator as screening tool for contrast injection safety. Healthcare providers use device to automate contrast delivery; output includes programmed flow rates, volumes, and pressures. Device benefits include precise, automated contrast administration and extravasation detection (via EDA accessory), aiding clinical decision-making during imaging procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Syringe-type injector; electric motor linear-actuated piston; medical grade switching power supply; color touch screen interface. Connectivity via CT trigger port or data communication. Software-controlled flow rates (0.1-10 mL/sec), volumes (1-200 mL), and pressure limits (40-300 psi).

Indications for Use

Indicated for humans undergoing computed tomography (CT) scanning requiring vascular administration of contrast and flushing media. The EDA component 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

• EmpowerCTA Injector System (K031571)
• EmpowerCT Injector System (K011160)
• EmpowerCT/CTA Injector System (K063029)

Reference Devices

• E-Z-EM EDA Device (K961845)
• E-Z-EM EDA Device (K974621)
• Fast*Load CT Syringe (K933846)
• Empower Transfer Set (K041178)
• CTA Dual Pack (K933846 and K031571)
• EmpowerCTA Connecting Tube (K031571)

Submission Summary (Full Text)

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# K071378

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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 - Regulatory Affairs<br>1111 Marcus Avenue, suite LL-26<br>Lake Success, NY 11042<br>Phone: [phone], ext. 3407<br>Fax: [phone]<br>JUN 1 3 2007 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Steven Hartman<br>E-Z-EM, Inc.<br>Director - 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: | EmpowerCTA Injector System (K031571) (K063029)<br>EmpowerCT Injector System (K011160) (K063029) |
| 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 and an<br>optional calculator for glomerular filtration rate (GFR) |

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#### Description of Modification:

The EmpowerCT and EmpowerCTA Injector Systems have been modified for a software change only specific to the Empower Remote Control. They have been modified to add an optional calculator for glomerular filtration rate (GFR). This optional calculator is used as an additional screening tool for the use of a CT contrast injection in conjunction with a CT scan. This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system.

#### 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) ●
- CTA Dual Pack (K933846 and K031571) .
- EDA Electrode Patch (K961845, K974621) .
- Empower Transfer Set (K041178) .
- EmpowerCTA Connecting Tube (K031571)

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### Comparative Summary:

A comparison between the proposed E-Z-EM EmpowerCTA and EmpowerCT Injector Systems against the currently marketed 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 GFR Calculator | Currently marketed<br>devices<br>E-Z-EM EmpowerCT<br>(K011160)(K063029) and<br>EmpowerCTA Injector<br>(K031571)(K063029) |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 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 | Same as Proposed |
| | Accuracy: ±5% of programmed rate<br>+0.1 mL/sec | |
| Delivery Volume | 1 to 200 mL in user specified<br>increments of 1 mL | Same as Proposed |
| | Accuracy: ±2% of programmed<br>volume +1ml) | |
| Maximum Pressure | 40 to 300 psi in user specified<br>increments of 1 psi | Same as proposed |
| | Accuracy: ±10% of programmed<br>pressure limit + 10 psi | |
| Pressure Limiting | Yes | Same as Proposed |
| 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 | Same as Proposed |
| Air Detection | User Observed | Same as Proposed |
| Display | Color Touch screen | Same as Proposed |
| Maximum Number of Injection<br>Phases per Protocol | 8 Contrast and Saline (CTA)<br>8 Contrast (CT) | Same as Proposed |
| Maximum Number of Stored<br>Injection Protocols | 50 | Same as Proposed |
| Programmed Pause | Yes | Same as Proposed |
| Connectivity | Yes either via a CT Trigger port or<br>via a data communication method. | Same as Proposed |
| Special Feature | Optional GFR Calculator | No |
| Target Population | Humans | Same as Proposed |

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three curved lines that resemble a bird in flight. The logo is black and white and appears to be of low resolution.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Steven Hartman Director Engineering E-Z-EM, Inc. 750 Summa Avenue WESTBURY NY 11590

# 机价1 3 2007

Re: K071378

Trade/Device Name: E-Z-EM EmpowerCT/CTA Injector System with Optional EDA Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II Product Code: JAK, DSB, and IZQ Dated: May 15, 2007 Received: May 17, 2007

#### Dear Mr. Hartman:

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.

Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The overall image appears to be a commemorative or celebratory design related to the FDA's centennial.

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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" (21 CFR 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 vours.

Nancy C Hodgon

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

| 510(k) Number: | K071378 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span> (Yes) </span> </div> |

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use ✓<br>(Per 21 CFR 801.109) | OR Over-the-Counter Use |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> (Division Sign-Off)</div> <div>Division of Reproductive, Abdominal, and Radiological Devices</div> <div>510(k) Number K071378</div> |

EmpowerCT/CTA Injector System Special 510k Submission

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