PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM

K983314 · Nycomed Amersham Imaging · IZQ · Feb 19, 1999 · Cardiovascular

Device Facts

• Record ID: K983314
• Device Name: PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
• Applicant: Nycomed Amersham Imaging
• Product Code: IZQ · Cardiovascular
• Decision Date: Feb 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.

Device Story

Automatic injector for contrast media (CM) used in CT imaging; operated by clinicians in clinical settings. System components: pump console, remote control panel, handswitch, bottle insulators, and disposables (Bottle Spike, Day Set, Patient Set). Device delivers CM at controlled flow rates (0.2–9.9 ml/s) and volumes (up to 300 ml). Features include air and pressure sensors for safety, saline flush capability, and multi-patient CM reservoir usage. Software prevents reuse of disposables via physical design (break-off spike) and electronic control. Healthcare providers use the remote panel to program injection protocols (up to 100 protocols of 2 phases each) and monitor delivery. Benefits include automated, precise CM administration and reduced risk of cross-contamination through validated disposable design.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including bacteriological studies demonstrating that the system does not introduce microbial contamination during normal operation and that retrograde migration of microorganisms is limited to the distal end of the Patient Set, preventing cross-contamination.

Technological Characteristics

Automatic contrast media injector. Components: pump, remote panel, handswitch, bottle insulators. Flow rate: 0.2–9.9 ml/s. Pressure limit: 8 bar. Features: air/pressure sensors, saline flush, multi-phase injection (up to 2 phases). Disposables: Bottle Spike, Day Set, Patient Set. Software-controlled protocol management and disposable reuse prevention.

Indications for Use

Indicated for controlled automatic venous administration of contrast media for CT scans in patients 16 years of age and older. Contraindicated for coronary arteriography or other non-indicated uses.

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

• DXT MEDRAD® ENVISION CT™ Injector System (K934086)

Submission Summary (Full Text)

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K983314

510(k) Summary Nycomed Amersham Imaging Premica™-CT Contrast Media Delivery System (per 21 CFR 807.92)

### SUBMITTER NAME AND ADDRESS 1.

Nycomed Amersham Imaging 101 Carnegie Center Princeton, NJ 08540-9998

Ms. Kathy Patterson Contact Person: Telephone: [phone], Extension 341

## DEVICE NAME 2.

| Proprietary Name: | Premica™-CT Contrast Media Delivery System |
|----------------------|--------------------------------------------|
| Common/Usual Name: | Automatic injector for contrast media |
| Classification Name: | Injector, contrast medium, automatic |

#### 3. PREDICATE DEVICE/S

74 - DXT MEDRAD® ENVISION CT™ Injector System - K934086

#### 4. DEVICE DESCRIPTION

The Premica™-CT Contrast Media Delivery System consists of the following components:

- the console consisting of the pump, the main control panel, and the power . supply,
- . the remote control panel,
- the remote test injection trigger (handswitch), and .
- associated cables. .
- . bottle insulators, and
- pedestal, connector, and wheels. .

The printer is provided as an accessory.

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# INTENDED USE 5.

The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.

# BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics. A side-by-side comparison of the Premica™-CT Contrast Media Delivery System with the MEDRAD® ENVISION CT™ Injector System is provided in Table J-1. below.

| Table J-1. Comparison of Premica™-CT Contrast Media Delivery System |
|---------------------------------------------------------------------|
| with the MEDRAD® ENVISION CT™ Injector System |

| Characteristic | Premica™-CT Contrast<br>Media Delivery System | MEDRAD®<br>ENVISION CT™<br>K934086 |
|-----------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------|
| <b>Indications</b> | | |
| Indicated for controlled<br>administration of contrast media<br>for computed tomography scans | Yes | Yes |
| <b>Physical design</b> | | |
| Remote Panel | Yes | Yes |
| Weight (kg) | Pump 8 (17.6 pounds)<br>Panel 1.7 (3.7 pounds) | Display 4.4 (9.7 pounds)<br>Console 5.8 (12.8 pounds)<br>Head Control 3.0 (6.7 pounds) |
| Temperature Control | Bottle Insulators | Syringe heater |
| Single Patient Use Disposables | Patient Set | Syringe |
| Connecting Tubing | 1.5 meters | 60 inches (1.52 meters) |
| Access Types | Rigid and flexible | Rigid and flexible |
| Access Gauge | 16 to 20 | Not specified |
| Multiple Patient Use CM | Yes | No |

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# Table J-1, Comparison of Premica™-CT Contrast Media Delivery System with the MEDRAD® ENVISION CT™ Injector System (Continued)

| Characteristic | Premica™-CT Contrast<br>Media Delivery System | MEDRAD®<br>ENVISION CT™<br>K934086 |
|----------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Designed to prevent reuse of<br>disposables? | Yes | No |
| Operational Characteristics | | |
| Flow Rate (ml/s) | 0.2 to 9.9 | 0.1 to 9.9 |
| Injection Volume/Injection | 0 to 300 ml | 1 ml to syringe capacity |
| Maximum Injection Duration | 10 s to 9 min 59 sec;<br>Depends on injection volume | Up to 33:20; Depends on<br>volume, rate, and syringe size |
| CM Container Volume (ml) | 0 to 500 | Syringe sizes:<br>125 or 200 ml |
| Air Sensor | Yes (One for each bottle and<br>one for the Patient Set) | No (Requires monitoring by<br>the Operator) |
| Pressure Sensor | Yes | Yes |
| Pressure Limit | 8 bar | Programmable from 25 to 300<br>psi in 5 psi increments |
| Test Injection Default | Default: 5 ml; 1 ml/s;<br>increments of 0.1 ml/s | Default: 5 ml; 1.5 ml/sec;<br>Volume: 1 - 10 ml; 1 ml<br>increments<br>Flow rate: 0.1 ml/sec to 9.9<br>ml/sec in 0.1 ml increments |
| Injection Capabilities | Up to 2 phases | 1 to 8 phases |
| Interphase Delay (sec) | 0-99 | Optional |
| Protocol Storage | Up to 100 of 2 phases each | Up to 50 of 8 phases each |
| Saline Flush | Yes | No |
| Audible Scan Delay Signal | 0 to 99 sec | 0 to 99 sec |

The major differences between the two systems are the ability of the Premica™-CT to be used for multiple patients without changing the reservoir of contrast medium, and System design which prevents disposables reuse. Nycomed Amersham Imaging has conducted testing to demonstrate that these differences do not raise new issues of safety and effectiveness. Bacteriological testing demonstrates that

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normal use of the disposables of the Premica™-CT System does not introduce Sets are not susceptible to microbial contamination into the contrast. contamination when the System is used according to instructions for normal operation. Studies also demonstrate that the risk of cross contamination from an infected patient is negligible since the retrograde migration of the microorganisms and viruses was limited solely to the distal end of the Patient Set. The design of the Bottle Spike prevents re-use since the tip breaks off within the bottle upon Spike removal. Software control prevents re-use of the Day Set and Patient Set, past their intended durations of use. Validation activities demonstrate that the System fulfills this specification.

Nycomed Amersham Imaging believes that the information provided within this premarket notification and summarized above demonstrates that the Premica™-CT Contrast Media Delivery System is substantially equivalent to the MEDRAD® ENVISION CT™ Injector System. Testing demonstrates that the procedural difference, specifically multiple dose versus single dose, is safe and raises no new issues of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1999

Nycomed Amerham Imaging, Inc. c/o Rosina Robinson, RN, MED, RAC Senior Staff Consultants Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K983314

Premica™ CT Contrast Media Delivery System Dated: January 6, 1999 Received: January 7, 1999 Regulatory class: II 21 CFR 870.1650/Procode: 74 IZQ

Dear Ms. Robinson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notfication"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sct

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 90 3314

Device Name: Nycomed Amersham Imaging Premica" -CT Contrast Media Delivery System

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Indications For Use:

The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™ -CT Contrast Media Delivery System is not intended for use with children under 16 years of age.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------|
| Prescription Use | <div style="display:inline-block;">✓</div> |
| (Per 21 CFR 801.109) | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, |
| | and Radiological Devices |
| 510(k) Number | K983314 |
| | |
| | Over-The-Counter Use |

Nycomed Amersham Imaging Inc 510(k) 9/18/98 CONFIDENTIALNycomed Amersham Imaging Inc. 510(k) Premica™-CT Contrast Media Delivery System

**CONFIDENTIAL**

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