MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T

K072886 · Medrad, Inc. · DXT · Dec 21, 2007 · Cardiovascular

Device Facts

• Record ID: K072886
• Device Name: MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The Stellant P3T CardiacFlow software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition. The Stellant P3T CardiacFlow software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.

Device Story

The MEDRAD Stellant CT Injector System is a syringe-based fluid delivery system for intravenous contrast media in CT applications. The P3T CardiacFlow software accessory is an optional, password-enabled module that computes patient-specific contrast injection protocols and scan timing. Inputs include patient characteristics, scanner parameters, and contrast concentration. The system operates in a clinical setting, managed by technologists; the practitioner must approve and lock every protocol before injection, with the ability to modify or delete the software-suggested protocol. The device aims to increase consistency in individualized injection protocols. It maintains the same safety architecture and operational parameters as the predicate Stellant system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics, intended use, and design comparisons to predicate devices.

Technological Characteristics

Syringe-based fluid delivery system; dual-syringe model; color LCD interface; non-dedicated software-determined programming keys; touchscreen; multi-phase injection capability (up to 6 phases); automated dock/retract/advance; pressure graph display; syringe heating; imaging system interface (ISI). Software accessory (P3T CardiacFlow) for protocol computation.

Indications for Use

Indicated for humans undergoing CT angiography of cardiac structures (coronary arteries, heart chambers, thoracic/abdominal aorta) during gated ECG acquisition. Contraindicated for ungated CT angiography of right heart/pulmonary arteries (PE studies), head/neck vessel angiography, peripheral angiography, and patients with compromised renal function or contrast-related health issues.

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 Stellant CT Injector System with Imaging System Interface Module (K033881)
• OptiVantage DH Injection System (K042744)

Submission Summary (Full Text)

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K072886

# 510(K) SUMMARY

| OFFICIAL CONTACT: | Lisa M. Casavant<br>Sr. Regulatory Affairs Specialist<br>MEDRAD, Inc.<br>One MEDRAD Drive<br>Indianola, PA 15051<br>[phone] ext. 3694 | DEC 21 2007 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic | |
| COMMON NAME(S): | Powered Injector with Syringe | |
| PROPRIETARY NAME: | MEDRAD Stellant CT Injector System with P3T<br>CardiacFlow | |
| PREDICATE DEVICES: | MEDRAD Stellant CT Injector System with Imaging<br>System Interface Module (K033881)<br><br>OptiVantage DH Injection System (K042744)<br>Mallinckrodt, Inc., Liebel-Flarsheim Business | |

INTENDED USE: The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

The Stellant P3T CardiacFlow software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition.

The Stellant P3T CardiacFlow software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.

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CONTRAINDICATIONS: Stellant P3T CardiacFlow is not intended for use in Ungated CT angiography of the Right heart, Pulmonary trunk and Pulmonary Arteries for assessment of thrombo-emboli (dedicated Pulmonary Embolism (PE) studies), for angiography of the head/neck vessels, or for peripheral angiography.

The P3T CardiacFlow feature on the Stellant CT Injector is not intended for use on patients with compromised renal or some other contrast adverse related health issue.

DEVICE DESCRIPTION AND COMPARISON TO PREDICATE: MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. P3T CardiacFlow is an optional, password-enabled accessory. The injector system, when used with P3T CardiacFlow, maintains the same intended use, same operational parameters, and same labeling (with the addition of a P3T CardiacFlow operations manual). This device is also used in the same manner as the predicate devices.

The MEDRAD Stellant CT Injector System with P3T CardiacFlow is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. MEDRAD Stellant CT Injector System with P3T CardiacFlow maintains the same intended use, operational parameters, and labeling as the MEDRAD Stellant CT Injector System, with the addition of P3T CardiacFlow Instructions For Use. The P3T CardiacFlow accessory provides the convenience of generating patient-specific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists. Stellant CT Injector System with P3T CardiacFlow is used in the same manner as the predicate device (Stellant CT Injector System without P3T CardiacFlow).

The Stellant safety architecture has not been modified nor impacted; additionally every injection protocol must be approved and locked by the practitioner. The practitioner

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always has the option of modifying or deleting the P3T CardiacFlow suggested protocol.

A comparison of features and principles of operation between the proposed device and predicate devices is provided in Table 1 on the following page.

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Table 1: Comparison of Stellant CT Injector System with P3T Cardiact Crow Accessory to Stellant CT Injector
System with ISI Accessory and to the Mallinckrodt Opti Power Injec

| Feature | Intended Use | Predicate Device:<br>Stellant CT Injector System<br>with ISI Accessory (K033881) | Predicate Device:<br>Mallinckrodt OptiVantage<br>DH Power Injector with<br>OptiBolus (K042744) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The MEDRAD Stellant CT<br>Injector System is intended<br>for the specific purpose of<br>injecting intravenous contrast<br>media into humans for<br>diagnostic studies in<br>computed tomography (CT)<br>applications. | The MEDRAD Stellant CT<br>Injector System with ISI<br>Module is intended for the<br>specific purpose of injecting<br>intravenous contrast media<br>into humans for diagnostic<br>studies in computed<br>tomography (CT)<br>applications. | The OptiVantage with<br>OptiBolus software feature is<br>designed to inject a<br>radiopaque contrast media<br>into a patient's vascular<br>system, which enhances<br>diagnostic images obtained<br>with computed tomography<br>(CT). |
| | The P3T CardiacFlow<br>software accessory computes<br>individual contrast injection<br>protocols and scan timing,<br>based on patient<br>characteristics, scanner<br>parameters and contrast<br>concentration. | | The OptiBolus software<br>feature is used to enable an<br>exponential decaying flow<br>rate injection that will<br>optimize the contrast usage<br>and provide an extended<br>period of uniform<br>enhancement. |
| | The P3T CardiacFlow<br>software accessory is | | |
| Feature | Proposed Device:<br>Stellant CT Injector System<br>with P3T CardiacFlow<br>Accessory | Predicate Device:<br>Stellant CT Injector System<br>with ISI Accessory (K033881) | Predicate Device:<br>Mallinckrodt OptiVantage<br>DH Power Injector with<br>OptiBolus (K042744) |
| | intended for use in CT<br>angiography of cardiac<br>structures, including coronary<br>arteries, chambers of the<br>heart, and thoracic and<br>abdominal aorta during gated<br>ECG acquisition. | | |
| | The P3T CardiacFlow<br>software accessory can be<br>turned on or off by the user<br>for any given injection The<br>user will be required to<br>confirm/change the suggested<br>protocol before beginning an<br>injection. | | The OptiBolus software<br>feature can be turned on or<br>off by the user for any given<br>injection protocol. |
| Single or Dual Syringe<br>System | Dual syringe model | Single and dual syringe<br>models | Dual syringe model |
| Information Display | Color LCD | Color LCD | Color LCD |
| Programming Keys | Non-dedicated keys –<br>software determined | Non-dedicated keys –<br>software determined | Control panel buttons: 8 soft-<br>keys on touchscreen interface |
| Touch screen | Yes | Yes | Yes |
| Multi-Phase | Up to 6 phases per P3T<br>CardiacFlow injection | 1 - 6 phases per injection | 6 phases per injection or a<br>single OptiBolus injection |

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mentaly
Performance, For life."

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| 5.12 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| $A_{wg} = \frac{A_w}{A_g}$ | |
| where:<br>$A_w =$ area of water surface<br>$A_g =$ gross surface area | |
| 5.13 | |
| <b>Albedo</b> is the ratio of the amount of radiation reflected by a body to the amount incident on it and is usually expressed as a percentage. Albedo is a measure of the reflectivity of a surface. The albedo is defined as the ratio of the reflected radiation to the incident radiation. It is a dimensionless quantity and ranges from 0 to 1. A perfect reflector has an albedo of 1, while a perfect absorber has an albedo of 0. | |

| Feature | Proposed Device:<br>Stellant CT Injector System<br>with P3T CardiacFlow<br>Accessory | Predicate Device:<br>Stellant CT Injector System<br>with ISI Accessory (K033881) | Predicate Device:<br>Mallinckrodt OptiVantage<br>DH Power Injector with<br>OptiBolus (K042744) |
|----------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Retract Control | Yes (Automatic) | Yes (Automatic) | Yes, manual |
| Remote Start Switch | Yes | Yes | Yes |
| Pressure Graph | Yes | Yes | No |
| Syringe Sensing | Yes | Yes | Yes |
| Autoload | Yes | Yes | No |
| Auto Dock/Retract/Advance | Yes; user-selectable autodock<br>and advance; user-selectable<br>auto-retract | Yes; user-selectable autodock<br>and advance; user-selectable<br>auto-retract | No |
| Protocol Lock /<br>Remote Arming | Yes | Yes | No lock however, user may<br>arm at head. (May have had<br>related recall) |
| Check for Air | Yes | Yes | Yes |
| Scan Delay | 1 sec to 300 sec in 1 sec<br>increments | 1 sec to 300 sec in 1 sec<br>increments | 1 sec increments starting at 1<br>sec. Max unknown |
| Test Inject | Yes | Yes | Yes |
| Syringe Heat<br>Maintainer | Yes | Yes | Yes |
| Flow Profile Display | Yes | Yes | Yes |
| Imaging System<br>Interface (ISI)<br>Functionality | Yes | Yes | Yes |
| Protocol specialization | The P3T CardiacFlow software<br>accessory computes individual | N/A | The OptiBolus software feature<br>is used to enable an exponential |
| Feature | Proposed Device: | Predicate Device: | Predicate Device: |
| | Stellant CT Injector System | Stellant CT Injector System | Mallinckrodt OptiVantage |
| | with P3T CardiacFlow | with ISI Accessory (K033881) | DH Power Injector with |
| | Accessory | | OptiBolus (K042744) |
| | contrast injection protocols | | decaying flow rate injection that |
| | and scan timing, based on | | will optimize the contrast usage |
| | patient characteristics, scanner | | and provide an extended |
| | parameters and contrast | | period of uniform |
| | concentration. | | enhancement. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEC 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDRAD, Inc. c/o Ms. Lisa M. Casavant Sr. Regulatory Affairs Specialist One Medrad Drive Indianola, PA 15051

Re: K072886

Stellant CT Injector System with Personalized Patient Protocol Technology (P3T) Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: October 4, 2007 Received: October 9, 2007

Dear Ms. Casavant:

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 (PMA), 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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Page 2 - Ms. Lisa M. Casavant

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

M. L. Williams

for 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): K072886

Device Name: MEDRAD Stellant CT Injector System with Personalized Patient Protocol Technology (P3T)

#### Indications for Use:

The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.

The Stellant P3T software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition.

The Stellant P3T software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.

## Contraindications:

Stellant P3T is not intended for use in Ungated CT angiography of the Right heart, Pulmonary trunk and Pulmonary Arteries for assessment of thrombo-emboli (dedicated Pulmonary Embolism (PE) studies), for angiography of the head/neck vessels, or for peripheral angiography.

The P3T feature on the Stellant CT Injector is not intended for use on patients with compromised renal or some other contrast adverse related health issue.

Prescription Use X (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 OF NEEDED)

M. . Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**

# Division of Cardiovascular Devices

510(k) Number. k072886