P3T ABDOMEN

K082458 · Medrad, Inc. · JAK · Oct 17, 2008 · Radiology

Device Facts

• Record ID: K082458
• Device Name: P3T ABDOMEN
• Applicant: Medrad, Inc.
• Product Code: JAK · Radiology
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

P3T™ Abdomen automates the calculation of individual contrast injection protocols, based on patient characteristics and contrast concentration. P3T™ Abdomen is a software application for use on a laptop computer. P3T™ Abdomen is indicated for use with CT angiography of abdominal organs (i.e., liver, pancreas, kidneys).

Device Story

P3T™ Abdomen is a software application running on a laptop computer in a CT control room. It automates the calculation of contrast injection protocols based on patient characteristics and contrast concentration. The clinician inputs patient data into the laptop; the software computes a protocol; the clinician manually enters this protocol into a separate Stellant CT Injector System. The injector system requires the user to approve and lock the protocol before injection. The device assists clinicians in standardizing contrast delivery for abdominal CT angiography. It does not control the injector directly; the practitioner retains the ability to modify or delete any computed protocol. Benefits include automated, personalized injection protocols for abdominal imaging.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Software application for laptop computer. Operates independently of the Stellant CT Injector System. Provides protocol calculation for contrast injection. Does not support DualFlow functionality. Enables three phases: test inject and two diagnostic phases (contrast and saline flush).

Indications for Use

Indicated for patients undergoing CT angiography of abdominal organs, including liver, pancreas, and kidneys. No contraindications stated.

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

• MEDRAD Stellant CT Injector System with P3T™ CardiacFlow (K072886)

Submission Summary (Full Text)

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# OCT 1 7 2008

## 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 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic |
| COMMON NAME(S): | Powered Injector with Syringe (Accessory) |
| PROPRIETARY NAME: | P3T™ Abdomen |
| PREDICATE DEVICES: | MEDRAD Stellant CT Injector System with P3T™<br>CardiacFlow (K072886) |

INTENDED USE: P3T™ Abdomen automates the calculation of individual contrast injection protocols, based on patient characteristics and contrast concentration. P3T™ Abdomen is a software application for use on a laptop computer.

INDICATIONS FOR USE: P3T™ Abdomen is indicated for use with CT angiography of abdominal organs (i.e., liver, pancreas, kidneys).

## DEVICE DESCRIPTION AND COMPARISON TO PREDICATE:

Similar to the predicate device, P3T™ Abdomen automates the calculation of individual contrast injection protocols for CT imaging, based on patient characteristics and contrast concentration. Different from the predicate device, P3T™ Abdomen is intended for imaging of the abdominal region and operates on a laptop computer in the control room.

The Stellant Injector System operating software has not been modified for P3T™ Abdomen. The injector system, when used in conjunction with the P3T™ Abdomen laptop computer application, maintains the same intended use, same operational parameters, and same labeling. Every protocol generated by the P3T™ Abdomen laptop application must be manually entered into the injector. The Stellant Injector System user interface has not been modified for P3T Abdomen. The injector continues to enable modification or deletion of the protocol, and requires the user to approve and lock the protocol prior to injection. The practitioner always has the option of modifying or deleting the P3T™ Abdomen computed protocol.

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

| Feature | Proposed Device:<br>P3TTM Abdomen | Predicate Device:<br>P3TTM CardiacFlow on Stellant<br>CT Injector System (K072886) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | P3TTM Abdomen automates the<br>calculation of individual contrast<br>injection protocols, based on<br>patient characteristics and contrast<br>concentration. P3TTM Abdomen is<br>a software application for use on a<br>laptop computer.<br>P3TTM Abdomen is indicated for<br>use with CT angiography of<br>abdominal organs (i.e., liver,<br>pancreas, kidneys). | The P3TTM CardiacFlow software<br>computes individual contrast<br>injection protocols and scan<br>timing, based on patient<br>characteristics, scanner<br>parameters and contrast<br>concentration.<br>The P3TTM CardiacFlow software<br>is intended for use in CT<br>angiography of cardiac structures,<br>including coronary arteries,<br>chambers of the heart, and<br>thoracic and abdominal aorta<br>during gated ECG acquisition. |
| Location of<br>Application | The P3TTM Abdomen software runs<br>on a laptop computer in the control<br>room, and has no impact on the<br>operation of the Stellant Injector.<br>The user will continue to be<br>required to confirm the protocol<br>entered into the injector before<br>beginning an injection. | The P3TTM CardiacFlow software is<br>contained within the Stellant<br>Injector operating software. The<br>P3T TM CardiacFlow software can<br>be turned on or off by the user for<br>any given injection. The user will<br>be required to confirm the<br>suggested protocol before<br>beginning an injection. |
| Dosing<br>method | P3TTM Abdomen allows the user<br>to select from three dosing<br>methods. | P3TTM CardiacFlow has a<br>predetermined dosing method. |

P3T™ Abdomen prevents the user

from setting a flow rate or

Flow Rate

Limiting

If P3T™ CardiacFlow calculates a

flow rate that exceeds the preset

Table 1: Comparison of P3T™ Abdomen Laptop Computer Application to P3T CardiacFlow on Stellant CT Injector System (K072886)

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:

| Feature | Proposed Device:<br>P3TTM Abdomen | Predicate Device:<br>P3TTM CardiacFlow on Stellant<br>CT Injector System (K072886) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | injection duration value that<br>would cause result in a flow rate<br>that exceeds the preset maximum<br>flow rate. | maximum flow rate, it modifies<br>(reduces) the flow rate. |
| Delivery<br>Programming | P3TTM Abdomen allows the user<br>to enter a flow rate or to create a<br>protocol based on injection<br>duration. | P3TTM CardiacFlow creates a<br>protocol based on flow rate. |
| Number of<br>Phases | P3TTM Abdomen enables three<br>phases, a test inject phase and two<br>diagnostic phases (contrast and<br>saline flush). | P3TTM CardiacFlow enables up to<br>seven phases including a test<br>inject phase, test bolus phase, and<br>multiple diagnostic phases. |
| DualFlow<br>Functionality | P3TTM Abdomen does not support<br>DualFlow functionality. | P3TTM CardiacFlow implements<br>DualFlow functionality (phases<br>with simultaneous injection of<br>contrast and saline). |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 7 2008

MEDRAD, INC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K082458

Trade/Device Name: P3T™ Abdomen Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, DXT Dated: October 6, 2008 Received: October 7, 2008

Dear Mr. Job:

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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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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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,

Jaque M. Zhang

Joyce M. Whang, Ph.D. Acting 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 (if known): K082458

Device Name: P3T™ Abdomen

### Indications for Use:

P3T™ Abdomen automates the calculation of individual contrast injection protocols, based on patient characteristics and contrast concentration. P3T™ Abdomen is a software application for use on a laptop computer.

P3T™ Abdomen is indicated for use with CT angiography of abdominal organs (i.e., liver, pancreas, kidneys).

Contraindications (if applicable): None

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hele Resen

(Division Sign-Off)

Division of Reproductive, Abdo Radiological Devices 510(k) Number