K Number
K082458
Device Name
P3T ABDOMEN
Manufacturer
Date Cleared
2008-10-17

(52 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
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.
More Information

No
The description focuses on automating calculations based on patient characteristics and contrast concentration, which is a rule-based or algorithmic approach, not explicitly mentioning or implying AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

No.
The device calculates contrast injection protocols for imaging, which is a diagnostic aid, not a therapeutic intervention.

No

Explanation: The device is designed to calculate contrast injection protocols for CT angiography. It does not analyze medical images or patient data to identify or diagnose diseases or conditions. Its function is to facilitate imaging, not interpret the results of imaging for diagnostic purposes.

Yes

The device is explicitly described as a "software application for use on a laptop computer" and its function is limited to calculating injection protocols, which is a software-based task. While it interacts with an injector system, it does not include or modify the hardware of the injector.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The P3T™ Abdomen software calculates contrast injection protocols for CT angiography. It does not analyze biological samples or provide diagnostic information based on those samples. Its function is to optimize the delivery of contrast agent during an imaging procedure.
  • Input: The input is patient characteristics and contrast concentration, not biological samples.
  • Output: The output is a calculated injection protocol, not a diagnostic result.

The device is a software application that aids in a medical imaging procedure, specifically CT angiography, by optimizing the contrast injection. This falls under the category of medical devices, but not specifically in vitro diagnostics.

N/A

Intended Use / Indications for Use

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).

Product codes

JAK, DXT

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT angiography

Anatomical Site

abdominal organs (i.e., liver, pancreas, kidneys)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

0

OCT 1 7 2008

510(K) SUMMARY

| OFFICIAL CONTACT: | Lisa M. Casavant
Sr. Regulatory Affairs Specialist
MEDRAD, Inc.
One MEDRAD Drive
Indianola, PA 15051
(412) 767-2400 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™
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.

1

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

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

2

:

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

3

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.

4

Page 2

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
Other240-276-0100

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 (800) 638-2041 or (240) 276-3150 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

5

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