Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration" and "generating patient-specific contrast injection protocols". While this involves computation and personalization, there is no explicit mention of AI, ML, or related terms, nor is there information about training or test data sets which are typical for AI/ML devices. The language suggests a rule-based or algorithmic approach rather than a learning-based one.

Therapeutic

No.
The device is used to compute contrast injection protocols for diagnostic imaging, not for treating a disease or medical condition.

Diagnostic

No
The device is an injector system designed to deliver contrast media for diagnostic studies (CT angiography), and the P3T Cardiac software calculates injection protocols, but it does not diagnose a disease or condition itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states that P3T™ Cardiac is an "optional, password-enabled software accessory" to the "MEDRAD Stellant CT Injector System," which is described as a "syringe-based fluid delivery system." This indicates the device is a combination product involving both hardware (the injector system) and software (P3T™ Cardiac).

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs are used to examine specimens derived from the human body. The description clearly states that this device is a "syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures" and is used for "injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications." It is directly interacting with the patient's body by injecting a substance, not analyzing a sample taken from the body.
The intended use and indications for use describe a process performed on the patient. The device computes injection protocols and scan timing for CT Angiography, which is a medical imaging procedure performed on a living patient.
The device description focuses on the injection system and software for protocol generation. There is no mention of analyzing blood, tissue, or any other biological sample.

Therefore, this device falls under the category of a medical device used for imaging procedures, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

INTENDED USE: P3T™ Cardiac is intended for use with CT Angiography. P3T™ Cardiac 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.

INDICATIONS FOR USE: P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.

Product codes

DXT

Device Description

The MEDRAD Stellant CT Injector System with P3T™ Cardiac 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 includes P3T™ Cardiac, an optional, password-enabled software accessory. The injector system, when used with P3T™ Cardiac, maintains the same intended use, same operational parameters, and same labeling (with the addition of the P3T™ Cardiac operation manual), and is used in the same manner as the injector system without the software accessory.

The P3T™ Cardiac software accessory provides the convenience of generating patientspecific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT Angiography

Anatomical Site

cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.

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)

K072886

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.

Summary

0

Kb82965

JAN ] 2 2009

510(K) SUMMARY

OFFICIAL CONTACT:

Fortunato (Tito) Aldape Director of Regulatory Affairs, CT SBU MEDRAD, Inc. One MEDRAD Drive Indianola, PA 15051 (412) 767-2400 ext. 4013

CLASSIFICATION NAME:

Injector with Syringe, Angiographic

Powered Injector with Syringe

COMMON NAME(S):

PROPRIETARY NAME:

MEDRAD Stellant CT Injector System with P3TTM Cardiac

PREDICATE DEVICES:

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

Stellant Injector System

INTENDED USE: P3T™ Cardiac is intended for use with CT Angiography. P3T™ Cardiac 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.

P3TTM Cardiac Software Accessory

INTENDED USE: P3T™ Cardiac is intended for use with CT Angiography. P3T™ Cardiac 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.

INDICATIONS FOR USE: P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.

DEVICE DESCRIPTION AND COMPARISON TO PREDICATE: The MEDRAD

Stellant CT Injector System with P3T™ Cardiac 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.

1

MEDRAD Stellant CT Injector System operating software includes P3T™ Cardiac, an optional, password-enabled software accessory. The injector system, when used with P3T™ Cardiac, maintains the same intended use, same operational parameters, and same labeling (with the addition of the P3T™ Cardiac operation manual), and is used in the same manner as the injector system without the software accessory.

The P3T™ Cardiac software accessory provides the convenience of generating patientspecific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists.

The purpose of this submission is to obtain FDA clearance of the expansion of the indications of MEDRAD's previously cleared device, Stellant CT Injector System with P3T™ CardiacFlow.

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

2

Table 1: Comparison of Stellant Injector System with P3T™ CardiacFlow (K072886) to Stellant Injector System with P3T™ Cardiac.

| Feature | Proposed Device:
Stellant CT Injector System
with P3T™ Cardiac | Predicate Device:
Stellant CT Injector System
with P3T™ CardiacFlow
(K072886) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 P3T™ Cardiac software
accessory computes individual
contrast injection protocols and
scan timing, based on patient
characteristics, scanner
parameters and contrast
concentration. | 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.

3

and the comments of the comments of the comments of

4

: :

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDRAD, Inc. c/o Mr. Fortunato (Tito) Aldape Director of Regulatory Affairs, CT SBU One MEDRAD Drive Indianola, PA 15051

JAN ] 2 2009

Re: K082905

Trade/Device Name: P3TTM Cardiac Common Name: Angiographic injector and syringe Regulation Number: 21 CFR 870.1650 Regulatory Class: II Product Code: DXT Dated: December 21, 2008 Received: December 30, 2008

Dear Mr. Fortunato:

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.

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

6

Page 2 - Mr. Fortunato (Tito) Aldape

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 (240) 276-0210. 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 vours.

Duna R. Vuchiner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use

510(k) Number (if known): K082905

Device Name: P3TTM Cardiac

Indications for Use:

INTENDED USE: P3TTM Cardiac is intended for use with CT Angiography. P3TTM Cardiac 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.

INDICATIONS FOR USE: P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.

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)

Dunna D (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K082905