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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the MEDRAD Stellant CT Injector System with P3TTM Cardiac. This document describes an injector system with a software accessory (P3TTM Cardiac) that computes contrast injection protocols and scan timing for CT Angiography.

Based on the content, this is not a study of an AI/ML diagnostic or prognostic device that would have specific performance metrics like sensitivity, specificity, or AUC against a ground truth dataset. Instead, it's a submission for an imaging accessory that aids in optimizing injection protocols. The submission focuses on substantial equivalence to a predicate device (MEDRAD Stellant CT Injector System with P3TTM CardiacFlow (K072886)) rather than presenting a performance study against specific acceptance criteria for diagnostic accuracy.

Therefore, many of the requested elements for a performance study (like test set size, expert ground truth, MRMC study, standalone performance, training set details) are not applicable or not present in this type of submission, as the device's function is to generate protocols, not to interpret images or diagnose conditions.

Here's a breakdown based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific quantitative "acceptance criteria" and "reported device performance" in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance" for this type of device is regulatory clearance based on substantial equivalence to a predicate device. The performance is indirectly supported by the device's functionalities being comparable or expanded from the predicate, and its ability to generate injection protocols as intended.

Key "performance" aspects discussed are functional equivalence to its predicate:

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. The P3T™ CardiacFlow software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration.
Indications	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.	The 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.
User Interface	The P3T™ software accessory can be turned on or off by the user for any given injection. The user will be required to confirm/change the suggested protocol before beginning an injection.	The P3T™ software accessory can be turned on or off by the user for any given injection. The user will be required to confirm/change the suggested protocol before beginning an injection.
Functional Equivalence	(Numerous features listed in Table 1, such as Multi-Phase, Arming Modes, Protocol Storage/Recall, Hold Capability, Safety Stop Mechanism, Syringe System, Programmed Volume, Volume Remaining Readout, Fill Rate, Flow Rate, Programmable Pressure Limit, Pause, Autofill, Retract Control, Remote Start Switch, Pressure Graph, Syringe Sensing, Autoload, Auto Dock/Retract/Advance, Protocol Lock / Remote Arming, Check for Air, Scan Delay, Test Inject, Flow Profile Display, Imaging System Interface (ISI))	All of these functionalities are listed as identical to the predicate device in Table 1.

Summary of "Acceptance": The device was deemed "substantially equivalent" to the predicate device (K072886) by the FDA, based on the comparison of features and intended use. The extension of indications to include pulmonary vasculature and abdominal aorta (beyond gated ECG acquisition) for the P3T™ Cardiac, while maintaining the same core functionality and safety features, was accepted.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. This document does not describe a clinical performance study using a test set of patient data for a diagnostic outcome. The P3T™ Cardiac software is an accessory that computes injection protocols, not interprets images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. As there is no test set for diagnostic performance, there is no need for experts to establish ground truth in this context. The "ground truth" for the device would be the accuracy of its computed injection protocols in practice, which is generally assessed through engineering validation and clinical use rather than a formal ground-truth-labeled dataset.

4. Adjudication method for the test set:

Not applicable / Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not a diagnostic AI device. An MRMC study is not relevant here. The device assists technologists in generating protocols, but not in image interpretation or diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable / Not provided in this context. While the P3T™ Cardiac software operates standalone to compute the protocol, it's explicitly stated that "The user will be required to confirm/change the suggested protocol before beginning an injection." This indicates a human-in-the-loop for final decision-making, which is part of its intended safe use. The submission focuses on the safety and functional equivalence of the injector system with the software rather than a standalone AI performance evaluation for diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided. The "ground truth" for an injection protocol computation device would involve whether the computed protocols lead to optimal image quality and patient outcomes, which is generally assured through engineering validation, simulated environments, and clinical experience/studies (not usually detailed in a 510(k) summary focused on substantial equivalence).

8. The sample size for the training set:

Not applicable / Not provided. The P3T™ Cardiac software computes protocols based on patient characteristics and scanner parameters using presumably pre-programmed algorithms or models, not a machine learning "training set" in the sense of image recognition or diagnostic AI.

9. How the ground truth for the training set was established:

Not applicable / Not provided.

Summary

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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

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.

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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.

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

Feature	Proposed Device:Stellant CT Injector Systemwith P3T™ Cardiac	Predicate Device:Stellant CT Injector Systemwith P3T™ CardiacFlow(K072886)
Intended Use	The MEDRAD Stellant CTInjector System is intended forthe specific purpose of injectingintravenous contrast media intohumans for diagnostic studies incomputed tomography (CT)applications.The P3T™ Cardiac softwareaccessory computes individualcontrast injection protocols andscan timing, based on patientcharacteristics, scannerparameters and contrastconcentration.	The MEDRAD Stellant CTInjector System is intended forthe specific purpose of injectingintravenous contrast media intohumans for diagnostic studies incomputed tomography (CT)applications.The P3T™ CardiacFlow softwareaccessory computes individualcontrast injection protocols andscan timing, based on patientcharacteristics, scannerparameters and contrastconcentration.
Indications	P3T™ Cardiac is indicated foruse with CT Angiography of thecardiac structures, coronaryarteries, chambers of the heart,pulmonary vasculature, thoracicand abdominal aorta.	The P3T™ CardiacFlow softwareaccessory is intended for use inCT angiography of cardiacstructures, including coronaryarteries, chambers of the heart,and thoracic and abdominalaorta during gated ECGacquisition.
User Interface	The P3T™ software accessorycan be turned on or off by theuser for any given injection Theuser will be required toconfirm/change the suggestedprotocol before beginning aninjection.	The P3T™ software accessorycan be turned on or off by theuser for any given injection Theuser will be required toconfirm/change the suggestedprotocol before beginning aninjection.
Single or Dual SyringeSystem	Dual syringe model	Dual syringe model
Information Display	Color LCD	Color LCD
Programming Keys	Non-dedicated keys - softwaredetermined	Non-dedicated keys - softwaredetermined
Feature	Proposed Device:Stellant CT Injector Systemwith P3T TM Cardiac	Predicate Device:Stellant CT Injector Systemwith P3TTM CardiacFlow(K072886)
Multi-Phase	Up to 6 phases per P3TTMinjection protocol	Up to 6 phases per P3TTMinjection protocol
Arming Modes	Single	Single
ProtocolStorage/RecallCapability	32 protocols	32 protocols
Hold Capability	20 minutes max.	20 minutes max.
Safety StopMechanism	Multi-layered software stopswith backup monitoring	Multi-layered software stopswith backup monitoring
Syringe System	Single syringe model: 200 mlsyringeDual syringe model: two 200 mlsyringes	Single syringe model: 200 mlsyringeDual syringe model: two 200 mlsyringes
Programmed Volume	1 to 200 ml	1 to 200 ml
Volume RemainingReadout	LED on injector head; graphicaland numeric on LCD	LED on injector head; graphicaland numeric on LCD
Fill Rate	Variable up to 10 mL/sec	Variable up to 10 mL/sec
Flow Rate	0.1mL/sec to 10.0 mL/sec	0.1mL/sec to 10.0 mL/sec
ProgrammablePressure Limit	325 psi default, user settable 50 to325 psi	325 psi default, user settable 50 to325 psi
Pause	Programmable - 1 sec to 900 sec in1 sec increments	Programmable – 1 sec to 900 sec in1 sec increments
Autofill	Fill rate 4 mL/sec	Fill rate 4 mL/sec
Retract Control	Yes (Automatic)	Yes (Automatic)
Remote Start Switch	Yes	Yes
Pressure Graph	Yes	Yes
Syringe Sensing	Yes	Yes
Autoload	Yes	Yes
AutoDock/Retract/Advance	Yes; user-selectable autodock andadvance; user-selectable auto-retract	Yes; user-selectable autodock andadvance; user-selectable auto-retract
Protocol Lock /Remote Arming	Yes	Yes
Check for Air	Yes	Yes
Scan Delay	1 sec to 300 sec in 1 secincrements	1 sec to 300 sec in 1 secincrements
Test Inject	Yes	Yes
Feature	Proposed Device:Stellant CT Injector Systemwith P3TTM Cardiac	Predicate Device:Stellant CT Injector Systemwith P3TTM CardiacFlow(K072886)
Maintainer
Flow Profile Display	Yes	Yes
Imaging SystemInterface (ISI)	Yes	Yes
Functionality

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and the comments of the comments of the comments of

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: :

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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

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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

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Indications for Use

510(k) Number (if known): K082905

Device Name: P3TTM Cardiac

Indications for Use:

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

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.