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 Description

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).

AI/ML Overview

The provided document, K072886, describes the MEDRAD Stellant CT Injector System with P3T CardiacFlow software accessory. This is a premarket notification (510(k)) and primarily focuses on establishing substantial equivalence to predicate devices, rather than an independent clinical study demonstrating specific performance metrics against defined acceptance criteria. Therefore, the details requested for a clinical study proving acceptance criteria compliance are not fully available in this document.

However, based on the information provided, we can infer the acceptance criteria and some aspects of performance. The substantial equivalence argument itself serves as the "study" in this context for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the proposed device is as safe and effective as the predicate devices. The performance is reported in terms of feature comparison.

Feature / Acceptance Criteria (Implicit)	Reported Device Performance (Proposed Device)
Intended Use Equivalence	- "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." (Same as predicate)
	- The P3T CardiacFlow accessory is intended for CT angiography of cardiac structures (coronary arteries, chambers, thoracic/abdominal aorta) during gated ECG acquisition.
Operational Parameters Equivalence	- "maintains the same intended use, same operational parameters, and same labeling (with the addition of a P3T CardiacFlow operations manual)." (Page 1)
	- Multiphase: Up to 6 phases per P3T CardiacFlow injection (Comparable to predicate's 1-6 phases and 6 phases).
	- Scan Delay: 1 sec to 300 sec in 1 sec increments (Same as predicate Stellant).
Safety Architecture Integrity	- "The Stellant safety architecture has not been modified nor impacted; additionally every injection protocol must be approved and locked by the practitioner. The practitioner always has the option of modifying or deleting the P3T CardiacFlow suggested protocol." (Page 1-2)
New Feature Functionality	- The P3T CardiacFlow software accessory computes individual contrast injection protocols and scan timing based on patient characteristics, scanner parameters, and contrast concentration. This provides "the convenience of generating patient-specific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists." (Page 1) - User confirmation/change of suggested protocol is required before injection. - P3T CardiacFlow can be turned on or off (Similar to OptiBolus predicate).
Contraindications	- Not intended for Ungated CT angiography of Right heart, Pulmonary trunk, Pulmonary Arteries for PE studies, head/neck vessels, or peripheral angiography. (Clear delineation of scope)
	- Not for use on patients with compromised renal or other contrast adverse related health issue. (Clear delineation of scope)
Hardware Equivalence	- Dual syringe model (Compared to single/dual for predicate Stellant, and dual for OptiVantage).
	- Color LCD, Touch screen, Remote Start Switch, Pressure Graph, Syringe Sensing, Autoload, Autodock/Retract/Advance, Protocol Lock/Remote Arming, Check for Air, Test Inject, Syringe Heat Maintainer, Flow Profile Display, Imaging System Interface (ISI) Functionality (All present and comparable to or exceeding predicate features).

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a clinical study with a "test set" in the traditional sense of patient data used to evaluate AI performance. The evaluation is based on a comparison of device features, intended use, and operational parameters against existing legally marketed predicate devices. The provenance of any underlying data that informed the development of the P3T CardiacFlow algorithm (e.g., patient characteristics, scanner parameters, contrast concentration relationships) is not specified. It is likely based on engineering principles, scientific literature, and potentially in-house data/simulations rather than a distinct, prospectively collected, and adjudicated clinical "test set" for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable, as this device's regulatory review is based on substantial equivalence to existing devices and its operational safety and effectiveness, rather than a diagnostic AI algorithm requiring ground truth established by experts on a test set. The efficacy of the P3T CardiacFlow algorithm itself (meaning its ability to accurately compute protocols for optimal cardiac CT angiography) would presumably be verified through internal engineering and potentially pre-clinical or limited clinical testing, but these details are not provided in the 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated in point 3.

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

Not applicable. This device is an injector system with software to assist in protocol generation, not an AI diagnostic algorithm meant to be read by human readers. Therefore, an MRMC study is not relevant to its regulatory submission in this context. The benefit of the P3T CardiacFlow is stated as "increases the consistency of individualized injection protocols among technologists" (page 1).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The P3T CardiacFlow is not a standalone algorithm that operates without human intervention. The document explicitly states: "The user will be required to confirm/change the suggested protocol before beginning an injection." and "every injection protocol must be approved and locked by the practitioner. The practitioner always has the option of modifying or deleting the P3T CardiacFlow suggested protocol." (Page 1-2). This indicates a human-in-the-loop design where the algorithm provides suggestions but requires final human approval and can be overridden.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Since this is not a diagnostic device establishing a "ground truth" for a medical condition, the concept of ground truth as typically applied to diagnostic AI is not directly applicable. For the P3T CardiacFlow software, the "ground truth" for its function would be whether the computed protocols are appropriate and effective for the intended CT angiography procedures, leading to diagnostic quality images while ensuring patient safety. This "truth" would likely be established through:

Engineering validation: Demonstrating that the algorithm correctly applies the defined logic based on input parameters.
Physical modeling, simulations, and phantom studies: Verifying that the proposed injection protocols achieve desired contrast enhancement profiles.
Possibly limited clinical evaluation or literature review: Confirming that the principles underlying the algorithm lead to clinically acceptable results in practice, as informed by medical expertise in CT angiography.
However, specific details of such validation are not provided in this 510(k) summary.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a machine learning model that requires a distinct "training set" of data for learning patterns, as might be the case for image recognition algorithms. The P3T CardiacFlow computes protocols based on predefined patient characteristics, scanner parameters, and contrast concentration, likely using a programmed algorithm based on scientific principles and clinical knowledge, rather than a learned model from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

Summary

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K072886

510(K) SUMMARY

OFFICIAL CONTACT:	Lisa M. CasavantSr. Regulatory Affairs SpecialistMEDRAD, Inc.One MEDRAD DriveIndianola, PA 15051(412) 767-2400 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 P3TCardiacFlow
PREDICATE DEVICES:	MEDRAD Stellant CT Injector System with ImagingSystem Interface Module (K033881)OptiVantage DH Injection System (K042744)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.

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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 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:Stellant CT Injector Systemwith ISI Accessory (K033881)	Predicate Device:Mallinckrodt OptiVantageDH Power Injector withOptiBolus (K042744)
	The MEDRAD Stellant CTInjector System is intendedfor the specific purpose ofinjecting intravenous contrastmedia into humans fordiagnostic studies incomputed tomography (CT)applications.	The MEDRAD Stellant CTInjector System with ISIModule is intended for thespecific purpose of injectingintravenous contrast mediainto humans for diagnosticstudies in computedtomography (CT)applications.	The OptiVantage withOptiBolus software feature isdesigned to inject aradiopaque contrast mediainto a patient's vascularsystem, which enhancesdiagnostic images obtainedwith computed tomography(CT).
	The P3T CardiacFlowsoftware accessory computesindividual contrast injectionprotocols and scan timing,based on patientcharacteristics, scannerparameters and contrastconcentration.		The OptiBolus softwarefeature is used to enable anexponential decaying flowrate injection that willoptimize the contrast usageand provide an extendedperiod of uniformenhancement.
	The P3T CardiacFlowsoftware accessory is
Feature	Proposed Device:Stellant CT Injector Systemwith P3T CardiacFlowAccessory	Predicate Device:Stellant CT Injector Systemwith ISI Accessory (K033881)	Predicate Device:Mallinckrodt OptiVantageDH Power Injector withOptiBolus (K042744)
	intended for use in CTangiography of cardiacstructures, including coronaryarteries, chambers of theheart, and thoracic andabdominal aorta during gatedECG acquisition.
	The P3T CardiacFlowsoftware accessory can beturned on or off by the userfor any given injection Theuser will be required toconfirm/change the suggestedprotocol before beginning aninjection.		The OptiBolus softwarefeature can be turned on oroff by the user for any giveninjection protocol.
Single or Dual SyringeSystem	Dual syringe model	Single and dual syringemodels	Dual syringe model
Information Display	Color LCD	Color LCD	Color LCD
Programming Keys	Non-dedicated keys –software determined	Non-dedicated keys –software determined	Control panel buttons: 8 soft-keys on touchscreen interface
Touch screen	Yes	Yes	Yes
Multi-Phase	Up to 6 phases per P3TCardiacFlow injection	1 - 6 phases per injection	6 phases per injection or asingle OptiBolus injection

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mentaly
Performance, For life."

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5.12
$A_{wg} = \frac{A_w}{A_g}$
where:$A_w =$ area of water surface$A_g =$ gross surface area
5.13
Albedo 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:Stellant CT Injector Systemwith P3T CardiacFlowAccessory	Predicate Device:Stellant CT Injector Systemwith ISI Accessory (K033881)	Predicate Device:Mallinckrodt OptiVantageDH Power Injector withOptiBolus (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 autodockand advance; user-selectableauto-retract	Yes; user-selectable autodockand advance; user-selectableauto-retract	No
Protocol Lock /Remote Arming	Yes	Yes	No lock however, user mayarm at head. (May have hadrelated recall)
Check for Air	Yes	Yes	Yes
Scan Delay	1 sec to 300 sec in 1 secincrements	1 sec to 300 sec in 1 secincrements	1 sec increments starting at 1sec. Max unknown
Test Inject	Yes	Yes	Yes
Syringe HeatMaintainer	Yes	Yes	Yes
Flow Profile Display	Yes	Yes	Yes
Imaging SystemInterface (ISI)Functionality	Yes	Yes	Yes
Protocol specialization	The P3T CardiacFlow softwareaccessory computes individual	N/A	The OptiBolus software featureis 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

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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.