The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

Device Description

The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol.

The major components of the system are:

Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack.
Power Pack- Contains the power supply and main microprocessor. The power supply converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions.
Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses.
Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.

AI/ML Overview

The provided text describes a Special 510(k) Summary for the CT9000ADV/OptiBolus Injection System. This document focuses on demonstrating substantial equivalence to a predicate device, the CT 8000 Digital Injection System, rather than presenting a study with acceptance criteria and device performance results in the context of diagnostic accuracy or clinical outcomes.

The "study" described herein is essentially a comparison and verification effort to ensure the new device functions similarly and safely to the predicate device, especially regarding its core function of injecting contrast media. The key difference highlighted is the "OptiBolus" feature for bolus shaping.

Here's an analysis based on the provided text, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, performance-metric sense often seen in diagnostic AI/image analysis studies. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device, the CT 8000 Digital Injection System, through a comparison of features and functional specifications. The "reported device performance" is essentially that the new device meets or matches the predicate device's capabilities, with the addition of the OptiBolus feature.

Here's a table summarizing the comparison, which serves as the "performance" relative to the predicate:

Feature	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (CT9000ADV / OptiBolus)
Multi-phasic Injections	4 phases per protocol	4 phases per protocol or a single OptiBolus injection protocol
Protocol Storage	12 protocols	12 protocols
X-ray Scan Delay Timer	99 seconds	99 seconds
Syringe Sizes	All pre-filled Mallinckrodt 125-ml; Liebel-Flarsheim 200-ml	All pre-filled Mallinckrodt 125-ml; Liebel-Flarsheim 200-ml
Syringe Drive System	Electromechanical	Electromechanical
Syringe Heater	Yes	Yes
Syringe Fill Rate	2 to 15-ml/sec	2 to 15-ml/sec
Flow Rate	0.1 to 8-ml/sec	0.1 to 8-ml/sec
Max Pressure Limit	300 psi	300 psi
Pressure Limit Control	User settable	User settable
Flushing System	Manual	Manual
Remote Start	Yes	Yes
Display Technology	LCD	LCD
Program Memory	Yes	Yes
Number of Control Panel Buttons	8	8 soft-keys on touchscreen interface (same functions as predicate)
Post Injection Readout	Yes	Yes
Printer Option	Yes	Yes
Interface	Relays & Optical Couplings	Relays & Optical Couplings
Safety Stop Mechanism	Electrical Stop when injection parameters are out of spec.	Electrical Stop when injection parameters are out of spec.
Remote Control	Yes	Yes
Fill/Expel Control	Push buttons on Power Head and Manual Knob	Push buttons on Power Head and Manual Knob
Programming Injections	Buttons on Console	Buttons on Console
Volume Remaining Display	Display on Powerhead and Console	Display on Powerhead and Console
Materials	Plastic and metal	Plastic and metal
Anatomical Injection Site	Injection into venous system	Injection into venous system
Function and Purpose	Injection of X-ray contrast agents for enhanced diagnostic CT imaging	Injection of X-ray contrast agents for enhanced diagnostic CT imaging
Target Population	Humans	Humans
Sterility (Syringe)	Syringes and disposables provided sterile	Syringes and disposables provided sterile

The primary "new performance" of the CT9000ADV/OptiBolus is its ability to perform a "bolus shaping injection" with an exponential decaying flow rate, which the predicate device did not explicitly offer. The document implies this feature functions as designed due to the overall substantial equivalence and safety of the system.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This type of information is not applicable to this 510(k) submission. This is a submission for an injection system, not a diagnostic algorithm or AI device that processes medical images. There is no "test set" of patient data in the sense of accuracy studies for image interpretation. The "testing" would involve engineering verification and validation of the device's mechanical and software functions. The document does not provide details on the specific sample sizes used for internal engineering tests (e.g., number of injections performed, number of devices tested), nor the provenance of such test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. As this is an injection system, not an interpretive diagnostic device, there is no "ground truth" to be established by medical experts in the context of interpreting images or diagnosing conditions. Medical experts (e.g., radiologists) use the output of such devices (enhanced CT images) for diagnosis, but their role is not to establish "ground truth" for the device's function as an injector. The "ground truth" for an injector would be its mechanical and software precision and safety, verified through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" requiring adjudication by multiple experts in this context.

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

This is not applicable. MRMC studies are used for evaluating diagnostic performance of image interpretation systems, often comparing human readers with and without AI assistance. This document describes an imaging injection system, not an AI-based diagnostic algorithm or an image analysis tool.

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

This is not applicable. This is a hardware device with software control, not an algorithm meant to perform a diagnostic task independently. Its "performance" is inherently tied to its interaction with a human operator for programming and monitoring, and its output (contrast injection) is then utilized by other diagnostic devices.

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

For an injection system, "ground truth" would relate to the precision of its mechanical and software functions (e.g., accurately delivering programmed flow rates and volumes, maintaining pressure limits). This "ground truth" is typically established through:

Engineering specifications and tests: The device is designed and tested to meet specific mechanical, electrical, and software performance criteria.
Calibration: Ensuring the device's sensors and actuators are accurate.
Verification and validation testing: Demonstrating that the device performs its intended functions safely and effectively under various conditions.

The document does not detail the specific test methods or "ground truth" establishment for these engineering aspects, as that level of detail is typically found in design control and testing documents, not in a 510(k) summary. However, it implicitly relies on the fact that the predicate device (CT 8000) was proven safe and effective through such methods. The new features (specifically OptiBolus) would have undergone similar internal verification.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software controls the injection based on pre-programmed algorithms and user inputs, not on learned patterns from a dataset.

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

This is not applicable for the same reasons as point 8.

Summary

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1031339

JUL 1 1 2003

Special 510(k) Summary

1. Company Identification

Mallinckrodt Inc., Liebel-Flarsheim Business 2111 East Galbraith Road Cincinnati, OH 45237

Establishment Registration: 1518293

2. Contact Person

Ellis Rogers Quality Manager Phone: (513) 948-4041 Fax: (513) 948-5708

3. 510(k) Preparation Date

4/15/2003

4. Device Name

Trade Name: CT9000ADV / OptiBolus Common Name: Power Injector

5. Device Classification

Class II

6. Indications for Use

7. Description of Device

The major components of the system are:

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Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. 1. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack.
Power Pack- Contains the power supply and main microprocessor. The power supply 2. converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions.
1. Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses.
Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 4. 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.

8. Substantial Equivalence

The Predicate injector to the CT9000ADV / OptiBolus Injection System is the CT 8000 Digital Injection System, 510(k) number K912944 currently marketed under the name CT 9000ADV.

The predicate device (CT 8000 Digital Injection System) is designed to meet both the ordinary needs of the market as well as advanced needs. Both devices share the same fundamental technology. The CT9000ADV / OptiBolus version of the system however is designed to provide a bolus shaping injection. A bolus shaping injection is an injection that ramps to a set flow rate and then once achieved, begins to deay using an exponential algorithm to a preset minimum flow rate. This injection process injection patented by Drs. Heiken. Bae and Brinks.

Below is a table comparing a predicate device to the proposed CT9000ADV / OptiBolus Injection System.

Feature	CT9000ADV / OptiBolusInjector System(New Device)	CT 8000Digital Injection SystemPredicate Device(K912944)
Multi-phasic Injections	4 phases per protocol or asingle OptiBolus injectionprotocol	4 phases per protocol
Protocol Storage	12 protocols	12 protocols
X-ray Scan Delay Timer	99 seconds	99 seconds
Syringe Sizes	All pre-filled volumes ofMallinckrodt 125-ml;Liebel-Flarsheim 200-ml	All pre-filled volumes ofMallinckrodt 125-ml;Liebel-Flarsheim 200-ml
Syringe Drive System	Electromechanical	Electromechanical
Syringe Heater	Yes	Yes
Syringe Fill Rate	2 to 15-ml/sec	2 to 15-ml/sec.
Flow Rate	0.1 to 8-ml/sec	0.1 to 8-ml/sec
Max Pressure Limit	300 psi	300 psi

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Pressure Limit Control	User settable	User settable
Flushing System	Manual	Manual
Remote Start	Yes	Yes
Display Technology	LCD	LCD
Program Memory	Yes	Yes
Number of Control Panel Buttons	8 soft-keys on touchscreen interface - same functions as predicate device.	8
Post Injection Readout	Yes	Yes
Printer Option	Yes	Yes
Interface	Relays & Optical Couplings	Relays & Optical Couplings
Safety Stop Mechanism	Electrical Stop when injection parameters are out of spec.	Electrical Stop when injection parameters are out of spec.
User Interface
Remote Control	Yes	Yes
Fill/ Expel Control	Push buttons on Power Head and Manual Knob	Push buttons on Power Head and Manual Knob
Programming Injections	Buttons on Console	Buttons on Console
Volume Remaining Display	Display on Powerhead and Console	Display on Powerhead and Console
Materials	Plastic and metal	Plastic and metal
Anatomical Injection Site	Injection into venous system	Injection into venous system
Function and Purpose	The injection of X-ray contrast agents for the purpose of enhancing diagnostic CT imaging of humans.	The injection of X-ray contrast agents for the purpose of enhancing diagnostic CT imaging of humans.
Target Population	Humans	Humans
Sterility (Syringe)	Injectors are not sterile products, Syringes and Disposables are provided sterile	Injectors are not sterile products, Syringes and Disposables are provided sterile

ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle is blank. Inside the circle is a symbol that looks like three curved lines.

JUL 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mallinckrodt, Inc. c/o Mr. Ellis Rogers Liebel-Flarsheim 2111 E. Galbraith Road Cincinnati, OH 45237

Re: K031339

CT9000ADV/OptiBolus Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 11, 2003 Received: June 17, 2003

Dear Mr. Rogers:

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. Iisting 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 - Mr. Ellis Rogers

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

XQaletu

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

Enclosure

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2. Statement of Indications

The intended use of the CT9000ADV / OptiBolus Injection System is the same as the predicate CT 8000 Digital Injection System.

Indications for Use: The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

NOCeTM

510(k) Number LOSS

Prescription Use Only

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.