The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

Device Description

The OptiVantage DH Injection System delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage is made up of the following major components:

Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
Power Supply- The power supply converts the line voltage to the working voltage for the power . head and console (approximately 24-vdc).
Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer.
Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "OptiVantage DH Injection System." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to clinical performance, diagnostic accuracy, or similar aspects that would typically involve statistical metrics (like sensitivity, specificity, AUC) and expert review.

Instead, the document focuses on design and functional equivalence to a predicate device. The "features" table (sections 8 and 9) compares technical specifications and functionalities of the new device against the predicate. The "study" referenced implicitly in this context is the comparison to the predicate device itself, aiming to demonstrate that the new device performs similarly or offers enhancements without raising new questions of safety or effectiveness.

Therefore, many of the requested fields cannot be directly answered from the provided text because such information is not present. Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicit "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output or clinical outcome. The document focuses on demonstrating substantial equivalence to a predicate device by comparing technical features. The "acceptance criteria" can be inferred as matching or improving upon the predicate device's functional specifications without introducing new safety/effectiveness concerns.

Feature / Criteria (Inferred from Predicate Comparison)	Acceptance Criteria (Implicit)	Reported Device Performance (OptiVantage DH)
Intended Use	Same as predicate	Intended to be used for injecting radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with CT equipment. (Matches predicate)
Multi-phasic Injections	At least 4 phases per protocol (predicate performance)	6 phases per protocol (Improvement over predicate)
OptiBolus	Yes (Matches predicate)	Yes (Matches predicate)
Protocol Storage	At least 12 protocols (predicate performance)	40 protocols (Improvement over predicate)
Syringe Sizes	Accommodate Mallinckrodt 125-ml contrast syringes & Liebel-Flarsheim 200 ml empty syringe (Matches predicate)	Accommodates all pre-filled volumes of Mallinckrodt 125-ml contrast syringes & Liebel-Flarsheim 200 ml empty syringe (Matches predicate)
Single or Dual Syringe Modality	Single syringe and Dual syringe (when interfaced) (predicate performance)	Single syringe and Dual syringe capability (Improvement/simplification over predicate, as dual syringe is inherent)
Syringe Drive System	Electromechanical (Matches predicate)	Electromechanical (Matches predicate)
Syringe Heater	Yes (Matches predicate)	Yes (Matches predicate)
Syringe Fill Rate	2 to 15 ml/sec (Matches predicate)	2 to 15 ml/sec (Matches predicate)
Flow Rate	0.1 to 9.9 ml/sec (predicate performance)	0.1 to 10 ml/sec (Slight improvement/expansion of range)
Max Pressure Limit	325 psi (Matches predicate)	325 psi (Matches predicate)
Pressure Limit Control	User-settable (predicate performance)	User-settable or automatic (Improvement over predicate)
Pressure Control Increments	25 psi increments (Matches predicate)	25 psi increments (Matches predicate)
Flushing System	Manual or via injector (with interface) (predicate performance)	Manual or via injector (simplification over predicate, as dual syringe is inherent)
Scan Delay	0 - 500 seconds (predicate performance)	0 - 600 seconds (Improvement over predicate)
Phase Delays	0 - 254 seconds plus Pause (predicate performance)	0 - 600 seconds plus Pause (Improvement over predicate)
Console Controls	Touch screen Color LCD (Matches predicate)	Touch screen Color LCD (Matches predicate)
Power Head Controls	Keypad (predicate performance)	Touch screen Color LCD (Improvement over predicate)
Safety Stop Mechanism	Electrical Stop when injection parameters are out of specifications (Matches predicate)	Electrical Stop when injection parameters are out of specifications (Matches predicate)
Volume Remaining Display	Displayed on Power Head and Console (Matches predicate)	Displayed on Power Head and Console (Matches predicate)
Used Syringe Detection	Yes (Matches predicate)	Yes (Matches predicate)
Target Population	Humans (Matches predicate)	Humans (Matches predicate)
Sterility	Injectors are not sterile products; syringes and disposables are provided sterile. (Matches predicate)	Injectors are not sterile products. Syringes and Disposables are provided sterile. (Matches predicate)

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

Not applicable. This document describes a 510(k) submission based on substantial equivalence to a predicate device, focusing on design and functional comparisons. It does not refer to a clinical study with a test set of data points or patients.

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):

Not applicable. As above, no clinical test set or ground truth establishment by experts is mentioned. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate device based on its design and performance.

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

Not applicable. No test set or adjudication process is described.

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 a power injector, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This device is hardware with software control; it's not an algorithm meant for standalone performance in the diagnostic sense. Its operation is "standalone" in that it performs its injection function without continuous human intervention during the injection process itself, once programmed. However, this is not the typical meaning of "standalone" in the context of diagnostic algorithms.

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

The "ground truth" for this 510(k) pertains to the safety and effectiveness profile of the predicate device (CT9000ADV / OptiBolus Injection System, K031339). The new device demonstrates substantial equivalence by showing that its design, materials, and operational parameters are either identical or offer improvements that do not introduce new risks, aligning with the already-cleared predicate.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI models that require a training set.

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

Not applicable. As above, there is no training set for this device.

Summary

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NOV 3 0 2004

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 Email: Ellis.Rogers@TycoHealthcare.com

3. 510(k) Preparation Date

10/2/04

4. Device Name

Trade Name: OptiVantage DH Injection System Common Name: Power Injector

5. Device Classification

Class II

6. Indications for Use

7. Description of Device

. Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
Power Supply- The power supply converts the line voltage to the working voltage for the power . head and console (approximately 24-vdc).

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Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer.
Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.

8. Substantial Equivalence

The predicate injector to the OptiVantage DH Injection System is the CT9000ADV / OptiBolus Injection System, 510(k) number K031339.

The OptiVantage DH Injector System maintains the same intended use as the predicate device. It is intended to be your a goten mastiants the same micheculas as a the predicate device. In vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System consists of four main components in the same manner as the predicate device: a Power Head, a Console, a Power Supply, and Syringes. Both the OptiVantage DH Injector System and the predicate device consist of the same fundamental technology. They are motor driven, electromechanical devices which are software controlled.

The OptiVantage DH Injector System differs primarily from the predicate device in that it contains a second identical drive system as a feature to conveniently inject a flushing solution (i.e. aline) in conjunction with the main contrast injection. The flushing injection can currently be accomplished with the predicate device by interfacing to another injector (K022116). The OptiVantage DH Injector System simply offers a more convenient method for accomplishing this.

Feature	OptiVantageInjector System(New Device)	CT9000ADV / OptiBolusInjection SystemPredicate Device(K031339)
Intended Use	Intended to be used for the specificpurpose of injecting radiopaque contrastmedia into a patient's vascular system toobtain diagnostic images when used withcomputed tomography (i.e. "CT")equipment	Intended to be used for the specificpurpose of injecting radiopaque contrastmedia into a patient's vascular system toobtain diagnostic images when used withcomputed tomography (i.e. "CT")equipment
Multi-phasicInjections	6 phases per protocol	4 phases per protocol
OptiBolus	Yes	Yes
Protocol Storage	40 protocols	12 protocols
Syringe Sizes	All pre-filled volumes of Mallinckrodt125-ml contrast syringes &Liebel-Flarsheim 200 ml empty syringe	All pre-filled volumes of Mallinckrodt125-ml contrast syringes &Liebel-Flarsheim 200 ml empty syringe
Single or Dual SyringeModality	Single syringe and Dual syringe capability	Single syringe and Dual syringe (wheninterfaced)
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 10 ml/sec	0.1 to 9.9 ml/sec
Max Pressure Limit	325 psi	325 psi
Pressure Limit	User-settable or automatic	User-settable

Below is a table that compares the predicate device to the proposed OptiVantage Injection System.

and and the many of the comments of the Management of the many of the more of the many of the many of the many

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Feature	OptiVantageInjector System(New Device)	CT9000ADV / OptiBolusInjection SystemPredicate Device(K031339)
Control	25 psi increments	25 psi increments
Flushing System	Manual or via injector	Manual or via injector (with interface)
Remote Start	Yes	Yes
Scan Delay	0 - 600 seconds	0 - 500 seconds
Phase Delays	0 - 600 seconds plus Pause	0 - 254 seconds plus Pause
Console Controls	Touch screen Color LCD	Touch screen Color LCD
Power head Controls	Touch screen Color LCD	Keypad
Post Injection Readout	Yes	Yes
OEM Interface(Optional)	Relays & Optical Couplings or Serial	Relays & Optical Couplings
Safety StopMechanism	Electrical Stop when injection parametersare out of specifications	Electrical Stop when injection parametersare out of specifications
Remote Check for Air	Yes	Yes
Volume RemainingDisplay	Displayed on Power Head and Console	Displayed on Power Head and Console
Used SyringeDetection	Yes	Yes
Materials	Plastic and metal	Plastic and metal
Target Population	Humans	Humans
Sterility (Syringe)	Injectors are not sterile products. Syringesand Disposables are provided sterile.	Injectors are not sterile products. Syringesand Disposables are provided sterile.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2004

Mallinckrodt, Inc. c/o Mr. Ellis Rogers Quality Manager 2111E East Galbraith Road Cincinnati. OH 45237

K042744 Re:

OptiVantage DH Power Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: November 1, 2004 Received: November 2, 2004

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, 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 - 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 (240) 276-0120. 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 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 yours,

Duna R. Holmes

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

Enclosure ..

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Attachment 5

Indications for Use

510(k) Number (if known): K042744

Device Name: OptiVantage DH Power Injection System

Indications For Use:

× 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma P. Varlines

(Division, St ... all) Cardiovascular Devices

... Number KOA 2

Page 1 of _ 1

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.