The OptiVantage DH Injector System with Enhanced Communication 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 Injector System with Enhanced Communication 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 DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate 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 knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives 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 DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

AI/ML Overview

The provided text is a 510(k) summary for the OptiVantage DH Injector System with Enhanced Communication. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a performance study.

The document is a submission to the FDA for market clearance, focusing on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K042744). The comparison table highlights features that are identical between the new device and the predicate. The "enhancement" mentioned is an additional layer of enforcement for existing safety features, rather than a new performance characteristic requiring a new clinical performance study with acceptance criteria.

Therefore, many of the requested details about performance studies, data provenance, expert ground truth, etc., are not present in this 510(k) summary document.

Here's a breakdown of what is and is not available in the provided text:

1. Table of acceptance criteria and reported device performance:

Not available. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy or pressure limits) against which a study's results would be measured. It rather lists specifications and features that are identical to the predicate device.

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

Not available. No performance study or test set is described.

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

Not available. Not applicable as no performance study with ground truth establishment is described.

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

Not available. Not applicable.

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

Not applicable. This device is a power injector for contrast media, not an AI-assisted diagnostic tool for human readers.

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

Not available. No standalone performance study is mentioned. The device's performance is implicit in its specifications, which are deemed substantially equivalent to the predicate device.

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

Not available. Not applicable.

8. The sample size for the training set:

Not available. Not applicable as no machine learning algorithm development is described.

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

Not available. Not applicable.

What can be extracted from the document related to "performance" and "criteria":

The document relies on substantial equivalence to a predicate device (OptiVantage DH Power Injection System, K042744). The "acceptance criteria" are implicitly that the new device performs identically or acceptably compared to the predicate for all relevant functions.

Reported Device Performance (based on comparison to predicate):

Feature	OptiVantage DH Injector System with Enhanced Communication (New Device)
Intended Use	Identical to predicate
Multi-phasic Injections	6 phases per protocol (Identical to predicate)
OptiBolus	Yes (Identical to predicate)
Protocol Storage	40 protocols (Identical to predicate)
Syringe Sizes	All Mallinckrodt 125-ml, Liebel-Flarsheim 200 ml (Identical to predicate)
Single or Dual Syringe Modality	Single syringe and Dual syringe (Identical to predicate)
Syringe Drive System	Electromechanical (Identical to predicate)
Syringe Heater	Yes (Built-in, Powerhead controlled) (Identical to predicate)
Syringe Fill Rate	2 to 15 ml/sec (Identical to predicate)
Flow Rate	0.1 to 10 ml/sec (Identical to predicate)
Max Pressure Limit	325 psi (Identical to predicate)
Pressure Limit Control	User-settable or automatic 25 psi increments (Identical to predicate)
Flushing System	Manual or via injector (Identical to predicate)
Remote Start	Yes (Identical to predicate)
Scan Delay	0-600 seconds (Identical to predicate)
Phase Delays	0-600 seconds plus Pause (Identical to predicate)
Console Controls	Touch screen Color LCD (Identical to predicate)
Power head Controls	Touch screen Color LCD (Identical to predicate)
Post Injection Readout	Yes (Identical to predicate)
OEM Interface	Relays & Optical Couplings/Serial (CAN) (Identical to predicate)
Safety Stop Mechanism	Electrical Stop when injection parameters are out of specifications (Identical to predicate)
Remote Check for Air	Yes (Identical to predicate)
Volume Remaining Display	Displayed on Power Head and Console (Identical to predicate)
Used Syringe Detection	Yes (with Enhanced Communication) (New enhancement, assumed to meet safety/function criteria)

Summary

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K063503

APR 2 7 2007

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

Dale Moore Quality Manager Phone: (513) 948-5771 Fax: (513) 948-5708 Email: dale.moore@tycohealthcare.com

3. 510(k) Preparation Date

11/15/2006

4. Device Name

Trade Name: OptiVantage DH Injector System with Enhanced Communication Common Name: Power Injector

5. Device Classification

Class II

6. Indications for Use

7. Description of Device

し、 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 knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives 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 2. and console (approximately 24-vdc).

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Console Communicates with the Power Head to program and initiate injection protocols, displays the 3. injection status, and displays a timer.
Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the 4. Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

8. Substantial Equivalence

The predicate injector to the OptiVantage DH Injector System with Enhanced Communication is the OptiVantage DH Power Injection System, 510(k) number K042744.

The OptiVantage DH Injector System with Enhanced Communication maintains the same intended use as the optivate device. It is intended to be used for the specific purpose of injecting radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System with Enhanced Communication 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 with Enhanced Communication and the predicate device consist of the same fundamental technology. They are motor driven, electromechanical devices which are software controlled. The OptiBolus function on the OptiVantage DH Injector System with Enhanced Communication and the predicate device implements a multiphasic injection method for injecting contrast media and/or saline.

The OptiVantage DH Injector System with Enhanced Communication differs from the predicate device in that it contains a product enhancement that adds a layer of enforcement for safety features found on the currently marketed predicate device.

Below is a table that compares the predicate device to the proposed OptiVantage DH Injector System with Enhanced Communication.

Feature	OptiVantage DH Injector System withEnhanced Communication (New Device)	OptiVantage DH Power InjectionSystem Predicate Device (K042744)
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	6 phases per protocol
OptiBolus	Yes	Yes
Protocol Storage	40 protocols	40 protocols
Syringe Sizes	All pre-filled volumes of Mallinckrodt125-ml syringes & Liebel-Flarsheim 200ml empty syringe	All pre-filled volumes of Mallinckrodt125-ml syringes & Liebel-Flarsheim 200ml empty syringe
Single or Dual SyringeModality	Single syringe and Dual syringe capability	Single syringe and Dual syringe capability
Syringe Drive System	Electromechanical	Electromechanical
Syringe Heater	Yes (Built-in, Powerhead controlled)	Yes (Built-in, Powerhead controlled)
Syringe Fill Rate	2 to 15 ml/sec	2 to 15 ml/sec
Flow Rate	0.1 to 10 ml/sec	0.1 to 10 ml/sec
Max Pressure Limit	325 psi	325 psi
Pressure LimitControl	User-settable or automatic25 psi increments	User-settable or automatic25 psi increments
Flushing System	Manual or via injector	Manual or via injector

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Feature	OptiVantage DH Injector System withEnhanced Communication (New Device)	OptiVantage DH Power InjectionSystem Predicate Device (K042744)
Remote Start	Yes	Yes
Scan Delay	0-600 seconds	0 - 600 seconds
Phase Delays	0 - 600 seconds plus Pause	0 - 600 seconds plus Pause
Console Controls	Touch screen Color LCD	Touch screen Color LCD
Power head Controls	Touch screen Color LCD	Touch screen Color LCD
Post Injection Readout	Yes	Yes
OEM Interface	Relays & Optical Couplings/Serial (CAN)	Relays & Optical Couplings/Serial (CAN)
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 (with Enhanced Communication)	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 & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2007

Mallinckrodt, Inc., Liebel-Flarsheim Business c/o Mr. Dale Moore Quality Manager 2111 East Galbraith Road Cincinnati, OH 45237

Re: K063503

OptiVantage DH Injector System with Enhanced Communication Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II (two) Product Code: IZQ Dated: March 30, 2007 Received: April 2, 2007

Dear Mr. Moore:

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. Ilisting 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. Dale Moore

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Varner

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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MALLINCKRODT ealthcare Divis

Attachment #14 Indications for Use

510(k) Number (if known): K063503

Device Name: OptiVantage DH Injector System with Enhanced Communication

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Dana R. Valunes

(Division Sign-Off) (Division Sign-Off)

Page 1 of 1

510(k) Number K063503

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.