The ELPH Injection System is a contrast delivery system which 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 ELPH Injection System will deliver 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 ELPH is made up of the following major components: Power Head, Power Pack, Remote Console (Optional), Syringes.

AI/ML Overview

The provided document is a 510(k) summary for the ELPH Injection System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (CT 8000 Digital Injection System, later marketed as CT 9000ADV).

However, this document does not contain acceptance criteria or detailed study information that would typically be found in a performance evaluation or clinical study report. It is a regulatory submission focused on demonstrating equivalence rather than proving performance against specific criteria through a dedicated study.

Therefore, many of your requested points cannot be answered from the provided text. The document primarily focuses on a comparison of features between the new device and the predicate device to argue for substantial equivalence.

Here's how much can be extracted from the provided text based on your request:

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

The document does not explicitly state "acceptance criteria" for the ELPH Injection System in the way a performance study would. Instead, it compares the features and performance specifications of the ELPH system to its predicate device, the CT 8000 Digital Injection System. The "reported device performance" is essentially the listed specifications for the ELPH.

Feature	Acceptance Criteria (Implied by Predicate - CT 8000)	Reported Device Performance (ELPH)
Multi-phasic Injections	4 phases per protocol	Single phase
Protocol Storage	12 protocols	1 protocol
X-ray Scan Delay Timer	99 seconds	Manual, 20 minutes
Syringe Sizes	Mallinckrodt 125-ml; Liebel-Flarsheim 200-ml	Mallinckrodt 125-ml; 130-ml (L-F # 600172)
Syringe Drive System	Electromechanical	Electromechanical
Syringe Heater	Yes	No
Syringe Fill Rate	2 to 15-ml/sec	1 to 8-ml/sec
Flow Rate	0.1 to 8-ml/sec	0.1 to 6-ml/sec
Max Pressure Limit	300 psi	250 psi
Pressure Limit Control	User settable	Automatic based on flow rate
Flushing System	Manual	Manual; Automatic with interface option
Remote Start	Yes	Yes
Display Technology	LCD	LED
Program Memory	Yes	Yes
Number of Control Panel Buttons	8	5
Post Injection Readout	Yes	Yes
Printer Option	Yes	No
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	Purge/Retract trigger
Programming Injections	Buttons on Console	Buttons on Console and Powerhead
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 and flushing solutions for enhancing diagnostic imaging
Target Population	Humans	Humans
Sterility (Syringe)	Injectors not sterile, Syringes/Disposables sterile	Injectors not sterile, Syringes/Disposables sterile

Note: The "acceptance criteria" here are implied by the performance of the predicate device. The submission makes a case that the ELPH system is "less expensive, smaller and less complicated to operate" and meets "only the ordinary needs," which sometimes results in lower specifications compared to the predicate, but is still considered substantially equivalent for its intended, more focused purpose.

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

This information is not provided in the document. The document presents a comparison of device features and specifications, not data from a test set or provenance of 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 information is not provided in the document, as it does not detail a study involving expert assessment or ground truth establishment.

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

This information is not provided in the document.

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 information is not provided in the document. The device is an injection system, not an AI-powered diagnostic tool.

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

This information is not provided in the document. The device is a hardware injection system and does not appear to involve algorithms in the context of diagnostic performance.

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

This information is not provided in the document, as it does not detail a study where ground truth would be established for evaluating diagnostic performance.

8. The sample size for the training set

This information is not provided in the document. The device is a hardware injection system and the submission does not mention a training set in the context of machine learning.

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

This information is not provided in the document.

Summary

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K022116

JUL 2 6 2002

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 Manager, Plant QA Phone: (513) 948-4041 Fax: (513) 948-5708

3. 510(k) Preparation Date

6/27/2002

4. Device Name

ELPH Trade Name: Power Injector Common Name:

5. Device Classification

Class II

6. Indications for Use

The ELPH Injection System used to inject Contrast Media and a flushing solution in order to enhance X-ray images.

7. Description of Device

Power Head- Contains the electromechanical syringe drive system, the syringe holding mechanism, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and a purge/retract trigger.

Power Pack- Contains the power supply and interface. The interface is made up of relays and optical couplings that provide communication between devices. One use for the interface is to harmonize two injectors so as to provide greater contrast volume capability or a flushing solution.

Remote Console (Optional)- Communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer.

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Syringes- Accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 130-ml syringe (Part Number 600172). These syringes are commonplace on the market.

8. Substantial Equivalence

The Predicate device to the ELPH Injection System is the CT 8000 Digital Injection System (K912944), currently marketed under the name CT 9000ADV. The predicate device is designed to meet both the ordinary needs of the market as well as advanced needs. The ELPH on the other hand is designed to meet only the ordinary needs and is therefore less expensive, smaller and less complicated to operate. Features such as stored protocols, multi-phasic injections, high flow rate, and optional printer have been omitted in order to reduce cost and simplify the user interface.

With an optional interface, the ELPH Injection System may be joined with another ELPH Injector or other compatible injector. Interfacing two injectors and connecting the syringes through "Y" tubing enables greater deliverable X-ray contrast volumes. Interfacing two ELPH Injection Systems provides a maximum of 260-ml capability, while the predicate injector is limited to 200-ml. The Angiomat CT contrast injector (K860204) has been marketed by Liebel-Flarsheim and is capable of delivering up to 260-ml of contrast. The package insert for the X-ray contrast media defines the maximum allowable dose based on patient parameters.

Another application for interfacing two injectors is to provide a means to automatically flush the injection site before and/or after a contrast injection. This would be accomplished by filling one of the syringes with a flushing agent, normally saline. With the predicate device, the flush is done manually with a separate hand-held flushing syringe. Automatic flushing capability is available on other marketed injectors such as the Optistar MR Injection System, 510(k) number K984088.

Feature	ELPHInjector System(New Device)	CT 8000Digital Injection SystemPredicate Device(K912944)
Multi-phasic Injections	Single phase	4 phases per protocol
Protocol Storage	1 protocol	12 protocols
X-ray Scan Delay Timer	Manual, 20 minutes	99 seconds
Syringe Sizes	All pre-filled volumes ofMallinckrodt 125-ml;130-ml (L-F # 600172)	All pre-filled volumes ofMallinckrodt 125-ml;Liebel-Flarsheim 200-ml
Syringe Drive System	Electromechanical	Electromechanical
Syringe Heater	No	Yes
Syringe Fill Rate	1 to 8-ml/sec	2 to 15-ml/sec
Flow Rate	0.1 to 6-ml/sec	0.1 to 8-ml/sec
Max Pressure Limit	250 psi	300 psi
Pressure Limit Control	Automatic based on flow rate	User settable
Flushing System	Manual;Automatic with interface option	Manual
Remote Start	Yes	Yes
Display Technology	LED	LCD
Program Memory	Yes	Yes
Number of Control PanelButtons	5	8
Post Injection Readout	Yes	Yes
Printer Option	No	Yes
Interface	Relays & Optical Couplings	Relays & Optical Couplings
Safety Stop Mechanism	Electrical Stop when injectionparameters are out of spec.	Electrical Stop when injectionparameters are out of spec.

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

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User Interface
Remote Control	Yes	Yes
Fill/ Expel Control	Purge/Retract trigger	Push buttons on Power Head andManual Knob
Programming Injections	Buttons on Console andPowerhead	Buttons on Console
Volume Remaining Display	Display on Powerhead andConsole	Display on Powerhead andConsole
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 contrastagents and flushing solutions forthe purpose of enhancingdiagnostic imaging of humans.	The injection of X-ray contrastagents for the purpose ofenhancing diagnostic CTimaging of humans.
Target Population	Humans	Humans
Sterility (Syringe)	Injectors are not sterile products,Syringes and Disposables areprovided sterile	Injectors are not sterile products,Syringes and Disposables areprovided sterile

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mallinckrodt Inc., Liebel-Flarsheim Business Mr. Ellis Rogers Manager, Plant QA 2111 East Galbraith Road Cincinnati, OH 45237

JUL 2 6 2002

Re: K022116

ELPH Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II (two) Product Code: 74 DXT Dated: June 28, 2002 Received: July 1, 2002

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.

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. Ellis Rogers

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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). 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 yours,

Darl Tuh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko22116

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Statement of Indications 2.

The intended use of the ELPH Injection System is the same as the predicate CT 8000 Digital Injection System. ・

Indications for Use: The ELPH Injection System is a contrast delivery system which 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.

Division of Cardiovascular & Respiratory Devices
510(k) Number K022116

Prescription Use
(Per 21 CFR 801.109)

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.