(25 days)
No
The summary describes a contrast injection system with standard components and functions, and there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No.
The device is used to inject contrast media for diagnostic imaging purposes, not for treating a disease or condition.
No
The device is a contrast delivery system used to inject radiopaque contrast media to obtain diagnostic images, but it does not perform the diagnostic imaging or analysis itself. It facilitates diagnostic imaging performed by other equipment (CT).
No
The device description explicitly lists hardware components (Power Head, Power Pack, Remote Console, Syringes) that are integral to the device's function of injecting contrast media.
Based on the provided information, the ELPH Injection System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves tests performed on samples like blood, urine, tissue, etc., outside of the living body.
- ELPH System Function: The ELPH Injection System is designed to inject contrast media directly into a patient's vascular system (in vivo) to enhance diagnostic images obtained through CT. It is a delivery system for a substance used in imaging, not a device that analyzes biological specimens.
Therefore, the ELPH Injection System falls under the category of medical devices used in vivo for diagnostic imaging procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ELPH Injection System used to inject Contrast Media and a flushing solution in order to enhance X-ray images.
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.
Product codes
DXT
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- 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images, computed tomography (i.e. "CT") equipment
Anatomical Site
vascular system, venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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- 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.
1
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 | ELPH
Injector System
(New Device) | CT 8000
Digital Injection System
Predicate 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 of
Mallinckrodt 125-ml;
130-ml (L-F # 600172) | All pre-filled volumes of
Mallinckrodt 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 Panel
Buttons | 5 | 8 |
| Post Injection Readout | Yes | Yes |
| Printer Option | No | 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. |
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 and |
| Manual Knob | ||
| Programming Injections | Buttons on Console and | |
| Powerhead | 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 and flushing solutions for | ||
| the purpose of enhancing | ||
| diagnostic 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 |
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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
5
Ko22116
-. " - @ -
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)