(158 days)
No
The description focuses on electromechanical components and standard control systems for contrast injection, with no mention of AI or ML.
No
The device is designed to inject contrast media for diagnostic images, not to treat a disease or condition.
No
This device is a contrast delivery system designed to inject contrast media for obtaining diagnostic images. It is not a diagnostic device itself; it aids in the process of generating images which are then used for diagnosis by other devices (e.g., CT equipment).
No
The device description clearly outlines multiple hardware components including a Power Head with electromechanical syringe drive systems, a Power Supply, a Console, and Syringes. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The OptiVantage DH Injector System is designed to inject contrast media into a patient's vascular system within the body. It is a delivery system, not a test that analyzes a sample outside the body.
- Intended Use: The intended use clearly states it's for injecting contrast media to obtain diagnostic images when used with CT equipment. This is an in-vivo (within the living organism) procedure.
Therefore, the OptiVantage DH Injector System is a medical device used in conjunction with imaging equipment for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IZQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (i.e. "CT") equipment
Anatomical Site
patient's vascular 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)
Not Found
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
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
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.
7. Description of Device
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:
- 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).
1
- 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 with
Enhanced Communication (New Device) | OptiVantage DH Power Injection
System Predicate Device (K042744) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 | 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 |
| Multi-phasic
Injections | 6 phases per protocol | 6 phases per protocol |
| OptiBolus | Yes | Yes |
| Protocol Storage | 40 protocols | 40 protocols |
| Syringe Sizes | All pre-filled volumes of Mallinckrodt
125-ml syringes & Liebel-Flarsheim 200
ml empty syringe | All pre-filled volumes of Mallinckrodt
125-ml syringes & Liebel-Flarsheim 200
ml empty syringe |
| Single or Dual Syringe
Modality | 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 Limit
Control | User-settable or automatic
25 psi increments | User-settable or automatic
25 psi increments |
| Flushing System | Manual or via injector | Manual or via injector |
2
| Feature | OptiVantage DH Injector System with
Enhanced Communication (New Device) | OptiVantage DH Power Injection
System 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 Stop
Mechanism | Electrical Stop when injection parameters
are out of specifications | Electrical Stop when injection parameters
are out of specifications |
| Remote Check for Air | Yes | Yes |
| Volume Remaining
Display | Displayed on Power Head and Console | Displayed on Power Head and Console |
| Used Syringe
Detection | Yes (with Enhanced Communication) | Yes |
| Materials | Plastic and metal | Plastic and metal |
| 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
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.
4
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
5
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:
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.
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