(52 days)
Not Found
No
The summary describes a software-controlled powered injector with preprogrammed injection parameters, but there is no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is used to inject contrast medium for diagnostic angiographic studies, which aids in diagnosis rather than providing direct therapy.
No
The device is described as an "Injection System" specifically for "injecting contrast medium and common flushing solutions into humans for angiographic studies." It is a "powered injector" that "inject[s] contrast agents." Its purpose is to deliver substances for imaging, not to interpret or diagnose.
No
The device description explicitly states that the Arterion consists of three basic hardware components: a Power Unit, Display Control Unit (DCU), and an injector head. While it is software-controlled, it is not a software-only device.
Based on the provided information, the MEDRAD Mark 7 Arterion Injection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to inject contrast medium and flushing solutions into humans for angiographic studies. This is an in-vivo (within a living organism) procedure, not an in-vitro (outside of a living organism) diagnostic test.
- Device Description: The device is described as a powered injector used to deliver substances into the body. This aligns with in-vivo procedures.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing diagnostic tests on those samples outside of the body, which are hallmarks of IVD devices.
Therefore, the MEDRAD Mark 7 Arterion Injection System is a medical device used for in-vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Product codes
DXT
Device Description
The MEDRAD Arterion Mark 7 is a software controlled medical device used to inject contrast agents from a 150ml disposable syringe. Commonly referred to as a powered injector it is designed to allow a user to fill a disposable syringe, and perform an injection with a preprogrammed volume and flow rate. The Arterion consists of three basic components or modules: a Power Unit, Display Control Unit (DCU), and an injector head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
• Pressure Jacket Pressure Cycle
• Pressure Jacket Syringe Insert/Remove Cycle
• Syringe High Pressure Life Use Case
• Disposables General Use Case
• Drop Front Engage/Disengage Cycle Test
• General Use Case Verification
• Software Verification/Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112086 Mark 7Arteion Injector System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
儿们引导了
DEC 1 5 2011
Section 5 – 510(k) Summary
.
| Submitter: | MEDRAD, INC.
One Medrad Drive
Indianola, PA 15051 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside
Manager, Regulatory Affairs
Phone: (763) 780-4555
Email: michael.burnside@possis.com |
| Date Prepared: | December 15, 2011 |
| Trade Name: | MEDRAD Mark 7 Arterion Injection System |
| Classification: | 870.1650 |
| Product Code: | DXT |
| Predicate Device(s): | The subject device is equivalent to the following devices:
• K112086 Mark 7Arteion Injector System |
| Device Description: | The MEDRAD Arterion Mark 7 is a software controlled medical device
used to inject contrast agents from a 150ml disposable syringe. Commonly
referred to as a powered injector it is designed to allow a user to fill a
disposable syringe, and perform an injection with a preprogrammed
volume and flow rate. The Arterion consists of three basic components or
modules: a Power Unit, Display Control Unit (DCU), and an injector
head. |
| Intended Use: | The MEDRAD Mark 7 Arterion Injection System is intended to be used
specifically for the purposes of injecting contrast medium and common
flushing solutions into humans for angiographic studies. |
| Comparison to
predicate: | Design changes were made to the predicate device which included: adding
a plastic seal that snaps on to the pressure jacket, adding a clear plastic
cover designed to fit onto the drop front cone, and software modifications. |
| Performance Data: | Bench and laboratory testing was performed to support a determination of
substantial equivalence to the predicate device.
Results from the testing provide assurance that the proposed device
conforms to the requirements for its intended use. This included the
following testing:
• Pressure Jacket Pressure Cycle
• Pressure Jacket Syringe Insert/Remove Cycle
• Syringe High Pressure Life Use Case
• Disposables General Use Case
• Drop Front Engage/Disengage Cycle Test
• General Use Case Verification
• Software Verification/Validation |
1
MEDRAD considers the Mark 7 Arterion Injection System to be Conclusion: substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indication for use, fundamental technology, and principles of operation. .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 9 2012
Medrad, Inc. c/o Mr. Mike Burnside Manager, Regulatory Affairs One Medrad Drive Indianola. PA 15051
Re: K113133
Trade/Device Name: Mark 7 Arterion™ Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II (two) Product Code: DXT Dated: November 29, 2011 Received: November 30, 2011
Dear Mr. Burnside:
This letter corrects our substantially equivalent letter of December 15, 2011.
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 (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 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.
3
Page 2 – Mr. Mike Burnside
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: MEDRAD Mark 7 Arterion™ Injection System
Indications for Use:
The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the The MEDKAD Mark 7 Alterior Injoction by solutions into historial into humans for angiographic studies.
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) | |
|---|---|
| ( | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number (K113/33