(85 days)
No
The summary describes a software-controlled powered injector for contrast media, focusing on preprogrammed volume and flow rate. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is used to inject contrast medium for diagnostic angiographic studies, not to provide therapy.
No
The device is described as an injection system for contrast medium, used for angiographic studies, but it does not perform any diagnostic analysis or interpretation of medical data.
No
The device description explicitly states it 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 solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 a patient. This aligns with an in-vivo application.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the core function of an IVD.
Therefore, the MEDRAD Mark 7 Arterion Injection System is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
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 were 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, and that its' intended use has not changed from the predicate. This included the following testing:
- Biocompatibility of Disposables (neat extracts)
- Cytotoxicity (ISO 10993-5)
- Intracutaneous Reactivity (ISO 10993-10)
- Sensitization (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18)
- Hemocompatibility
- Device Operational Characteristics
- Fluid Delivery Testing
- Human Factors Engineering
- Electrical Design Element Testing
- Mechanical Design Element Testing
- Software Verification/Validation
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
年112086
OCT 1 4 2011
Section 16 – 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: | September 15, 2011 |
| Trade Name: | MEDRAD Mark 7 Arterion Injection System |
| Classification: | II |
| Product Code: | DXT |
| Predicate Device(s): | The subject device is equivalent to the following devices:
MEDRAD Mark V Provis Injection System (NFJ)
K903390 MEDRAD Mark V Plus Injection System
K050456 MEDRAD Avanta Fluid Management 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:
newer technology for the display/user interface encompassing
associated software changes or enhancements, architectural changes to
the injector head (front load of the syringe), and modernization of the
power supply. The device is lighter in weight and also has a smaller
imprint for ease of placement and movement. |
1
Performance Data Bench and laboratory testing were 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, and that its' intended use has not changed from the predicate. This included the following testing:
- . Biocompatibility of Disposables (neat extracts)
- Cytotoxicity (ISO 10993-5) o
- Intracutaneous Reactivity (ISO 10993-10) o
- Sensitization (ISO 10993-10) o
- Acute Systemic Toxicity (ISO 10993-11) o
- O Material Mediated Pyrogen (ISO 10993-11)
- Physiochemical (ISO 10993-18) o
- Hemocompatibility o
- Device Operational Characteristics �
- Fluid Delivery Testing ●
- Human Factors Engineering .
- Electrical Design Element Testing .
- Mechanical Design Element Testing .
- Software Verification/Validation ●
- MEDRAD considers the Mark 7 Arterion Injection System to be Conclusion: substantially equivalent to the predicate devices 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 a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter is not clear enough to read. The symbol in the center appears to be a stylized representation of an eagle or bird in flight, with three curved lines forming the body and wings. The image is black and white and has a slightly grainy texture.
Food and Drug Administration 10903 New Flamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 4 2011
Medrad, Inc. c/o Mr. Mike Burnside Manager, Regulatory Affairs ()ne Medrad Drive Indianola, PA 15051
Re: K112086
Trade/Device Name: MEDRAD Mark 7 Arterion™ Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injection Syringe Regulatory Class: Class II Product Code: DXT Dated: September 15, 2011 Received: September 16, 2011
Dear Mr. Burnside:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four over been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession the 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 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
3
Page 2 - Mr. Mike Burnside
(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 (OS) 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 requiration (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Skidderey years.
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): K112086
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 purposes of injecting contrast medium and common flushing solutions 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) (Div/sion Sign-Off) Division of Cardiovascular Devices 510(k) Number