(52 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "MEDRAD Mark 7 Arterion Injection System."
Important Note: The provided document is a 510(k) summary and an FDA clearance letter. It describes a medical device and its intended use, and indicates that substantial equivalence was demonstrated through bench and laboratory testing. However, it does not contain detailed "acceptance criteria" in the format of specific performance metrics with quantitative thresholds. Similarly, it does not describe a "study" in the sense of a clinical trial or a formal statistical evaluation of performance against clinical outcomes or expert ground truth. Instead, it details engineering tests to ensure safety and functionality.
Based on the provided information, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance (Inferred from Performance Data)
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic AI devices. Instead, the performance data section lists types of bench and laboratory tests performed to demonstrate safety and functionality. The "reported device performance" is implicitly that the device conformed to the requirements for its intended use based on these tests.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Pressure Jacket Integrity | Passed "Pressure Jacket Pressure Cycle" testing, indicating its ability to withstand operational pressures over time. |
| Syringe Interface Functionality | Passed "Pressure Jacket Syringe Insert/Remove Cycle" testing, demonstrating reliable engagement and disengagement of syringes. |
| Syringe Durability/High-Pressure Operation | Passed "Syringe High Pressure Life Use Case" testing, confirming the syringes' ability to perform under high-pressure conditions throughout their lifecycle. |
| Disposables General Use | Performed as intended in "Disposables General Use Case" testing, ensuring proper function of disposable components. |
| Drop Front Mechanism Reliability | Passed "Drop Front Engage/Disengage Cycle Test," verifying the robust operation of the drop front cone mechanism. |
| Overall System Functionality | Passed "General Use Case Verification," indicating the system operates as expected during typical usage scenarios. |
| Software Functionality & Safety | Passed "Software Verification/Validation," confirming that the software controls operate correctly and safely according to specifications. |
| Substantial Equivalence to Predicate Device | Concluded to be substantially equivalent to the predicate device based on similarities in functional design, materials, indication for use, fundamental technology, and principles of operation. |
Study Information
Given the nature of the device (an angiographic injector) and the 510(k) summary, the "study" conducted was primarily bench and laboratory testing rather than a clinical trial or an AI performance study against a clinical ground truth.
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of cases/patients. The sample sizes would have been for component cycling (e.g., number of cycles for pressure jackets, syringe insertions/removals, drop front engagements) and simulated use tests.
- Data Provenance: The testing was "bench and laboratory testing," which means it was conducted in a controlled lab environment. There is no mention of country of origin for data as it's not patient data. It was retrospective in the sense that it evaluates the manufactured device against pre-defined specifications, not prospective patient outcomes.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not Applicable. For this type of device (a powered injector), "ground truth" is typically defined by engineering specifications, safety standards, and functional requirements, not by expert consensus on clinical images or diagnoses. Engineers and quality assurance personnel would set these standards.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing a clinical ground truth, often in image interpretation studies. This device's evaluation relied on objective measurements against engineering specifications.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No. This device is an injector, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI enhancement analysis are not relevant or performed for this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, for the software component. The "Software Verification/Validation" would have tested the algorithm's performance in a standalone manner, ensuring it controls the injector's functions (e.g., flow rate, volume) accurately and safely according to its programming. However, this is for operational control, not for a diagnostic output.
-
The type of ground truth used:
- Engineering Specifications and Safety Standards. The "ground truth" was the device's ability to reliably and safely perform its intended mechanical and software functions according to predetermined engineering design specifications and relevant medical device standards.
-
The sample size for the training set:
- Not Applicable. The concept of a "training set" is usually for machine learning algorithms. This device is a mechanical and software-controlled system for fluid injection, not a learning algorithm. Its software is programmed based on engineering principles, not trained on data.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no "training set" in the AI sense, there's no ground truth derivation for it. The operational "truth" for the device's design is dictated by fluid dynamics, mechanical engineering, and safety regulations.
Summary of Device and Evaluation Approach:
The MEDRAD Mark 7 Arterion Injection System is a powered angiographic injector. Its 510(k) clearance was based on demonstrating substantial equivalence to a predicate device (K112086 Mark 7 Arterion Injector System) through robust bench and laboratory testing. This testing focused on ensuring the mechanical integrity, functional reliability, and software correctness of the modified device components (plastic seal, clear plastic cover, software modifications). The evaluation was centered on verifying that the device could safely and effectively perform its intended function of injecting contrast medium, rather than on diagnostic accuracy or AI performance.
{0}------------------------------------------------
儿们引导了
DEC 1 5 2011
Section 5 – 510(k) Summary
.
| Submitter: | MEDRAD, INC.One Medrad DriveIndianola, PA 15051 |
|---|---|
| Contact Person: | Mike BurnsideManager, Regulatory AffairsPhone: (763) 780-4555Email: 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 deviceused to inject contrast agents from a 150ml disposable syringe. Commonlyreferred to as a powered injector it is designed to allow a user to fill adisposable syringe, and perform an injection with a preprogrammedvolume and flow rate. The Arterion consists of three basic components ormodules: a Power Unit, Display Control Unit (DCU), and an injectorhead. |
| Intended Use: | The MEDRAD Mark 7 Arterion Injection System is intended to be usedspecifically for the purposes of injecting contrast medium and commonflushing solutions into humans for angiographic studies. |
| Comparison topredicate: | Design changes were made to the predicate device which included: addinga plastic seal that snaps on to the pressure jacket, adding a clear plasticcover designed to fit onto the drop front cone, and software modifications. |
| Performance Data: | Bench and laboratory testing was performed to support a determination ofsubstantial equivalence to the predicate device.Results from the testing provide assurance that the proposed deviceconforms to the requirements for its intended use. This included thefollowing 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
§ 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.