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.

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.

AI/ML Overview

This submission describes a medical device, the MEDRAD Mark 7 Arterion Injection System, which is a powered injector for contrast media. The provided document is a 510(k) summary and related FDA correspondence, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a primary clinical trial or performance study report.

Based on the provided text, the device is an injection system, not an AI-powered diagnostic device, therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding performance results. Instead, it lists various types of performance data bench and laboratory testing that were performed to support substantial equivalence. The "performance" in this context refers to the device's operational characteristics and safety, not diagnostic accuracy.

Category of Testing	Reported Performance (Type of Conclusion)
Biocompatibility of Disposables	Testing included 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), and Hemocompatibility. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Device Operational Characteristics	Performed to ensure the device functions as intended. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Fluid Delivery Testing	Performed to ensure accurate and consistent delivery of contrast and flushing solutions. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Human Factors Engineering	Performed to ensure safe and effective interaction between users and the device. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Electrical Design Element Testing	Performed to ensure electrical safety and performance. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Mechanical Design Element Testing	Performed to ensure mechanical integrity and performance. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Software Verification/Validation	Performed to ensure software functions correctly and reliably. Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent.
Overall Substantial Equivalence	The MEDRAD Mark 7 Arterion Injection System is considered substantially equivalent to the predicate devices based on similarities in functional design, materials, indication for use, fundamental technology, and principles of operation.

2. Sample Size Used for the Test Set and Data Provenance

Given that this is a hardware device (injector) with software control, the "test set" does not refer to a set of medical images or patient data in the way it would for an AI diagnostic device. Instead, "testing" refers to various engineering and biocompatibility tests.

The document does not specify sample sizes for any of the listed tests (e.g., how many disposable units were tested for biocompatibility, how many injection cycles were performed for fluid delivery testing, etc.).
Data Provenance: The nature of these tests means they are typically performed in a controlled laboratory setting (bench testing) by the manufacturer. The document does not specify country of origin for the data or whether the tests were retrospective or prospective; these terms are less applicable to engineering verification and validation testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable. The device is not an AI diagnostic tool and does not generate "ground truth" through expert interpretation. The "ground truth" for its performance would be engineering specifications, established safety standards (like ISO 10993 for biocompatibility), and regulatory requirements.

4. Adjudication Method for the Test Set

This question is not applicable. There is no expert adjudication process for assessing the performance of this type of medical device in the context of this 510(k) summary. Performance is assessed against engineering specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. An MRMC study is relevant for AI diagnostic algorithms where human readers' performance is compared with and without AI assistance on a set of medical cases. This device is an injector, not a diagnostic imaging interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. While the device has software, it is part of a complete injection system that requires human operation. "Standalone" performance in the AI context refers to an algorithm's diagnostic accuracy without human intervention, which is not relevant here. The software verification/validation ensures the software components function as designed within the system.

7. The Type of Ground Truth Used

For an injection system, "ground truth" refers to the established engineering specifications and safety standards that the device must meet.

Engineering Specifications: E.g., precise fluid volume delivery, flow rate accuracy, pressure limits, mechanical durability, electrical safety parameters.
Safety Standards: Such as those for biocompatibility (ISO 10993 series for disposables), electrical safety, and electromagnetic compatibility.
The results of internal bench and laboratory testing are compared against these predetermined specifications and standards.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI/ML model that learns from a "training set" of data. Its functionality is based on predefined programming and mechanical/electrical design, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as #8. There is no training set or associated ground truth for a device of this nature.

Summary

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年112086

OCT 1 4 2011

Section 16 – 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:	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 SystemK050456 MEDRAD Avanta Fluid Management System
Device Description:	The MEDRAD Arterion Mark 7 is a software controlled medicaldevice used to inject contrast agents from a 150ml disposable syringe.Commonly referred to as a powered injector it is designed to allow auser to fill a disposable syringe, and perform an injection with apreprogrammed volume and flow rate. The Arterion consists of threebasic 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 beused specifically for the purposes of injecting contrast medium andcommon flushing solutions into humans for angiographic studies.
Comparison topredicate:	Design changes were made to the predicate device which included:newer technology for the display/user interface encompassingassociated software changes or enhancements, architectural changes tothe injector head (front load of the syringe), and modernization of thepower supply. The device is lighter in weight and also has a smallerimprint for ease of placement and movement.

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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.

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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

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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

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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

Regulation Number and Section

§ 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.