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 Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

Device Description

The MEDRAD Mark 7 Arterion Injector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user-programmed volume and flow rate.

For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations.

When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection.

The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe.

AI/ML Overview

Below is a summary of the acceptance criteria and study information for the MEDRAD Mark 7 Arterion Injection System, MEDRAD Mark 7 Arterion Syringe, and MEDRAD Twist & Go Syringe, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria for a new clinical performance study. The "Performance Data" section in the document broadly states that "Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use."

The tables provided (Tables 1 and 2) compare the features and specifications of the proposed devices against their predicate devices. Since the changes are primarily the addition of a variable flow rate option and a new syringe configuration, the acceptance criteria are implicitly that the new features function as intended and that the core functionalities (shared with the predicate) remain equivalent.

For instance, for the "Variable Flow Rate" feature:

Acceptance Criteria (Implicit): The variable flow rate should operate within the specified range of 1.0 - 10.0 ml/sec in 0.1 ml/sec increments.
Reported Device Performance: The proposed device includes a "Variable: 1.0 - 10.0 ml/sec in 0.1 ml/sec increments". This indicates that it meets its own defined specification.

For the syringes:

Acceptance Criteria (Implicit): The pressure rating should be 1200 psi.
Reported Device Performance: The proposed MEDRAD Mark 7 Arterion Syringe and MEDRAD Twist & Go Syringe both have a "Pressure rating" of "1200 psi".

Below are the performance-related criteria explicitly mentioned in the comparison tables, and their reported performance, which demonstrates equivalence to the predicate or adherence to new specifications.

Specification / Feature	Acceptance Criteria (based on predicate or new spec)	Reported Device Performance (Proposed Device)
Fill Volume	1 - 150 ml in 1 ml increments	1 - 150 ml in 1 ml increments
Fill Speed (user configurable)	1 - 10 ml/sec	1 - 10 ml/sec
Fill Speed (manual control)	1 - 20 ml/sec	1 - 20 ml/sec
Fixed Flow Rate	0.1 to 45.0 ml/sec; 0.1 to 59.9 ml/min	0.1 to 45.0 ml/sec; 0.1 to 59.9 ml/min
Variable Flow Rate	1.0 - 10.0 ml/sec in 0.1 ml/sec increments	Variable: 1.0 - 10.0 ml/sec in 0.1 ml/sec increments
Flow Rate Rise Time	0.0 to 9.9 seconds in 0.1sec increments	0.0 to 9.9 seconds in 0.1 sec increments
Delay Time	0.0-99.9 seconds in 0.1 sec increments	0.0-99.9 seconds in 0.1 sec increments
Pressure Limit (150 ml syringe)	100-1200 psi or 689-8273 kPa	100-1200 psi or 689-8273 kPa
Syringe Heat Maintainer	$35°C \pm 5°C$	$35°C \pm 5°C$
Syringe Pressure Rating	1200 psi	1200 psi (for both MEDRAD Mark 7 Arterion Syringe and MEDRAD Twist & Go Syringe)
Sterility Assurance Level (SAL)	10-6	10-6
Shelf Life	2 years	2 years
Pyrogenicity	Non-Pyrogenic Fluid Path	Non-Pyrogenic Fluid Path
Latex content	Not made with natural rubber latex	Not made with natural rubber latex

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

The document describes "Bench and laboratory testing" and "System level testing with a MEDRAD automated injector (syringe)" but does not specify sample sizes for these tests. The provenance is internal laboratory testing ("Bench and laboratory testing"). It does not appear to be retrospective or prospective in the clinical sense, as it refers to device functionality testing.

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

This information is not provided in the document. Given that the testing detailed is "Bench and laboratory testing" focused on physical and mechanical properties, as well as software functionality, it's unlikely that ground truth in the context of expert medical interpretation (e.g., radiologist consensus) was established for these tests. The term "ground truth" as typically used in medical device AI/ML contexts does not apply here.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the tests relate to engineering performance and functional compliance, not subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed or reported. The submission describes a device for injecting contrast agents, not a diagnostic or AI-assisted interpretation tool that would typically involve human readers.

6. Standalone Performance Study:

A standalone performance study (algorithm only performance without human-in-the-loop) was not performed or reported. This device is an injector, not an AI algorithm. The performance testing evaluated the functionality of the device itself (injector and syringes) and its new variable flow rate software.

7. Type of Ground Truth Used:

The "ground truth" for the performance data in this submission would be defined by the engineering specifications and physical measurements from the bench and laboratory tests. For example, testing the pressure rating of the syringe against a known standard (1200 psi), or measuring flow rates and volumes to ensure they match programmed settings. This is distinct from ground truth based on pathology, expert consensus, or outcomes data, which are typically used for diagnostic or AI-powered devices.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The device is an electro-mechanical angiographic injector system, not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The "software-controlled" aspect implies programmed logic and control algorithms, not machine learning or AI models trained on data.

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

This information is not applicable and not provided for the same reasons as #8.

Summary

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MEDRAD, INC.

(412) 767-2400

www.ri.bayer.com

U.S.A.

One Medrad Drive

Indianola, PA 15051

K132928
JAN 23 2014

510(k) Summary

Submitter:

MEDRAD, Inc. / Bayer Medical Care, Inc. One Medrad Drive Indianola, PA 15051

Contact Person:

Lisa A. Ewing Principal Regulatory Affairs Specialist Phone: (412) 406-3780 Fax: (412) 406-4052 Email: lisa.ewing@bayer.com

Date Prepared:

Device Trade Name:

Common Name:

Classification Name:

Product Code:

Classification:

Predicate Device(s):

September 16, 2013

MEDRAD Mark 7 Arterion Injection System MEDRAD Mark 7 Arterion Syringe MEDRAD Twist & Go Syringe

Angiographic Injector and Syringe

Injector and Syringe, Angiographic [21 CFR 870.1650]

DXT

Class II

The subject devices are equivalent to the following devices: MEDRAD Mark 7 Arterion Injection System K113133, December 15, 2011 O

K112086, October 14, 2011 o

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Device Description:

MEDRAD Mark 7 Arterion Injector

MEDRAD VFlow Hand Controller

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Mark 7 Arterion Syringe and Twist & Go Syringe

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.

Intended Use:

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Comparison to Predicate:

Design changes were made to the predicate device which included: updating injector software to include a new variable flow rate option, adding a variable flow rate ("VFIow") hand controller and adding a new configuration of the Arterion Syringe, which is called the Twist and Go Syringe.

Performance Data:

Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use. This included the following testing:

. Pérformance
Safety .
EMC .
. Package Integrity
Environmental .
. Pressure, burst, wet friction testing (syringe)
System level testing with a MEDRAD . automated injector (syringe)

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Comparison Tables

Table 1. Comparison of Features in MEDRAD Mark 7 Arterion Injection System (predicate) and the modified MEDRAD Mark 7 Arterion Injection System (proposed).

Specification /Feature	Predicate Device:MEDRAD Mark 7Arterion InjectionSystem (K113133)	Proposed Device:MEDRAD Mark 7Arterion InjectionSystem	Rationale forChange
Indications for Use /Intended Use	The MEDRAD Mark7 Arterion InjectionSystem is intendedto be usedspecifically for thepurposes of injectingcontrast medium andcommon flushingsolutions intohumans forangiographic studies.	The MEDRAD Mark7 Arterion InjectionSystem is intendedto be usedspecifically for thepurposes of injectingcontrast medium andcommon flushingsolutions intohumans forangiographic studies.	No change.
Fill Volume	1 - 150 ml in 1 mlincrements	1 - 150 ml in 1 mlincrements	No change.
Fill Speed (userconfigurable forAutoFill)	1 - 10 ml/sec	1 - 10 ml/sec	No change.
Fill Speed (manualcontrol by user)	1 - 20 ml/sec	1 - 20 ml/sec	No change.
Fixed Flow Rate	0.1 to 45.0 ml/sec in0.1 ml increments(single and phasedprotocols)0.1 to 59.9 ml/min in0.1 ml/minincrements (singleml/min protocol)	0.1 to 45.0 ml/sec in0.1 ml increments(Single and Phasedprotocols)0.1 to 59.9 ml/min in0.1 ml/minincrements (ml/mprotocol)	No change.
Variable Flow Rate	N/A - not available	Variable: 1.0 - 10.0ml/sec in 0.1 ml/secincrements	Variable Flow Rateis being added as anadditional, optionalfeature to inject aset volume ofcontrast at a flowrate determined bythe hand controller.
Flow Rate Rise Time	0.0 to 9.9 seconds in0.1sec increments	0.0 to 9.9 seconds in0.1 sec increments	No change.
Delay Time	0.0-99.9 seconds in0.1 sec increments	0.0-99.9 seconds in0.1 sec increments	No change.
Pressure Limit (150ml syringe)	100-1200 psi or 689-8273 kPa inincrements of 1 psi(kPa)	100-1200 psi or 689-8273 kPa inincrements of 1 psi(kPa)	No change.

Syringe HeatMaintainer	$35°C ± 5°C$	$35°C ± 5°C$	No change.
Protocol Memory	40 Protocols	40 Protocols	No change.
Injection HistoryMemory	50 Injections	50 Injections	No change.
Information Display	Color LCD	Color LCD	No change.
Programming Keys	Software generatedvia an LCD touchscreen	Software generatedvia an LCD touchscreen	No change.
Touch Screen	Yes	Yes	No change.
Multi-Phase	4 phases perprotocol	4 phases perprotocol	No change.
Arming Modes	Single and Multiarming modes	Single and Multiarming modes	No change.
Syringe System	Single (150 ml)syringe	Single (150 ml)syringe	No change.
Manual RetractControl	Yes	Yes	No change.
Check for Air Control	Yes	Yes	No change.
Variable Flow Option	No	Yes	Variable Flow Rateis being offered asan additional,optional feature toinject a set volumeof contrast at a flowrate determined bythe hand controller.
Hand Switch(start switch)	Yes	Yes	No change.
Foot Switch(start switch)	Yes	Yes	No change.
Variable Flow HandController	No	Yes	Hand controller isbeing offered as anadditional, optionalaccessory for usewith the newvariable flow ratesoftware feature.
Splash Guard	Yes	Yes	No change.
Wiper Seal	Yes	Optional	Wiper seal is aredundant featureand is not a required

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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Table 2. Comparison of Features in MEDRAD Mark 7 Arterion Syringe (predicate), MEDRAD Mark 7 Arterion Syringe (proposed) and the MEDRAD Twist & Go Syringe (proposed).

. . . .

	Component / Feature	Predicate Device:MEDRAD Mark 7Arterion Syringe(K112086, K113133)	Proposed Device:MEDRAD Mark 7Arterion Syringe	Proposed Device:MEDRAD Twist &Go Syringe	Rationale for Change
Labeling	Intended Use	The MEDRAD Mark 7Arterion Syringe, QuickFill Tube and otherMEDRAD supplieddisposables arespecifically intended forsingle use only with theMEDRAD Mark 7Arterion InjectionSystem in the x-rayangiographyenvironment.	The MEDRAD Mark 7Arterion Syringe,Quick Fill Tube andother MEDRADsupplied disposablesare specificallyintended for single useonly with theMEDRAD Mark 7Arterion InjectionSystem forangiographic studies.	The MEDRAD Twist& Go Syringe, QuickFill Tube and otherMEDRAD supplieddisposables arespecifically intendedfor single use onlywith the MEDRADMark 7 ArterionInjection System forangiographic studies.	No change in intendeduse, only updated syringeproduct name.
	Syringe Volume	150 mL	150 mL	150 mL	No change.
	Syringe Length	8.61 inches	8.61 inches	8.61 inches	No change.
	Barrel OD	1.81 inches	1.81 inches	1.81 inches	No change.
	Barrel ID	1.60 inches	1.60 inches	1.60 inches	No change.
	FasTurn Nut atSyringe Tip	Yes	Yes	No	FasTurn Nut is notrequired for Twist & Goconnection
	Construction	Dust Cover	Yes (sized to fit syringetip with FasTurn nut)	Yes (sized to fitsyringe tip withFasTurn nut)	Yes (sized to fitsyringe tip withoutFasTurn nut)
		Tubing SetCompatibility	Connects to female lueron high pressureconnector tubing	Connects to femaleluer on high pressureconnector tubing	Connects to Twist &Go luer connector onthe MEDRAD Twist &Go High PressureConnector Tubing
		Detents	Yes, molded in tosyringe tip	Yes, molded in tosyringe tip	No

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Materials	Syringe Barrel	Polycarbonate	Polycarbonate	Polycarbonate	No change.
	Syringe Barrel ID.Coating	Silicone	Silicone	Silicone	No change.
	Plunger	Polycarbonate	Polycarbonate	Polycarbonate	No change.
	Plunger Rubber Cover	Polyisoprene	Polyisoprene	Polyisoprene	No change.
	Plunger Coating	Silicone	Silicone	Silicone	No change.
	FasTurn Nut	Polycarbonate	Polycarbonate	N/A	FasTurn Nut is notrequired for Twist & Goconnection

Packaging	Dust Cover	Polypropylene	Polypropylene	Polypropylene	No change.
	Type	Tyvek lid coveringpolystyrene tray	Tyvek lid coveringpolystyrene tray	Tyvek lid coveringpolystyrene tray	No change.

Biological	Sterilization	E-beam radiation	Gamma radiation	Gamma radiation	Updated mode ofsterilization; SAL isunchanged.
	Sterility AssuranceLevel (SAL)	10-6	10-6	10-6	No change.
	Shelf Life	2 years	2 years	2 years	No change.
	Pyrogenicity	Non-Pyrogenic FluidPath	Non-Pyrogenic FluidPath	Non-Pyrogenic FluidPath	No change.
	Latex content	Not made with naturalrubber latex	Not made with naturalrubber latex	Not made withnatural rubber latex	No change.
	Performance	Pressure rating	1200 psi	1200 psi	1200 psi

Conclusion:

MEDRAD considers the MEDRAD Mark 7 Arterion Injection System, Mark 7 Arterion Syringe and Twist & Go Syringe to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, fundamental scientific technology, and principles of operation.

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2014

MEDRAD, Inc. C/O Ms. Lisa A. Ewing Principal Regulatory Affairs Specialist One Medrad Drive Indianola, PA 1505 I

Re: K132928

Trade/Device Name: MEDRAD Mark 7 Arterion Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: DXT Dated: December 23, 2013 Received: December 24, 2013

Dear Ms. Ewing:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Lisa A. Ewing

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for 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 Statement

510(k) Number:

K132928

Device Name:

MEDRAD Mark 7 Arterion Injection System MEDRAD Mark 7 Arterion Syringe MEDRAD Twist & Go Syringe

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 2 (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)

M.A. Hillerman

Page 1 of 1

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.