The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Imaging System Interface (ISI)

The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.

Device Description

The MEDRAD Mark 7 Arterion Iniector 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.

AI/ML Overview

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the MEDRAD Mark 7 Arterion Injection System:

It's important to note that this 510(k) submission is for an administrative update to include an Imaging System Interface (ISI) module in the Indications for Use. Therefore, the information related to comprehensive acceptance criteria and standalone performance studies for the core injection system itself is not present in this document, as it refers back to previous 510(k) clearances.

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is an administrative update and points to a previously cleared predicate device (K132928) for performance, there are no new acceptance criteria or reported device performance metrics specifically established or tested for this submission. The document explicitly states:

"Verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective. Performance testing performed with MEDRAD Mark 7 Arterion Injection System which was provided in previous 510(k)s remains applicable."

However, the comparison table (Table 1) provides the specifications of the device, which can be seen as the operational parameters that the device is designed to meet.

Parameter	Predicate Device Specification (K132928)	Proposed Device Specification
Indications for Use	Injecting contrast medium and common flushing solutions into humans for angiographic studies.	Same, PLUS ISI option indicated for interfacing with an angiography imaging system.
Fill Volume	1 – 150 ml in 1 ml increments	Same
Fill Speed (user)	1 — 10 ml/sec	Same
Fill Speed (manual control by user)	1 - 20 ml/sec	Same
Fixed Flow Rate	0.1 to 45.0 ml/sec in 0.1 ml increments (Single and Phased protocols); 0.1 to 59.9 ml/min in 0.1 ml/min increments (ml/m protocol)	Same
Variable Flow Rate	1.0 – 10.0 ml/sec in 0.1 ml/sec increments	Same
Flow Rate Rise Time	0.0 to 9.9 seconds in 0.1sec increments	Same
Delay	0.0 to 9.9 seconds in 0.1sec increments	Same
Pressure Limit (150 ml syringe)	100-1200 psi or 689-8273 kPa in increments of 1 psi (kPa)	Same
Syringe Heat Maintainer	35°C ± 5°C	Same
Protocol Memory	40 protocols	Same
Injection History Memory	50 injections	Same
Information Display	Color LCD	Same
Programming Keys	Software-generated via an LCD touch screen	Same
Touch Screen	Yes	Same
Multi-Phase	4 phases per protocol	Same
Arming Modes	Single and Multi-arming modes	Same
Syringe System	Single (150 ml) syringe	Same
Manual Retract Control	Yes	Same
Check for Air Control	Yes	Same
Variable Flow Option	Yes	Same
Hand Switch (start switch)	Yes	Same
Foot Switch (start switch)	Yes	Same
Variable Flow Hand Controller	Yes	Same
Splash Guard	Yes	Same
Wiper Seal	Optional	Same

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/Not provided in this document. This submission is an administrative update and did not involve new performance testing. It refers to previous 510(k)s for performance data.
- Data Provenance: Not applicable/Not provided in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for an administrative update and did not involve clinical or performance studies requiring expert-established ground truth.
Adjudication method for the test set:
- Not applicable. No new test set was evaluated for this submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done or is relevant. This device is an angiographic injector, not an AI-assisted diagnostic or decision support system. The update is purely administrative to expand the indications for use of the ISI module.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done or is relevant for this submission. The device is a hardware/software system for injecting contrast media, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable to this administrative update. Performance data for the core device relies on engineering and functional testing, not diagnostic ground truth.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense. The software in the injector is control software, not a learning algorithm.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary of Device and Submission Type:

This 510(k) (K193028) is a Special 510(k) Premarket Notification for an administrative update to the MEDRAD Mark 7 Arterion Injection System. The core device functions and performance are unchanged from its predicate (K132928). The modification solely adds the "Imaging System Interface (ISI) option" to the Indications for Use, allowing the injector to interface with angiography imaging systems. Because the changes are administrative and do not impact the fundamental scientific technology, principle of operation, or introduce new issues of safety and effectiveness, no new performance testing, clinical testing, or studies described in your prompt (e.g., MRMC, standalone algorithm performance, expert ground truth, training/test sets) were required for this specific submission. The FDA's clearance is based on the substantial equivalence to the predicate device, including its previously demonstrated performance.

Summary

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December 5, 2019 Bayer Medical Care Inc. Kelly Frank Project Manager 1 Bayer Drive Indianola, Pennsylvania 15051

Re: K193028

Trade/Device Name: MEDRAD Mark 7 Arterion Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: November 4, 2019 Received: November 5, 2019

Dear Kelly Frank:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193028

Device Name MEDRAD Mark 7 Arterion Injection System

Indications for Use (Describe)

MEDRAD® Mark 7 Arterion Injection System

The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Imaging System Interface (ISI)

The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Bayer Medical Care, Inc.1 Bayer DriveIndianola, PA 15051
Contact Person:	Kelly FrankProject ManagerPhone: (412) 576-7583Email: kelly.frank@bayer.com
Date Prepared:	October 24, 2019
Device Trade Name:	MEDRAD® Mark 7 Arterion InjectionSystem
Common Name:	Angiographic Injector and Syringe
Classification Name:	Injector and Syringe, Angiographic [21 CFR870.1650]
Product Code:	DXT
Classification:	Class II
Predicate Device:	The subject device is substantiallyequivalent to the following device:MEDRAD® Mark 7 Arterion InjectionSystem, K132928.

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Image /page/4/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are in a dark blue color. The wordmark is encircled by two curved lines, one in green and the other in blue, forming a ring around the name.

Device Description:

Indications for Use:

MEDRAD Mark 7 Arterion Injection System

The MEDRAD Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Imaging System Interface (ISI)

The ISI option is indicated for the specific purpose of allowing a MEDRAD Mark 7 Arterion Injection System to interface with an angiography imaging system.

Comparison to the Predicate Device:

The modification is an administrative update to include mention of the ISI (Imaging System Interface) module in the Indications for Use for the MEDRAD Mark 7 Arterion Injection System. This update does not involve any changes to the MEDRAD Mark 7 Arterion Injection System Syringe Kit. Table 1 provides a comparison of the proposed MEDRAD Mark 7 Arterion Injection System with the predicate device, the MEDRAD Mark 7 Arterion Injection System cleared per K132928.

The fundamental scientific technology, principle of operation, and intended use are unchanged from the predicate device, the MEDRAD Mark 7 Arterion Injection System cleared per K132928. The differences between the proposed device and the predicate device do not introduce new issues of safety and effectiveness.

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Image /page/5/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are a dark blue color. The wordmark is encircled by a ring that is green on the top half and blue on the bottom half.

Table 1. Comparison of MEDRAD Mark 7 Arterion Injection System (proposed device) with predicate device.

PARAMETER	PREDICATEDEVICE	PROPOSEDDEVICE	RATIONALE FORCHANGE
	Mark 7 ArterionInjection System(K132928)	Mark 7 ArterionInjection System
Indications forUse	The MEDRAD Mark 7Arterion InjectionSystem is intended tobe used specificallyfor the purposes ofinjecting contrastmedium and commonflushing solutions intohumans forangiographic studies.	The MEDRAD Mark7 Arterion InjectionSystem is indicatedto be usedspecifically for thepurposes of injectingcontrast medium andcommon flushingsolutions intohumans forangiographic studies.The ISI option isindicated for thespecific purpose ofallowing a MEDRADMark 7 ArterionInjection System tointerface with anangiography imagingsystem.	Administrativeupdate to add ISImodule specificindications for usestatement
Fill Volume	1 – 150 ml in 1 mlincrements	Same	No change
Fill Speed (user)	1 — 10 ml/sec	Same	No change
PARAMETER	PREDICATEDEVICEMark 7 ArterionInjection System(K132928)	PROPOSEDDEVICEMark 7 ArterionInjection System	RATIONALE FORCHANGE
configurable forAutoFill)
Fill Speed(manual controlby user)	1 - 20 ml/sec	Same	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 (ml/mprotocol)	Same	No change
Variable FlowRate	1.0 – 10.0 ml/sec in0.1 ml/secincrements	Same	No change
Flow Rate RiseTime	0.0 to 9.9 seconds in0.1sec increments	Same	No change
Delay	0.0 to 9.9 seconds in0.1sec increments	Same	No change
Pressure Limit(150 ml syringe)	100-1200 psi or 689-8273 kPa inincrements of 1 psi(kPa)	Same	No change
Syringe HeatMaintainer	35°C + 5°C	Same	No change
Protocol Memory	40 protocols	Same	No change
Injection History	50 injections	Same	No change
PARAMETER	PREDICATEDEVICEMark 7 ArterionInjection System(K132928)	PROPOSEDDEVICEMark 7 ArterionInjection System	RATIONALE FORCHANGE
Memory
InformationDisplay	Color LCD	Same	No change
ProgrammingKeys	Software-generatedvia an LCD touchscreen	Same	No change
Touch Screen	Yes	Same	No change
Multi-Phase	4 phases per protocol	Same	No change
Arming Modes	Single and Multi-arming modes	Same	No change
Syringe System	Single (150 ml)syringe	Same	No change
Manual RetractControl	Yes	Same	No change
Check for AirControl	Yes	Same	No change
Variable FlowOption	Yes	Same	No change
Hand Switch(start switch)	Yes	Same	No change
Foot Switch(start switch)	Yes	Same	No change
Variable FlowHand Controller	Yes	Same	No change
Splash Guard	Yes	Same	No change
Wiper Seal	Optional	Same	No change

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Image /page/6/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are arranged in the center of a circle that is divided into two halves. The top half of the circle is green, and the bottom half is blue.

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Image /page/7/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically in a bold, sans-serif font. The letters are arranged in the center of a circle that is divided into two halves. The top half of the circle is green, and the bottom half is blue.

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Image /page/8/Picture/1 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with each letter in a bold, sans-serif font. The word is enclosed in a circular shape, with the top half of the circle being green and the bottom half being blue. The logo is simple and modern, and the colors are bright and eye-catching.

Performance Data:

Verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective. Performance testing performed with MEDRAD Mark 7 Arterion Injection System which was provided in previous 510(k)s remains applicable.

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes.

Clinical Testing:

No clinical testing was required or performed to support this Special 510(k) Premarket Notification.

Conclusion:

Bayer Medical Care Inc. considers the MEDRAD Mark 7 Arterion Injection System to be substantially equivalent to the predicate device listed above. The fundamental scientific technology, principle of operation, and intended use are unchanged from the predicate device. The differences between the proposed device and the predicate device do not introduce new issues of safety and effectiveness.

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.