ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection, - GE Healthcare Inc. contrast media as supplied in approved single dose bottles.

Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravasular administration of contrast agent.

The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.

ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol), - Bracco Diagnostics Inc, MultiHance (gadobenate dimeglumine) – Bracco Diagnostics, Inc, Clariscan™ (Gadoterate Meglumine) Injection, - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection - Guerbet, LLC, and Gadavist™ (gadobutrol) Injection, - Bayer HealthCare Pharmaceuticals Inc., contrast media as supplied in approved single dose vials.

Easy-Click-Cassette - flex Max 3 is used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.

Device Description

ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects underqoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).

The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:

. Spikes,
. Easy-Click-Cassette - flex
. Patient Tubing

The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing), ulricheasylNJECT Max is intended to be used with the following components that are not supplied with the system:

Saline containers,
Single-dose contrast media bottles, and .
. Cannula.

ulricheasylNJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulricheasyINJECT Max is provided in three models:

. ulricheasyINJECT Max 2M (XD 10140),
. ulricheasyINJECT Max 3 (XD 10150), and
. ulricheasyINJECT Max 3 (XD 10180).

The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.

AI/ML Overview

The ulricheasyINJECT Max system, a contrast media management system, underwent a comprehensive study to demonstrate its substantial equivalence to a predicate device, ulrichINJECT CT motion (K192872). The study focused on non-clinical testing to ensure its safety and effectiveness for its intended use in magnetic resonance (MR) applications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it states that "Verification results indicate that the ulricheasyINJECT Max tubing system complies with the standard" or "conforms to its predetermined specifications." The "Comparison" column in the Comparative Analysis table acts as a high-level summary of performance against the predicate.

Below is a table summarizing the areas tested and the reported performance based on the provided text:

Acceptance Criteria (Inferred)	Reported Device Performance
Conformance with established performance criteria for overall system and software.	Software verification and validation performed.
Compliance with Electromagnetic Compatibility (EMC) and Electrical Safety standards (IEC 60601-1).	Complies with FDA recognized standard ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
Sterilization to a Sterility Assurance Level (SAL) of $10^{-6}$ and appropriate shelf life.	Validated to a SAL of $10^{-6}$ using Ethylene Oxide (EtO) according to ISO 11135:2014. Real-time and accelerated aging studies performed.
Material compatibility with specified contrast media.	Chemical compatibility testing performed with Gadavist, Clariscan™, VUEWAY™, MultiHance, and Dotarem. Results support material compatibility.
Maintenance of sterility of injection media and resistance to microbial ingress.	Microbial ingress study and cross-contamination study performed. Concluded that the system maintains sterility and resists ingress. Residuals between contrast media's active compounds after rinsing are within defined limits.
Biocompatibility of indirect patient contact materials.	Verified in accordance with ISO 10993-1. Materials comply with the standard.
Conformance to predetermined specifications and applicable standards for tubing system performance.	Tested for performance and verified in accordance with applicable requirements from ISO 8536-4:2010. Conforms to predetermined specifications and applicable standards.
Absence of unacceptable leachable compounds.	Extractables and simulation testing for leachable compounds included.
Safe and effective operation by users.	Human Factors / Usability assessments performed in a simulated use environment. Results demonstrated that users can operate ulricheasyINJECT Max as safely and effectively as the predicate device.
(Differentiation from predicate that does not raise new safety/effectiveness concerns)	Extensive comparative analysis (Table in the document) highlights differences in indications for use (CT vs. MRI), environment of use (CT vs. MR), accessories, disposables, weight, dimensions, remaining volume readout, pressure limit, injection pause, priming/venting rate, air detection principle, occlusion detection alarm limit, time limit for disposables, patient tubing components, and tubing materials. For each difference, the document states: "This difference does not change the intended use of the device. The safety and effectiveness of the ulricheasyINJECT Max has been confirmed through [specific testing, e.g., MR compatibility testing, chemical compatibility testing, and Safety / EMC testing]".

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

The document does not explicitly state the numerical sample sizes for the test sets used in the non-clinical studies (e.g., number of units tested for EMC, number of samples for chemical compatibility). It refers to the tests performed and their general outcomes.

The data provenance is from non-clinical testing performed by ulrich GmbH & Co. KG, for the purpose of a 510(k) premarket notification. This indicates the data is prospective in the context of device validation. The "country of origin of the data" is not explicitly stated but the submitter is based in Ulm, Germany.

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

This information is not applicable as the described studies are non-clinical (bench testing, software validation, biocompatibility, etc.) and do not involve human readers or refer to "ground truth" in the context of expert review of clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing and comparison to a predicate device, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies described are analogous to standalone performance evaluation for the device's functional and safety aspects. The software and various physical parameters (e.g., flow rate accuracy, air detection) were tested independently of human intervention during the functional tests, demonstrating the device's inherent performance. Human Factors/Usability assessments considered human interaction but focused on the device design's safety and effectiveness, not the clinical performance of an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by recognized industry standards and predetermined specifications for device performance, safety, and material properties. Examples include:

IEC 60601-1 for electrical safety and EMC.
ISO 11135:2014 for sterilization.
ISO 10993-1 for biocompatibility.
ISO 8536-4:2010 (applicable requirements) for infusion equipment performance.
Internal predetermined specifications for aspects like flow rate accuracy ($\pm$ 5%), volume accuracy ($\pm$ 5%), air detection limit (0.05 mL), and alarm limits.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes a contrast media injector system, not an AI/ML algorithm that requires a separate training set. The "software verification and validation" refers to traditional software testing, not machine learning model training.

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

This information is not applicable as there is no mention of an AI/ML training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 19, 2024

ulrich GmbH & Co. KG % Rita King Chief Executive Officer MethodSense, Inc. 1 Copley Pkwy. Suite 130 Morrisville, North Carolina 27560

Re: K233737

Trade/Device Name: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: IZQ Dated: November 21, 2023 Received: March 21, 2024

Dear Rita King:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

Sincerelv.

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

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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) K233737

Device Name ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150): ulricheasyINJECT Max 3 (XD 10180)

Indications for Use (Describe)

Indications for Use - ulricheasyINJECT Max System (Max 2M (XD 10140) and Max 3 (XD 10150)) ulricheasylNJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for highpressure angiography.

Indications for Use - ulricheasyINJECT Max 3 (XD 10180)

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

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ulricheasylNJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Summary of 510(k)

Ulrich GmbH & Co. KG K233737

This 510(k) Summary is in conformance with 21CFR 807.92

Submitter:	ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermanyPhone: +49 731 9654-1714Fax: +49 731 9654-2807
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979
Company Contact:	Sven ErdmannVice President of Technology - Regulatory

Device Name and Classification
Trade Name:	ulricheasyINJECT Max
Common Name:	Contrast Media Management System
Classification:	Class II
Regulation Number:	21 CFR 870.1650, Angiographic Injector and Syringe
Classification Panel:	Cardiovascular Panel
Product Code:	IZQ

Predicate Device:

	Predicate
Trade Name	ulrichINJECT CT motion
Common Name	Contrast Media Management System
510(k) Submitter / Holder	Class II
510(k) Number	K192872
Regulation Number	21 CFR 870.1650, Angiographic Injector and Syringe
Classification Panel	Cardiovascular Panel
Product Code	IZQ

The predicate device has not been subject to a design-related recall.

Device Description

. Spikes,

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. Easy-Click-Cassette - flex
. Patient Tubing

Saline containers,
Single-dose contrast media bottles, and .
. Cannula.

The ulricheasyINJECT Max is provided in three models:

. ulricheasyINJECT Max 2M (XD 10140),
. ulricheasyINJECT Max 3 (XD 10150), and
. ulricheasyINJECT Max 3 (XD 10180).

Indications for Use

Indications for Use – ulricheasyINJECT Max System (Max 2M (XD 10140) and Max 3 (XD 10150))

ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCI), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasylNJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection, - GE Healthcare Inc. contrast media as supplied in approved single dose bottles.

Easy-Click-Cassette - flex Max 2M and Easy-Click-Cassette - flex Max 3 are used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.

Indications for Use – ulricheasyINJECT Max 3 (XD 10180)

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ulricheasylNJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCI), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasylNJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (qadopiclenol), - Bracco Diagnostics Inc. MultiHance (gadobenate dimeqlumine) - Bracco Diagnostics, Inc, Clariscan™ (Gadoterate Meglumine) Injection, - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection – Guerbet, LLC, and Gadavist™ (gadobutrol) Injection, - Bayer HealthCare Pharmaceuticals Inc., contrast media as supplied in approved single dose vials.

Easy-Click-Cassette - flex Max 3 is used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for highpressure angiography.

Predicate Device Comparison

ulricheasyINJECT Max is substantially equivalent to the ulrichINJECT CT Motion (K192872) by ulrich GmbH & Co. KG that is currently on the market.

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Comparative Analysis of the ulricheasyINJECT Max to the Predicate Device

Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Intended Use	ulricheasyINJECT Max 2M (XD 10140) / 3 (XD10150 / XD 10180) is a contrast mediamanagement system that is indicated for thecontrolled, automatic administration, on thevenous side, of contrast media and saline(NaCl), to human subjects undergoingdiagnostic examinations	ulrichINJECT CT motion is a contrast mediamanagement system that is intended for thecontrolled, automatic administration, on thevenous side, of contrast media and saline(NaCl), to human subjects undergoingdiagnostic examinations	Same
Indications for Use	ulricheasyINJECT Max 2M (XD 10140) / 3 (XD10150)ulricheasyINJECT Max 2M (XD 10140) / 3 (XD10150) is a contrast media managementsystem that is indicated for the controlled,automatic administration, on the venous side, ofcontrast media and saline (NaCl), to humansubjects undergoing diagnostic examinations inmagnetic resonance (MR) applications.ulricheasyINJECT Max 2M / 3 (XD 10140 / XD10150) is specifically indicated for use in MRIprocedures for the delivery of Clariscan(Gadoterate Meglumine) Injection, - GEHealthcare Inc. contrast media as supplied inapproved single dose bottles.Easy-Click-Cassette - flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for amaximum time of twenty four (24) hours or amaximum of 96 bottles of contrast media, orwhichever comes first. Use time expiration persingle dose contrast media container is amaximum of four (4) hours per contrast mediacontainer, unless otherwise stated by thecontrast media labeling.Spike for MRI disposable is for single-bottle useonly and must be discarded with the media	ulrichINJECT CT motion is a contrast mediamanagement system that is indicated for thecontrolled, automatic administration, on thevenous side, of contrast media and saline(NaCl), to human subjects undergoingdiagnostic examinations in computedtomography (CT) applications.ulrichINJECT CT motion is specificallyindicated for use in CT procedures for thedelivery of Omnipaque™ (Iohexol) Injection,solution - GE Healthcare Inc. contrast mediaas supplied in Imaging Bulk Packages (IBP),Omnipaque™ (Iohexol) Injection, solution - GEHealthcare Inc., and Visipaque™ (iodixanol)Injection - GE Healthcare Inc. contrast mediaas supplied in single dose bottles.Pump tubing-flex is used for a maximum timeof twenty four (24) hours. When used withOmnipaque™ IBP, Omnipaque™ single dosebottles, or Visipaque™ single dose bottles, amaximum of 19 bottles of contrast media canbe used or maximum time of twenty four (24)hours of Pump tubing-flex, or whichevercomes first. Time per contrast media or salinecontainer depends on each contrast media'sor saline's use time expiration with a maximum	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through MRcompatibility testing, chemicalcompatibility testing, and Safety /EMC testing.
Characteristic	Subject Device	Predicate Device	Comparison
	ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	ulrichINJECT CT motion(K192872)
	(K233737)
	container. The Patient tubing must be	of eight (8) hours per contrast media or saline
	discarded after each patient procedure.	container.
	ulricheasyINJECT Max 2M / 3 (XD 10140 / XD10150) is to be used only by and under quasi-continuous supervision of trained healthcareprofessionals in an appropriate licensedhealthcare facility, in a room designated forradiological procedures that involveintravascular administration of contrast agent.The ulricheasyINJECT Max 2M / 3 (XD 10140 /XD 10150) is not intended for injection ofcontrast media (CM) for high-pressureangiography.	Spike for CT disposable is for single-bottle useonly and must be discarded with the mediacontainer. The Patient tubing must bediscarded after each patient procedure.ulrichINJECT CT motion is to be used only byand under quasi-continuous supervision oftrained healthcare professionals in anappropriate licensed healthcare facility, in aroom designated for radiological proceduresthat involve intravascular administration ofcontrast agent.
	ulricheasyINJECT Max 3 (XD 10180)ulricheasyINJECT Max 3 (XD 10180) is acontrast media management system that isindicated for the controlled, automaticadministration, on the venous side, of contrastmedia and saline (NaCl), to human subjectsundergoing diagnostic examinations inmagnetic resonance (MR) applications.
	ulricheasyINJECT Max 3 (XD 10180) isspecifically indicated for use in MRI proceduresfor the delivery of VUEWAY™ (gadopiclenol)Injection - Bracco Diagnostics, Inc., MultiHance(gadobenate dimeglumine) - BraccoDiagnostics, Inc, Clariscan™ (GadoterateMeglumine) Injection, - GE Healthcare Inc.,Dotarem® (gadoterate meglumine) Injection -Guerbet, LLC, and Gadavist™ (gadobutrol)Injection, - Bayer HealthCare PharmaceuticalsInc., contrast media as supplied in approvedsingle dose vials.
	Easy-Click-Cassette - flex Max 3 is used for amaximum time of twenty four (24) hours or amaximum of 96 bottles of contrast media, or
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
	whichever comes first. Use time expiration persingle dose contrast media container is amaximum of four (4) hours per contrast mediacontainer, unless otherwise stated by thecontrast media labeling.Spike for MRI disposable is for single-bottle useonly and must be discarded with the mediacontainer. The Patient tubing must bediscarded after each patient procedure.ulricheasyINJECT Max 3 (XD 10180) is to beused only by and under quasi-continuoussupervision of trained healthcare professionalsin an appropriate licensed healthcare facility, ina room designated for radiological proceduresthat involve intravascular administration ofcontrast agent.
	The ulricheasyINJECT Max 3 (XD 10180) isnot intended for injection of contrast media(CM) for high-pressure angiography.
Product Codes
Product Codes	IZQ(21 CFR 870.1650)	IZQ(21 CFR 870.1650)	Same
Device Use
Environment ofUse	MR Environment	CT Environment	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through MRcompatibility testing, chemicalcompatibility testing, and Safety /EMC testing.
Physical
System	Injector HeadTouch Terminal	Injector HeadTouch Terminal	Same
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Accessories	Injector Base	Injector Base;Wall Mount with moveable arm;Ceiling Mount with moveable arm;Contrast Media Housing with Heater	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through humanfactors validation.
Disposables	Easy-Click-Cassette 3 - flexEasy-Click-Cassette 2M - flexPatient tubing 250 cmPatient tubing 320 cmPatient tubing without RFID, 250 cmPatient tubing without RFID, 320 cmSpike for CT (CM/NaCI) and MRI (NaCI)Spike for MRI (CM) - holder ISpike for MRI (CM) – holder s	ulrichINJECT CT Motion Pump Tubing-flexPatient Tubing for Pump Tubing-flexulrichINJECT CT Motion Spike	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed throughcontamination control studies,chemical compatibility studies, andbiocompatibility studies.
Weight	Injector: Approx. 40 kgTerminal: Approx. 3 kg	Injector (pedestal version): Approx. 80 kgInjector (ceiling and wall mount version):Approx. 40 kgTerminal: Approx. 3 kg	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through humanfactors validation.
Dimensions	Injector (with bottle holder): 53 cm x 53 cm x137.2 cmInjector (with media rod): 530 mm x 530 mm x1730 mmTerminal: 29.3 cm x 28.3 cm x 16 cm	Injector (pedestal version and wall mountversion): 64.5 x 64.5 x 144.5 cmInjector (ceiling version): Depends on thesystem selected and the length of the fixedheight armTerminal: 31 x 27.5 x 17 cm	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through humanfactors validation.
PowerRequirement	Rated Voltage: 100-240 V ACRated Watts: 1.6 A / 200 WRated Frequency: 50/60 Hz	Rated Voltage: 100-240 V ACRated Current: 1.6 ARated Frequency: 50/60Hz	Same
Battery	Li-lon battery	Li-lon battery	Same
Display Type	Color LCD Terminal with touch screen	Color LCD Terminal with touch screen	Same
SyringelessSystem	Yes	Yes	Same
Remote Operation	Yes, via the Touch Terminal	Yes, via the Touch Terminal	Same
Single PatientUse Disposable	Patient Tubing	Patient Tubing for Pump Tubing-flex	Same
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Designed toPrevent Reuse ofDisposables	Yes - via the use of software controls and RFID	Yes - via the use of software controls	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Rotary peristalticpump	Yes	Yes	Same
Used toadministercontrast mediaand saline	Yes	Yes	Same
Disposable usesspikes to spikemedia container	Yes	Yes	Same
Safety StopMechanism	Multi-layered software stops; Used PatientTubing detector and Cassette detector	Multi-layered software stops; Used PatientTubing detector and Pump Tubing-flexdetector	Same
VolumeRemainingReadout	Yes, displayed on control unit at all times	Yes, displayed on control unit if programmedvolume is higher than remaining volume	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed though softwareverification and validation and safetytesting.
ProgrammablePressure Limit	Yes, 159.5 PSI; user-programmable orautomatic	Yes, 195 PSI; user-programmable orautomatic	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Operational Characteristics
InjectionCapabilities	40 phases per protocol	40 phases per protocol	Same
Injection Rates forContrast Media	0.1 mL/s to 10.0 mL/s	0.1 mL/s to 10.0 mL/s	Same
Injection Rates forSaline	0.1 mL/s to 10.0 mL/s	0.1 mL/s to 10.0 mL/s	Same
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Injection Volumeper Injection	1 to 200 mL max volume of contrast media perpatient with a max of 400 mL total media(contrast and saline) per patient	1 to 200 mL max volume of contrast media perpatient with a max of 400 mL total media(contrast and saline) per patient	Same
Flow Rate andVolume Accuracy	10-400 mL of contrast media with volumeaccuracy of $\pm$ 5%Flow rate accuracy of $\pm$ 5%	10-200 mL of contrast media with volumeaccuracy of $\pm$ 5%Flow rate accuracy of $\pm$ 5%	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Contrast MediaContainer Volume	10–200 mL	500 mL (OMNIPAQUE IBP)100 mL and 150 mL (VISIPAQUE single dose)150 mL (OMNIPAQUE single dose)	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed throughcontamination control, chemicalcompatibility, software safety, andsoftware verification and validationtesting.
CompatibleContrast Media	VUEWAY™ (gadopiclenol) single doseMultiHance (gadobenate dimeglumine) singledoseClariscan™ (Gadoterate Meglumine) singledoseDotarem® (gadoterate meglumine) single doseGadavist™ (gadobutrol) single dose	OMNIPAQUE™ IBPOMNIPAQUE™ single doseVISIPAQUE™ single dose	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through chemicalcompatibility and extractables andleachables testing.
Saline Flush	Yes	Yes	Same
Needle Size	16-24 G	14-24 G	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Injection Pause	Programmable - 0 sec to 1800 sec in 1 secincrements	Programmable - 0 sec to 999 sec in 1 secincrements	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Injection ProtocolStorage	Yes	Yes	Same
Priming/VentingRate	4 mL/s	2 mL/s (manual)	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Air DetectionPrinciple	Optical re-fraction sensor	Ultrasound	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
TechnicalDetectionLimit of air intubing	0.05 mL	0.05 mL	Same
Air Detector AlarmLimit	1 mL	1 mL	Same
OcclusionDetectionPrinciple	Fail safe piezo-resistive pressure sensor	Fail safe piezo-resistive pressure sensor	Same
OcclusionDetection AlarmLimit	203 PSI	246 PSI	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through softwareverification and validation and safetytesting.
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Time Limit forDisposables	24 hours for Easy-Click-Cassette - flex12 hours for Patient Tubing24 hours for Spike	24 hours for Pump Tubing-flex12 hours for Patient Tubing8 hours for Spike for CT	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed throughcontamination control, chemicalcompatibility, and extractables andleachables testing.
Package Sterile	Yes	Yes	Same
SterilizationMethod	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Same
PackagingConfiguration	Tyvek lid covering polystyrene tray	Tyvek lid covering polystyrene tray	Same
Patient TubingComponents	Patient TubingOne Luer Connector with safety capOne SafeConnect with safety capTwo check valves	Patient TubingTwo Patient Luer Connectors with safety capsTwo check valves	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen evaluated via risk managementactivities and confirmed throughcontamination testing.
Contrast MediaLine TubingMaterial	PVC / PUR / polycarbonate	PVC / PUR	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen evaluated via risk managementactivities and confirmed throughbiocompatibility, chemicalcompatibility, and extractables /leachables testing.
Saline LineTubing Material	PVC / PUR / polycarbonate	PVC / PUR	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen evaluated via risk managementactivities and confirmed throughbiocompatibility, chemicalcompatibility, and extractables /leachables testing.
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)(K233737)	Predicate DeviceulrichINJECT CT motion(K192872)	Comparison
Spike Length	Saline: 34.2 mmContrast Media: 19.2 mm	28.5 mm	Different - This difference does notchange the intended use of thedevice. The safety and effectivenessof the ulricheasyINJECT Max hasbeen confirmed through benchtesting and data

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Non-Clinical Testing

ulricheasyINJECT Max system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria.

Software

Software verification and validation was performed.

Electromagnetic Compatibility / Electrical Safety Testing

Electromagnetic compatibility and electrical safety testing was performed following IEC 60601-1:2005. AMD 1:2012 and under compliance with the FDA recognized standard ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].

Sterilization and Shelf Life

The ulricheasyINJECT Max System is ethylene oxide (EtO) sterilized and was validated to a SAL of 10 °.

ISO 11135:2014 standard was used for sterilization process validation.

ulrich performed real time aging and accelerated aging studies. The ulricheasyINJECT Max tubing system was sterilized and its packaging was validated.

Verification results indicate that the ulricheasyINJECT Max tubing system complies with the standard. Additional testing performed includes transport validation.

Chemical Compatibility

Chemical Compatibility testing was performed to support the material compatibility of the ulricheasyINJECT Max tubing system with the following contrast media:

. Gadavist (gadobutrol) single dose,
. Clariscan™ (Gadoterate Meglumine) single dose bottle,
VUEWAY™ (gadopiclenol) single dose bottle, .
MultiHance (gabobenate dimeglumine) single dose bottle, and
Dotarem (gadoterate meglumine) single dose bottle.

Contamination Control

ulrich performed the following contamination control studies:

. Microbial ingress study, and
Cross contamination study. ●

Based on these results, it has been concluded that ulricheasyINJECT Max has the ability to maintain the sterility of injection media and resist the ingress of microorganisms when used as intended. Additionally, it has been concluded that the residuals between the contrast media's active compounds after rinsing the system with physiological saline solution are within the defined limits.

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Biocompatibility

The ulricheasyINJECT Max tubing system indirect patient contact materials were verified in accordance with the following standards:

. ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Verification results indicated that the materials comply with the standard.

Performance - Bench

The ulricheasyINJECT Max tubing system was tested for performance and verified in accordance with the following standard:

. ISO 8536-4:2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ulricheasyINJECT tubing system is not a gravity feed device; therefore, only the applicable requirements from ISO 8536-4 were tested.

Test and verification results indicate that the ulricheasyINJECT Max tubing system conforms to its predetermined specifications and the applicable standards.

Extractables and Simulation

Additional testing was included extractables and simulation testing for leachable compounds.

Human Factors / Usability

Human Factors / Usability assessments were performed in a simulated use environment to optimize the device design and support the safe use of ulricheasyINJECT Max. The results demonstrated that users can operate ulricheasyINJECT Max as safely and effectively as the predicate device.

Conclusion

In conclusion, the intended use of the ulricheasyINJECT Max is the same as that of the predicate device (K192872). The difference between the predicate and subject device do not raise any new or different questions of safety and effectiveness. The non-clinical testing has demonstrated that the ulricheasylNJECT Max is substantially equivalent to the predicate device (K192872).

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.