ulricheasyINJECT Max 2M (XD 10140) / 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., Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., VUEWAY™ (gadopiclenol) – Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved single dose bottles and Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).

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) Injection - Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., Clariscan™ (Gadoterate Meglumine) Injection - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection -Guerbet, LLC, Gadavist™ (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection -Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist™ (gadobutrol) Injection -Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Iniection - Fresenius Kabi AG. contrast media as supplied in approved Imaging Bulk Packages (IBPs).

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 undergoing 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). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:

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

ulricheasyINJECT 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 detectors to 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),
ulricheasylNJECT Max 3 (XD 10150), and
ulricheasylNJECT 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 provided text describes a 510(k) premarket notification for the ulricheasyINJECT Max contrast media management system, which primarily references a previously cleared predicate device (K233737) for most of its acceptance criteria and supporting studies. The information available focuses on the differences between the current device and its predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in a separate column. Instead, it describes various non-clinical tests conducted for the predicate device (K233737) and states that the subject device (ulricheasyINJECT Max) supports a broader range of contrast media, with additional testing performed to address this difference.

The following table summarizes the performance characteristics and states of verification for the device and its predicate:

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (as stated in the document)
Software	Conformance with established performance criteria.	Software verification and validation performed as part of K233737, and repeated for software updates for the current submission.
EMC / Electrical Safety	Adherence to IEC 60601-1:2005, AMD 1:2012, AMD 2:2020 and ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012.	Testing performed in accordance with the specified standards as part of K233737.
Sterilization Validation	Sterility assurance level of 10-6.	Validated to a sterility assurance level of 10-6 as part of K233737 (Ethylene Oxide).
Shelf Life & Transport	Packaging integrity and functional stability over time and through transport.	Real-time and accelerated aging studies performed as part of K233737. Transport validation performed on tubing system, injector, and terminal as part of K233737.
Chemical Compatibility	Material compatibility with specified contrast media.	Additional Chemical Compatibility testing performed for the current submission to support new contrast media (Gadobutrol single dose bottle, Gadavist™ (gadobutrol) IBP, Gadobutrol IBP). Previous testing done for K233737. "The safety and effectiveness of the ulricheasyINJECT Max has been confirmed through contamination control testing, chemical compatibility testing, and extractables and leachables testing."
Contamination Control	Ability to prevent microbial ingress and cross-contamination; residuals within defined limits after rinsing.	Microbial ingress study demonstrated ability to prevent ingress during use. Cross-contamination study demonstrated effectiveness in preventing contamination. Rinsing study demonstrated residuals within defined limits. (All performed as part of K233737).
Biocompatibility	Compliance with ISO 10993-1.	Verification results indicated compliance with ISO 10993-1 as part of K233737 for indirect patient contact materials.
Performance – Bench	Conformance to predetermined specifications and applicable standards (ISO 8536-4 for applicable requirements).	Test and verification results indicated that the ulricheasyINJECT Max tubing system conforms to its predetermined specifications and the applicable standards (performed as part of K233737).
Extractables & Simulation	Leachable compounds within acceptable limits.	Testing included extractables and simulation testing for leachable compounds as part of K233737.
Human Factors / Usability	Safe and effective for use by intended users.	Usability study performed as part of K233737 to confirm that the ulricheasyINJECT Max is safe and effective for use by its intended users.
Flow Rate Accuracy	± 5%	± 5% (Same as predicate, implied validation via K233737 non-clinical testing).
Volume Accuracy	± 5% (for 10-400 mL)	± 5% (for 10-400 mL of contrast media; Same as predicate, implied validation via K233737 non-clinical testing).
Technical Detection Limit of Air in Tubing	0.05 mL	0.05 mL (Same as predicate, implied validation via K233737 non-clinical testing).
Air Detector Alarm Limit	1 mL	1 mL (Same as predicate, implied validation via K233737 non-clinical testing).
Occlusion Detection Alarm Limit	203 PSI	203 PSI (Same as predicate, implied validation via K233737 non-clinical testing).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify exact sample sizes for each test set. It mentions "studies" and "testing" without providing numerical details for the number of units or data points tested in non-clinical assessments.
Data Provenance: All non-clinical testing (Software, EMC/Electrical Safety, Sterilization Validation, Shelf Life and Transport Validation, Contamination Control and Rinsing, Biocompatibility, Performance – Bench, Extractables and Simulation, Human Factors / Usability) was performed as part of K233737, indicating it was conducted for the predicate device. Additional chemical compatibility testing was conducted for the current submission (K241850) to support new contrast media. The origin of the data (e.g., country) is not specified beyond being part of ulrich GmbH & Co. KG's submission, implying internal company testing. Studies are described as "non-clinical" and "bench," which means they are not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document discusses non-clinical bench testing, not image-based diagnostic performance involving expert readers establishing ground truth. The "Human Factors / Usability" study confirms the device's safety and effectiveness for its intended users (trained healthcare professionals), but it's not about expert clinical interpretation for a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies involving multiple human readers, which is not described in this document.

5. 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

Not applicable. This device is a contrast media management system, not an AI-powered diagnostic imaging tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical medical device (an injector) with software controls, not an algorithm meant for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For non-clinical testing, "ground truth" generally refers to established scientific principles, engineering specifications, recognized industry standards (e.g., ISO, IEC), and predetermined specifications for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's achieving a specified Sterility Assurance Level. For performance metrics like flow rate and volume accuracy, it's meeting the ±5% specification.

8. The sample size for the training set

Not applicable. The document refers to a physical medical device and its controls, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

August 26, 2024

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

Re: K241850

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: June 20, 2024 Received: June 27, 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.

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).

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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).

Sincerely,

Shruti N. Mistry -S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K241850

Device Name

ulricheasylNJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Indications for Use (Describe)

ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150)

ulricheasyINJECT Max 2M / 3 (XD 10140 / 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.

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, whichever comes first.

Use time expiration per single dose container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling. Use time expiration per IBP contrast is a maximum of twenty-four (24) 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 2M / 3 (XD 10140 / XD 10150) 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.

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

ulricheasyINJECT Max 3 (XD 10180)

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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, 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.

Use time expiration per IBP contrast media container is a maximum of twenty-four (24) 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.

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 K241850

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

Submitter:	ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermany
Primary Contact:	Rita KingCEOMethodSense, Inc.
Company Contact:	Sven ErdmannVice President of Technology - Regulatory
Device Name and Classification
Trade Name:Common Name:Classification:Regulation Number:Classification Panel:Product Code:	ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD10150); ulricheasyINJECT Max 3 (XD 10180)Contrast Media Management SystemClass II21 CFR 870.1650, Angiographic Injector and SyringeCardiovascular PanelIZQ

Predicate Device:

	Predicate
Trade Name	ulricheasyINJECT Max
Common Name	Contrast Media Management System
510(k) Submitter / Holder	Class II
510(k) Number	K233737
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,
Easy-Click-Cassette flex ●
. Patient Tubing

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

The ulricheasyINJECT Max is provided in three models:

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

Indications for Use

Indications for Use - ulricheasylNJECT Max System (Max 2M (XD 10140) and Max 3 (XD 10150))

ulricheasylNJECT Max 2M / 3 (XD 10140 / 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.

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., Gadavist (gadobutrol) Injection – Bayer HealthCare Pharmaceuticals Inc., VUEWAY™ (gadopiclenol) – Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) – Bracco Diagnostics, Inc., and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved single dose bottles and Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).

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, 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.

Use time expiration per IBP contrast media container is a maximum of twenty-four (24) 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.

{6}------------------------------------------------

designated for radiological procedures that involve intravascular administration of contrast agent.

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

Indications for Use - ulricheasylNJECT Max 3 (XD 10180)

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 (NaCI), 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) Injection - Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., Clariscan™ (Gadoterate Meglumine) Injection - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection - Guerbet, LLC, Gadavist™ (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist™ (gadobutrol) Injection – Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).

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, 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.

Use time expiration per IBP contrast media container is a maximum of twenty-four (24) 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 ulricheasyINJECT Max (K233737) 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)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
Intended Use	ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150 / XD 10180) is a contrast media management systemthat is indicated for the controlled, automaticadministration, on the venous side, of contrast mediaand saline (NaCl), to human subjects undergoingdiagnostic examinations.	ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150 / XD 10180) is a contrast media management systemthat is indicated for the controlled, automaticadministration, on the venous side, of contrast mediaand saline (NaCl), to human subjects undergoingdiagnostic examinations.	Same
Indications for Use	ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150)ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is a contrast media management system thatis indicated for the controlled, automaticadministration, on the venous side, of contrast mediaand saline (NaCl), to human subjects undergoingdiagnostic examinations in magnetic resonance (MR)applications.ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRIprocedures for the delivery of Clariscan (GadoterateMeglumine) Injection - GE Healthcare Inc., Gadavist(gadobutrol) Injection - Bayer HealthCarePharmaceuticals Inc., VUEWAY™ (gadopiclenol) -Bracco Diagnostics, Inc., MultiHance (gadobenatedimeglumine) - Bracco Diagnostics, Inc., andGadobutrol Injection - Fresenius Kabi AG, contrastmedia as supplied in approved single dose bottlesand Gadavist (gadobutrol) Injection - BayerHealthCare Pharmaceuticals Inc. and GadobutrolInjection – Fresenius Kabi AG, contrast media assupplied in approved Imaging Bulk Packages (IBPs).Easy-Click-Cassette - flex Max 2M and Easy-Click-Cassette - flex Max 3 are used for a maximum timeof twenty-four (24) hours or a maximum of 96 bottlesof contrast media, whichever comes first.	ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150)ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150) is a contrast media management system thatis indicated for the controlled, automaticadministration, on the venous side, of contrast mediaand saline (NaCl), to human subjects undergoingdiagnostic examinations in magnetic resonance (MR)applications.ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRIprocedures for the delivery of Clariscan (GadoterateMeglumine) Injection, - GE Healthcare Inc. contrastmedia 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 timeof twenty four (24) hours or a maximum of 96 bottlesof contrast media, or whichever comes first. Use timeexpiration per single dose contrast media container isa maximum of four (4) hours per contrast mediacontainer, unless otherwise stated by the contrastmedia labeling.Spike for MRI disposable is for single-bottle use onlyand must be discarded with the media container. ThePatient tubing must be discarded after each patientprocedure.	Different - This differencedoes not change theintended use of thedevice. The safety andeffectiveness of theulricheasyINJECT Maxhas been confirmedthrough contaminationcontrol testing, chemicalcompatibility testing, andextractables andleachables testing.
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
	Use time expiration per single dose contrast mediacontainer is a maximum of four (4) hours per contrastmedia container, unless otherwise stated by thecontrast media labeling.	ulricheasyINJECT Max 2M / 3 (XD 10140 / XD10150) is to be used only by and under quasi-continuous supervision of trained healthcareprofessionals in an appropriate licensed healthcarefacility, in a room designated for radiologicalprocedures that involve intravascular administrationof contrast agent.
	Use time expiration per IBP contrast media containeris a maximum of twenty-four (24) hours per contrastmedia container, unless otherwise stated by thecontrast media labeling.	The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD10150) is not intended for injection of contrast media(CM) for high-pressure angiography.
	Spike for MRI disposable is for single-bottle use onlyand must be discarded with the media container. ThePatient tubing must be discarded after each patientprocedure.	ulricheasyINJECT Max 3 (XD 10180)ulricheasyINJECT Max 3 (XD 10180) is a contrastmedia management system that is indicated for thecontrolled, automatic administration, on the venousside, of contrast media and saline (NaCl), to humansubjects undergoing diagnostic examinations inmagnetic resonance (MR) applications.
	ulricheasyINJECT Max 2M / 3 (XD 10140 / XD10150) is to be used only by and under quasi-continuous supervision of trained healthcareprofessionals in an appropriate licensed healthcarefacility, in a room designated for radiologicalprocedures that involve intravascular administrationof contrast agent.	ulricheasyINJECT Max 3 (XD 10180) is specificallyindicated for use in MRI procedures for the delivery ofVUEWAY™ (gadopiclenol) Injection – BraccoDiagnostics, Inc., MultiHance (gadobenatedimeglumine) – Bracco Diagnostics, Inc, Clariscan™(Gadoterate Meglumine) Injection, - GE HealthcareInc., Dotarem® (gadoterate meglumine) Injection -Guerbet, LLC, and Gadavist™ (gadobutrol) Injection,- Bayer HealthCare Pharmaceuticals Inc., contrastmedia as supplied in approved single dose vials.
	ulricheasyINJECT Max 2M / 3 (XD 10140 / XD10150) is not intended for injection of contrast media(CM) for high-pressure angiography.	Easy-Click-Cassette – flex Max 3 is used for amaximum time of twenty four (24) hours or amaximum of 96 bottles of contrast media, orwhichever comes first. Use time expiration per singledose contrast media container is a maximum of four(4) hours per contrast media container, unlessotherwise stated by the contrast media labeling.
	ulricheasyINJECT Max 3 (XD 10180)ulricheasyINJECT Max 3 (XD 10180) is a contrastmedia management system that is indicated for thecontrolled, automatic administration, on the venousside, of contrast media and saline (NaCl), to humansubjects undergoing diagnostic examinations inmagnetic resonance (MR) applications.	Spike for MRI disposable is for single-bottle use onlyand must be discarded with the media container. The
	ulricheasyINJECT Max 3 (XD 10180) is specificallyindicated for use in MRI procedures for the delivery ofVUEWAY™ (gadopiclenol) Injection - BraccoDiagnostics, Inc., MultiHance (gadobenatedimeglumine) - Bracco Diagnostics, Inc., Clariscan™(Gadoterate Meglumine) Injection - GE HealthcareInc Dotarem® (gadoterate meglumine) Injection.
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
Product Codes	Guerbet, LLC, Gadavist™ (gadobutrol) Injection –Bayer HealthCare Pharmaceuticals Inc., andGadobutrol Injection - Fresenius Kabi AG, contrastmedia as supplied in approved single dose vials andGadavist™ (gadobutrol) Injection - Bayer HealthCarePharmaceuticals Inc. and Gadobutrol Injection –Fresenius Kabi AG, contrast media as supplied inapproved Imaging Bulk Packages (IBPs).Easy-Click-Cassette - flex Max 3 is used for amaximum time of twenty-four (24) hours or amaximum of 96 bottles of contrast media, whichevercomes first.Use time expiration per single dose contrast mediacontainer is a maximum of four (4) hours per contrastmedia container, unless otherwise stated by thecontrast media labeling.Use time expiration per IBP contrast media containeris a maximum of twenty-four (24) hours per contrastmedia container, unless otherwise stated by thecontrast media labeling.Spike for MRI disposable is for single-bottle use onlyand must be discarded with the media container. ThePatient tubing must be discarded after each patientprocedure.ulricheasyINJECT Max 3 (XD 10180) is to be usedonly by and under quasi-continuous supervision oftrained healthcare professionals in an appropriatelicensed healthcare facility, in a room designated forradiological procedures that involve intravascularadministration of contrast agent.The ulricheasyINJECT Max 3 (XD 10180) is notintended for injection of contrast media (CM) for high-pressure angiography.	Patient tubing must be discarded after each patientprocedure.ulricheasyINJECT Max 3 (XD 10180) is to be usedonly by and under quasi-continuous supervision oftrained healthcare professionals in an appropriatelicensed healthcare facility, in a room designated forradiological procedures that involve intravascularadministration of contrast agent.The ulricheasyINJECT Max 3 (XD 10180) is notintended for injection of contrast media (CM) for high-pressure angiography.
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
Product Codes	IZQ(21 CFR 870.1650)	IZQ(21 CFR 870.1650)	Same
Device Use
Environment ofUse	MR Environment	MR Environment	Same
Physical
System	Injector HeadTouch Terminal	Injector HeadTouch Terminal	Same
Accessories	Injector Base	Injector Base	Same
	Easy-Click-Cassette 3 - flexEasy-Click-Cassette 2M - flex	Easy-Click-Cassette 3 - flexEasy-Click-Cassette 2M - flex
Disposables	Patient tubing 250 cmPatient tubing 320 cmPatient tubing without RFID, 250 cmPatient tubing without RFID, 320 cm	Patient tubing 250 cmPatient tubing 320 cmPatient tubing without RFID, 250 cmPatient tubing without RFID, 320 cm	Same
	Spike for CT (CM/NaCI) and MRI (NaCI)Spike for MRI (CM) - holder lSpike for MRI (CM) – holder s	Spike for CT (CM/NaCI) and MRI (NaCI)Spike for MRI (CM) - holder lSpike for MRI (CM) - holder s
Weight	Injector: Approx. 40 kgTerminal: Approx. 3 kg	Injector: Approx. 40 kgTerminal: Approx. 3 kg	Same
Dimensions	Injector (with bottle holder): 53 cm x 53 cm x 137.2cmInjector (with media rod): 530 mm x 530 mm x 1730mmTerminal: 29.3 cm x 28.3 cm x 16 cm	Injector (with bottle holder): 53 cm x 53 cm x 137.2cmInjector (with media rod): 530 mm x 530 mm x 1730mmTerminal: 29.3 cm x 28.3 cm x 16 cm	Same
PowerRequirement	Rated Voltage: 100-240 V ACRated Watts: 1.6 A / 200 WRated Frequency: 50/60 Hz	Rated Voltage: 100-240 V ACRated Watts: 1.6 A / 200 WRated Frequency: 50/60 Hz	Same
Battery	Li-Ion battery	Li-Ion 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 Patient UseDisposable	Patient Tubing	Patient Tubing	Same
Designed toPrevent Reuse ofDisposables	Yes - via the use of software controls and RFID	Yes - via the use of software controls and RFID	Same
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
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 Patient Tubingdetector and Cassette detector	Multi-layered software stops; Used Patient Tubingdetector and Cassette detector	Same
VolumeRemainingReadout	Yes, displayed on control unit at all times	Yes, displayed on control unit at all times	Same
ProgrammablePressure Limit	Yes, 159.5 PSI; user-programmable or automatic	Yes, 159.5 PSI; user-programmable or automatic	Same
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
Injection Volumeper Injection	1 to 200 mL max volume of contrast media perpatient with a max of 400 mL total media (contrastand saline) per patient	1 to 200 mL max volume of contrast media perpatient with a max of 400 mL total media (contrastand saline) per patient	Same
Flow Rate andVolume Accuracy	10-400 mL of contrast media with volume accuracy of± 5%Flow rate accuracy of ± 5%	10-400 mL of contrast media with volume accuracy of± 5%Flow rate accuracy of ± 5%	Same
Contrast MediaContainer Volume	10–200 mL	10-200 mL	Same
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
CompatibleContrast Media	VUEWAY™ (gadopiclenol) single doseMultiHance (gadobenate dimeglumine) single doseClariscan™ (Gadoterate Meglumine) single doseDotarem® (gadoterate meglumine) single doseGadavist™ (gadobutrol) single doseGadobutrol single doseGadavist™ (gadobutrol) IBPGadobutrol IBP	VUEWAY™ (gadopiclenol) single doseMultiHance (gadobenate dimeglumine) single doseClariscan™ (Gadoterate Meglumine) single doseDotarem® (gadoterate meglumine) single doseGadavist™ (gadobutrol) single dose	Different - This differencedoes not change theintended use of thedevice. The safety andeffectiveness of theulricheasyINJECT Maxhas been confirmedthrough contaminationcontrol testing, chemicalcompatibility testing, andextractables andleachables testing.
Saline Flush	Yes	Yes	Same
Needle Size	16-24 G	16-24 G	Same
Injection Pause	Programmable - 0 sec to 1800 sec in 1 secincrements	Programmable – 0 sec to 1800 sec in 1 secincrements	Same
Injection ProtocolStorage	Yes	Yes	Same
Priming/VentingRate	4 mL/s	4 mL/s	Same
Air DetectionPrinciple	Optical re-fraction sensor	Optical re-fraction sensor	Same
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	203 PSI	Same
Time Limit forDisposables	24 hours for Easy-Click-Cassette - flex12 hours for Patient Tubing24 hours for Spike	24 hours for Easy-Click-Cassette - flex12 hours for Patient Tubing24 hours for Spike	Same
Package Sterile	Yes	Yes	Same
SterilizationMethod	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Same
Characteristic	Subject DeviceulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Predicate Device (K233737)ulricheasyINJECT Max(XD 10140 / XD 10150 / XD 10180)	Comparison
PackagingConfiguration	Tyvek lid covering polystyrele tray	Tyvek lid covering polystyrele tray	Same
Patient TubingComponents	Patient TubingOne Luer Connector with safety capOne SafeConnect with safety capTwo check valves	Patient TubingOne Luer Connector with safety capOne SafeConnect with safety capTwo check valves	Same
Contrast MediaLine TubingMaterial	PVC / PUR / polycarbonate	PVC / PUR / polycarbonate	Same
Saline LineTubing Material	PVC / PUR / polycarbonate	PVC / PUR / polycarbonate	Same
Spike Length	Saline: 34.2 mmContrast Media: 19.2 mm	Saline: 34.2 mmContrast Media: 19.2 mm	Same

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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 as part of K233737 and has been repeated for the software updates made as part of this submission.

Electromagnetic Compatibility / Electrical Safety Testing

Electromagnetic compatibility and electrical safety testing was performed in accordance with the following standard as part of K233737:

IEC 60601-1:2005, AMD 1:2012, AMD 2:2020 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 Validation

The ulricheasyINJECT Max System is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 as part of K233737.

Shelf Life and Transport Validation

Real-time aging and accelerated aging studies were performed as part of K233737. The ulricheasyINJECT Max tubing system is sterilized and its packaging was validated.

ulrich performed transport validation on the ulricheasyINJECT Max tubing system, injector, and terminal as part of K233737.

Chemical Compatibility

In addition to Chemical Compatibility testing performed in support of K233737, additional Chemical Compatibility testing was performed to support the material compatibility of the ulricheasyINJECT Max tubing system with the following contrast media:

. Gadobutrol single dose bottle,
. Gadavist™ (gadobutrol) IBP,
Gadobutrol IBP.

Contamination Control and Rinsing

ulrich performed Contamination Control and Rinsing Studies for the ulricheasyINJECT Max as part of K233737.

A microbial ingress study demonstrated the ability of the ulricheasyINJECT Max system to ● prevent the ingress of microorganisms during use.
. A cross contamination study demonstrated the effectiveness of the tubing system in preventing contamination from one patient to another.
. A rinsing study demonstrated that the residuals of the single 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 as part of K233737:

. 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 as part of K233737:

. 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 indicated that the ulricheasyINJECT Max tubing system conforms to its predetermined specifications and the applicable standards.

Extractables and Simulation

Testing included extractables and simulation testing for leachable compounds as part of K233737.

Human Factors / Usability

A usability study was performed as part of K233737 to confirm that the ulricheasylNJECT Max is safe and effective for use by its intended users.

Conclusion

In conclusion, the intended use of the ulricheasyINJECT Max is the same as that of the predicate device (K233737). The differences 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 (K233737).

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.