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

K241850 · Ulrich GmbH & Co. KG · IZQ · Aug 26, 2024 · Cardiovascular

Device Facts

• Record ID: K241850
• Device Name: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
• Applicant: Ulrich GmbH & Co. KG
• Product Code: IZQ · Cardiovascular
• Decision Date: Aug 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

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

Device Story

Syringeless contrast media management system for MRI; consists of mobile injector base, touch terminal, and disposable tubing system (spikes, Easy-Click-Cassette, patient tubing). Peristaltic pump transports contrast media and saline from containers to patient. System features air detectors (optical refraction), pressure controls (piezo-resistive sensor), and check valves to prevent backflow/contamination. Operated by trained healthcare professionals in radiological suites via touch terminal. Provides automated, controlled delivery; monitors volume remaining. Enhances safety through multi-layered software stops and disposable-use tracking via RFID. Patient tubing discarded after each procedure; cassettes/spikes used for up to 24 hours. Benefits include precise, automated contrast administration for diagnostic imaging.

Clinical Evidence

Bench testing only. Validated via contamination control (microbial ingress, cross-contamination, rinsing), chemical compatibility, biocompatibility (ISO 10993-1), and performance testing (ISO 8536-4). Usability study confirmed safe operation by intended users.

Technological Characteristics

Syringeless peristaltic pump system. Materials: PVC, PUR, polycarbonate. Connectivity: Touch terminal. Sterilization: Ethylene Oxide (EtO). Standards: IEC 60601-1, ISO 10993-1, ISO 8536-4. Software: Multi-layered safety stops, RFID-based disposable tracking.

Indications for Use

Indicated for controlled, automatic venous administration of contrast media and saline to human subjects undergoing MRI diagnostic examinations. Compatible with specific gadolinium-based contrast agents (Clariscan, Gadavist, VUEWAY, MultiHance, Dotarem, Gadobutrol) in single-dose or Imaging Bulk Packages (IBP). Contraindicated for high-pressure angiography. For use by trained healthcare professionals in licensed radiological facilities.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• ulricheasyINJECT Max (K233737)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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 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)

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).

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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. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King<br>CEO<br>MethodSense, Inc. |
| Company Contact: | Sven Erdmann<br>Vice President of Technology - Regulatory |
| Device Name and Classification | |
| Trade Name:<br>Common Name:<br>Classification:<br>Regulation Number:<br>Classification Panel:<br>Product Code: | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD<br>10150); ulricheasyINJECT Max 3 (XD 10180)<br>Contrast Media Management System<br>Class II<br>21 CFR 870.1650, Angiographic Injector and Syringe<br>Cardiovascular Panel<br>IZQ |

#### 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

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

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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.

#### 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.

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

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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.

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 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 Device<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Comparison |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150 / XD 10180) is a contrast media management system<br>that is indicated for the controlled, automatic<br>administration, on the venous side, of contrast media<br>and saline (NaCl), to human subjects undergoing<br>diagnostic examinations. | ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150 / XD 10180) is a contrast media management system<br>that is indicated for the controlled, automatic<br>administration, on the venous side, of contrast media<br>and saline (NaCl), to human subjects undergoing<br>diagnostic examinations. | Same |
| Indications for Use | ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150)<br>ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is a contrast media management system that<br>is indicated for the controlled, automatic<br>administration, on the venous side, of contrast media<br>and saline (NaCl), to human subjects undergoing<br>diagnostic examinations in magnetic resonance (MR)<br>applications.<br>ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI<br>procedures for the delivery of Clariscan (Gadoterate<br>Meglumine) Injection - GE Healthcare Inc., Gadavist<br>(gadobutrol) Injection - Bayer HealthCare<br>Pharmaceuticals Inc., VUEWAY™ (gadopiclenol) -<br>Bracco Diagnostics, Inc., MultiHance (gadobenate<br>dimeglumine) - Bracco Diagnostics, Inc., and<br>Gadobutrol Injection - Fresenius Kabi AG, contrast<br>media as supplied in approved single dose bottles<br>and Gadavist (gadobutrol) Injection - Bayer<br>HealthCare Pharmaceuticals Inc. and Gadobutrol<br>Injection – Fresenius Kabi AG, contrast media as<br>supplied in approved Imaging Bulk Packages (IBPs).<br>Easy-Click-Cassette - flex Max 2M and Easy-Click-<br>Cassette - flex Max 3 are used for a maximum time<br>of twenty-four (24) hours or a maximum of 96 bottles<br>of contrast media, whichever comes first. | ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150)<br>ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150) is a contrast media management system that<br>is indicated for the controlled, automatic<br>administration, on the venous side, of contrast media<br>and saline (NaCl), to human subjects undergoing<br>diagnostic examinations in magnetic resonance (MR)<br>applications.<br>ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI<br>procedures for the delivery of Clariscan (Gadoterate<br>Meglumine) Injection, - GE Healthcare Inc. contrast<br>media as supplied in approved single dose bottles.<br>Easy-Click-Cassette - flex Max 2M and Easy-Click-<br>Cassette - flex Max 3 are used for a maximum time<br>of twenty four (24) hours or a maximum of 96 bottles<br>of contrast media, or whichever comes first. Use time<br>expiration per single dose contrast media container is<br>a maximum of four (4) hours per contrast media<br>container, unless otherwise stated by the contrast<br>media labeling.<br>Spike for MRI disposable is for single-bottle use only<br>and must be discarded with the media container. The<br>Patient tubing must be discarded after each patient<br>procedure. | Different - This difference<br>does not change the<br>intended use of the<br>device. The safety and<br>effectiveness of the<br>ulricheasyINJECT Max<br>has been confirmed<br>through contamination<br>control testing, chemical<br>compatibility testing, and<br>extractables and<br>leachables testing. |
| Characteristic | Subject Device<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Comparison |
| | Use time expiration per single dose contrast media<br>container is a maximum of four (4) hours per contrast<br>media container, unless otherwise stated by the<br>contrast media labeling. | ulricheasyINJECT Max 2M / 3 (XD 10140 / XD<br>10150) is to be used only by and under quasi-<br>continuous supervision of trained healthcare<br>professionals in an appropriate licensed healthcare<br>facility, in a room designated for radiological<br>procedures that involve intravascular administration<br>of contrast agent. | |
| | Use time expiration per IBP contrast media container<br>is a maximum of twenty-four (24) hours per contrast<br>media container, unless otherwise stated by the<br>contrast media labeling. | The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD<br>10150) is not intended for injection of contrast media<br>(CM) for high-pressure angiography. | |
| | Spike for MRI disposable is for single-bottle use only<br>and must be discarded with the media container. The<br>Patient tubing must be discarded after each patient<br>procedure. | ulricheasyINJECT Max 3 (XD 10180)<br>ulricheasyINJECT Max 3 (XD 10180) is a contrast<br>media management system that is indicated for the<br>controlled, automatic administration, on the venous<br>side, of contrast media and saline (NaCl), to human<br>subjects undergoing diagnostic examinations in<br>magnetic resonance (MR) applications. | |
| | ulricheasyINJECT Max 2M / 3 (XD 10140 / XD<br>10150) is to be used only by and under quasi-<br>continuous supervision of trained healthcare<br>professionals in an appropriate licensed healthcare<br>facility, in a room designated for radiological<br>procedures that involve intravascular administration<br>of contrast agent. | ulricheasyINJECT Max 3 (XD 10180) is specifically<br>indicated for use in MRI procedures for the delivery of<br>VUEWAY™ (gadopiclenol) Injection – Bracco<br>Diagnostics, Inc., MultiHance (gadobenate<br>dimeglumine) – Bracco Diagnostics, Inc, Clariscan™<br>(Gadoterate Meglumine) Injection, - GE Healthcare<br>Inc., Dotarem® (gadoterate meglumine) Injection -<br>Guerbet, LLC, and Gadavist™ (gadobutrol) Injection,<br>- Bayer HealthCare Pharmaceuticals Inc., contrast<br>media as supplied in approved single dose vials. | |
| | ulricheasyINJECT Max 2M / 3 (XD 10140 / XD<br>10150) is not intended for injection of contrast media<br>(CM) for high-pressure angiography. | Easy-Click-Cassette – flex Max 3 is used for a<br>maximum time of twenty four (24) hours or a<br>maximum of 96 bottles of contrast media, or<br>whichever comes first. Use time expiration per single<br>dose contrast media container is a maximum of four<br>(4) hours per contrast media container, unless<br>otherwise stated by the contrast media labeling. | |
| | ulricheasyINJECT Max 3 (XD 10180)<br>ulricheasyINJECT Max 3 (XD 10180) is a contrast<br>media management system that is indicated for the<br>controlled, automatic administration, on the venous<br>side, of contrast media and saline (NaCl), to human<br>subjects undergoing diagnostic examinations in<br>magnetic resonance (MR) applications. | Spike for MRI disposable is for single-bottle use only<br>and must be discarded with the media container. The | |
| | ulricheasyINJECT Max 3 (XD 10180) is specifically<br>indicated for use in MRI procedures for the delivery of<br>VUEWAY™ (gadopiclenol) Injection - Bracco<br>Diagnostics, Inc., MultiHance (gadobenate<br>dimeglumine) - Bracco Diagnostics, Inc., Clariscan™<br>(Gadoterate Meglumine) Injection - GE Healthcare<br>Inc Dotarem® (gadoterate meglumine) Injection. | | |
| Characteristic | Subject Device<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Comparison |
| Product Codes | Guerbet, LLC, Gadavist™ (gadobutrol) Injection –<br>Bayer HealthCare Pharmaceuticals Inc., and<br>Gadobutrol Injection - Fresenius Kabi AG, contrast<br>media as supplied in approved single dose vials and<br>Gadavist™ (gadobutrol) Injection - Bayer HealthCare<br>Pharmaceuticals Inc. and Gadobutrol Injection –<br>Fresenius Kabi AG, contrast media as supplied in<br>approved Imaging Bulk Packages (IBPs).<br>Easy-Click-Cassette - flex Max 3 is used for a<br>maximum time of twenty-four (24) hours or a<br>maximum of 96 bottles of contrast media, whichever<br>comes first.<br>Use time expiration per single dose contrast media<br>container is a maximum of four (4) hours per contrast<br>media container, unless otherwise stated by the<br>contrast media labeling.<br>Use time expiration per IBP contrast media container<br>is a maximum of twenty-four (24) hours per contrast<br>media container, unless otherwise stated by the<br>contrast media labeling.<br>Spike for MRI disposable is for single-bottle use only<br>and must be discarded with the media container. The<br>Patient tubing must be discarded after each patient<br>procedure.<br>ulricheasyINJECT Max 3 (XD 10180) is to be used<br>only by and under quasi-continuous supervision of<br>trained healthcare professionals in an appropriate<br>licensed healthcare facility, in a room designated for<br>radiological procedures that involve intravascular<br>administration of contrast agent.<br>The ulricheasyINJECT Max 3 (XD 10180) is not<br>intended for injection of contrast media (CM) for high-<br>pressure angiography. | Patient tubing must be discarded after each patient<br>procedure.<br>ulricheasyINJECT Max 3 (XD 10180) is to be used<br>only by and under quasi-continuous supervision of<br>trained healthcare professionals in an appropriate<br>licensed healthcare facility, in a room designated for<br>radiological procedures that involve intravascular<br>administration of contrast agent.<br>The ulricheasyINJECT Max 3 (XD 10180) is not<br>intended for injection of contrast media (CM) for high-<br>pressure angiography. | |
| Characteristic | Subject Device<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)<br>ulricheasyINJECT Max<br>(XD 10140 / XD 10150 / XD 10180) | Comparison |
| Product Codes | IZQ<br>(21 CFR 870.1650) | IZQ<br>(21 CFR 870.1650) | Same |
| Device Use | | | |
| Environment of<br>Use | MR Environment | MR Environment | Same |
| Physical |…