(149 days)
Not Found
No
The summary describes a contrast media management system with hardware and software controls for automatic administration, but there is no mention of AI or ML capabilities for tasks like image analysis, dose optimization, or workflow prediction.
No.
The device is a contrast media management system indicated for the administration of contrast media and saline to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications. It is not designed to treat a disease or condition, but rather to aid in diagnostic procedures.
No
The device is a contrast media management system used for the administration of contrast media and saline during diagnostic examinations (MRI). It does not perform diagnostic functions itself, but rather assists in the delivery of agents necessary for diagnostic imaging procedures.
No
The device description explicitly states it consists of a terminal, injector, and tubing system, and mentions hardware controls and components like a peristaltic pump, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ulricheasyINJECT Max system is a contrast media management system used to administer contrast media and saline into the patient's body during MRI procedures. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use clearly states the device is for "controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications." This describes an in-vivo (within the living body) procedure, not an in-vitro (in glass/outside the body) diagnostic test.
Therefore, the ulricheasyINJECT Max system is a medical device used in diagnostic imaging procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
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 highpressure angiography.
Indications for Use - 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.
ulricheasylNJECT 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.
Product codes (comma separated list FDA assigned to the subject device)
IZQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) applications (MRI or PET MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 intravascular administration of contrast agent.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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.
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 highpressure angiography.
Indications for Use - 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), - 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.
4
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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5
Summary of 510(k)
Ulrich GmbH & Co. KG K233737
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm
Germany
Phone: +49 731 9654-1714
Fax: +49 731 9654-2807 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Sven Erdmann
Vice 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
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,
6
- . 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.
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.
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 intravascular 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.
Indications for Use – ulricheasyINJECT Max 3 (XD 10180)
7
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.
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 ulrichINJECT CT Motion (K192872) by ulrich GmbH & Co. KG that is currently on the market.
8
Comparative Analysis of the ulricheasyINJECT Max to the Predicate Device
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | ulrichINJECT CT motion is a contrast media
management system that is intended for the
controlled, automatic administration, on the
venous side, of contrast media and saline
(NaCl), to human subjects undergoing
diagnostic examinations | Same |
| Indications for Use | ulricheasyINJECT Max 2M (XD 10140) / 3 (XD
10150)
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. 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 | ulrichINJECT CT motion 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 computed
tomography (CT) applications.
ulrichINJECT CT motion is specifically
indicated for use in CT procedures for the
delivery of Omnipaque™ (Iohexol) Injection,
solution - GE Healthcare Inc. contrast media
as supplied in Imaging Bulk Packages (IBP),
Omnipaque™ (Iohexol) Injection, solution - GE
Healthcare Inc., and Visipaque™ (iodixanol)
Injection - GE Healthcare Inc. contrast media
as supplied in single dose bottles.
Pump tubing-flex is used for a maximum time
of twenty four (24) hours. When used with
Omnipaque™ IBP, Omnipaque™ single dose
bottles, or Visipaque™ single dose bottles, a
maximum of 19 bottles of contrast media can
be used or maximum time of twenty four (24)
hours of Pump tubing-flex, or whichever
comes first. Time per contrast media or saline
container depends on each contrast media's
or saline's use time expiration with a maximum | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through MR
compatibility testing, chemical
compatibility 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 / 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.
The ulricheasyINJECT Max 2M / 3 (XD 10140 /
XD 10150) is not intended for injection of
contrast media (CM) for high-pressure
angiography. | Spike for CT 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.
ulrichINJECT CT motion 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 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, 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 | | |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
| | 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 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. | | |
| Product Codes | | | |
| Product Codes | IZQ
(21 CFR 870.1650) | IZQ
(21 CFR 870.1650) | Same |
| Device Use | | | |
| Environment of
Use | MR Environment | CT Environment | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through MR
compatibility testing, chemical
compatibility testing, and Safety /
EMC testing. |
| Physical | | | |
| System | Injector Head
Touch Terminal | Injector Head
Touch Terminal | Same |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT 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 not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through human
factors validation. |
| Disposables | Easy-Click-Cassette 3 - flex
Easy-Click-Cassette 2M - flex
Patient tubing 250 cm
Patient tubing 320 cm
Patient tubing without RFID, 250 cm
Patient tubing without RFID, 320 cm
Spike for CT (CM/NaCI) and MRI (NaCI)
Spike for MRI (CM) - holder I
Spike for MRI (CM) – holder s | ulrichINJECT CT Motion Pump Tubing-flex
Patient Tubing for Pump Tubing-flex
ulrichINJECT CT Motion Spike | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through
contamination control studies,
chemical compatibility studies, and
biocompatibility studies. |
| Weight | Injector: Approx. 40 kg
Terminal: Approx. 3 kg | Injector (pedestal version): Approx. 80 kg
Injector (ceiling and wall mount version):
Approx. 40 kg
Terminal: Approx. 3 kg | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through human
factors validation. |
| Dimensions | Injector (with bottle holder): 53 cm x 53 cm x
137.2 cm
Injector (with media rod): 530 mm x 530 mm x
1730 mm
Terminal: 29.3 cm x 28.3 cm x 16 cm | Injector (pedestal version and wall mount
version): 64.5 x 64.5 x 144.5 cm
Injector (ceiling version): Depends on the
system selected and the length of the fixed
height arm
Terminal: 31 x 27.5 x 17 cm | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through human
factors validation. |
| Power
Requirement | Rated Voltage: 100-240 V AC
Rated Watts: 1.6 A / 200 W
Rated Frequency: 50/60 Hz | Rated Voltage: 100-240 V AC
Rated Current: 1.6 A
Rated 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 |
| Syringeless
System | Yes | Yes | Same |
| Remote Operation | Yes, via the Touch Terminal | Yes, via the Touch Terminal | Same |
| Single Patient
Use Disposable | Patient Tubing | Patient Tubing for Pump Tubing-flex | Same |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
| Designed to
Prevent Reuse of
Disposables | Yes - via the use of software controls and RFID | Yes - via the use of software controls | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Rotary peristaltic
pump | Yes | Yes | Same |
| Used to
administer
contrast media
and saline | Yes | Yes | Same |
| Disposable uses
spikes to spike
media container | Yes | Yes | Same |
| Safety Stop
Mechanism | Multi-layered software stops; Used Patient
Tubing detector and Cassette detector | Multi-layered software stops; Used Patient
Tubing detector and Pump Tubing-flex
detector | Same |
| Volume
Remaining
Readout | Yes, displayed on control unit at all times | Yes, displayed on control unit if programmed
volume is higher than remaining volume | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed though software
verification and validation and safety
testing. |
| Programmable
Pressure Limit | Yes, 159.5 PSI; user-programmable or
automatic | Yes, 195 PSI; user-programmable or
automatic | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Operational Characteristics | | | |
| Injection
Capabilities | 40 phases per protocol | 40 phases per protocol | Same |
| Injection Rates for
Contrast Media | 0.1 mL/s to 10.0 mL/s | 0.1 mL/s to 10.0 mL/s | Same |
| Injection Rates for
Saline | 0.1 mL/s to 10.0 mL/s | 0.1 mL/s to 10.0 mL/s | Same |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
| Injection Volume
per Injection | 1 to 200 mL max volume of contrast media per
patient with a max of 400 mL total media
(contrast and saline) per patient | 1 to 200 mL max volume of contrast media per
patient with a max of 400 mL total media
(contrast and saline) per patient | Same |
| Flow Rate and
Volume Accuracy | 10-400 mL of contrast media with volume
accuracy of $\pm$ 5%
Flow rate accuracy of $\pm$ 5% | 10-200 mL of contrast media with volume
accuracy of $\pm$ 5%
Flow rate accuracy of $\pm$ 5% | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Contrast Media
Container 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 not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through
contamination control, chemical
compatibility, software safety, and
software verification and validation
testing. |
| Compatible
Contrast Media | VUEWAY™ (gadopiclenol) single dose
MultiHance (gadobenate dimeglumine) single
dose
Clariscan™ (Gadoterate Meglumine) single
dose
Dotarem® (gadoterate meglumine) single dose
Gadavist™ (gadobutrol) single dose | OMNIPAQUE™ IBP
OMNIPAQUE™ single dose
VISIPAQUE™ single dose | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through chemical
compatibility and extractables and
leachables testing. |
| Saline Flush | Yes | Yes | Same |
| Needle Size | 16-24 G | 14-24 G | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
| Injection Pause | Programmable - 0 sec to 1800 sec in 1 sec
increments | Programmable - 0 sec to 999 sec in 1 sec
increments | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Injection Protocol
Storage | Yes | Yes | Same |
| Priming/Venting
Rate | 4 mL/s | 2 mL/s (manual) | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Air Detection
Principle | Optical re-fraction sensor | Ultrasound | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Technical
Detection
Limit of air in
tubing | 0.05 mL | 0.05 mL | Same |
| Air Detector Alarm
Limit | 1 mL | 1 mL | Same |
| Occlusion
Detection
Principle | Fail safe piezo-resistive pressure sensor | Fail safe piezo-resistive pressure sensor | Same |
| Occlusion
Detection Alarm
Limit | 203 PSI | 246 PSI | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through software
verification and validation and safety
testing. |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
| Time Limit for
Disposables | 24 hours for Easy-Click-Cassette - flex
12 hours for Patient Tubing
24 hours for Spike | 24 hours for Pump Tubing-flex
12 hours for Patient Tubing
8 hours for Spike for CT | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through
contamination control, chemical
compatibility, and extractables and
leachables testing. |
| Package Sterile | Yes | Yes | Same |
| Sterilization
Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Packaging
Configuration | Tyvek lid covering polystyrene tray | Tyvek lid covering polystyrene tray | Same |
| Patient Tubing
Components | Patient Tubing
One Luer Connector with safety cap
One SafeConnect with safety cap
Two check valves | Patient Tubing
Two Patient Luer Connectors with safety caps
Two check valves | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been evaluated via risk management
activities and confirmed through
contamination testing. |
| Contrast Media
Line Tubing
Material | PVC / PUR / polycarbonate | PVC / PUR | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been evaluated via risk management
activities and confirmed through
biocompatibility, chemical
compatibility, and extractables /
leachables testing. |
| Saline Line
Tubing Material | PVC / PUR / polycarbonate | PVC / PUR | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been evaluated via risk management
activities and confirmed through
biocompatibility, chemical
compatibility, and extractables /
leachables testing. |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180)
(K233737) | Predicate Device
ulrichINJECT CT motion
(K192872) | Comparison |
| Spike Length | Saline: 34.2 mm
Contrast Media: 19.2 mm | 28.5 mm | Different - This difference does not
change the intended use of the
device. The safety and effectiveness
of the ulricheasyINJECT Max has
been confirmed through bench
testing and data |
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10
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12
13
14
15
16
17
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.
18
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).