(60 days)
No
The description focuses on the mechanical and software controls for automated contrast media administration using a peristaltic pump, with no mention of AI or ML capabilities for decision-making, image analysis, or adaptive control.
No
The device is a contrast media management system used for diagnostic examinations, not for treating a disease or condition.
No
This device is a contrast media management system used to administer contrast media and saline during diagnostic examinations; it does not perform the diagnostic examination itself.
No
The device description clearly states that the ulricheasyINJECT Max device consists of a terminal, injector, and tubing system, and describes physical components like a mobile pedestal device, peristaltic pump, spikes, cassette, and patient tubing. It also mentions hardware controls. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ulricheasyINJECT Max is a contrast media management system used for the administration of contrast media and saline into the human body during diagnostic imaging procedures (MRI). It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states it's for the "controlled, automatic administration... to human subjects undergoing diagnostic examinations." This describes a therapeutic or procedural function, not an in vitro diagnostic function.
Therefore, the ulricheasyINJECT Max falls under the category of a medical device used for administering substances to a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
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) 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).
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.
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 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),
- 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 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 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.
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:
- 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 and electrical safety testing was performed in accordance with 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 (Cons. Text) [Incl. AMD2:2021] as part of K233737.
- Sterilization validation was performed to a sterility assurance level of 10-6 using ethylene oxide (EtO) as part of K233737.
- Shelf Life and Transport Validation: Real-time aging and accelerated aging studies were performed as part of K233737. Transport validation was performed as part of K233737 for the tubing system, injector, and terminal.
- Chemical Compatibility: Additional Chemical Compatibility testing was performed to support the material compatibility of the ulricheasyINJECT Max tubing system with Gadobutrol single dose bottle, Gadavist™ (gadobutrol) IBP, and Gadobutrol IBP.
- Contamination Control and Rinsing: A microbial ingress study and a cross contamination study were performed as part of K233737. 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.
- Biocompatibility: Verified in accordance with ISO 10993-1 as part of K233737. Verification results indicated that the materials comply with the standard.
- Performance – Bench: The tubing system was tested and verified in accordance with applicable requirements from ISO 8536-4:2010 as part of K233737. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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).
1
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
2
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).
3
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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4
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
Buchbrunnenweg 12
89081 Ulm
Germany |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King
CEO
MethodSense, Inc. |
| Company Contact: | Sven Erdmann
Vice 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 (XD
10150); ulricheasyINJECT Max 3 (XD 10180)
Contrast Media Management System
Class II
21 CFR 870.1650, Angiographic Injector and Syringe
Cardiovascular Panel
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
5
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
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.
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.
7
Comparative Analysis of the ulricheasyINJECT Max to the Predicate Device
| Characteristic | Subject Device
ulricheasyINJECT 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 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. | 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. | 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 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. | 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 container. The
Patient tubing must be discarded after each patient
procedure. | 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 testing, chemical
compatibility testing, and
extractables and
leachables testing. |
| Characteristic | Subject Device
ulricheasyINJECT 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 media
container is a maximum of four (4) hours per contrast
media container, unless otherwise stated by the
contrast media labeling. | 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. | |
| | 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. | The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD
10150) is not intended for injection of contrast media
(CM) for high-pressure angiography. | |
| | 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)
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 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 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. | |
| | ulricheasyINJECT Max 2M / 3 (XD 10140 / XD
- is not intended for injection of contrast media
(CM) for high-pressure angiography. | 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. | |
| | 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. | Spike for MRI disposable is for single-bottle use only
and must be discarded with the media container. The | |
| | 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. | | |
| Characteristic | Subject Device
ulricheasyINJECT 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., 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 high-
pressure angiography. | 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. | |
| Characteristic | Subject Device
ulricheasyINJECT 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 of
Use | MR Environment | MR Environment | Same |
| Physical | | | |
| System | Injector Head
Touch Terminal | Injector Head
Touch Terminal | Same |
| Accessories | Injector Base | Injector Base | Same |
| | Easy-Click-Cassette 3 - flex
Easy-Click-Cassette 2M - flex | Easy-Click-Cassette 3 - flex
Easy-Click-Cassette 2M - flex | |
| Disposables | Patient tubing 250 cm
Patient tubing 320 cm
Patient tubing without RFID, 250 cm
Patient tubing without RFID, 320 cm | Patient tubing 250 cm
Patient tubing 320 cm
Patient tubing without RFID, 250 cm
Patient tubing without RFID, 320 cm | Same |
| | Spike for CT (CM/NaCI) and MRI (NaCI)
Spike for MRI (CM) - holder l
Spike for MRI (CM) – holder s | Spike for CT (CM/NaCI) and MRI (NaCI)
Spike for MRI (CM) - holder l
Spike for MRI (CM) - holder s | |
| Weight | Injector: Approx. 40 kg
Terminal: Approx. 3 kg | Injector: Approx. 40 kg
Terminal: Approx. 3 kg | Same |
| 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 (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 | Same |
| 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 Watts: 1.6 A / 200 W
Rated 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 |
| 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 | Same |
| Designed to
Prevent Reuse of
Disposables | Yes - via the use of software controls and RFID | Yes - via the use of software controls and RFID | Same |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180) | Comparison |
| 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 Cassette detector | Same |
| Volume
Remaining
Readout | Yes, displayed on control unit at all times | Yes, displayed on control unit at all times | Same |
| Programmable
Pressure Limit | Yes, 159.5 PSI; user-programmable or automatic | Yes, 159.5 PSI; user-programmable or automatic | Same |
| 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 |
| 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
± 5%
Flow rate accuracy of ± 5% | 10-400 mL of contrast media with volume accuracy of
± 5%
Flow rate accuracy of ± 5% | Same |
| Contrast Media
Container Volume | 10–200 mL | 10-200 mL | Same |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180) | Comparison |
| 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
Gadobutrol single dose
Gadavist™ (gadobutrol) IBP
Gadobutrol IBP | VUEWAY™ (gadopiclenol) single dose
MultiHance (gadobenate dimeglumine) single dose
Clariscan™ (Gadoterate Meglumine) single dose
Dotarem® (gadoterate meglumine) single dose
Gadavist™ (gadobutrol) 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 testing, chemical
compatibility testing, and
extractables and
leachables 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 sec
increments | Programmable – 0 sec to 1800 sec in 1 sec
increments | Same |
| Injection Protocol
Storage | Yes | Yes | Same |
| Priming/Venting
Rate | 4 mL/s | 4 mL/s | Same |
| Air Detection
Principle | Optical re-fraction sensor | Optical re-fraction sensor | Same |
| 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 | 203 PSI | Same |
| Time Limit for
Disposables | 24 hours for Easy-Click-Cassette - flex
12 hours for Patient Tubing
24 hours for Spike | 24 hours for Easy-Click-Cassette - flex
12 hours for Patient Tubing
24 hours for Spike | Same |
| Package Sterile | Yes | Yes | Same |
| Sterilization
Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Characteristic | Subject Device
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180) | Predicate Device (K233737)
ulricheasyINJECT Max
(XD 10140 / XD 10150 / XD 10180) | Comparison |
| Packaging
Configuration | Tyvek lid covering polystyrele tray | Tyvek lid covering polystyrele tray | Same |
| Patient Tubing
Components | Patient Tubing
One Luer Connector with safety cap
One SafeConnect with safety cap
Two check valves | Patient Tubing
One Luer Connector with safety cap
One SafeConnect with safety cap
Two check valves | Same |
| Contrast Media
Line Tubing
Material | PVC / PUR / polycarbonate | PVC / PUR / polycarbonate | Same |
| Saline Line
Tubing Material | PVC / PUR / polycarbonate | PVC / PUR / polycarbonate | Same |
| Spike Length | Saline: 34.2 mm
Contrast Media: 19.2 mm | Saline: 34.2 mm
Contrast Media: 19.2 mm | Same |
8
9
10
11
12
13
14
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.
15
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).