(149 days)
ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection, - GE Healthcare Inc. contrast media as supplied in approved single dose bottles.
Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravasular administration of contrast agent.
The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.
ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol), - Bracco Diagnostics Inc, MultiHance (gadobenate dimeglumine) – Bracco Diagnostics, Inc, Clariscan™ (Gadoterate Meglumine) Injection, - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection - Guerbet, LLC, and Gadavist™ (gadobutrol) Injection, - Bayer HealthCare Pharmaceuticals Inc., contrast media as supplied in approved single dose vials.
Easy-Click-Cassette - flex Max 3 is used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.
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.
The ulricheasyINJECT Max system, a contrast media management system, underwent a comprehensive study to demonstrate its substantial equivalence to a predicate device, ulrichINJECT CT motion (K192872). The study focused on non-clinical testing to ensure its safety and effectiveness for its intended use in magnetic resonance (MR) applications.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it states that "Verification results indicate that the ulricheasyINJECT Max tubing system complies with the standard" or "conforms to its predetermined specifications." The "Comparison" column in the Comparative Analysis table acts as a high-level summary of performance against the predicate.
Below is a table summarizing the areas tested and the reported performance based on the provided text:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance with established performance criteria for overall system and software. | Software verification and validation performed. |
| Compliance with Electromagnetic Compatibility (EMC) and Electrical Safety standards (IEC 60601-1). | Complies with FDA recognized standard ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]. |
| Sterilization to a Sterility Assurance Level (SAL) of $10^{-6}$ and appropriate shelf life. | Validated to a SAL of $10^{-6}$ using Ethylene Oxide (EtO) according to ISO 11135:2014. Real-time and accelerated aging studies performed. |
| Material compatibility with specified contrast media. | Chemical compatibility testing performed with Gadavist, Clariscan™, VUEWAY™, MultiHance, and Dotarem. Results support material compatibility. |
| Maintenance of sterility of injection media and resistance to microbial ingress. | Microbial ingress study and cross-contamination study performed. Concluded that the system maintains sterility and resists ingress. Residuals between contrast media's active compounds after rinsing are within defined limits. |
| Biocompatibility of indirect patient contact materials. | Verified in accordance with ISO 10993-1. Materials comply with the standard. |
| Conformance to predetermined specifications and applicable standards for tubing system performance. | Tested for performance and verified in accordance with applicable requirements from ISO 8536-4:2010. Conforms to predetermined specifications and applicable standards. |
| Absence of unacceptable leachable compounds. | Extractables and simulation testing for leachable compounds included. |
| Safe and effective operation by users. | Human Factors / Usability assessments performed in a simulated use environment. Results demonstrated that users can operate ulricheasyINJECT Max as safely and effectively as the predicate device. |
| (Differentiation from predicate that does not raise new safety/effectiveness concerns) | Extensive comparative analysis (Table in the document) highlights differences in indications for use (CT vs. MRI), environment of use (CT vs. MR), accessories, disposables, weight, dimensions, remaining volume readout, pressure limit, injection pause, priming/venting rate, air detection principle, occlusion detection alarm limit, time limit for disposables, patient tubing components, and tubing materials. For each difference, the document states: "This difference does not change the intended use of the device. The safety and effectiveness of the ulricheasyINJECT Max has been confirmed through [specific testing, e.g., MR compatibility testing, chemical compatibility testing, and Safety / EMC testing]". |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes for the test sets used in the non-clinical studies (e.g., number of units tested for EMC, number of samples for chemical compatibility). It refers to the tests performed and their general outcomes.
The data provenance is from non-clinical testing performed by ulrich GmbH & Co. KG, for the purpose of a 510(k) premarket notification. This indicates the data is prospective in the context of device validation. The "country of origin of the data" is not explicitly stated but the submitter is based in Ulm, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described studies are non-clinical (bench testing, software validation, biocompatibility, etc.) and do not involve human readers or refer to "ground truth" in the context of expert review of clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing and comparison to a predicate device, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the studies described are analogous to standalone performance evaluation for the device's functional and safety aspects. The software and various physical parameters (e.g., flow rate accuracy, air detection) were tested independently of human intervention during the functional tests, demonstrating the device's inherent performance. Human Factors/Usability assessments considered human interaction but focused on the device design's safety and effectiveness, not the clinical performance of an algorithm.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by recognized industry standards and predetermined specifications for device performance, safety, and material properties. Examples include:
- IEC 60601-1 for electrical safety and EMC.
- ISO 11135:2014 for sterilization.
- ISO 10993-1 for biocompatibility.
- ISO 8536-4:2010 (applicable requirements) for infusion equipment performance.
- Internal predetermined specifications for aspects like flow rate accuracy (± 5%), volume accuracy (± 5%), air detection limit (0.05 mL), and alarm limits.
8. The Sample Size for the Training Set:
This information is not applicable. The document describes a contrast media injector system, not an AI/ML algorithm that requires a separate training set. The "software verification and validation" refers to traditional software testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of an AI/ML training set.
§ 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.