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510(k) Data Aggregation
(60 days)
ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection - GE Healthcare Inc., Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., VUEWAY™ (gadopiclenol) – Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved single dose bottles and Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).
ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol) Injection - Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., Clariscan™ (Gadoterate Meglumine) Injection - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection -Guerbet, LLC, Gadavist™ (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection -Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist™ (gadobutrol) Injection -Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Iniection - Fresenius Kabi AG. contrast media as supplied in approved Imaging Bulk Packages (IBPs).
ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).
The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:
- Spikes,
- Easy-Click-Cassette flex
- Patient Tubing
The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:
- Saline containers.
- Single-dose contrast media bottles,
- IBP contrast media containers, and
- Cannula.
ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulricheasyINJECT Max is provided in three models:
- ulricheasyINJECT Max 2M (XD 10140),
- ulricheasylNJECT Max 3 (XD 10150), and
- ulricheasylNJECT Max 3 (XD 10180).
The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.
The provided text describes a 510(k) premarket notification for the ulricheasyINJECT Max contrast media management system, which primarily references a previously cleared predicate device (K233737) for most of its acceptance criteria and supporting studies. The information available focuses on the differences between the current device and its predicate.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in a separate column. Instead, it describes various non-clinical tests conducted for the predicate device (K233737) and states that the subject device (ulricheasyINJECT Max) supports a broader range of contrast media, with additional testing performed to address this difference.
The following table summarizes the performance characteristics and states of verification for the device and its predicate:
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Software | Conformance with established performance criteria. | Software verification and validation performed as part of K233737, and repeated for software updates for the current submission. |
| EMC / Electrical Safety | Adherence to IEC 60601-1:2005, AMD 1:2012, AMD 2:2020 and ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012. | Testing performed in accordance with the specified standards as part of K233737. |
| Sterilization Validation | Sterility assurance level of 10-6. | Validated to a sterility assurance level of 10-6 as part of K233737 (Ethylene Oxide). |
| Shelf Life & Transport | Packaging integrity and functional stability over time and through transport. | Real-time and accelerated aging studies performed as part of K233737. Transport validation performed on tubing system, injector, and terminal as part of K233737. |
| Chemical Compatibility | Material compatibility with specified contrast media. | Additional Chemical Compatibility testing performed for the current submission to support new contrast media (Gadobutrol single dose bottle, Gadavist™ (gadobutrol) IBP, Gadobutrol IBP). Previous testing done for K233737. "The safety and effectiveness of the ulricheasyINJECT Max has been confirmed through contamination control testing, chemical compatibility testing, and extractables and leachables testing." |
| Contamination Control | Ability to prevent microbial ingress and cross-contamination; residuals within defined limits after rinsing. | Microbial ingress study demonstrated ability to prevent ingress during use. Cross-contamination study demonstrated effectiveness in preventing contamination. Rinsing study demonstrated residuals within defined limits. (All performed as part of K233737). |
| Biocompatibility | Compliance with ISO 10993-1. | Verification results indicated compliance with ISO 10993-1 as part of K233737 for indirect patient contact materials. |
| Performance – Bench | Conformance to predetermined specifications and applicable standards (ISO 8536-4 for applicable requirements). | Test and verification results indicated that the ulricheasyINJECT Max tubing system conforms to its predetermined specifications and the applicable standards (performed as part of K233737). |
| Extractables & Simulation | Leachable compounds within acceptable limits. | Testing included extractables and simulation testing for leachable compounds as part of K233737. |
| Human Factors / Usability | Safe and effective for use by intended users. | Usability study performed as part of K233737 to confirm that the ulricheasyINJECT Max is safe and effective for use by its intended users. |
| Flow Rate Accuracy | ± 5% | ± 5% (Same as predicate, implied validation via K233737 non-clinical testing). |
| Volume Accuracy | ± 5% (for 10-400 mL) | ± 5% (for 10-400 mL of contrast media; Same as predicate, implied validation via K233737 non-clinical testing). |
| Technical Detection Limit of Air in Tubing | 0.05 mL | 0.05 mL (Same as predicate, implied validation via K233737 non-clinical testing). |
| Air Detector Alarm Limit | 1 mL | 1 mL (Same as predicate, implied validation via K233737 non-clinical testing). |
| Occlusion Detection Alarm Limit | 203 PSI | 203 PSI (Same as predicate, implied validation via K233737 non-clinical testing). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact sample sizes for each test set. It mentions "studies" and "testing" without providing numerical details for the number of units or data points tested in non-clinical assessments.
- Data Provenance: All non-clinical testing (Software, EMC/Electrical Safety, Sterilization Validation, Shelf Life and Transport Validation, Contamination Control and Rinsing, Biocompatibility, Performance – Bench, Extractables and Simulation, Human Factors / Usability) was performed as part of K233737, indicating it was conducted for the predicate device. Additional chemical compatibility testing was conducted for the current submission (K241850) to support new contrast media. The origin of the data (e.g., country) is not specified beyond being part of ulrich GmbH & Co. KG's submission, implying internal company testing. Studies are described as "non-clinical" and "bench," which means they are not human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document discusses non-clinical bench testing, not image-based diagnostic performance involving expert readers establishing ground truth. The "Human Factors / Usability" study confirms the device's safety and effectiveness for its intended users (trained healthcare professionals), but it's not about expert clinical interpretation for a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies involving multiple human readers, which is not described in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a contrast media management system, not an AI-powered diagnostic imaging tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device (an injector) with software controls, not an algorithm meant for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For non-clinical testing, "ground truth" generally refers to established scientific principles, engineering specifications, recognized industry standards (e.g., ISO, IEC), and predetermined specifications for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's achieving a specified Sterility Assurance Level. For performance metrics like flow rate and volume accuracy, it's meeting the ±5% specification.
8. The sample size for the training set
Not applicable. The document refers to a physical medical device and its controls, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned.
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