(163 days)
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™ (lohexol) Injection, solution - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP), Omipaque™ (lohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (lodixanol) Injection, solution - 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 of eight (8) hours per contrast media or saline container.
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.
SYNCopen is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
RIS/PACS is indicated for the specific purpose of allowing an injector to interface with a Radiological Information System (RIS) and a Picture Archiving and Communications System (PACS).
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 intravasular administration of contrast agent.
ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector, and the CT motion tubing system. The CT motion 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 CT motion tubing system consists of three components:
- Spike for CT
- Pump tubing-flex .
- . Patient Tubing
ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex, and patient tubing for pump tubing-flex). The ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:
- Multiple patient use saline containers, ●
- . Omnipaque IBP contrast media containers,
- Omnipaque single-dose contrast media bottles. ●
- Visipaque single-dose contrast media bottles, and
- Cannula. .
The ulrichINJECT CT motion system is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (lohexol) 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.
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the device. Controls include air detectors, which are designed to detect air 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 ulrichINJECT CT motion is provided in three versions:
- Mobile pedestal version ●
- Ceiling version ●
- Wall mounted version .
The mobile pedestal version consists of the injector head and the injector base with rechargeable battery. The ceiling version and the wall-mounted version consist of the injector head, a fixed-height arm, and a movable arm.
The software option SYNCopen is a new software and hardware option which allows a connection between the injector system and a validated CT scanner. Both systems can communicate with each other and thus synchronize time sequences. The software option is only available if the manufacturer of the CT scanner has enabled the connection to the injector system.
The ulrich medical RIS/PACS Interface is a new software option supports transferring documentation-related parameters for a contrast media injection to healthcare IT systems. A worklist can be retrieved from a RIS server by means of the DICOM modality worklist information model. After selecting a patient from the worklist and performing the iniection, a comprehensive contrast media dose report is automatically transmitted to the configured PACS and/or Dose Reporting system.
The FDA 510(k) Summary for the ulrichINJECT CT motion outlines a series of non-clinical tests to demonstrate that the device meets its performance criteria. While the acceptance criteria are implicitly stated through adherence to various international standards and specific thresholds (e.g., air detection limit, volume accuracy), they are not presented in a single, consolidated table with reported device performance. No clinical studies (MRMC or standalone based on expert consensus/pathology) were performed or referenced for this 510(k) submission, as the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's a summary based on the provided text, addressing your specific points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
A consolidated table of acceptance criteria and reported device performance is not explicitly provided in the document. Instead, acceptance criteria are described as conformance to specific international standards and pre-defined thresholds for certain parameters. The reported performance is generally stated as "complies with the standard," "satisfactorily met," or "met the requirements of the pre-defined acceptance criteria."
| Acceptance Criteria Category | Specific Acceptance Criteria (implicit or stated) | Reported Device Performance |
|---|---|---|
| Software | Conformance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005); All acceptance criteria for installation qualification and operational and performance qualification. | All acceptance criteria for installation qualification and operational and performance qualification are satisfactorily met. |
| Electromagnetic Compatibility / Electrical Safety | Conformance with IEC 60601-1:2012 (Edition 3.1) and IEC 60601-1-2:2014 (Edition 4.0). | The ulrichINJECT CT motion complies with the listed standards. |
| Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$ in accordance with ISO 11135-1:2007. | Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard. |
| Shelf-Life | Conformance with ISO 11607-1:2006 for packaging; maintenance of integrity for a specified duration. | Verification results indicate compliance for a shelf life of 5 years. |
| Chemical Compatibility | No interaction with Omnipaque™ or Visipaque™; chemical integrity of contrast media not compromised. | The ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™; chemical integrity of contrast media is not compromised. |
| Contamination Control | Maintain sterility of injection media; resist ingress of microorganisms; residuals between compounds within defined limits after rinsing. | Maintains sterility, resists ingress of microorganisms, and residuals are within defined limits. |
| Biocompatibility | Conformance with ISO 10993-1:2009 for indirect patient contact materials. | Materials comply with the standard (based on cytotoxicity, intracutaneous reactivity, allergic sensitization, systemic acute toxicity, pyrogen shelf-life, hemocompatibility, LAL test). |
| Extractables and Leachables | Met requirements of pre-defined acceptance criteria for intended uses. | Testing and toxicological assessment demonstrated that the device is safe and effective and met the requirements. |
| Human Factors | No new unacceptable usability risks introduced by modifications; intended user population able to perform tasks. | No new unacceptable usability risks were introduced; intended user population is able to perform use tasks. |
| Performance - Bench | Conformance with applicable requirements of ISO 8536-4:2010; confirmation that mixing of contrast media will not occur. | The ulrichINJECT CT motion tubing system conforms to its predetermined specifications and applicable standards. |
| Technical Detection Limit of Air in Tubing | 0.05 mL | 0.05 mL |
| Air Detector Alarm Limit | 1 mL | 1 mL |
| Occlusion Detection Alarm Limit | 246 PSI | 246 PSI |
| Volume Accuracy | $\pm 5%$ for 10-200 mL of contrast media | $\pm 5%$ |
| Flow Rate Accuracy | $\pm 5%$ | $\pm 5%$ |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states that non-clinical testing (bench testing, software verification and validation, EMC testing, sterilization validation, shelf-life studies, chemical compatibility, contamination control, biocompatibility, extractables/leachables, and human factors) was performed.
- No "test set" in the context of clinical images or patient data is mentioned because this is a medical device for contrast media administration, not an imaging AI diagnostic device.
- The tests mentioned are primarily laboratory or simulated use tests. Therefore, there is no direct information on a "sample size for the test set" as would be applicable to an AI diagnostic device evaluating patient data.
- Data Provenance: Not applicable in the context of clinical data. The studies are primarily engineering validation and verification tests.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. Since this is a submission for a contrast media injector device and not an AI diagnostic tool requiring image interpretation or disease detection, there is no mention of experts establishing a "ground truth" for a test set of patient data. The "ground truth" for the tests performed relates to engineering specifications, safety standards, and functional performance.
4. Adjudication Method for the Test Set
- Not applicable. As there is no "test set" requiring expert interpretation or consensus for clinical ground truth, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe any MRMC comparative effectiveness study. The device is a contrast media injector, and the submission focuses on its technical and functional equivalence and safety, not on improving human reader performance in interpreting medical images.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Yes, implicitly. All the non-clinical tests described (software validation, EMC, sterilization, shelf-life, chemical compatibility, contamination control, biocompatibility, extractables/leachables, and performance bench tests) are evaluations of the device's inherent functional performance without human intervention in the loop of the test itself. The "Human Factors" study assessed the user interaction with the device, but the core performance criteria were evaluated without human interaction during the test.
7. Type of Ground Truth Used
The "ground truth" for the various non-clinical tests described is based on:
- Technical Specifications: Pre-defined design requirements for flow rate accuracy, volume accuracy, alarm limits (air, occlusion).
- International Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ISO 11135-1, ISO 11607-1, ISO 10993-1, ISO 8536-4.
- Safety and Efficacy Assessments: Demonstrating no adverse interactions with contrast media, maintaining sterility, preventing contamination, and ensuring biocompatibility.
- Usability Objectives: Confirmation that intended users can safely and effectively operate the device.
8. Sample Size for the Training Set
- Not applicable. This submission is for a medical device (contrast media injector), not an AI algorithm that would require a "training set" of data for machine learning. The software mentioned is control software, verified and validated against functional requirements.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI algorithm training set, there is no ground truth established for such a set. The "ground truth" for the device's control software functionality would be its design specifications, regulatory requirements, and established safety and performance parameters.
§ 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.