(163 days)
No
The document describes a contrast media management system with hardware and software controls for safe operation and interfacing with CT scanners and IT systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is designed for the controlled administration of contrast media and saline for diagnostic examinations in CT applications, not for treating any disease or condition.
No
This device is a contrast media management system designed to administer contrast media and saline during CT examinations. It facilitates diagnostic procedures but does not perform the diagnosis itself.
No
The device description clearly outlines hardware components such as the CT motion terminal, CT motion injector, CT motion tubing system (including spike, pump tubing, and patient tubing), a peristaltic pump, air detectors, pressure controls, check valves, and different physical versions (mobile pedestal, ceiling, wall-mounted). While it includes software options (SYNCopen, RIS/PACS Interface), it is fundamentally a hardware system with integrated software controls.
Based on the provided text, the ulrichINJECT CT motion is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. This typically involves testing blood, urine, tissue, etc., outside of the body.
- ulrichINJECT CT motion's Function: The ulrichINJECT CT motion is a system for administering contrast media and saline into the human body during a CT scan. It is a delivery system, not a system for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "controlled, automatic administration...to human subjects undergoing diagnostic examinations in computed tomography (CT) applications." This describes an in-vivo procedure (within the living body).
Therefore, the ulrichINJECT CT motion falls under the category of a medical device used for in-vivo procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IZQ
Device Description
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™ (Ioexol) 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 injection, a comprehensive contrast media dose report is automatically transmitted to the configured PACS and/or Dose Reporting system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
ulrichINJECT CT motion 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 K171392 and K192872 and has been repeated for the software updates made as part of this submission. FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005) has been followed.
Validation included installation qualification and operational performance qualification. All acceptance criteria for the installation qualification and operational and performance qualification are satisfactorily met so that the ulrichINJECT CT motion software is released for its intended use.
Electromagnetic Compatibility / Electrical Safety:
Testing was performed in accordance with the following standards:
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance; Edition 3.1 (2012)
- IEC 60601-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests; Edition 4.0 (2014)
Testing results indicate that the ulrichINJECT CT motion complies with the standards listed.
Sterilization:
The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standard prior to commercial distribution as part of K192872:
- ISO 11135-1: Sterilization of health care products Ethylene oxide Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices; 2007
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Shelf-Life:
Real-time aging and accelerated-aging studies were performed as part of K171392 and K192872. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with the following standard:
- ISO 11607-1: Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems; 2006
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard for a shelf life of 5 years.
Chemical Compatibility:
Material compatibility of the ulrichINJECT CT motion tubing system was performed as part of K192872 using Omnipaque™ and Visipaque™ as the solvents. The results of the testing concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™ and the chemical integrity of Omnipaque™ or Visipaque™ is not compromised throughout use. Therefore, ulrichINJECT CT motion is safe and effective for its intended uses.
Contamination Control:
ulrich performed the following contamination control studies as part of K192872:
- Process Simulation Studies
- Microbial Ingress Study
- Cross Contamination Study
- Rinsing Study
Contamination control study results have concluded that ulrichINJECT CT motion has the ability to maintain the sterility of the injection media and resist the ingress of microorganisms when used with Omnipaque™ Imaging Bulk Package (IBP), Omnipaque single dose bottles, and Visipaque single dose bottles during its intended use. Additionally, it has been concluded that the residuals between the single active compounds (lohexol and lodixanol) after rinsing the system with physiological saline solution are within the defined limits.
Biocompatibility:
The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard as part of K171392 and K192872:
- ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process; 2009
The following tests have been performed: - Cytotoxicity
- Intracutaneous reactivity
- Allergic sensitization
- Systemic acute toxicity
- Pyrogen shelf-life:
- Hemocompatibility: Hemolysis
- LAL test: Bacterial endotoxins
Verification results indicated that the materials comply with the standard.
Extractables and Leachables:
Testing was performed for extractables and simulation testing for leachable compounds and particulates as part of K171392 and K192872 for OMNIPAQUE and VISIPAQUE.
Testing and a toxicological assessment demonstrated that ulrichINJECT CT motion is safe and effective for its intended uses. The results of the testing and toxicological assessment met the requirements of the pre-defined acceptance criteria for the intended uses of the device.
Human Factors:
A usability study was performed as part of K171392 to confirm that the ulrichINJECT CT motion was safe and effective for use by its intended users. Usability evaluations, including a usability study, were performed as part of K210541 to confirm that the updated ulrichINJECT CT motion system with RIS/PACS and SYNCopen software options is still safe and effective for use by the intended user population. Results demonstrated that no new unacceptable usability risks were introduced by the modifications and the intended user population is able to perform use tasks.
Performance - Bench:
The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards as part of K171392:
- ISO 8536-4: Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed: 2010
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.
Transport validation and cleaning instructions validation was also performed as part of K171392.
Testing was also performed as part of K192872 to confirm that mixing of contrast media will not occur.
Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards
Conclusion
Based on the performance testing, comparison, and analysis in this submission, the subject device, ulrichINJECT CT motion, is substantially equivalent to the predicate device, K192872.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 6, 2021
ulrich GmbH & Co. KG % Rita King CEO MethodSense Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560
Re: K210541
Trade/Device Name: ulrichINJECT CT motion Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: IZQ Dated: July 8, 2021 Received: July 9, 2021
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210541
Device Name ulrichINJECT CT motion
Indications for Use (Describe)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
ulrich GmbH & Co. KG K210541
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm
Germany
Phone: +49 731 9654-1714
Fax: +49 731 9654-2807 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Sven Erdmann
Vice President Technology & Regulation |
| Date Prepared: | August 6, 2021 |
Device Name and Classification
| Trade Name: | ulrichINJECT CT motion |
|---|---|
| Common Name: | Contrast Media Management System |
| Classification: | Class II |
| Regulation Number: | CFR 870.1650, Angiographic Injector and Syringe; |
| Classification Panel: | Cardiovascular Panel |
| Product Code: | IZQ |
Predicate Device:
| Predicate | |
|---|---|
| Trade Name | ulrichINJECT CT motion |
| Common Name | Contrast Media Management System |
| 510(k) Submitter / Holder | ulrich GmbH & Co. KG |
| 510(k) Number | K192872 |
| Classification | Class II |
| Regulation Number | CFR 870.1650, Angiographic Injector and Syringe |
| Classification Panel | Cardiovascular Panel |
| Product Code | IZQ |
5
| Reference Device | |
|---|---|
| Trade Name | MEDRAD Stellant FLEX CT Injection System with Certegra |
| Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD | |
| Stellant CT Injection System with Certegra Workstation, | |
| MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector | |
| Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | |
| Common Name | Injector And Syringe, Angiographic |
| 510(k) Submitter / Holder | Bayer Medical Care, Inc. |
| 510(k) Number | K182273 |
| Classification | Class II |
| Regulation Number | CFR 870.1650 |
| Classification Panel | Cardiovascular |
| Product Code | DXT |
6
Device Description
ulrichINJECT CT motion is a svringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subiects 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
7
available if the manufacturer of the CT scanner has enabled the connection to the injector svstem.
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.
Indications for Use
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 (NaCI), 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), Omnipaque™ (Iohexol) Injection, solution - GE Healthcare Inc., and Visipaque™ (iodixanol) Injection - GE Healthcare Inc. contrast media as supplied in single dose bottles.
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, Omnipaque™ single dose bottles, or Visipaque™ single dose bottles, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first. Time per contrast media or saline container depends on each contrast media's or saline's use time expiration with a maximum 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 Communication 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 intravascular administration of contrast agent.
Risk Analvsis Method
The ulrichINJECT CT motion was assessed to determine the risks to health associated with the use of the syringeless injector. A risk analysis was conducted in accordance with ISO
8
14971:2007, Medical devices - Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, contamination and infection, and improper use.
Substantial Equivalence
The ulrichINJECT CT motion is substantially equivalent to the predicate, ulrichINJECT CT motion (K192872) currently on the market. The table below provides a detailed comparison of ulrichINJECT CT motion to the predicate device.
Additionally, the ulrichINJECT CT motion SYNCopen component is substantially equivalent to the reference device, MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits. MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (K182273), ISI component. The reference device (K182273) ISI functionality allows start of the injector and CT scanner simultaneously and communicates information between the injector and CT scanner, similar to the ulrichINJECT CT motion SYNCopen functionality.
9
Detailed Comparison of the Subject and Predicate Device
| Item | Subject Device | Primary Predicate | Comparison |
|---|---|---|---|
| Indications for | |||
| Use | ulrichINJECT CT motion | ||
| 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 (K192872) | ||
| 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 OmnipaqueTM (Iohexol) Injection, | |||
| solution - GE Healthcare Inc. contrast media | |||
| as supplied in Imaging Bulk Packages (IBP), | |||
| OmnipaqueTM (lohexol) Injection, solution - | |||
| GE Healthcare Inc., and VisipaqueTM | |||
| (iodixanol) Injection - GE Healthcare Inc. | |||
| contrast media as supplied | |||
| in single dose bottles. | ulrichINJECT CT motion is specifically | ||
| indicated for use in CT procedures for the | |||
| delivery of OmnipaqueTM (Iohexol) Injection, | |||
| solution - GE Healthcare Inc. contrast media | |||
| as supplied in Imaging Bulk Packages (IBP), | |||
| OmnipaqueTM (lohexol) Injection, solution - | |||
| GE Healthcare Inc., and VisipaqueTM | |||
| (iodixanol) Injection - GE Healthcare Inc. | |||
| contrast media as supplied | |||
| in single dose bottles. | Similar. See | ||
| Note 1. | |||
| Pump tubing-flex is used for a maximum time | |||
| of twenty four (24) hours. When used with | |||
| OmnipaqueTM IBP, OmnipaqueTM single | |||
| dose bottles, or VisipaqueTM 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. | Pump tubing-flex is used for a maximum time | ||
| of twenty four (24) hours. When used with | |||
| OmnipaqueTM IBP, OmnipaqueTM single | |||
| dose bottles, or VisipaqueTM 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. | |||
| Item | Subject Device | Primary Predicate | Comparison |
| ulrichINJECT CT motion | ulrichINJECT CT motion (K192872) | ||
| 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 Communication | |||
| 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 intravascular administration of | |||
| contrast agent. | Spike for CT disposable is for single-bottle | ||
| use only and must be discarded with the | |||
| media container. The Patient tubing must be | |||
| discarded after each patient procedure. | |||
| ulrichINJECT CT motion is to be used only | |||
| by and under quasi-continuous supervision | |||
| of trained healthcare professionals in an | |||
| appropriate licensed healthcare facility, in a | |||
| room designated for radiological procedures | |||
| that involve intravascular administration of | |||
| contrast agent. | |||
| System | Injector Head | ||
| Touch Terminal | Injector Head | ||
| Touch Terminal | Same | ||
| Accessories | Injector Base | ||
| Wall Mount with moveable arm | |||
| Ceiling Mount with moveable arm | |||
| Contrast Media Housing with Heater | Injector Base | ||
| Wall Mount with moveable arm | |||
| Ceiling Mount with moveable arm | |||
| Contrast Media Housing with Heater | Same | ||
| Subject Device | Primary Predicate | ||
| Item | ulrichINJECT CT motion | ulrichINJECT CT motion (K192872) | Comparison |
| Disposables | ulrichINJECT CT Motion Pump Tubing-flex | ulrichINJECT CT Motion Pump Tubing-flex | |
| Patient Tubing for Pump Tubing-flex | Patient Tubing for Pump Tubing-flex | Same | |
| ulrichINJECT CT Motion Spike for CT | ulrichINJECT CT Motion Spike for CT | Same | |
| Weight | Injector (pedestal version): Approx. 80 kg | Injector (pedestal version): Approx. 80 kg | |
| Injector (ceiling and wall mount version): | |||
| Approx. 40 kg | Injector (ceiling and wall mount version): | ||
| Approx. 40 kg | Same | ||
| Terminal: Approx. 3 kg | Terminal: Approx. 3 kg | Same | |
| Dimensions | Injector (pedestal version and wall mount | ||
| version): 64.5 x 64.5 x 144.5 cm | Injector (pedestal version and wall mount | ||
| version): 64.5 x 64.5 x 144.5 cm | |||
| Injector (ceiling version): Depends on the | |||
| system selected and the length of the fixed | |||
| height arm | Injector (ceiling version): Depends on the | ||
| system selected and the length of the fixed | |||
| height arm | Same | ||
| Terminal: 31 x 27.5 x 17 cm | Terminal: 31 x 27.5 x 17 cm | Same | |
| Power | |||
| Requirement | Rated Voltage: 100 to 240 V AC | Rated Voltage: 100 to 240 V AC | |
| Rated Current: 1.6 A | Rated Current: 1.6 A | Same | |
| Rated Frequency: 50/60Hz | Rated Frequency: 50/60Hz | Same | |
| Battery | Li-Ion battery | Lead gel battery or 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 for Pump Tubing-flex | Patient Tubing for Pump Tubing-flex | Same |
| Item | Subject Device | ||
| ulrichINJECT CT motion | Primary Predicate | ||
| ulrichINJECT CT motion (K192872) | Comparison | ||
| Designed to | |||
| Prevent Reuse | |||
| of Disposables | Yes – via the use of software controls | Yes – via the use of software controls | Same |
| Rotary | |||
| peristaltic | |||
| pump | |||
| 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 Pump Tubing-flex | |||
| detector | Multi-layered software stops; Used Patient | ||
| Tubing detector and Pump Tubing-flex | |||
| detector | Same | ||
| Volume | |||
| Remaining | |||
| Readout | Yes, displayed on control unit if programmed | ||
| volume is higher than remaining volume | Yes, displayed on control unit if programmed | ||
| volume is higher than remaining volume | Same | ||
| Programmable | |||
| Pressure Limit | Yes, 195 PSI; user-programmable or | ||
| automatic | Yes, 195 PSI; user-programmable or | ||
| automatic | Same | ||
| Injector- | |||
| Scanner | |||
| Interface | SYNCopen functionality allows start of the | ||
| injector and CT scanner simultaneously and | |||
| communicates information from the CT | |||
| motion to the CT scanner. | Not available. | Different. See | |
| Note 2. | |||
| 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 |
| Item | Subject Device | Primary Predicate | Comparison |
| Injection | |||
| Volume per | |||
| Injection | ulrichINJECT CT motion | ||
| 1 to 200 mL max volume of contrast media | |||
| per patient with a max of 400 mL total media | |||
| (contrast and saline) per patient | ulrichINJECT CT motion (K192872) | ||
| 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 | 10-200 mL of contrast media with volume | ||
| accuracy of ± 5% |
Flow rate accuracy of ± 5% | 10-200 mL of contrast media with volume
accuracy of ± 5%
Flow rate accuracy of ± 5% | Same |
| Contrast Media
Container
Volume | 500 mL (OMNIPAQUE IBP)
100 mL and 150 mL (VISIPAQUE single
dose)
150 mL (OMNIPAQUE single dose) | 500 mL (OMNIPAQUE IBP)
100 mL and 150 mL (VISIPAQUE single
dose)
150 mL (OMNIPAQUE single dose) | Same |
| Compatible
Contrast Media | OMNIPAQUE™ IBP
OMNIPAQUE™ single dose
VISIPAQUE™ single dose | OMNIPAQUE™ IBP
OMNIPAQUE™ single dose
VISIPAQUE™ single dose | Same |
| Saline Flush | Yes | Yes | Same |
| Needle Size | 14-24 G | 14-24 G | Same |
| Injection Pause | Programmable - 0 sec to 999 sec in 1 sec
increments | Programmable - 0 sec to 999 sec in 1 sec
increments | Same |
| Injection
Protocol
Storage | Yes | Yes | Same |
| Priming/Venting
Rate | 2 mL/s (manual) | 2 mL/s (manual) | Same |
| Air Detection
Principle | Ultrasound | Ultrasound | Same |
| Item | Subject Device | Primary Predicate | Comparison |
| 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 | 246 PSI | 246 PSI | Same |
| Time Limit for Disposables | 24 hours for ulrichINJECT CT Motion Pump Tubing-flex
12 hours for Patient Tubing for Pump Tubing-flex
8 hours for ulrichINJECT CT Motion Spike for CT | 24 hours for ulrichINJECT CT Motion Pump Tubing-flex
12 hours for Patient Tubing for Pump Tubing-flex
8 hours for ulrichINJECT CT Motion Spike for CT | Same |
| Package Sterile | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Packaging Configuration | Tyvek lid covering polystyrele tray | Tyvek lid covering polystyrele tray | Same |
| Components | Patient Tubing
Two Patient Luer Connectors with safety caps
Two check valves | Patient Tubing
Two Patient Luer Connectors with safety caps
Two check valves | Same |
| Safety Feature Against Re-use | Yes, via software controls | Yes, via software controls | Same |
| Item | Subject Device | Primary Predicate | Comparison |
| | ulrichINJECT CT motion | ulrichINJECT CT motion (K192872) | |
| Components | Contrast media lines x2 | Contrast media lines x2 | Same |
| | Saline Line | Saline Line | |
| | W-piece | W-piece | |
| | Pressure sensor unit with integrated particle
filter | Pressure sensor unit with integrated particle
filter | |
| | Check valve | Check valve | |
| | Swabable valves x 4 | Swabable valves x 4 | |
| Contrast Media
Line Tubing
Material | PVC / PUR | PVC / PUR | Same |
| Saline Line
Tubing Material | PVC / PUR | PVC / PUR | Same |
| Spike Size | 28.5 mm | 28.5 mm | Same |
| Safety Feature
Against Re-Use | Yes, via software controls | Yes, via software controls | Same |
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- Note 1. The Indications for Use related to contrast media management and the disposable components of the CT motion are identical to the Indications for Use of the previously cleared ulrichINJECT CT motion (K192872). The ulrichINJECT CT motion's Indications for Use as it relates to new SYNCopen functionality and new Class I, 510(k) exempt Indications related to interfacing with RIS and PACS systems are different from the predicate device (K192872). The introduction of SYNCopen and RISIPACS functionality in the indications for use any questions of safety and effectiveness as software verification and validation and safety testing have been performed to confirm the device remains as safe and effective as the predicate device (K192872).
- The injector scanner interface (SYNCopen) is a new functionality that was not present on the previously cleared Note 2. ulrichINJECT CT motion (K192872). The introduction of SYNCopen functionality does not raise any questions of safety and effectiveness as software verification and safety testing have been performed to confirm the device remains as safe and effective as the predicate device (K192872).
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Non-Clinical Testing
ulrichINJECT CT motion 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 K171392 and K192872 and has been repeated for the software updates made as part of this submission. FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005) has been followed.
Validation included installation qualification and operational performance qualification. All acceptance criteria for the installation qualification and operational and performance qualification are satisfactorily met so that the ulrichINJECT CT motion software is released for its intended use.
Electromagnetic Compatibility / Electrical Safety:
Testing was performed in accordance with the following standards:
- . IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance; Edition 3.1 (2012)
- . IEC 60601-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests; Edition 4.0 (2014)
Testing results indicate that the ulrichINJECT CT motion complies with the standards listed.
Sterilization:
The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standard prior to commercial distribution as part of K192872:
- ISO 11135-1: Sterilization of health care products Ethylene oxide Part 1: . Requirements for the development validation and routine control of a sterilization process for medical devices; 2007
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Shelf-Life:
Real-time aging and accelerated-aging studies were performed as part of K171392 and K192872. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with the following standard:
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- ISO 11607-1: Packaging for terminally sterilized medical devices Part 1: Requirements ● for materials, sterile barrier systems and packaging systems; 2006
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard for a shelf life of 5 years.
Chemical Compatibility:
Material compatibility of the ulrichINJECT CT motion tubing system was performed as part of K192872 using Omnipaque™ and Visipaque™ as the solvents. The results of the testing concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™ and the chemical integrity of Omnipaque™ or Visipaque™ is not compromised throughout use. Therefore, ulrichINJECT CT motion is safe and effective for its intended uses.
Contamination Control:
ulrich performed the following contamination control studies as part of K192872:
- . Process Simulation Studies
- . Microbial Ingress Study
- . Cross Contamination Study
- Rinsing Study ●
Contamination control study results have concluded that ulrichINJECT CT motion has the ability to maintain the sterility of the injection media and resist the ingress of microorganisms when used with Omnipaque™ Imaging Bulk Package (IBP), Omnipaque single dose bottles, and Visipaque single dose bottles during its intended use. Additionally, it has been concluded that the residuals between the single active compounds (lohexol and lodixanol) after rinsing the system with physiological saline solution are within the defined limits.
Biocompatibility:
The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard as part of K171392 and K192872:
-
ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing . within a risk management process; 2009
The following tests have been performed: -
Cytotoxicity
-
. Intracutaneous reactivity
-
Allergic sensitization .
-
Systemic acute toxicity .
-
. Pyrogen shelf-life:
-
Hemocompatibility: Hemolysis ●
-
LAL test: Bacterial endotoxins
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Verification results indicated that the materials comply with the standard.
Extractables and Leachables:
Testing was performed for extractables and simulation testing for leachable compounds and particulates as part of K171392 and K192872 for OMNIPAQUE and VISIPAQUE.
Testing and a toxicological assessment demonstrated that ulrichINJECT CT motion is safe and effective for its intended uses. The results of the testing and toxicological assessment met the requirements of the pre-defined acceptance criteria for the intended uses of the device.
Human Factors:
A usability study was performed as part of K171392 to confirm that the ulrichINJECT CT motion was safe and effective for use by its intended users. Usability evaluations, including a usability study, were performed as part of K210541 to confirm that the updated ulrichINJECT CT motion system with RIS/PACS and SYNCopen software options is still safe and effective for use by the intended user population. Results demonstrated that no new unacceptable usability risks were introduced by the modifications and the intended user population is able to perform use tasks.
Performance - Bench:
The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards as part of K171392:
- . ISO 8536-4: Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed: 2010
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.
Transport validation and cleaning instructions validation was also performed as part of K171392.
Testing was also performed as part of K192872 to confirm that mixing of contrast media will not occur.
Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards
Conclusion
Based on the performance testing, comparison, and analysis in this submission, the subject device, ulrichINJECT CT motion, is substantially equivalent to the predicate device, K192872.