ulrichINJECT CT Motion
Device Facts
| Record ID | K192872 |
|---|---|
| Device Name | ulrichINJECT CT Motion |
| Applicant | Ulrich GmbH & Co. KG |
| Product Code | IZQ · Cardiovascular |
| Decision Date | Jul 2, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
Indications for Use
ulrichINJECT CT motion is a 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.
Device Story
Syringeless contrast media management system; utilizes peristaltic pump to transport contrast media and saline from containers to patient via disposable tubing system. System components: injector head, touch terminal, injector base, and tubing (spike, pump tubing-flex, patient tubing). Operated by trained healthcare professionals in radiological suites. Hardware/software controls include air detectors (ultrasound), pressure sensors, and check valves to prevent backflow/contamination. Software manages injection protocols, monitors volume, and prevents disposable reuse. Provides controlled, automatic delivery of contrast agents for CT imaging; benefits include precise dosing and reduced risk of retrograde contamination. Updated version supports additional contrast media types and includes Li-ion battery option.
Clinical Evidence
Bench testing only. No clinical data presented. Validation included software verification, EMC testing (IEC 60601-1-2 4th ed), sterilization validation (ISO 11135-1), biocompatibility (ISO 10993-1), chemical compatibility, and contamination control studies (process simulation, microbial ingress, cross-contamination, and rinsing).
Technological Characteristics
Syringeless peristaltic pump system. Materials: PVC/PUR tubing. Energy: 110-240V AC or rechargeable Li-ion/lead gel battery. Connectivity: Standalone with touch terminal. Sterilization: Ethylene Oxide (EtO). Software: Rule-based controls for pressure, air detection, and flow. Dimensions: Pedestal (64.5x64.5x144.5 cm), Terminal (31x27.5x17 cm).
Indications for Use
Indicated for controlled, automatic venous administration of contrast media and saline in CT diagnostic procedures. Specifically for delivery of Omnipaque (Iohexol) IBP, Omnipaque (Iohexol) single-dose, and Visipaque (iodixanol) single-dose. Used by trained healthcare professionals in licensed radiological facilities.
Regulatory Classification
Special Controls
*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.
Predicate Devices
- ulrichINJECT CT motion (K171392)
Submission Summary (Full Text)
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July 2, 2020
ulrich GmbH & Co. KG % Rita King CEO MethodSense, Inc. 1 Copley Parkway. Suite 410 Morrisville, North Carolina 27560
Re: K192872
Trade/Device Name: ulrichINJECT CT Motion Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: IZO Dated: May 29, 2020 Received: June 2, 2020
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
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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 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 (QS) 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 medical devices and radiation-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,
For CAPT Alan 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
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# Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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## Summary of 510(k)
## Ulrich GmbH & Co. KG
## K192872
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | ulrich GmbH & Co. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany<br>Phone: +49 731 9654-1714<br>Fax: +49 731 9654-2807 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: ritaking@methodsense.com<br>Phone: 919-313-3961<br>Fax: 919-313-3979 |
| Company Contact: | Sven Erdmann<br>Director Development & Product Management Devices |
| Date Prepared: | May 29, 2020 |
### Device Name and Classification
| Trade Name: | ulrichINJECT CT motion |
|-----------------------|----------------------------------------------------|
| Common Name: | Contrast Media Management System |
| Classification: | Class II |
| Regulation Number: | 21 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 | Class II |
| 510(k) Number | K171392 |
| Regulation Number | 21 CFR 870.1650, Angiographic Injector and Syringe |
| Classification Panel | Cardiovascular Panel |
| Product Code | IZQ |
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### 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 underqoing 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 updated 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 updated 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 ●
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The mobile pedestal version consists of the iniector head and the iniector base and has been updated to operate with a rechargeable Li-ion battery or lead gel battery in addition to the power supply. The ceiling version and the wall mounted version consist of the injector head, a fixed height arm, and a movable arm.
### 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-flexis 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.
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 updated ulrichINJECT CT motion system was assessed to determine the risks to health associated with the use of the device specifically as it relates to the use of OMNIPAQUE and VISIPAQUE single dose bottles and the new Li-ion battery. Risks related to safety. contamination and usability were considered. A risk analysis was conducted in accordance with ISO 14971:2007, Medical devices -- Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, mixing of contrast media, contamination and infection, and improper use.
### Substantial Equivalence
ulrichINJECT CT motion is substantially equivalent to the ulrichINJECT CT motion system (K171392) currently on the market.
The table below provides a detailed comparison of ulrichINJECT CT motion to the predicate device.
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## Detailed Comparison of the Subject and Predicate Device
| Characteristic | ulrichINJECT CT motion<br>(Subject Device) | ulrichINJECT CT motion (K171392)<br>(Primary Predicate) | Comparison |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | ulrichINJECT CT motion is a contrast<br>media management system that is<br>indicated for the controlled, automatic<br>administration, on the venous side, of<br>contrast media and saline (NaCl), to<br>human subjects undergoing diagnostic<br>examinations in computed tomography<br>(CT) applications.<br><br>ulrichINJECT CT motion is specifically<br>indicated for use in CT procedures for<br>the delivery of Omnipaque™ (lohexol)<br>Injection, solution - GE Healthcare Inc.<br>contrast media as supplied in Imaging<br>Bulk Packages (IBP), Omnipaque™<br>(lohexol) Injection, solution – GE<br>Healthcare Inc., and Visipaque™<br>(iodixanol) Injection - GE Healthcare<br>Inc. contrast media as supplied in<br>single dose bottles.<br><br>Pump tubing-flex is used for a<br>maximum time of twenty four (24)<br>hours. When used with Omnipaque™<br>IBP, Omnipaque™ single dose bottles,<br>or Visipaque™ single dose bottles, a<br>maximum of 19 bottles of contrast<br>media can be used or maximum time<br>of twenty four (24) hours of Pump<br>tubing-flex, or whichever comes first.<br>Time per contrast media or saline<br>container depends on each contrast | ulrichINJECT CT motion is a contrast<br>media management system that is<br>indicated for the controlled, automatic<br>administration, on the venous side, of<br>contrast media and saline, to human<br>subjects undergoing diagnostic<br>examinations in computed tomography<br>(CT) applications.<br><br>ulrichINJECT CT motion is specifically<br>indicated for use in CT procedures for<br>the delivery of Omnipaque™ (lohexol)<br>Injection, solution - GE Healthcare Inc.<br>contrast media as supplied in Imaging<br>Bulk Packages (IBP).<br><br>Pump tubing-flex is used for a<br>maximum time of twenty four (24)<br>hours. When used with Omnipaque™<br>IBP, a maximum of 19 bottles of<br>contrast media can be used or<br>maximum time of twenty four (24)<br>hours of pump tubing-flex, or<br>whichever comes first, with a maximum<br>of eight (8) hours per contrast media or<br>saline container.<br><br>Spike for CT disposable is for single-<br>bottle use only and must be discarded<br>with the media container. The patient<br>tubing must be discarded after each<br>patient procedure. | The intended use of the<br>ulrichINJECT CT motion is<br>identical to the intended use of<br>the previously cleared<br>ulrichINJECT CT motion<br>(K171392).<br><br>The indications for use of the<br>ulrichINJECT CT motion are<br>equivalent to the indications<br>for use of the previously<br>cleared ulrichINJECT CT<br>motion (K171392).<br><br>The only difference is that the<br>ulrichINJECT CT motion<br>supports two additional<br>contrast media, OMNIPAQUE<br>single dose and VISIPAQUE<br>single dose. This difference<br>does not affect the intended<br>use or safety and<br>effectiveness of the device. |
| Characteristic | ulrichINJECT CT motion<br>(Subject Device) | ulrichINJECT CT motion (K171392)<br>(Primary Predicate) | Comparison |
| | media's or saline's use time expiration,<br>with a maximum of eight (8) hours per<br>contrast media or saline container.<br>Spike for CT disposable is for single-<br>bottle use only and must be discarded<br>with the media container. The Patient<br>tubing must be discarded after each<br>patient procedure.<br><br>ulrichINJECT CT motion is to be used<br>only by and under quasi-continuous<br>supervision of trained healthcare<br>professionals in an appropriate<br>licensed healthcare facility, in a room<br>designated for radiological procedures<br>that involve intravascular<br>administration of contrast agent. | ulrichINJECT CT motion is to be used<br>only by and under quasi-continuous<br>supervision of trained healthcare<br>professionals in an appropriate<br>licensed healthcare facility, in a room<br>designated for radiological procedures<br>that involve intravascular<br>administration of contrast agent. | |
| System Components | | | |
| System | Injector Head<br>Touch Terminal | Injector Head<br>Touch Terminal | The system components of the<br>ulrichINJECT CT motion are<br>identical to the system<br>components of the previously<br>cleared ulrichINJECT CT<br>motion (K171392). |
| Accessories | Injector Base<br>Wall Mount with moveable arm<br>Ceiling Mount with moveable arm<br>Contrast Media Housing with Heater | Injector Base<br>Wall Mount with moveable arm<br>Ceiling Mount with moveable arm<br>Contrast Media Housing with Heater | The accessories of the<br>ulrichINJECT CT motion are<br>identical to the system<br>components of the previously<br>cleared ulrichINJECT CT<br>motion (K171392). |
| Characteristic | ulrichINJECT CT motion<br>(Subject Device) | ulrichINJECT CT motion (K171392)<br>(Primary Predicate) | Comparison |
| Disposables | ulrichINJECT CT Motion Pump Tubing-<br>flex<br>Patient Tubing for Pump Tubing-flex<br>ulrichINJECT CT Motion Spike for CT | ulrichINJECT CT Motion Pump Tubing-<br>flex<br>Patient Tubing for Pump Tubing-flex<br>ulrichINJECT CT Motion Spike for CT | The disposables of the<br>ulrichINJECT CT motion are<br>identical to the disposables of<br>the previously cleared<br>ulrichINJECT CT motion<br>(K171392). |
| Physical Design | | | |
| Weight | Injector (pedestal version): Approx. 80<br>kg<br>Injector (ceiling and wall mount<br>version): Approx. 40 kg<br>Terminal: Approx. 3 kg | Injector (pedestal version): Approx. 80<br>kg<br>Injector (ceiling and wall mount<br>version): Approx. 40 kg<br>Terminal: Approx. 3 kg | The weight of the<br>ulrichINJECT CT motion is<br>identical to the weight of the<br>previously cleared<br>ulrichINJECT CT motion<br>(K171392). |
| Dimensions | Injector (pedestal version and wall<br>mount version): 64.5 x 64.5 x 144.5 cm<br>Injector (ceiling version): Depends on<br>the system selected and the length of<br>the fixed height arm<br>Terminal: 31 x 27.5 x 17 cm | Injector (pedestal version and wall<br>mount version): 64.5 x 64.5 x 144.5 cm<br>Injector (ceiling version): Depends on<br>the system selected and the length of<br>the fixed height arm<br>Terminal: 31 x 27.5 x 17 cm | The dimensions of the<br>ulrichINJECT CT motion are<br>identical to the dimensions of<br>the previously cleared<br>ulrichINJECT CT motion<br>(K171392). |
| Power Requirement<br>Rated Voltage:<br>Rated Current:<br>Rated Frequency: | 110 to 240 V AC<br>1.6 A<br>50/60Hz | 110 to 240 V AC<br>1.6 A<br>50/60Hz | The power requirements of the<br>ulrichINJECT CT motion are<br>identical to the power<br>requirements of the previously<br>cleared ulrichINJECT CT<br>motion (K171392). |
| Battery | Lead gel battery or Li-Ion battery | Lead gel battery | The battery of the<br>ulrichINJECT CT motion is<br>different from the previously<br>cleared ulrichINJECT CT<br>motion (K171392). This<br>difference does not affect the<br>intended use or safety or<br>effectiveness of the device. |
| Characteristic | ulrichINJECT CT motion<br>(Subject Device) | ulrichINJECT CT motion (K171392)<br>(Primary Predicate) | Comparison |
| Display Type | Color LCD Terminal with touch screen | Color LCD Terminal with touch screen | The display of the<br>ulrichINJECT CT motion is<br>identical to the display of the<br>previously cleared<br>ulrichINJECT CT motion<br>(K171392). |
| Characteristics | | | |
| Syringeless system | Yes | Yes | ulrichINJECT CT motion is<br>identical to the previously<br>cleared ulrichINJECT CT<br>motion (K171392). Both<br>systems are syringeless. |
| Remote Operation | Yes, via the Touch Terminal | Yes, via the Touch Terminal | ulrichINJECT CT motion is<br>identical to the previously<br>cleared ulrichINJECT CT<br>motion (K171392). Both<br>systems provide remote<br>operation. |
| Single Patient Use<br>Disposable | Patient Tubing for Pump Tubing-flex | Patient Tubing for Pump Tubing-flex | The single patient use<br>disposable of the<br>ulrichINJECT CT motion is<br>identical to the previously<br>cleared ulrichINJECT CT<br>motion (K171392). |
| Designed to Prevent<br>Reuse of Disposables | Yes - via the use of software controls | Yes - via the use of software controls | ulrichINJECT CT motion is<br>identical to the previously<br>cleared ulrichINJECT CT<br>motion (K171392). Both<br>systems provide software<br>controls to prevent user from<br>reuse of disposables. |
| Characteristic | ulrichINJECT CT motion<br>(Subject Device) | ulrichINJECT CT motion (K171392)<br>(Primary Predicate) | Comparison…
