ulrichINJECT CT motion

K210541 · Ulrich GmbH & Co. KG · IZQ · Aug 6, 2021 · Cardiovascular

Device Facts

• Record ID: K210541
• Device Name: ulrichINJECT CT motion
• Applicant: Ulrich GmbH & Co. KG
• Product Code: IZQ · Cardiovascular
• Decision Date: Aug 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended 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), 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 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.

Device Story

Syringeless contrast media management system; utilizes peristaltic pump to deliver contrast/saline from bulk/single-dose containers to patient via disposable tubing set (spike, pump tubing, patient tubing). Operated by trained healthcare professionals in radiological suites. Features include ultrasound air detection, pressure monitoring, and check valves. New SYNCopen module enables injector-CT scanner synchronization; RIS/PACS interface allows DICOM worklist retrieval and automated dose report transmission. System prevents disposable reuse via software controls. Benefits include automated, precise contrast delivery and streamlined documentation/workflow integration.

Clinical Evidence

Bench testing only. Includes software verification/validation, electromagnetic compatibility (IEC 60601-1/1-2), sterilization validation (ISO 11135-1), shelf-life (ISO 11607-1), biocompatibility (ISO 10993-1), extractables/leachables, and contamination control (microbial ingress, cross-contamination). Usability studies confirmed safe operation of new software options.

Technological Characteristics

Syringeless peristaltic pump system. Materials: PVC/PUR tubing. Connectivity: DICOM (RIS/PACS), proprietary scanner interface (SYNCopen). Power: 100-240V AC, Li-Ion battery. Sterilization: EtO. Safety: Ultrasound air detection, piezo-resistive pressure sensors, software-based reuse prevention.

Indications for Use

Indicated for human subjects undergoing CT diagnostic examinations requiring controlled, automatic venous administration of contrast media (Omnipaque/Visipaque) and saline. 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 (K192872)

Reference Devices

• MEDRAD Stellant FLEX CT Injection System with Certegra Workstation (K182273)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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# 510(k) Summary

# ulrich GmbH & Co. KG K210541

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: [phone]<br>Fax: [phone] |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Company Contact: | Sven Erdmann<br>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 |

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| Reference Device | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | MEDRAD Stellant FLEX CT Injection System with Certegra<br>Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD<br>Stellant CT Injection System with Certegra Workstation,<br>MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector<br>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 |

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### 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

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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

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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.

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# Detailed Comparison of the Subject and Predicate Device

| Item | Subject Device | Primary Predicate | Comparison |
|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for<br>Use | ulrichINJECT CT motion<br>ulrichINJECT CT motion is a contrast media<br>management system that is indicated for the<br>controlled, automatic administration, on the<br>venous side, of contrast media and saline<br>(NaCl), to human subjects undergoing<br>diagnostic examinations in computed<br>tomography (CT) applications. | ulrichINJECT CT motion (K192872)<br>ulrichINJECT CT motion is a contrast media<br>management system that is indicated for the<br>controlled, automatic administration, on the<br>venous side, of contrast media and saline<br>(NaCl), to human subjects undergoing<br>diagnostic examinations in computed<br>tomography (CT) applications. | |
| | ulrichINJECT CT motion is specifically<br>indicated for use in CT procedures for the<br>delivery of OmnipaqueTM (Iohexol) Injection,<br>solution - GE Healthcare Inc. contrast media<br>as supplied in Imaging Bulk Packages (IBP),<br>OmnipaqueTM (lohexol) Injection, solution -<br>GE Healthcare Inc., and VisipaqueTM<br>(iodixanol) Injection - GE Healthcare Inc.<br>contrast media as supplied<br>in single dose bottles. | ulrichINJECT CT motion is specifically<br>indicated for use in CT procedures for the<br>delivery of OmnipaqueTM (Iohexol) Injection,<br>solution - GE Healthcare Inc. contrast media<br>as supplied in Imaging Bulk Packages (IBP),<br>OmnipaqueTM (lohexol) Injection, solution -<br>GE Healthcare Inc., and VisipaqueTM<br>(iodixanol) Injection - GE Healthcare Inc.<br>contrast media as supplied<br>in single dose bottles. | Similar. See<br>Note 1. |
| | Pump tubing-flex is used for a maximum time<br>of twenty four (24) hours. When used with<br>OmnipaqueTM IBP, OmnipaqueTM single<br>dose bottles, or VisipaqueTM single dose<br>bottles, a maximum of 19 bottles of contrast<br>media can be used or maximum time of<br>twenty four (24) hours of Pump tubing-flex, or<br>whichever comes first. Time per contrast<br>media or saline container depends on each<br>contrast media's or saline's use time<br>expiration with a maximum of eight (8) hours<br>per contrast media or saline container. | Pump tubing-flex is used for a maximum time<br>of twenty four (24) hours. When used with<br>OmnipaqueTM IBP, OmnipaqueTM single<br>dose bottles, or VisipaqueTM single dose<br>bottles, a maximum of 19 bottles of contrast<br>media can be used or maximum time of<br>twenty four (24) hours of Pump tubing-flex, or<br>whichever comes first. Time per contrast<br>media or saline container depends on each<br>contrast media's or saline's use time<br>expiration with a maximum of eight (8) hours<br>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<br>use only and must be discarded with the<br>media container. The Patient tubing must be<br>discarded after each patient procedure.<br>SYNCopen is indicated for the specific<br>purpose of allowing an injector to interface<br>with a CT scanner.<br>RIS/PACS is indicated for the specific<br>purpose of allowing an injector to interface<br>with a Radiological Information System (RIS)<br>and a Picture Archiving and Communication<br>System (PACS).<br>ulrichINJECT CT motion is to be used only<br>by and under quasi-continuous supervision<br>of trained healthcare professionals in an<br>appropriate licensed healthcare facility, in a<br>room designated for radiological procedures<br>that involve intravascular administration of<br>contrast agent. | Spike for CT disposable is for single-bottle<br>use only and must be discarded with the<br>media container. The Patient tubing must be<br>discarded after each patient procedure.<br>ulrichINJECT CT motion is to be used only<br>by and under quasi-continuous supervision<br>of trained healthcare professionals in an<br>appropriate licensed healthcare facility, in a<br>room designated for radiological procedures<br>that involve intravascular administration of<br>contrast agent. | |
| System | Injector Head<br>Touch Terminal | Injector Head<br>Touch Terminal | Same |
| 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 | 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):<br>Approx. 40 kg | Injector (ceiling and wall mount version):<br>Approx. 40 kg | Same |
| | Terminal: Approx. 3 kg | Terminal: Approx. 3 kg | Same |
| Dimensions | Injector (pedestal version and wall mount<br>version): 64.5 x 64.5 x 144.5 cm | Injector (pedestal version and wall mount<br>version): 64.5 x 64.5 x 144.5 cm | |
| | Injector (ceiling version): Depends on the<br>system selected and the length of the fixed<br>height arm | Injector (ceiling version): Depends on the<br>system selected and the length of the fixed<br>height arm | Same |
| | Terminal: 31 x 27.5 x 17 cm | Terminal: 31 x 27.5 x 17 cm | Same |
| Power<br>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<br>system | Yes | Yes | Same |
| Remote<br>Operation | Yes, via the Touch Terminal | Yes, via the Touch Terminal | Same |
| Single Patient<br>Use Disposable | Patient Tubing for Pump Tubing-flex | Patient Tubing for Pump Tubing-flex | Same |
| Item | Subject Device<br>ulrichINJECT CT motion | Primary Predicate<br>ulrichINJECT CT motion (K192872) | Comparison |
| Designed to<br>Prevent Reuse<br>of Disposables | Yes – via the use of software controls | Yes – via the use of software controls | Same |
| Rotary<br>peristaltic<br>pump<br>Used to<br>administer<br>contrast media<br>and saline | Yes | Yes | Same |
| Disposable<br>uses spikes to<br>spike media<br>container | Yes | Yes | Same |
| Safety Stop<br>Mechanism | Multi-layered software stops; Used Patient<br>Tubing detector and Pump Tubing-flex<br>detector | Multi-layered software stops; Used Patient<br>Tubing detector and Pump Tubing-flex<br>detector | Same |
| Volume<br>Remaining<br>Readout | Yes, displayed on control unit if programmed<br>volume is higher than remaining volume | Yes, displayed on control unit if programmed<br>volume is higher than remaining volume | Same |
| Programmable<br>Pressure Limit | Yes, 195 PSI; user-programmable or<br>automatic | Yes, 195 PSI; user-programmable or<br>automatic | Same |
| Injector-<br>Scanner<br>Interface | SYNCopen functionality allows start of the<br>injector and CT scanner simultaneously and<br>communicates information from the CT<br>motion to the CT scanner. | Not available. | Different. See<br>Note 2. |
| Injection<br>Capabilities | 40 phases per protocol | 40 phases per protocol | Same |
| Injection Rates<br>for Contrast<br>Media | 0.1 mL/s to 10.0 mL/s | 0.1 mL/s to 10.0 mL/s | Same |
| Injection Rates<br>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<br>Volume per<br>Injection | ulrichINJECT CT motion<br>1 to 200 mL max volume of contrast media<br>per patient with a m…