(182 days)
Not Found
No
The summary describes a contrast media management system with hardware and software controls for fluid administration, but there is no mention of AI or ML capabilities.
No.
The device administers contrast media and saline for diagnostic examinations, specifically CT applications, not for treating a disease or medical condition.
No
The device is a contrast media management system used to administer contrast media and saline to patients undergoing diagnostic examinations (CT scans), but it does not perform the diagnosis itself. Its function is to facilitate the diagnostic process performed by other medical equipment.
No
The device description explicitly states the system consists of hardware components like a terminal, injector, tubing system, and a peristaltic pump, in addition to software controls.
Based on the provided text, the ulrichINJECT CT motion is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a device used in vivo (within a living organism) for administering substances, not for testing samples in vitro (outside of a living organism).
- Device Description: The description details a system for transporting fluids into a patient's bloodstream via tubing. It mentions contact with the patient's blood path, which is characteristic of in vivo administration devices.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.
Therefore, the ulrichINJECT CT motion is a medical device used for administering contrast media during CT procedures, but it does not fit the definition of 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).
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, 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, 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.
Product codes
IZO, 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.
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 only component of the ulrichINJECT CT motion that comes in contact with the patient is the ulrichINJECT CT motion tubing system. The tubing system consists of three components:
- . Spike for CT
- Pump tubing-flex .
- . Patient Tubing
The ulrichINJECT CT motion tubing system has indirect contact with the blood path of a patient for a limited duration (few minutes).
The ulrichINJECT CT motion system is also intended to be used with the following components, which are not supplied with the system:
- . Multiple patient use saline containers,
- . Omnipaque™ IBP contrast media containers, and
- . Cannula.
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).
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for 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
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
trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular 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)
ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria.
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
- . IEC 60601-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
Additional testing performed is listed below.
Sterilization:
The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10° in accordance with the following standard prior to commercial distribution:
- . 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:
ulrich performed real time aging and accelerating aging studies. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems.
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Chemical Compatibility
The only component of the ulrichINJECT CT motion that comes in contact with the patient is the ulrichINJECT CT motion tubing system. To support the material compatibility of the ulrichINJECT CT motion tubing system with Omnipaque™ Imaging Bulk Package (IBP), material compatibility testing was performed using Omnipaque™ 350 mg//ml as the solvent. The results concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ and the chemical integrity of Omnipaque™ is not compromised throughout use.
Contamination Control:
Ulrich performed three contamination control studies:
- . Process simulation study
- . Microbial ingress study
- . Cross contamination study
Based on these results, it has been 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) during its intended use.
Biocompatibility:
The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard:
- . ISO 10993-1: 2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Verification results indicated that the materials comply with the standard.
Performance - Bench:
The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards:
- . ISO 8536-4 - 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.
Additional performance bench testing included testing using each disposable component of the ulrichINJECT CT motion tubing system to evaluate the device pressure when using the device with multiple size cannulas at multiple flow rates and to demonstrate that the device is capable of delivering contrast media and saline at the prescribed rate and total volume for the expected range of cannulas.
Additional testing included extractables and simulation testing for leachable compounds and particulates. Transport validation and cleaning instructions validation was performed.
Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards
Summary of the clinical testing as a basis for Substantial Equivalence
No clinical studies were performed using ulrichINJECT CT motion. Human Factors / Usability assessments were performed in a simulated use environment. The results demonstrated that users can operate ulrichINJECT CT motion as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flow Rate and Volume Accuracy:
10-200 mL of contrast media with volume accuracy of + 5%
Flow rate accuracy of + 5%
Predicate Device(s)
Reference Device(s)
Not Found
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 contains 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.
November 9, 2017
ulrich GmbH & Co. KG % Rita King CEO MethodSense, Inc. PO Box 110352 Durham, North Carolina 27709
Re: K171392
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: October 3, 2017 Received: October 10, 2017
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Rita King
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171392
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).
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, 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, 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.
ulrichINIECT 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.
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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3
K171392
510(k) Summary
ulrich GmbH & Co. KG
This 510(k) Summary is in conformance with 21 CFR 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
Director Development & Product Management Devices |
| Date Prepared: | November 7, 2017 |
| 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: | |
| Trade Name: | CT Exprès 3D Contrast Media Delivery System |
| Common Name: | Automatic injector for contrast media |
| 510(k) Submitter / Holder | Bracco Injeneering S.A. |
| 510(k) Number | K151048 |
| Classification: | Class II |
4
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.
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 only component of the ulrichINJECT CT motion that comes in contact with the patient is the ulrichINJECT CT motion tubing system. The tubing system consists of three components:
- . Spike for CT
- Pump tubing-flex .
- . Patient Tubing
The ulrichINJECT CT motion tubing system has indirect contact with the blood path of a patient for a limited duration (few minutes).
The ulrichINJECT CT motion system is also intended to be used with the following components, which are not supplied with the system:
- . Multiple patient use saline containers,
- . Omnipaque™ IBP contrast media containers, and
- . Cannula.
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).
ulrichINJECT CT motion is equipped with multiple hardware and software controls that work together for 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
5
The mobile pedestal version consists of the injector head and the injector base and it is designed to operate with a rechargeable 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 (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).
Pump tubing-flex is used for a maximum time of twenty four (24) hours. When used with Omnipaque™ IBP, 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, 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 Analysis Method
The ulrichINJECT CT motion was assessed to determine the risks to health associated with the use of the device in the CT suite and evaluated risks related to safety, contamination and usability. 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, adverse tissue reaction, infection and improper use.
Substantial Equivalence
ulrichINJECT CT motion is substantially equivalent to CT Expres 3D Contrast Media Delivery System by Bracco Injeneering S.A., (K151048) currently on the market.
ulrichINJECT CT motion has the same indications for use as the Bracco Injeneering CT Expres 3D Contrast Media Delivery System and uses equivalent overall design and operating principals.
The table below provides a detailed comparison of ulrichINJECT CT motion to the predicate device.
6
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The CT Expres 3D Contrast
Media Delivery System is
indicated for controlled
automatic administration, on
the venous side, of contrast
and saline, to human
subjects while undergoing
examination by means of a
computed tomography (CT)
scanner. | ulrichINJECT CT motion is
equivalent to CT Expres 3D.
The differences in the time limits
of the disposables components
are addressed through the
results of contamination control
studies. |
| | 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). | The CT Expres 3D Contrast
Media Delivery System is
specifically indicated for use
in CT procedures for the
delivery of Isovue (lopamidol
Injection) contrast media as
supplied in Imaging Bulk
Package (IBP), for a
maximum of 20 bottles of | |
| | Pump tubing-flex is used for a
maximum time of twenty four (24)
hours. When used with
Omnipaque™ IBP, 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, with a | contrast media or a
maximum of ten (10) hours,
whichever comes first, per
Day Set III HP disposable.
The Bottle Spike disposable
is for single-bottle use only
and must be discarded with
the contrast media bottle.
The Patient Set disposable
must be discarded after each | |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| | 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. | patient procedure.
The CT Expres 3D is to be
used only by and under
quasi-continuous supervision
of trained health care
professionals in an
appropriate licensed health
care facility, in a room
designated for radiological
procedures that involve
intravascular administration
of a contrast agent. | |
| System Components | | | |
| System | Injector Head
Touch Terminal | CT Expres Injector Unit
CT Expres Control Panel | ulrichINJECT CT motion is
equivalent to CT Expres 3D. |
| Accessories | Injector Base
Wall Mount with moveable arm
Ceiling Mount with moveable arm
Contrast Media Housing with Heater | CT Expres Hand Switch
CT Expres Bottle Insulator
CT Expres Stand
CT Expres Ceiling mount | ulrichINJECT CT motion
Pedestal, Ceiling Mount and
Contrast Media Housing with
Heater are equivalent to the CT
Expres 3D Stand |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| | | | ulrichINJECT CT motion does
not include a hand switch. |
| Disposables | ulrichINJECT CT Motion Pump
Tubing-flex
Patient Tubing for Pump Tubing-flex
ulrichINJECT CT Motion Spike for
CT | CT Expres Day Set III HP
CT Expres Patient Set
CT Express Bottle Spike
Type B (25mm) | ulrichINJECT CT motion
disposables are equivalent to the
CT Expres 3D disposables. |
| Physical Design | | | |
| Weight | Injector: Approx. 79 kg
Terminal: Approx. 3 kg | Injector: Approx. 10 kg
Remote Control Panel:
Approx. 2.1 kg | ulrichINJECT CT motion weight
is equivalent to the CT Expres
3D weight.
ulrichINJECT CT motion Injector
is heavier than the CT Express
3D injector. However, this
difference does not have an
impact on the intended use of
the device. |
| Dimensions | Injector: 64.5 x 64.5 x 144.5 cm
Terminal: 31 x 27.5 x 17 cm | Injector: 44 x 32 x 16 cm
Remote Control Panel: 30 x
20 x 22 cm | ulrichINJECT CT motion
dimensions are equivalent to the
CT Expres 3D dimensions. |
| Power Requirement
Rated Voltage:
Rated Current:
Rated Frequency: | 110 to 240 V AC
1.6 A
50/60Hz | 110 to 240 V AC
1.6 A
50/60Hz | ulrichINJECT CT is identical to
the CT Expres 3D related to
power requirements. |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Display Type | Color LCD Terminal with touch
screen | Color LCD with touch screen | ulrichINJECT CT motion
Terminal is equivalent to the CT
Expres 3D Console. |
| Characteristics | | | |
| Syringeless system | Yes | Yes | CT motion is identical to CT
Express 3D |
| Remote Operation | Yes, via the Touch Terminal | Yes, via the Remote Control
Panel and the Hand Switch | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to remote operation. |
| Single Patient Use Disposable | Patient Tubing for Pump Tubing-flex | Patient Set | ulrichINJECT CT motion Patient
Tubing for Pump Tubing-flex is
equivalent to the CT Expres 3D
Patient Set.
CT Expres 3D Patient Set
includes the peristaltic pump into
the disposable. The peristaltic
pump is part of the injector of the
ulrichINJECT CT motion. This
difference in technology does not
affect the intended use of the
device. |
| Designed to Prevent Reuse of
Disposables | Yes - via the use of software
controls | Yes - via a breakaway pin
designed to break on
insertion | ulrichINJECT CT motion is
equivalent to the CT Expres 3D.
ulrichINJECT CT motion
provides software controls to |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| | | | prevent user from reuse of
disposables. |
| Rotary peristaltic pump | Yes | Yes | CT motion is equivalent to CT
Express 3D |
| Used to administer contrast
media and saline | Yes | Yes | CT motion is equivalent to CT
Express 3D |
| Disposable uses spikes to
spike media container | Yes | Yes | CT motion is equivalent to CT
Express 3D |
| Safety Stop Mechanism | Multi-layered software stops; Used
Patient Tubing detector and Pump
Tubing-flex detector | Multi-layered software stops;
Used Pump Tubing detector | CT motion is equivalent to CT
Express 3D |
| Volume Remaining Readout | Yes, displayed on control unit if
programmed volume is higher than
remaining volume | Yes, LED on injector head;
graphical and numeric on
LCD | CT motion is equivalent to CT
Express 3D |
| Programmable Pressure Limit | Yes, 195 PSI; user-programmable or
automatic | Yes, 8 bar (ca. 120 psi) | CT motion is equivalent to CT
Express 3D |
| Operational Characteristics | | | |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Injection Capabilities | 40 phases per protocol | Up to 24 phases per patient
(8 phases per injection; up to
3 injections per patient) | ulrichINJECT CT motion is
equivalent to the CT Expres 3D.
ulrichINJECT CT motion
provides additional flexibility with
a greater number of phases for
programming different speed and
volume of contrast media and
saline for better imaging quality. |
| Injection Rates for Contrast
Media | 0.1 ml/s to 10.0 ml/s | 0.5-9.9 mL/s | ulrichINJECT CT motion is
equivalent to the CT Expres 3D. |
| Injection Rates for Saline | 0.1 ml/s to 10.0 ml/s | 0.1-9.9 mL/s | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to the injection rates for
saline. |
| Injection Volume per Injection | 1 to 200 mL max volume of contrast
media per patient with a max of 400
mL total media (contrast and saline)
per patient | 10-200 mL with a max of
400 mL total media (contrast
and saline) per patient | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to injection volume per
injection. |
| Flow Rate and Volume
Accuracy | 10-200 mL of contrast media with
volume accuracy of + 5%
Flow rate accuracy of + 5% | +/- 10% for a programmed
injection volume between 10
mL and 59 mL
+/- 6% for a programmed
injection volume between 60
mL and 200 mL | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to flow rate and volume
accuracy with a greater flow rate
accuracy delivered by
ulrichINJECT CT motion. |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Contrast Media Container
Volume | 500 mL | 200 & 500 mL | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to contrast media
container volume. |
| Saline Flush | Yes | Yes | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to saline flush. |
| Needle Size | 14-24 G | 16-24 G | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to needle sizes |
| Injection Pause | Programmable - 0 sec to 999 sec in
1 sec increments | 0-400 seconds | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to injection pause |
| Injection Protocol Storage | Yes | Yes | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to injection protocol
storage |
| Priming/Venting Rate | 2 mL/s (manual) | 1.5 mL/s (manual)
6.0 mL/s (automatic) | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to priming/venting rate |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Air Detection Principle | Ultrasound | Ultrasound | ulrichINJECT CT motion is
identical to the CT Expres 3D
related to air detection principle |
| Technical Detection Limit of
air in tubing | 0.05 mL | 0.04 mL | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to technical detection
limit of air in tubing. |
| Air Detector Alarm Limit | 1 mL | For programmed injection
volume or equal to 35 mL
CM, 1.25 mL if fragment air
bubble, otherwise an
additional air volume of 0.75
mL is tolerated.
Note: The volume of the
Patient Set (after the air
detector) is 8 mL | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to air detection alarm
limit. |
| Occlusion Detection Principle | Fail safe piezo-resistive pressure
sensor | Fail safe piezo-resistive
pressure sensor | ulrichINJECT CT motion is
identical to the CT Expres 3D
related to occlusion detection
principle. |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Occlusion Detection Alarm
Limit | 246 PSI | 132 PSI | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
related to occlusion detection
alarm limit. |
| Disposables | | | |
| Time Limit | 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 | 12 hours for CT Expres Day
Set III HP
3 hours for CT Expres
Patient Set
10 hours for CT Express
Bottle Spike Type B (25mm) | ulrichINJECT CT motion is
equivalent to CT Expres 3D.
The differences in time limits
between the ulrichINJECT CT
motion and the predicate device
are addressed with the
completion of contamination
control studies. |
| Package Sterile | Yes | Yes | ulrichINJECT CT motion is
identical to CT Expres 3D. |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | ulrichINJECT CT motion is
identical to CT Expres 3D. |
| Packaging Configuration | Tyvek lid covering polystyrene tray | Tyvek lid covering
polystyrene tray | ulrichINJECT CT motion is
equivalent to CT Expres 3D. |
| Patient Tubing | | | |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Components | Patient Tubing
Two Patient Luer Connectors with
safety caps
Two check valves | Patient Set Cassette
Patient Set Tubing
Pinch Clamp
Patient Connector with
Safety Cap | ulrichINJECT CT motion is
equivalent to the CT Expres 3D.
ulrichINJECT CT motion
peristaltic pump is part of the
injector. |
| Safety Feature Against Re-use | Yes, via software controls | Break away pin designed to
break on insertion | ulrichINJECT CT motion is
equivalent to the CT Expres 3D.
ulrichINJECT CT motion
provides software controls that
includes notifications to the user
that disposables have expired
and requires user action in order
for the system to continue. |
| Pump Tubing-flex | | | |
| Components | Contrast media lines x2
Saline Line
W-piece
Pressure sensor unit with integrated
particle filter
Check valve
Swabable valves x 4 | T-connector
Contrast media line x2
Spike for saline line
Saline line
Filter x2
Reservoir x2
Tubing guide x2 | ulrichINJECT CT motion is
equivalent to the CT Expres 3D
Day Set III HP. |
| Contrast Media Line Tubing
Material | PVC / PUR | PVC tubing | ulrichINJECT CT motion is
equivalent to the CT Expres 3D. |
| Product Name: | ulrichINJECT CT motion
by ulrich Medical | CT Expres 3D Contrast
Media Delivery System by
Bracco Injeneering S.A.
K151048 | Comparison |
| Saline Line Tubing Material | PVC / PUR | PVC tubing | ulrichINJECT CT motion is
equivalent to the CT Expres 3D. |
| Spike for CT | | | |
| Spike Size | 28.5 mm | 25 mm | ulrichINJECT CT motion is
equivalent to the CT Expres 3D. |
| Safety Feature Against Re-Use | Yes, via software controls | Spike tip designed to break
off into bottle on removal | ulrichINJECT CT motion
provides software controls that
includes notifications to the user
that disposables have expired
and requires user action in order
for the system to continue. |
Detailed Comparison of the Subject and Predicate Device
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Summary of the nonclinical testing as a basis for Substantial Equivalence
ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria.
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
- . IEC 60601-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
Additional testing performed is listed below.
Sterilization:
The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10° in accordance with the following standard prior to commercial distribution:
- . 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:
ulrich performed real time aging and accelerating aging studies. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems.
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Chemical Compatibility
The only component of the ulrichINJECT CT motion that comes in contact with the patient is the ulrichINJECT CT motion tubing system. To support the material compatibility of the ulrichINJECT CT motion tubing system with Omnipaque™ Imaging Bulk Package (IBP), material compatibility testing was performed using Omnipaque™ 350 mg//ml as the solvent. The results concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ and the chemical integrity of Omnipaque™ is not compromised throughout use.
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Contamination Control:
Ulrich performed three contamination control studies:
- . Process simulation study
- . Microbial ingress study
- . Cross contamination study
Based on these results, it has been 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) during its intended use.
Biocompatibility:
The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard:
- . ISO 10993-1: 2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Verification results indicated that the materials comply with the standard.
Performance - Bench:
The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards:
- . ISO 8536-4 - 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.
Additional performance bench testing included testing using each disposable component of the ulrichINJECT CT motion tubing system to evaluate the device pressure when using the device with multiple size cannulas at multiple flow rates and to demonstrate that the device is capable of delivering contrast media and saline at the prescribed rate and total volume for the expected range of cannulas.
Additional testing included extractables and simulation testing for leachable compounds and particulates. Transport validation and cleaning instructions validation was performed.
Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards
Summary of the clinical testing as a basis for Substantial Equivalence
No clinical studies were performed using ulrichINJECT CT motion. Human Factors / Usability assessments were performed in a simulated use environment. The results demonstrated that users can operate ulrichINJECT CT motion as the predicate device.
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Substantial Equivalence Conclusions
In conclusion, the indications for use for the ulrichINJECT CT motion are substantially equivalent to that of the predicate device. The technological characteristics comparison demonstrates that the ulrichINJECT CT motion is equivalent to the predicate device, and the testing shows that the ulrich ulrichINJECT CT motion is substantially equivalent to the predicate device.
Conclusion
The 510(k) Pre-market Notification for the ulrichINJECT CT motion contains adequate information and data to determine that ulrichINJECT CT motion is substantially equivalent to the legally marketed predicate device.