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.

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 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

AI/ML Overview

The document provided is a 510(k) Summary for the ulrichINJECT CT motion device, seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device to the predicate and listing non-clinical tests conducted to support its safety and performance.

However, the document does not contain the specific information requested regarding acceptance criteria and a structured study demonstrating the device meets those criteria, as typically found in clinical evaluation reports or detailed performance studies for AI/software devices. The ulrichINJECT CT motion is a contrast media management system, a hardware device, not an AI or software device that would typically have the requested metrics (e.g., sensitivity, specificity, F1 score).

Therefore, I cannot fulfill the request for information like:

A table of acceptance criteria and reported device performance (in the context of AI metrics).
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document explicitly states: "No clinical studies were performed using ulrichINJECT CT motion." (Page 18).

Instead, the document details non-clinical testing performed to establish substantial equivalence to a predicate device, as summarized below:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria (Based on Non-Clinical Testing for Substantial Equivalence)

The ulrichINJECT CT motion is a contrast media management system (a hardware device) that was evaluated for substantial equivalence primarily through non-clinical testing. The "acceptance criteria" here refer to compliance with various engineering standards and performance requirements demonstrated through bench testing and material compatibility studies, rather than AI-specific performance metrics. No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (hardware medical device rather than an AI diagnostic tool), the "acceptance criteria" are compliance with established standards and demonstrated functional equivalence to a predicate device. The table below summarizes these and the reported performance.

Category / Standard	Acceptance Criteria (Implied by Compliance)	Reported Device Performance (as stated in document)
General Performance	Conformance with established performance criteria; controlled, automatic administration of contrast media and saline on the venous side. Safe and effective during diagnostic CT examinations.	"ulrichINJECT CT motion system and software were validated in accordance with a Verification & Validation plan to ensure conformance with established performance criteria." It 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."
Electromagnetic Compatibility / Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2.	"Electromagnetic Compatibility / Electrical Safety testing was performed in accordance with... IEC 60601-1... IEC 60601-2..."
Sterilization	Sterility Assurance Level of 10⁻⁶ (SAL 10⁻⁶) in accordance with ISO 11135-1.	"The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10⁻⁶ in accordance with... ISO 11135-1... Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard."
Shelf-Life & Packaging	Packaging integrity and shelf-life validated in accordance with ISO 11607-1.	"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... Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard."
Chemical Compatibility	No interaction with Omnipaque™ (Iohexol) and chemical integrity of Omnipaque™ not compromised.	"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	Maintain sterility of injection media and resist microorganism ingress when used with Omnipaque™ IBP.	"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." (Studies included process simulation, microbial ingress, cross contamination).
Biocompatibility	Compliance of indirect patient contact materials with ISO 10993-1.	"The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with... ISO 10993-1... Verification results indicated that the materials comply with the standard."
Performance - Bench	Applicability to ISO 8536-4 (where relevant), capability to deliver contrast media and saline at prescribed rates and volumes for expected cannula ranges, acceptable pressure during operation with various cannulas and flow rates, acceptable levels of extractables and leachables, and successful transport validation.	"ulrichINJECT CT motion tubing system... evaluated 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."
Use within defined disposable time limits	The differing time limits for disposables (Pump tubing-flex, Patient tubing, Spike for CT) compared to the predicate device must be supported by contamination control studies. (Pump tubing-flex: 24hrs; Patient Tubing: 12hrs; Spike for CT: 8hrs)	"The differences in the time limits of the disposables components are addressed through the results of contamination control studies." "The differences in time limits between the ulrichINJECT CT motion and the predicate device are addressed with the completion of contamination control studies."
Human Factors / Usability	Users can operate ulrichINJECT CT motion as the predicate device.	"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."
Functional Equivalence to Predicate Device (CT Expres 3D Contrast Media Delivery System)	The ulrichINJECT CT motion should be equivalent in indications for use, overall design, and operating principles to the predicate device, with any differences not raising new questions of safety or effectiveness. Specific parameters like flow rates, volumes, pressure limits, air detection, etc., should be comparable or improved.	The document provides a detailed comparison table (pages 6-7) indicating equivalence or similar performance for numerous parameters (e.g., syringeless system, remote operation, rotary peristaltic pump, administration of contrast/saline, disposable uses spikes, safety stop, volume readout, programmable pressure limit, injection capabilities, injection rates, injection volume, flow rate/volume accuracy, contrast media container volume, saline flush, needle size, injection pause, protocol storage, priming/venting rate, air detection, occlusion detection).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable or not specified within the provided text. The testing conducted was primarily bench testing and simulated use, not clinical trials with human subjects or retrospective/prospective data analysis in the manner typically associated with AI/software performance studies. The provenance of the manufacturing entity is Germany (ulrich GmbH & Co. KG).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or not specified as the evaluation did not involve expert-labeled ground truth for a diagnostic task. The "ground truth" for the non-clinical tests was established by compliance with engineering standards and predefined performance specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or not specified because the testing described does not involve human adjudication of results in the context of diagnostic performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The ulrichINJECT CT motion is a hardware device for administering contrast media, not a diagnostic AI system intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable as the device is a hardware system, not a standalone algorithm. Its performance is inherent in its electromechanical operation and tubing system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" was based on:

Compliance with recognized standards: e.g., ISO, IEC standards for sterility, biocompatibility, electrical safety, etc.
Engineering specifications: predefined operational ranges for flow rate, volume accuracy, pressure limits, air detection, etc.
Chemical and microbiological tests: laboratory measurements to confirm material compatibility, absence of contamination, and sterility.

8. The sample size for the training set

This information is not applicable. The ulrichINJECT CT motion is a hardware device and does not involve AI/machine learning training sets.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI/machine learning model.

Summary

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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);

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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

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Indications for Use

510(k) Number (if known) K171392

Device Name ulrichINJECT CT motion

Indications for Use (Describe)

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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K171392

510(k) Summary

ulrich GmbH & Co. KG

This 510(k) Summary is in conformance with 21 CFR 807.92

Submitter:	ulrich GmbH & Co. KGBuchbrunnenweg 1289081 UlmGermanyPhone: +49 731 9654-1714Fax: +49 731 9654-2807
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979
Company Contact:	Sven ErdmannDirector 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

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Device Description

The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector and the CT motion tubing system.

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.

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 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

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.

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.

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Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Indications for Use	ulrichINJECT CT motion is a contrastmedia management system that isindicated for the controlled,automatic administration, on thevenous side, of contrast media andsaline (NaCl), to human subjectsundergoing diagnostic examinationsin computed tomography (CT)applications.	The CT Expres 3D ContrastMedia Delivery System isindicated for controlledautomatic administration, onthe venous side, of contrastand saline, to humansubjects while undergoingexamination by means of acomputed tomography (CT)scanner.	ulrichINJECT CT motion isequivalent to CT Expres 3D.The differences in the time limitsof the disposables componentsare addressed through theresults of contamination controlstudies.
	ulrichINJECT CT motion isspecifically indicated for use in CTprocedures for the delivery ofOmnipaque™ (lohexol) Injection,solution - GE Healthcare Inc.contrast media as supplied inImaging Bulk Packages (IBP).	The CT Expres 3D ContrastMedia Delivery System isspecifically indicated for usein CT procedures for thedelivery of Isovue (lopamidolInjection) contrast media assupplied in Imaging BulkPackage (IBP), for amaximum of 20 bottles of
	Pump tubing-flex is used for amaximum time of twenty four (24)hours. When used withOmnipaque™ IBP, a maximum of 19bottles of contrast media can beused or maximum time of twenty four(24) hours of Pump tubing-flex, orwhichever comes first, with a	contrast media or amaximum of ten (10) hours,whichever comes first, perDay Set III HP disposable.The Bottle Spike disposableis for single-bottle use onlyand must be discarded withthe contrast media bottle.The Patient Set disposablemust be discarded after each
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
	maximum of eight (8) hours percontrast media or saline container.Spike for CT disposable is for single-bottle use only and must bediscarded with the media container.The Patient tubing must bediscarded after each patientprocedure.ulrichINJECT CT motion is to beused only by and under quasi-continuous supervision of trainedhealthcare professionals in anappropriate licensed healthcarefacility, in a room designated forradiological procedures that involveintravascular administration ofcontrast agent.	patient procedure.The CT Expres 3D is to beused only by and underquasi-continuous supervisionof trained health careprofessionals in anappropriate licensed healthcare facility, in a roomdesignated for radiologicalprocedures that involveintravascular administrationof a contrast agent.
System Components
System	Injector HeadTouch Terminal	CT Expres Injector UnitCT Expres Control Panel	ulrichINJECT CT motion isequivalent to CT Expres 3D.
Accessories	Injector BaseWall Mount with moveable armCeiling Mount with moveable armContrast Media Housing with Heater	CT Expres Hand SwitchCT Expres Bottle InsulatorCT Expres StandCT Expres Ceiling mount	ulrichINJECT CT motionPedestal, Ceiling Mount andContrast Media Housing withHeater are equivalent to the CTExpres 3D Stand
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
			ulrichINJECT CT motion doesnot include a hand switch.
Disposables	ulrichINJECT CT Motion PumpTubing-flexPatient Tubing for Pump Tubing-flexulrichINJECT CT Motion Spike forCT	CT Expres Day Set III HPCT Expres Patient SetCT Express Bottle SpikeType B (25mm)	ulrichINJECT CT motiondisposables are equivalent to theCT Expres 3D disposables.
Physical Design
Weight	Injector: Approx. 79 kgTerminal: Approx. 3 kg	Injector: Approx. 10 kgRemote Control Panel:Approx. 2.1 kg	ulrichINJECT CT motion weightis equivalent to the CT Expres3D weight.ulrichINJECT CT motion Injectoris heavier than the CT Express3D injector. However, thisdifference does not have animpact on the intended use ofthe device.
Dimensions	Injector: 64.5 x 64.5 x 144.5 cmTerminal: 31 x 27.5 x 17 cm	Injector: 44 x 32 x 16 cmRemote Control Panel: 30 x20 x 22 cm	ulrichINJECT CT motiondimensions are equivalent to theCT Expres 3D dimensions.
Power RequirementRated Voltage:Rated Current:Rated Frequency:	110 to 240 V AC1.6 A50/60Hz	110 to 240 V AC1.6 A50/60Hz	ulrichINJECT CT is identical tothe CT Expres 3D related topower requirements.
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Display Type	Color LCD Terminal with touchscreen	Color LCD with touch screen	ulrichINJECT CT motionTerminal is equivalent to the CTExpres 3D Console.
Characteristics
Syringeless system	Yes	Yes	CT motion is identical to CTExpress 3D
Remote Operation	Yes, via the Touch Terminal	Yes, via the Remote ControlPanel and the Hand Switch	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to remote operation.
Single Patient Use Disposable	Patient Tubing for Pump Tubing-flex	Patient Set	ulrichINJECT CT motion PatientTubing for Pump Tubing-flex isequivalent to the CT Expres 3DPatient Set.CT Expres 3D Patient Setincludes the peristaltic pump intothe disposable. The peristalticpump is part of the injector of theulrichINJECT CT motion. Thisdifference in technology does notaffect the intended use of thedevice.
Designed to Prevent Reuse ofDisposables	Yes - via the use of softwarecontrols	Yes - via a breakaway pindesigned to break oninsertion	ulrichINJECT CT motion isequivalent to the CT Expres 3D.ulrichINJECT CT motionprovides software controls to
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
			prevent user from reuse ofdisposables.
Rotary peristaltic pump	Yes	Yes	CT motion is equivalent to CTExpress 3D
Used to administer contrastmedia and saline	Yes	Yes	CT motion is equivalent to CTExpress 3D
Disposable uses spikes tospike media container	Yes	Yes	CT motion is equivalent to CTExpress 3D
Safety Stop Mechanism	Multi-layered software stops; UsedPatient Tubing detector and PumpTubing-flex detector	Multi-layered software stops;Used Pump Tubing detector	CT motion is equivalent to CTExpress 3D
Volume Remaining Readout	Yes, displayed on control unit ifprogrammed volume is higher thanremaining volume	Yes, LED on injector head;graphical and numeric onLCD	CT motion is equivalent to CTExpress 3D
Programmable Pressure Limit	Yes, 195 PSI; user-programmable orautomatic	Yes, 8 bar (ca. 120 psi)	CT motion is equivalent to CTExpress 3D
Operational Characteristics
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Injection Capabilities	40 phases per protocol	Up to 24 phases per patient(8 phases per injection; up to3 injections per patient)	ulrichINJECT CT motion isequivalent to the CT Expres 3D.ulrichINJECT CT motionprovides additional flexibility witha greater number of phases forprogramming different speed andvolume of contrast media andsaline for better imaging quality.
Injection Rates for ContrastMedia	0.1 ml/s to 10.0 ml/s	0.5-9.9 mL/s	ulrichINJECT CT motion isequivalent 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 isequivalent to the CT Expres 3Drelated to the injection rates forsaline.
Injection Volume per Injection	1 to 200 mL max volume of contrastmedia per patient with a max of 400mL total media (contrast and saline)per patient	10-200 mL with a max of400 mL total media (contrastand saline) per patient	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to injection volume perinjection.
Flow Rate and VolumeAccuracy	10-200 mL of contrast media withvolume accuracy of + 5%Flow rate accuracy of + 5%	+/- 10% for a programmedinjection volume between 10mL and 59 mL+/- 6% for a programmedinjection volume between 60mL and 200 mL	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to flow rate and volumeaccuracy with a greater flow rateaccuracy delivered byulrichINJECT CT motion.
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Contrast Media ContainerVolume	500 mL	200 & 500 mL	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to contrast mediacontainer volume.
Saline Flush	Yes	Yes	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to saline flush.
Needle Size	14-24 G	16-24 G	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to needle sizes
Injection Pause	Programmable - 0 sec to 999 sec in1 sec increments	0-400 seconds	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to injection pause
Injection Protocol Storage	Yes	Yes	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to injection protocolstorage
Priming/Venting Rate	2 mL/s (manual)	1.5 mL/s (manual)6.0 mL/s (automatic)	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to priming/venting rate
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Air Detection Principle	Ultrasound	Ultrasound	ulrichINJECT CT motion isidentical to the CT Expres 3Drelated to air detection principle
Technical Detection Limit ofair in tubing	0.05 mL	0.04 mL	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to technical detectionlimit of air in tubing.
Air Detector Alarm Limit	1 mL	For programmed injectionvolume < or equal to 35 mLCM, 1.25 mLFor programmed injectionvolume > or equal to 35 mLCM, 1.25 mL if fragment airbubble, otherwise anadditional air volume of 0.75mL is tolerated.Note: The volume of thePatient Set (after the airdetector) is 8 mL	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to air detection alarmlimit.
Occlusion Detection Principle	Fail safe piezo-resistive pressuresensor	Fail safe piezo-resistivepressure sensor	ulrichINJECT CT motion isidentical to the CT Expres 3Drelated to occlusion detectionprinciple.
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Occlusion Detection AlarmLimit	246 PSI	132 PSI	ulrichINJECT CT motion isequivalent to the CT Expres 3Drelated to occlusion detectionalarm limit.
Disposables
Time Limit	24 hours for ulrichINJECT CT MotionPump Tubing-flex12 hours for Patient Tubing for PumpTubing-flex8 hours for ulrichINJECT CT MotionSpike for CT	12 hours for CT Expres DaySet III HP3 hours for CT ExpresPatient Set10 hours for CT ExpressBottle Spike Type B (25mm)	ulrichINJECT CT motion isequivalent to CT Expres 3D.The differences in time limitsbetween the ulrichINJECT CTmotion and the predicate deviceare addressed with thecompletion of contaminationcontrol studies.
Package Sterile	Yes	Yes	ulrichINJECT CT motion isidentical to CT Expres 3D.
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	ulrichINJECT CT motion isidentical to CT Expres 3D.
Packaging Configuration	Tyvek lid covering polystyrene tray	Tyvek lid coveringpolystyrene tray	ulrichINJECT CT motion isequivalent to CT Expres 3D.
Patient Tubing
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Components	Patient TubingTwo Patient Luer Connectors withsafety capsTwo check valves	Patient Set CassettePatient Set TubingPinch ClampPatient Connector withSafety Cap	ulrichINJECT CT motion isequivalent to the CT Expres 3D.ulrichINJECT CT motionperistaltic pump is part of theinjector.
Safety Feature Against Re-use	Yes, via software controls	Break away pin designed tobreak on insertion	ulrichINJECT CT motion isequivalent to the CT Expres 3D.ulrichINJECT CT motionprovides software controls thatincludes notifications to the userthat disposables have expiredand requires user action in orderfor the system to continue.
Pump Tubing-flex
Components	Contrast media lines x2Saline LineW-piecePressure sensor unit with integratedparticle filterCheck valveSwabable valves x 4	T-connectorContrast media line x2Spike for saline lineSaline lineFilter x2Reservoir x2Tubing guide x2	ulrichINJECT CT motion isequivalent to the CT Expres 3DDay Set III HP.
Contrast Media Line TubingMaterial	PVC / PUR	PVC tubing	ulrichINJECT CT motion isequivalent to the CT Expres 3D.
Product Name:	ulrichINJECT CT motionby ulrich Medical	CT Expres 3D ContrastMedia Delivery System byBracco Injeneering S.A.K151048	Comparison
Saline Line Tubing Material	PVC / PUR	PVC tubing	ulrichINJECT CT motion isequivalent to the CT Expres 3D.
Spike for CT
Spike Size	28.5 mm	25 mm	ulrichINJECT CT motion isequivalent to the CT Expres 3D.
Safety Feature Against Re-Use	Yes, via software controls	Spike tip designed to breakoff into bottle on removal	ulrichINJECT CT motionprovides software controls thatincludes notifications to the userthat disposables have expiredand requires user action in orderfor 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.

Regulation Number and Section

§ 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.