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.

Device Description

ulrichINJECT CT motion is a syringeless contrast media management system that is designed for the controlled, automatic administration, on the venous side, of contrast media and saline, to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.

The ulrichINJECT CT motion system consists of the CT motion terminal, CT motion injector, and the CT motion tubing system. The CT motion tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The CT motion tubing system consists of three components:

Spike for CT
Pump tubing-flex .
. Patient Tubing

ulrichINJECT CT motion uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the CT motion tubing system (spikes for CT, CT motion pump tubing-flex, and patient tubing for pump tubing-flex). The ulrichINJECT CT motion system is intended to be used with the following components that are not supplied with the system:

Multiple patient use saline containers, ●
. Omnipaque IBP contrast media containers,
Omnipaque single-dose contrast media bottles. ●
Visipaque single-dose contrast media bottles, and
Cannula. .

The ulrichINJECT CT motion system is specifically indicated for use in CT procedures for the delivery of Omnipaque™ (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 available if the manufacturer of the CT scanner has enabled the connection to the injector system.

The ulrich medical RIS/PACS Interface is a new software option supports transferring documentation-related parameters for a contrast media injection to healthcare IT systems. A worklist can be retrieved from a RIS server by means of the DICOM modality worklist information model. After selecting a patient from the worklist and performing the iniection, a comprehensive contrast media dose report is automatically transmitted to the configured PACS and/or Dose Reporting system.

AI/ML Overview

The FDA 510(k) Summary for the ulrichINJECT CT motion outlines a series of non-clinical tests to demonstrate that the device meets its performance criteria. While the acceptance criteria are implicitly stated through adherence to various international standards and specific thresholds (e.g., air detection limit, volume accuracy), they are not presented in a single, consolidated table with reported device performance. No clinical studies (MRMC or standalone based on expert consensus/pathology) were performed or referenced for this 510(k) submission, as the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's a summary based on the provided text, addressing your specific points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

A consolidated table of acceptance criteria and reported device performance is not explicitly provided in the document. Instead, acceptance criteria are described as conformance to specific international standards and pre-defined thresholds for certain parameters. The reported performance is generally stated as "complies with the standard," "satisfactorily met," or "met the requirements of the pre-defined acceptance criteria."

Acceptance Criteria Category	Specific Acceptance Criteria (implicit or stated)	Reported Device Performance
Software	Conformance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005); All acceptance criteria for installation qualification and operational and performance qualification.	All acceptance criteria for installation qualification and operational and performance qualification are satisfactorily met.
Electromagnetic Compatibility / Electrical Safety	Conformance with IEC 60601-1:2012 (Edition 3.1) and IEC 60601-1-2:2014 (Edition 4.0).	The ulrichINJECT CT motion complies with the listed standards.
Sterilization	Sterility Assurance Level (SAL) of $10^{-6}$ in accordance with ISO 11135-1:2007.	Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.
Shelf-Life	Conformance with ISO 11607-1:2006 for packaging; maintenance of integrity for a specified duration.	Verification results indicate compliance for a shelf life of 5 years.
Chemical Compatibility	No interaction with Omnipaque™ or Visipaque™; chemical integrity of contrast media not compromised.	The ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™; chemical integrity of contrast media is not compromised.
Contamination Control	Maintain sterility of injection media; resist ingress of microorganisms; residuals between compounds within defined limits after rinsing.	Maintains sterility, resists ingress of microorganisms, and residuals are within defined limits.
Biocompatibility	Conformance with ISO 10993-1:2009 for indirect patient contact materials.	Materials comply with the standard (based on cytotoxicity, intracutaneous reactivity, allergic sensitization, systemic acute toxicity, pyrogen shelf-life, hemocompatibility, LAL test).
Extractables and Leachables	Met requirements of pre-defined acceptance criteria for intended uses.	Testing and toxicological assessment demonstrated that the device is safe and effective and met the requirements.
Human Factors	No new unacceptable usability risks introduced by modifications; intended user population able to perform tasks.	No new unacceptable usability risks were introduced; intended user population is able to perform use tasks.
Performance - Bench	Conformance with applicable requirements of ISO 8536-4:2010; confirmation that mixing of contrast media will not occur.	The ulrichINJECT CT motion tubing system conforms to its predetermined specifications and applicable standards.
Technical Detection Limit of Air in Tubing	0.05 mL	0.05 mL
Air Detector Alarm Limit	1 mL	1 mL
Occlusion Detection Alarm Limit	246 PSI	246 PSI
Volume Accuracy	$\pm 5%$ for 10-200 mL of contrast media	$\pm 5%$
Flow Rate Accuracy	$\pm 5%$	$\pm 5%$

2. Sample Size for the Test Set and Data Provenance

The document explicitly states that non-clinical testing (bench testing, software verification and validation, EMC testing, sterilization validation, shelf-life studies, chemical compatibility, contamination control, biocompatibility, extractables/leachables, and human factors) was performed.

No "test set" in the context of clinical images or patient data is mentioned because this is a medical device for contrast media administration, not an imaging AI diagnostic device.
The tests mentioned are primarily laboratory or simulated use tests. Therefore, there is no direct information on a "sample size for the test set" as would be applicable to an AI diagnostic device evaluating patient data.
Data Provenance: Not applicable in the context of clinical data. The studies are primarily engineering validation and verification tests.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Since this is a submission for a contrast media injector device and not an AI diagnostic tool requiring image interpretation or disease detection, there is no mention of experts establishing a "ground truth" for a test set of patient data. The "ground truth" for the tests performed relates to engineering specifications, safety standards, and functional performance.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" requiring expert interpretation or consensus for clinical ground truth, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study. The device is a contrast media injector, and the submission focuses on its technical and functional equivalence and safety, not on improving human reader performance in interpreting medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, implicitly. All the non-clinical tests described (software validation, EMC, sterilization, shelf-life, chemical compatibility, contamination control, biocompatibility, extractables/leachables, and performance bench tests) are evaluations of the device's inherent functional performance without human intervention in the loop of the test itself. The "Human Factors" study assessed the user interaction with the device, but the core performance criteria were evaluated without human interaction during the test.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests described is based on:

Technical Specifications: Pre-defined design requirements for flow rate accuracy, volume accuracy, alarm limits (air, occlusion).
International Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ISO 11135-1, ISO 11607-1, ISO 10993-1, ISO 8536-4.
Safety and Efficacy Assessments: Demonstrating no adverse interactions with contrast media, maintaining sterility, preventing contamination, and ensuring biocompatibility.
Usability Objectives: Confirmation that intended users can safely and effectively operate the device.

8. Sample Size for the Training Set

Not applicable. This submission is for a medical device (contrast media injector), not an AI algorithm that would require a "training set" of data for machine learning. The software mentioned is control software, verified and validated against functional requirements.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no AI algorithm training set, there is no ground truth established for such a set. The "ground truth" for the device's control software functionality would be its design specifications, regulatory requirements, and established safety and performance parameters.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 6, 2021

ulrich GmbH & Co. KG % Rita King CEO MethodSense Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560

Re: K210541

Trade/Device Name: ulrichINJECT CT motion Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: IZQ Dated: July 8, 2021 Received: July 9, 2021

Dear Rita King:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210541

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.

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).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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. 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 ErdmannVice 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 CertegraWorkstation, MEDRAD Stellant FLEX Syringe Kits, MEDRADStellant CT Injection System with Certegra Workstation,MEDRAD Stellant Syringe Kits, MEDRAD Stellant ConnectorTubing, 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.

Spike for CT
Pump tubing-flex .
. Patient Tubing

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 is provided in three versions:

Mobile pedestal version ●
Ceiling version ●
Wall mounted version .

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available if the manufacturer of the CT scanner has enabled the connection to the injector svstem.

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).

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 forUse	ulrichINJECT CT motionulrichINJECT CT motion is a contrast mediamanagement system that is indicated for thecontrolled, automatic administration, on thevenous side, of contrast media and saline(NaCl), to human subjects undergoingdiagnostic examinations in computedtomography (CT) applications.	ulrichINJECT CT motion (K192872)ulrichINJECT CT motion is a contrast mediamanagement system that is indicated for thecontrolled, automatic administration, on thevenous side, of contrast media and saline(NaCl), to human subjects undergoingdiagnostic examinations in computedtomography (CT) applications.
	ulrichINJECT CT motion is specificallyindicated for use in CT procedures for thedelivery of OmnipaqueTM (Iohexol) Injection,solution - GE Healthcare Inc. contrast mediaas supplied in Imaging Bulk Packages (IBP),OmnipaqueTM (lohexol) Injection, solution -GE Healthcare Inc., and VisipaqueTM(iodixanol) Injection - GE Healthcare Inc.contrast media as suppliedin single dose bottles.	ulrichINJECT CT motion is specificallyindicated for use in CT procedures for thedelivery of OmnipaqueTM (Iohexol) Injection,solution - GE Healthcare Inc. contrast mediaas supplied in Imaging Bulk Packages (IBP),OmnipaqueTM (lohexol) Injection, solution -GE Healthcare Inc., and VisipaqueTM(iodixanol) Injection - GE Healthcare Inc.contrast media as suppliedin single dose bottles.	Similar. SeeNote 1.
	Pump tubing-flex is used for a maximum timeof twenty four (24) hours. When used withOmnipaqueTM IBP, OmnipaqueTM singledose bottles, or VisipaqueTM single dosebottles, a maximum of 19 bottles of contrastmedia can be used or maximum time oftwenty four (24) hours of Pump tubing-flex, orwhichever comes first. Time per contrastmedia or saline container depends on eachcontrast media's or saline's use timeexpiration with a maximum of eight (8) hoursper contrast media or saline container.	Pump tubing-flex is used for a maximum timeof twenty four (24) hours. When used withOmnipaqueTM IBP, OmnipaqueTM singledose bottles, or VisipaqueTM single dosebottles, a maximum of 19 bottles of contrastmedia can be used or maximum time oftwenty four (24) hours of Pump tubing-flex, orwhichever comes first. Time per contrastmedia or saline container depends on eachcontrast media's or saline's use timeexpiration with a maximum of eight (8) hoursper 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-bottleuse only and must be discarded with themedia container. The Patient tubing must bediscarded after each patient procedure.SYNCopen is indicated for the specificpurpose of allowing an injector to interfacewith a CT scanner.RIS/PACS is indicated for the specificpurpose of allowing an injector to interfacewith a Radiological Information System (RIS)and a Picture Archiving and CommunicationSystem (PACS).ulrichINJECT CT motion is to be used onlyby and under quasi-continuous supervisionof trained healthcare professionals in anappropriate licensed healthcare facility, in aroom designated for radiological proceduresthat involve intravascular administration ofcontrast agent.	Spike for CT disposable is for single-bottleuse only and must be discarded with themedia container. The Patient tubing must bediscarded after each patient procedure.ulrichINJECT CT motion is to be used onlyby and under quasi-continuous supervisionof trained healthcare professionals in anappropriate licensed healthcare facility, in aroom designated for radiological proceduresthat involve intravascular administration ofcontrast agent.
System	Injector HeadTouch Terminal	Injector HeadTouch Terminal	Same
Accessories	Injector BaseWall Mount with moveable armCeiling Mount with moveable armContrast Media Housing with Heater	Injector BaseWall Mount with moveable armCeiling Mount with moveable armContrast Media Housing with Heater	Same
	Subject Device	Primary Predicate
Item	ulrichINJECT CT motion	ulrichINJECT CT motion (K192872)	Comparison
Disposables	ulrichINJECT CT Motion Pump Tubing-flex	ulrichINJECT CT Motion Pump Tubing-flex
	Patient Tubing for Pump Tubing-flex	Patient Tubing for Pump Tubing-flex	Same
	ulrichINJECT CT Motion Spike for CT	ulrichINJECT CT Motion Spike for CT	Same
Weight	Injector (pedestal version): Approx. 80 kg	Injector (pedestal version): Approx. 80 kg
	Injector (ceiling and wall mount version):Approx. 40 kg	Injector (ceiling and wall mount version):Approx. 40 kg	Same
	Terminal: Approx. 3 kg	Terminal: Approx. 3 kg	Same
Dimensions	Injector (pedestal version and wall mountversion): 64.5 x 64.5 x 144.5 cm	Injector (pedestal version and wall mountversion): 64.5 x 64.5 x 144.5 cm
	Injector (ceiling version): Depends on thesystem selected and the length of the fixedheight arm	Injector (ceiling version): Depends on thesystem selected and the length of the fixedheight arm	Same
	Terminal: 31 x 27.5 x 17 cm	Terminal: 31 x 27.5 x 17 cm	Same
PowerRequirement	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
Syringelesssystem	Yes	Yes	Same
RemoteOperation	Yes, via the Touch Terminal	Yes, via the Touch Terminal	Same
Single PatientUse Disposable	Patient Tubing for Pump Tubing-flex	Patient Tubing for Pump Tubing-flex	Same
Item	Subject DeviceulrichINJECT CT motion	Primary PredicateulrichINJECT CT motion (K192872)	Comparison
Designed toPrevent Reuseof Disposables	Yes – via the use of software controls	Yes – via the use of software controls	Same
RotaryperistalticpumpUsed toadministercontrast mediaand saline	Yes	Yes	Same
Disposableuses spikes tospike mediacontainer	Yes	Yes	Same
Safety StopMechanism	Multi-layered software stops; Used PatientTubing detector and Pump Tubing-flexdetector	Multi-layered software stops; Used PatientTubing detector and Pump Tubing-flexdetector	Same
VolumeRemainingReadout	Yes, displayed on control unit if programmedvolume is higher than remaining volume	Yes, displayed on control unit if programmedvolume is higher than remaining volume	Same
ProgrammablePressure Limit	Yes, 195 PSI; user-programmable orautomatic	Yes, 195 PSI; user-programmable orautomatic	Same
Injector-ScannerInterface	SYNCopen functionality allows start of theinjector and CT scanner simultaneously andcommunicates information from the CTmotion to the CT scanner.	Not available.	Different. SeeNote 2.
InjectionCapabilities	40 phases per protocol	40 phases per protocol	Same
Injection Ratesfor ContrastMedia	0.1 mL/s to 10.0 mL/s	0.1 mL/s to 10.0 mL/s	Same
Injection Ratesfor 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
InjectionVolume perInjection	ulrichINJECT CT motion1 to 200 mL max volume of contrast mediaper patient with a max of 400 mL total media(contrast and saline) per patient	ulrichINJECT CT motion (K192872)1 to 200 mL max volume of contrast mediaper patient with a max of 400 mL total media(contrast and saline) per patient	Same
Flow Rate andVolumeAccuracy	10-200 mL of contrast media with volumeaccuracy of ± 5%Flow rate accuracy of ± 5%	10-200 mL of contrast media with volumeaccuracy of ± 5%Flow rate accuracy of ± 5%	Same
Contrast MediaContainerVolume	500 mL (OMNIPAQUE IBP)100 mL and 150 mL (VISIPAQUE singledose)150 mL (OMNIPAQUE single dose)	500 mL (OMNIPAQUE IBP)100 mL and 150 mL (VISIPAQUE singledose)150 mL (OMNIPAQUE single dose)	Same
CompatibleContrast Media	OMNIPAQUE™ IBPOMNIPAQUE™ single doseVISIPAQUE™ single dose	OMNIPAQUE™ IBPOMNIPAQUE™ single doseVISIPAQUE™ single dose	Same
Saline Flush	Yes	Yes	Same
Needle Size	14-24 G	14-24 G	Same
Injection Pause	Programmable - 0 sec to 999 sec in 1 secincrements	Programmable - 0 sec to 999 sec in 1 secincrements	Same
InjectionProtocolStorage	Yes	Yes	Same
Priming/VentingRate	2 mL/s (manual)	2 mL/s (manual)	Same
Air DetectionPrinciple	Ultrasound	Ultrasound	Same
Item	Subject Device	Primary Predicate	Comparison
Technical Detection Limit of air in tubing	0.05 mL	0.05 mL	Same
Air Detector Alarm Limit	1 mL	1 mL	Same
Occlusion Detection Principle	Fail safe piezo-resistive pressure sensor	Fail safe piezo-resistive pressure sensor	Same
Occlusion Detection Alarm Limit	246 PSI	246 PSI	Same
Time Limit for Disposables	24 hours for ulrichINJECT CT Motion Pump Tubing-flex12 hours for Patient Tubing for Pump Tubing-flex8 hours for ulrichINJECT CT Motion Spike for CT	24 hours for ulrichINJECT CT Motion Pump Tubing-flex12 hours for Patient Tubing for Pump Tubing-flex8 hours for ulrichINJECT CT Motion Spike for CT	Same
Package Sterile	Yes	Yes	Same
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Same
Packaging Configuration	Tyvek lid covering polystyrele tray	Tyvek lid covering polystyrele tray	Same
Components	Patient TubingTwo Patient Luer Connectors with safety capsTwo check valves	Patient TubingTwo Patient Luer Connectors with safety capsTwo check valves	Same
Safety Feature Against Re-use	Yes, via software controls	Yes, via software controls	Same
Item	Subject Device	Primary Predicate	Comparison
	ulrichINJECT CT motion	ulrichINJECT CT motion (K192872)
Components	Contrast media lines x2	Contrast media lines x2	Same
	Saline Line	Saline Line
	W-piece	W-piece
	Pressure sensor unit with integrated particlefilter	Pressure sensor unit with integrated particlefilter
	Check valve	Check valve
	Swabable valves x 4	Swabable valves x 4
Contrast MediaLine TubingMaterial	PVC / PUR	PVC / PUR	Same
Saline LineTubing Material	PVC / PUR	PVC / PUR	Same
Spike Size	28.5 mm	28.5 mm	Same
Safety FeatureAgainst Re-Use	Yes, via software controls	Yes, via software controls	Same

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Note 1. The Indications for Use related to contrast media management and the disposable components of the CT motion are identical to the Indications for Use of the previously cleared ulrichINJECT CT motion (K192872). The ulrichINJECT CT motion's Indications for Use as it relates to new SYNCopen functionality and new Class I, 510(k) exempt Indications related to interfacing with RIS and PACS systems are different from the predicate device (K192872). The introduction of SYNCopen and RISIPACS functionality in the indications for use any questions of safety and effectiveness as software verification and validation and safety testing have been performed to confirm the device remains as safe and effective as the predicate device (K192872).
The injector scanner interface (SYNCopen) is a new functionality that was not present on the previously cleared Note 2. ulrichINJECT CT motion (K192872). The introduction of SYNCopen functionality does not raise any questions of safety and effectiveness as software verification and safety testing have been performed to confirm the device remains as safe and effective as the predicate device (K192872).

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Non-Clinical Testing

ulrichINJECT CT motion system and software were validated in accordance with a verification & validation plan to ensure conformance with established performance criteria.

Software:

Software verification and validation was performed as part of K171392 and K192872 and has been repeated for the software updates made as part of this submission. FDA's guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry and FDA Staff" (2005) has been followed.

Validation included installation qualification and operational performance qualification. All acceptance criteria for the installation qualification and operational and performance qualification are satisfactorily met so that the ulrichINJECT CT motion software is released for its intended use.

Electromagnetic Compatibility / Electrical Safety:

Testing was performed in accordance with the following standards:

. IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance; Edition 3.1 (2012)
. IEC 60601-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests; Edition 4.0 (2014)

Testing results indicate that the ulrichINJECT CT motion complies with the standards listed.

Sterilization:

The ulrichINJECT CT motion tubing system is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standard prior to commercial distribution as part of K192872:

ISO 11135-1: Sterilization of health care products Ethylene oxide Part 1: . Requirements for the development validation and routine control of a sterilization process for medical devices; 2007
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard.

Shelf-Life:

Real-time aging and accelerated-aging studies were performed as part of K171392 and K192872. The ulrichINJECT CT motion tubing system is sterilized and its packaging was validated in accordance with the following standard:

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ISO 11607-1: Packaging for terminally sterilized medical devices Part 1: Requirements ● for materials, sterile barrier systems and packaging systems; 2006
Verification results indicate that the ulrichINJECT CT motion tubing system complies with the standard for a shelf life of 5 years.

Chemical Compatibility:

Material compatibility of the ulrichINJECT CT motion tubing system was performed as part of K192872 using Omnipaque™ and Visipaque™ as the solvents. The results of the testing concluded that the ulrichINJECT CT motion tubing system does not interact with Omnipaque™ or Visipaque™ and the chemical integrity of Omnipaque™ or Visipaque™ is not compromised throughout use. Therefore, ulrichINJECT CT motion is safe and effective for its intended uses.

Contamination Control:

ulrich performed the following contamination control studies as part of K192872:

. Process Simulation Studies
. Microbial Ingress Study
. Cross Contamination Study
Rinsing Study ●

Contamination control study results have concluded that ulrichINJECT CT motion has the ability to maintain the sterility of the injection media and resist the ingress of microorganisms when used with Omnipaque™ Imaging Bulk Package (IBP), Omnipaque single dose bottles, and Visipaque single dose bottles during its intended use. Additionally, it has been concluded that the residuals between the single active compounds (lohexol and lodixanol) after rinsing the system with physiological saline solution are within the defined limits.

Biocompatibility:

The ulrichINJECT CT motion tubing system indirect patient contact materials were verified in accordance with the following standard as part of K171392 and K192872:

ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing . within a risk management process; 2009
The following tests have been performed:
Cytotoxicity
. Intracutaneous reactivity
Allergic sensitization .
Systemic acute toxicity .
. Pyrogen shelf-life:
Hemocompatibility: Hemolysis ●
LAL test: Bacterial endotoxins

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Verification results indicated that the materials comply with the standard.

Extractables and Leachables:

Testing was performed for extractables and simulation testing for leachable compounds and particulates as part of K171392 and K192872 for OMNIPAQUE and VISIPAQUE.

Testing and a toxicological assessment demonstrated that ulrichINJECT CT motion is safe and effective for its intended uses. The results of the testing and toxicological assessment met the requirements of the pre-defined acceptance criteria for the intended uses of the device.

Human Factors:

A usability study was performed as part of K171392 to confirm that the ulrichINJECT CT motion was safe and effective for use by its intended users. Usability evaluations, including a usability study, were performed as part of K210541 to confirm that the updated ulrichINJECT CT motion system with RIS/PACS and SYNCopen software options is still safe and effective for use by the intended user population. Results demonstrated that no new unacceptable usability risks were introduced by the modifications and the intended user population is able to perform use tasks.

Performance - Bench:

The ulrichINJECT CT motion tubing system was tested for performance and verified in accordance with the following standards as part of K171392:

. ISO 8536-4: Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed: 2010
ulrichINJECT tubing system is not a gravity feed device. Therefore, only the applicable requirements from ISO 8536-4 were tested.

Transport validation and cleaning instructions validation was also performed as part of K171392.

Testing was also performed as part of K192872 to confirm that mixing of contrast media will not occur.

Test and verification results indicate that the ulrichINJECT CT motion tubing system conforms to its predetermined specifications and the applicable standards

Conclusion

Based on the performance testing, comparison, and analysis in this submission, the subject device, ulrichINJECT CT motion, is substantially equivalent to the predicate device, K192872.

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.

Indications for Use

Indications for Use (Describe)

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510(k) Summary

ulrich GmbH & Co. KG K210541

Device Name and Classification

Predicate Device:

Device Description

Indications for Use

Risk Analvsis Method

Substantial Equivalence

Detailed Comparison of the Subject and Predicate Device

Non-Clinical Testing

Software:

Electromagnetic Compatibility / Electrical Safety:

Sterilization:

Shelf-Life:

Chemical Compatibility:

Contamination Control:

Biocompatibility:

Extractables and Leachables:

Human Factors:

Performance - Bench:

Conclusion

§ 870.1650 Angiographic injector and syringe.

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