The CT Expres™ 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Expres™ 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of 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 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.

Device Description

The CT Exprès™ 3D Contrast Media Delivery System (CT Exprès™ 3D) is designed for the controlled, automatic administration, on the venous side, of water-soluble radiographic medical imaging products for contrast enhancement of computed tomography (CECT) imaging. The positive pressure necessary for the injection is generated by a rotary peristaltic pump that is part of the disposable Patient Set. The system is designed to protect the patient against air injection and occlusion by incorporating sensors to detect air and pressure within the fluid pathway.

The system consisting of the CT Exprès™ 3D injector unit, main and remote control panels, hand switch, bottle insulators, floor stand and disposables (Bottle Spike Type B, Day Set III HP, Patient Set), is specifically designed for the delivery of Isovue® (Iopamidol Injection) contrast media and saline. The Isovue is supplied for use in the CT Exprès™ 3D System as an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media per Day Set III HP disposable or 10 hours, whichever comes first.

The CT Exprès™ 3D Contrast Media Delivery System is a combination product. As stated above, the CT Exprès™ 3D is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), (submitted in the supplemental New Drug Application sNDA to the Isovue NDA 20-327 (S011)).

AI/ML Overview

The provided text describes a medical device, the CT Exprès 3D Contrast Media Delivery System, and its substantial equivalence to a predicate device (CT Exprès III) based on non-clinical performance testing. It does not contain information about acceptance criteria and device performance in the context of an AI/ML-driven medical device study. Therefore, I cannot fulfill your request for that specific information from this document.

However, I can extract information related to the device itself and the non-clinical testing performed, which serves a similar purpose to acceptance criteria in the context of device validation.

Here's an attempt to structure the information based on your request, as much as possible with the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of an AI/ML study. Instead, it details design verification and validation testing for the CT Exprès™ 3D Contrast Media Delivery System and compares it to a predicate device. The performance values listed are implicitly the accepted performance for the device.

Performance Characteristic	Acceptance Criteria (Implied) & Reported Device Performance (CT Exprès™ 3D)	Predicate Device Performance (CT Exprès™ III™)
Injection capabilities	Up to 24 phases per patient (8 phases per injection; up to 3 injections per patient)	Up to 15 phases (5 phases per injection; up to 3 injections per patient)
Injection rates for contrast media	0.5 – 9.0 mL/s	0.5 – 9.9 mL/s
Injection rates for saline	0.1 – 9.0 mL/s	0.5 – 9.9 mL/s
Injection Volume per injection	10 – 200 mL per injection	0 – 200 mL
Flow rate and Volume accuracy	± 10% for a programmed injection volume between 10mL and 59mL± 6% for a programmed injection volume between 60mL and 200mL	± 6%
Needle Size	16-24G	16-27 G
Injection pause	0 - 400 sec	0-99 sec
Scan delay	0 - 400 sec	0-99 sec
Priming rate	1.5mL/s (manual)6.0mL/s (automatic)	1 mL/s
Air Detection Technical Limit	0.04mL	0.04mL
Air Detector Alarm Limit	For programmed injection volume ≤ 35mL CM, 1.25mLFor programmed injection volume >35mL CM, 1.25mL if fragment air bubble, otherwise an additional air volume of 0.75mL is tolerated.	0.3 mL
Occlusion Detection Alarm Limit	132 PSI ± 17.4 PSI (9.1 bar ± 1.2 bar)	8 bar ± 1 bar
Biocompatibility	Conformance confirmed (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, pyrogenicity)	N/A (tested as part of predicate submission, assumed to conform)
Electrical safety, EMC	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Software V&V	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Reliability	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Sterilization validation	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Real time aging	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Packaging validation	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Transportation testing	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Cleaning/disinfection	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Microbial ingress	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Cross-contamination	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Chemical compatibility	Conformance demonstrated	N/A (tested as part of predicate submission, assumed to conform)
Simulated use usability validation	Users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device.	N/A (tested as part of predicate submission, assumed to conform)

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

The document primarily describes non-clinical performance testing and simulated use usability validation. It does not mention a "test set" in the context of an AI/ML study, nor does it specify sample sizes for data used in such a context. The testing appears to be primarily laboratory-based or simulated.

Non-clinical performance testing: No specific sample sizes for tests like electrical safety, reliability, flow rate accuracy, etc., are provided, other than the general statement that they were performed to demonstrate conformance.
Simulated use usability validation: This involved "users" but no specific number of participants or data provenance information is given.

The document is a 510(k) submission to the FDA (USA), implying the evaluation occurred within a regulatory framework applicable to the US market. The manufacturer is Bracco Injeneering S.A., based in Switzerland. The data provenance for the non-clinical testing and simulated use is not explicitly stated beyond these general facts. The testing conducted would be considered prospective for the device under review.

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 as the document describes a medical device, a contrast media delivery system, not an AI/ML algorithm that requires expert ground truth labeling in the way a diagnostic AI would. The "ground truth" for this device would be established through engineering specifications, physical measurements, and adherence to medical device standards.

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

This information is not applicable for the reasons stated above.

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 as the document describes a contrast media delivery system, not an AI/ML diagnostic or assistive device that would involve human readers interpreting output with or without AI assistance.

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

This information is not applicable as the document describes a physical medical device, not an algorithm.

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

For the reported non-clinical performance and simulated use testing, the "ground truth" would be established by:

Engineering specifications and standards: For characteristics like electrical safety, electromagnetic compatibility, dimensions, weight, power requirements.
Physical measurements and laboratory testing: For accuracy of injection volume, flow rate, air detection limits, occlusion detection limits, tubing dimensions.
Biocompatibility standards: For disposable materials.
Validated testing protocols: For sterilization, aging, packaging, transportation, microbial ingress, cross-contamination, chemical compatibility.
Usability assessments: For "users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device" through observation and feedback in a simulated environment.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the performance characteristics measured or validated in this submission.

8. The sample size for the training set

This information is not applicable as the document describes a deterministic medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, repeated three times to create a sense of depth and connection. The figures are rendered in a flowing, abstract manner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 22, 2016

Bracco Injeneering S.A. % Cynthia Nolte Senior Director, Regulatory Affairs Icon Clinical Research LLC 62 Forest Street Suite 300 Marlborough, Massachusetts 01752

Re: K151048

Trade/Device Name: CT Exprès 11 3D Contrast Media Delivery System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: IZQ Dated: December 30, 2015 Received: December 31, 2015

Dear Cynthia Nolte:

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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) K151048

Device Name

CT Expres" 3D Contrast Media Delivery System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K151048

510(k) Summary for the Bracco Injeneering CT Exprès™ 3D Contrast Media Delivery System (per 21CFR 807. 92)

1. SUBMITTER/510(K) HOLDER

Bracco Injeneering S.A. Avenue de Sévelin 46 CH - 1004 Lausanne, Switzerland

Contact Person:	Maud Giorgi, Sr. Regulatory Affairs Manager
Telephone:	+41 21 621 74 00
Date Prepared:	January 21, 2016

2. DEVICE NAME

Proprietary Name:	CT Exprès™ 3D Contrast Media Delivery System
Common/Usual Name:	Automatic injector for contrast media
Classification Name:	Injector, contrast medium, automatic
Regulation Description:	Angiographic injector and syringe

3. PREDICATE DEVICE

CT Exprés III™ Contrast Media Delivery System, K062265 (Swiss Medical Care, S.A.)

4. DEVICE DESCRIPTION

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5. INDICATION FOR USE/INTENDED USE

The CT Exprès™ 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Exprès™ 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of 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 must be discarded after each patient procedure.

The CT Exprès™ 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.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

Both the CT Exprès™ 3D and predicate CT Exprès™ systems have identical overall designs. These systems consist of identical components (injector unit, main and remote control panels, hand switch, bottle insulator and Floor Stand). Both systems have similar weights and dimensions. Power requirements are identical for the two systems. The major design changes involve an upgrade to an LCD screen for the control panel interface and an increase in the number of programmable phases for an injection cycle to allow greater programming flexibility.

Both the CT Exprès™ 3D and predicate CT Exprès™ systems are used in conjunction with disposables that create a fluid pathway from the bottles of Contrast Media and the saline container to the patient. The fluid pathway of the systems is comprised of multipatient Bottle Spike Type B and a Day Set and a single patient use Patient Set. All of these disposables are designed to prevent reuse beyond their specified usage lifetime. The CT Exprès™ 3D and predicate disposables have identical functions, where the Patient Set connects the Day Set III HP to the patient and contains the rotary peristaltic pump cassette that generates the positive pressure necessary for the injection. The Day Set III HP connects the contrast media and

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saline fluid containers to the Patient Set, and the Bottle Spike connects the bottle of contrast media to the Day Set III HP.

The difference in the disposables design is limited to the diameters of the contrast media tubing in the Day Set. The Day Set III HP (CT Exprès™ 3D) has a 4mm (inner) and 6mm (outer) diameter as compared to the predicate Day Set III (predicate) which has an inner diameter of 3mm and an outer diameter of 4.1mm. The larger diameter reduces fluid resistance and allows for an increase in maximal flow rate (but still within the maximal limit of the predicate).

Both systems are able to accept a similar range of needle sizes, including those normally used for injecting contrast media (16-22G), as well as needle sizes of up to 24G for the CT Exprès™ 3D and up to 27G for the CT Exprés III™, making both systems suitable for use with patients or injection conditions where small needle sizes are preferred.

Various small material changes have been made between the predicate and CT Exprès™ 3D Patient Set and Day Set III HP. The Bottle Spike Type B supplied with the two systems is identical.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Design verification and validation for the CT Exprès™ 3D Contrast Media Injection System was performed in accordance with the Master Design Verification and Validation Plan for the product. Specific testing conducted is listed below.

The disposables were tested to confirm biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, pyrogenicity).

The CT Exprès™ main unit and accessories were tested to demonstrate conformance with established performance criteria:

Electrical safety, electromagnetic interference/compatibility ●
. Software verification and validation
Reliability ●
Injection volume accuracy ●
Air detection
Occlusion ●
. Flow rate accuracy

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The system validation tests listed below were performed to validate specific performance criteria and confirm that the CT Exprès™ 3D is safe for the indications for use:

Sterilization validation
Real time aging ●
Packaging validation ●
Transportation testing ●
. Cleaning/disinfection instructions
Microbial ingress
Cross-contamination ●
Chemical compatibility ●
Simulated use usability validation .

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical studies were performed using the CT Exprès™ 3D. Usability assessments were conducted in a simulated use environment to optimize the device design and support the safe use of the CT Exprès™ 3D Injector with the Isovue IBP and saline. The results demonstrated that users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device.

9. SUMMARY OF OTHER INFORMATION

No other information is available.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Extensive preclinical testing has been performed to verify and validate the safety and performance of the multi-patient CT Exprès™ 3D injector platform for the specific indications for use of Isovue contrast media as supplied in an IBP and saline. With the exception of the disposables material changes for which additional biocompatibility testing was conducted, the technological characteristics and overall design of the CT Exprès™ 3D are essentially identical to those of the predicate device, with any differences limited to minor differences in design and performance that do not raise any new questions of safety or effectiveness.

Therefore, Bracco Injeneering considers the CT Exprès™ 3D to be substantially equivalent to the CT Exprés III™, subject of K062265. A side-by-side comparison of the predicate and subject devices is provided in Tables 1 and 2.

Contrast Media Delivery	Subject Device	Predicate
System	CT Exprès™ 3D	CT Exprés III™
Manufacturer	Bracco Injeneering S.A.	Swiss Medical Care
Regulatory Status	K151048	K062265
Indication
Intended Use/Indicationsfor Use	The CT Exprès™ 3D Contrast Media DeliverySystem is indicated for the controlled automaticadministration, on the venous side, of contrast mediaand saline, to human subjects while undergoingexamination by means of a computed tomography(CT) scanner.The CT Exprès™ 3D Contrast Media DeliverySystem is specifically indicated for use in CTprocedures for the delivery of Isovue (IopamidolInjection) contrast media as supplied in an ImagingBulk Package (IBP), for a maximum of 20 bottles ofcontrast media or a maximum of ten (10) hours,whichever comes first, per Day Set III HPdisposable. The Bottle Spike disposable is forsingle-bottle use only and must be discarded with thecontrast media bottle. The Patient Set disposablemust be discarded after each patient procedure.The CT Exprès™ 3D is to be used only by and underquasi-continuous supervision of trained health careprofessionals in an appropriate licensed health carefacility, in a room designated for radiologicalprocedures that involve intravascular administrationof a contrast agent.	The CT Exprés III™ Contrast Media DeliverySystem (CMDS) is indicated for controlledautomatic administration, on the venous side, ofcontrast media (CM) to human subjects whileundergoing examination by means of computedtomography (CT) scanner.The system consists of the CT Exprés III™Instrument, the Bottle Spike, the Day Set III, thePatient Set, accessories and detachable parts.This device is not intended for injection of CMfor coronary arteriography, or for any other usefor which the device is not indicated. Thisdevice is only to be operated by and under quasi-continuous supervision of qualified medical staffin an appropriate licensed health care facility.
System Components
System	CT Exprès Injector UnitCT Exprès Control Panel	CT Exprés III Injector UnitCT Exprés III Control Panel
Accessories	CT Exprès Hand SwitchCT Exprès Bottle InsulatorCT Exprès Stand	CT Exprés III Hand SwitchCT Exprés III Bottle InsulatorCT Exprés III Pedestal Pole and Wheel BaseCT Exprés III Printer (Optional)
Disposables	CT Exprès Day Set III HPCT Exprès Patient SetCT Exprès Bottle Spike Type B (25mm)	CT Exprés Day Set IIICT Exprés Patient SetCT Exprés Bottle Spike Type A (30mm)CT Exprés Bottle Spike Type B (25mm)
Physical Design
Weight	Injector: Approx. 10 kgConsole: Approx. 2.1 kg	Injector: Approx. 10kgConsole: Approx. 1.7kg
Dimensions	Injector: 44 x 32 x 16 cmConsole: 30 x 20 x 22 cm	Injector: 44 x 32 x 16 cmConsole: 30 x 20 x 20 cm
Power Requirement:
Rated voltage:	110 to 120 V AC	110 to 120 V ac
Rated current:	1.6 A	1.6 A
Rated frequency:	60Hz	60 Hz
Display:Type:Resolution:	Colour LCD with touch screen800 x 600 pixel	VFD display with hard button technology
Technology:	TFT (Thin Film Transistor)
Characteristic
Remote operation	Yes	Yes
Single patient usedisposable	Patient Set	Patient Set
Designed to prevent reuseof disposables	Yes	Yes
Operational Characteristics
Injection capabilities	Up to 24 phases per patient (8 phases per injection;	Up to 15 phases (5 phases per injection; up to 3
Contrast Media DeliverySystem	Subject DeviceCT Exprès™ 3D	PredicateCT Exprés III™
	up to 3 injections per patient)	injections per patient)
Injection rates for contrastmedia	0.5 – 9.0 mL/s	0.5 – 9.9 mL/s
Injection rates for saline	0.1 – 9.0mL/s	0.5 – 9.9 mL/s
Injection Volume perinjection	10 – 200mL per injection	0 – 200 mL
Flow rate and Volumeaccuracy	± 10% for a programmed injection volume between10mL and 59mL± 6% for a programmed injection volume between60mL and 200mL	± 6%
Contrast media containervolume	200 & 500mL	50 – 500 mL
Saline flush	Yes	Yes
Needle Size	16-24G	16-27 G
Injection pause	0 - 400 sec	0-99 sec
Scan delay	0 - 400 sec	0-99 sec
Injection protocol storage	unrestricted	100 protocols
Priming rate	1.5mL/s (manual)6.0mL/s (automatic)	1 mL/s
Air Detection Principle	Ultrasound	Ultrasound
Technical Detection limit	0.04mL	0.04mL
Air Detector Alarm Limit	For programmed injection volume ≤ 35mL CM,1.25mLFor programmed injection volume >35mL CM,1.25mL if fragment air bubble, otherwise anadditional air volume of 0.75mL is tolerated.Note: The volume of the Patient Set (after the airdetector) is 8mL	0.3 mL
Occlusion DetectionPrinciple	Fail safe piezo-resistive pressure sensor	Fail-safe piezo-resistive pressure sensor
Occlusion Detection AlarmLimit	132 PSI ± 17.4 PSI (9.1 bar ± 1.2 bar)	8 bar ± 1 bar

Table 1. Side-by-Side Comparison, System

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Table 2. Side-by-Side Comparison Table, Disposables

Disposable	Subject Device	Predicate
Contrast Media Delivery System	CT Exprès™ 3D	CT Exprés™ IIITM
Manufacturer	Bracco Injeneering S.A.	Swiss Medical Care
Regulatory Status	K151048	K062265
Patient Set	Patient Set	Patient Set
Components	Patient Set Cassette	Patient Set Cassette
	Patient Set Tubing	Patient Set Tubing
	Pinch Clamp	Pinch Clamp
	Patient connector with safety cap	Patient connector with safety cap
Colour of Pinch Clamp	Blue	White
Safety Feature against re-use	Break away pin designed to break on	Break away pin designed to break on
	insertion	insertion
Day Set	Day Set III HP	Day Set III
Components	T-connector	T-connector
	Contrast media line x2	Contrast media line x2
	Spike for saline line	Spike for saline line
	Saline line	Saline Line
	Filter x2	Filter x2
	Reservoir x2	Reservoir x2
	Tubing guide x2	Tubing guide x2

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Disposable	Subject Device	Predicate
Contrast Media Delivery System	CT Exprès™ 3D	CT Exprès™ III™
Tubing inner diameter	$4 \pm 0.07$ mm	$3 \pm 0.05$ mm
Tubing outer diameter	$6 \pm 0.07$ mm	$4.1 \pm 0.05$ mm
Contrast media line tubing material	PVC tubing	PVC tubing
Saline line tubing material	PVC tubing	PVC tubing
Bottle Spike	Bottle Spike Type B	Bottle Spike Type B
Size	25mm	25mm
Safety Feature against re-use	Spike tip designed to break off into bottle on removal	Spike tip designed to break off into bottle on removal

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.