(277 days)
No
The description focuses on the mechanical and sensor-based functions of a contrast media injector, with no mention of AI or ML capabilities for image processing, decision making, or adaptive control.
No.
The device administers contrast media and saline but does not cure, mitigate, treat, or prevent a disease or condition, which is the definition of a therapeutic device.
No
This device is a contrast media delivery system, whose purpose is to administer contrast media and saline to facilitate brighter images for a CT scanner. It does not perform a diagnostic function itself.
No
The device description explicitly states it is a "Contrast Media Delivery System" and includes hardware components such as a "rotary peristaltic pump," "sensors," "injector unit," "main and remote control panels," "hand switch," "bottle insulators," "floor stand," and "disposables." It also mentions testing for electrical safety, electromagnetic interference/compatibility, and reliability, which are associated with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled administration of contrast media and saline to human subjects while undergoing examination by means of a computed tomography (CT) scanner. This describes a device used in vivo (within the living body) to facilitate an imaging procedure.
- Device Description: The device description reinforces this by explaining it's designed for the administration of radiographic medical imaging products for contrast enhancement of CT imaging. It describes a system that injects substances into the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro), such as blood, urine, or tissue samples, which is the defining characteristic of an IVD.
- Performance Studies: The performance studies focus on the device's ability to accurately and safely deliver fluids into a patient (injection volume accuracy, air detection, occlusion detection, flow rate accuracy). These are relevant to an in vivo administration device, not an in vitro diagnostic test.
In summary, the CT Expres™ 3D Contrast Media Delivery System is a medical device used to administer substances into a patient for the purpose of improving the quality of a CT scan. It does not perform any diagnostic testing on samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
IZQ
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)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study Type: Usability assessments
Sample Size: Not specified
Key Results: The results demonstrated that users can operate the CT Exprès™ 3D as safely and as effectively as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/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
1
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
2
Indications for Use
510(k) Number (if known) K151048
Device Name
CT Expres" 3D Contrast Media Delivery System
Indications for Use (Describe)
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.
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
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.
4
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)).
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
5
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
6
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/Indications | ||
| for Use | The CT Exprès™ 3D Contrast Media Delivery | |
| System is indicated for the 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 disposable
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. | The CT Exprés III™ Contrast Media Delivery
System (CMDS) is indicated for controlled
automatic administration, on the venous side, of
contrast media (CM) to human subjects while
undergoing examination by means of computed
tomography (CT) scanner.
The system consists of the CT Exprés III™
Instrument, the Bottle Spike, the Day Set III, the
Patient Set, accessories and detachable parts.
This device is not intended for injection of CM
for coronary arteriography, or for any other use
for which the device is not indicated. This
device is only to be operated by and under quasi-
continuous supervision of qualified medical staff
in an appropriate licensed health care facility. |
| System Components | | |
| System | CT Exprès Injector Unit
CT Exprès Control Panel | CT Exprés III Injector Unit
CT Exprés III Control Panel |
| Accessories | CT Exprès Hand Switch
CT Exprès Bottle Insulator
CT Exprès Stand | CT Exprés III Hand Switch
CT Exprés III Bottle Insulator
CT Exprés III Pedestal Pole and Wheel Base
CT Exprés III Printer (Optional) |
| Disposables | CT Exprès Day Set III HP
CT Exprès Patient Set
CT Exprès Bottle Spike Type B (25mm) | CT Exprés Day Set III
CT Exprés Patient Set
CT Exprés Bottle Spike Type A (30mm)
CT Exprés Bottle Spike Type B (25mm) |
| Physical Design | | |
| Weight | Injector: Approx. 10 kg
Console: Approx. 2.1 kg | Injector: Approx. 10kg
Console: Approx. 1.7kg |
| Dimensions | Injector: 44 x 32 x 16 cm
Console: 30 x 20 x 22 cm | Injector: 44 x 32 x 16 cm
Console: 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 screen
800 x 600 pixel | VFD display with hard button technology |
| Technology: | TFT (Thin Film Transistor) | |
| Characteristic | | |
| Remote operation | Yes | Yes |
| Single patient use
disposable | Patient Set | Patient Set |
| Designed to prevent reuse
of 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 Delivery
System | Subject Device
CT Exprès™ 3D | Predicate
CT Exprés III™ |
| | up to 3 injections per patient) | 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 – 9.0mL/s | 0.5 – 9.9 mL/s |
| Injection Volume per
injection | 10 – 200mL 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% |
| Contrast media container
volume | 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,
1.25mL
For programmed injection volume >35mL CM,
1.25mL if fragment air bubble, otherwise an
additional air volume of 0.75mL is tolerated.
Note: The volume of the Patient Set (after the air
detector) is 8mL | 0.3 mL |
| Occlusion Detection
Principle | Fail safe piezo-resistive pressure sensor | Fail-safe piezo-resistive pressure sensor |
| Occlusion Detection Alarm
Limit | 132 PSI ± 17.4 PSI (9.1 bar ± 1.2 bar) | 8 bar ± 1 bar |
Table 1. Side-by-Side Comparison, System
7
8
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 |
9
| 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 |