CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

K151048 · Bracco Injeneering · IZQ · Jan 22, 2016 · Cardiovascular

Device Facts

• Record ID: K151048
• Device Name: CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
• Applicant: Bracco Injeneering
• Product Code: IZQ · Cardiovascular
• Decision Date: Jan 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

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 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.

Device Story

System provides controlled, automatic venous administration of contrast media and saline for CT imaging. Operates via rotary peristaltic pump within disposable Patient Set; generates positive pressure for fluid delivery. Includes injector unit, control panels, hand switch, and disposables (Bottle Spike, Day Set III HP, Patient Set). Used in radiological procedure rooms by trained healthcare professionals. Sensors detect air and pressure to protect patients. Larger tubing diameter in Day Set III HP reduces fluid resistance compared to predicate. Output is automated fluid delivery; healthcare providers monitor via control panel interface. Benefits include precise, automated contrast administration and enhanced programming flexibility for injection phases.

Clinical Evidence

No clinical studies performed. Evidence based on bench testing and simulated use usability assessments. Bench testing verified electrical safety, electromagnetic compatibility, software validation, injection volume/flow rate accuracy, air detection, and occlusion detection. Biocompatibility testing performed on disposables. Usability testing confirmed safe and effective operation comparable to predicate.

Technological Characteristics

Rotary peristaltic pump; piezo-resistive pressure sensor for occlusion; ultrasound sensor for air detection. Materials include PVC tubing. Interface: Color LCD touchscreen. Connectivity: Standalone system with remote control panel. Power: 110-120V AC. Disposables: Single-patient use Patient Set, multi-patient Day Set III HP, single-use Bottle Spike. Sterilization: Not specified.

Indications for Use

Indicated for human subjects undergoing CT scanner examinations requiring venous administration of contrast media and saline. Specifically for delivery of Isovue (Iopamidol Injection) via Imaging Bulk Package (IBP). Contraindicated for use outside of licensed healthcare facilities or without quasi-continuous supervision by trained professionals.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• CT Exprés III™ Contrast Media Delivery System (K062265)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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)

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#### 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: | [phone] |
| 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.

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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

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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/Indications<br>for Use | The CT Exprès™ 3D Contrast Media Delivery<br>System is indicated for the controlled automatic<br>administration, on the venous side, of contrast media<br>and saline, to human subjects while undergoing<br>examination by means of a computed tomography<br>(CT) scanner.<br><br>The CT Exprès™ 3D Contrast Media Delivery<br>System is specifically indicated for use in CT<br>procedures for the delivery of Isovue (Iopamidol<br>Injection) contrast media as supplied in an Imaging<br>Bulk Package (IBP), for a maximum of 20 bottles of<br>contrast media or a maximum of ten (10) hours,<br>whichever comes first, per Day Set III HP<br>disposable. The Bottle Spike disposable is for<br>single-bottle use only and must be discarded with the<br>contrast media bottle. The Patient Set disposable<br>must be discarded after each patient procedure.<br><br>The CT Exprès™ 3D is to be used only by and under<br>quasi-continuous supervision of trained health care<br>professionals in an appropriate licensed health care<br>facility, in a room designated for radiological<br>procedures that involve intravascular administration<br>of a contrast agent. | The CT Exprés III™ Contrast Media Delivery<br>System (CMDS) is indicated for controlled<br>automatic administration, on the venous side, of<br>contrast media (CM) to human subjects while<br>undergoing examination by means of computed<br>tomography (CT) scanner.<br><br>The system consists of the CT Exprés III™<br>Instrument, the Bottle Spike, the Day Set III, the<br>Patient Set, accessories and detachable parts.<br><br>This device is not intended for injection of CM<br>for coronary arteriography, or for any other use<br>for which the device is not indicated. This<br>device is only to be operated by and under quasi-<br>continuous supervision of qualified medical staff<br>in an appropriate licensed health care facility. |
| System Components | | |
| System | CT Exprès Injector Unit<br>CT Exprès Control Panel | CT Exprés III Injector Unit<br>CT Exprés III Control Panel |
| Accessories | CT Exprès Hand Switch<br>CT Exprès Bottle Insulator<br>CT Exprès Stand | CT Exprés III Hand Switch<br>CT Exprés III Bottle Insulator<br>CT Exprés III Pedestal Pole and Wheel Base<br>CT Exprés III Printer (Optional) |
| Disposables | CT Exprès Day Set III HP<br>CT Exprès Patient Set<br>CT Exprès Bottle Spike Type B (25mm) | CT Exprés Day Set III<br>CT Exprés Patient Set<br>CT Exprés Bottle Spike Type A (30mm)<br>CT Exprés Bottle Spike Type B (25mm) |
| Physical Design | | |
| Weight | Injector: Approx. 10 kg<br>Console: Approx. 2.1 kg | Injector: Approx. 10kg<br>Console: Approx. 1.7kg |
| Dimensions | Injector: 44 x 32 x 16 cm<br>Console: 30 x 20 x 22 cm | Injector: 44 x 32 x 16 cm<br>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:<br>Type:<br>Resolution: | Colour LCD with touch screen<br>800 x 600 pixel | VFD display with hard button technology |
| Technology: | TFT (Thin Film Transistor) | |
| Characteristic | | |
| Remote operation | Yes | Yes |
| Single patient use<br>disposable | Patient Set | Patient Set |
| Designed to prevent reuse<br>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<br>System | Subject Device<br>CT Exprès™ 3D | Predicate<br>CT Exprés III™ |
| | up to 3 injections per patient) | injections per patient) |
| Injection rates for contrast<br>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<br>injection | 10 – 200mL per injection | 0 – 200 mL |
| Flow rate and Volume<br>accuracy | ± 10% for a programmed injection volume between<br>10mL and 59mL<br>± 6% for a programmed injection volume between<br>60mL and 200mL | ± 6% |
| Contrast media container<br>volume | 200 & 500mL | 50 – 500 mL |
| Saline flush | Yes…