Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical injection and detection of extravasation, with no mention of AI or ML terms or capabilities.

Therapeutic

No
The device is used for the administration of contrast and flushing media in conjunction with CT scanning, and for the detection of extravasations. It assists in diagnostic imaging procedures rather than directly treating a disease or medical condition.

Diagnostic

No

The device is a CT injector used for administering contrast and flushing media. Its accessory, EDA, is for detecting extravasations, not diagnosing medical conditions. While it aids in a diagnostic procedure (CT scan), the device itself does not perform diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "injection system that uses one or two consumable syringe(s) to displace contrast media and flushing media to the patient" and a "motor driven linear actuator controls displacement of the syringe piston." This indicates the device includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The EmpowerCTA Injector System is a device used to administer substances (contrast and flushing media) into a patient's body during a medical imaging procedure (CT scan). It is an in vivo device, meaning it interacts directly with the living body.
Intended Use: The intended use clearly states "Administration of contrast and flushing media" and "detection of extravasations of contrast media". These are actions performed on or within the patient, not tests performed on samples outside the body.

Therefore, based on the provided information, the EmpowerCTA Injector System is a medical device used for administering substances during a CT scan, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CT Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body.
EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

Product codes (comma separated list FDA assigned to the subject device)

74 IZQ, 90 JAK

Device Description

The EmpowerCTA Injector System is an injection system that uses one or two consumable syringe(s) to displace contrast media and flushing media to the patient. A motor driven linear actuator controls displacement of the syringe piston. This method of contrast injection is consistent with predicate devices from E-Z-EM for over 12 years. This new version of the EmpowerCT Injector family addresses the addition of a second syringe for the device for purposes of displacing flushing media.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

inject contrast and flushing media into a peripheral vein

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011160

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle head with three lines representing its feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Mr. Steven Hartman Senior Project Engineer, CT Products E-Z-EM, Inc. 717 Main Street WESTBURY NY 11590

Re: K031571

Trade/Device Name: E-Z-EM EmpowerCTA Injector System with Optional EDA Regulation Number: 21 CFR 870.1650 Regulation Name: Automatic contrast medium injector Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 74 IZQ and 90 JAK Dated: May 19, 2003 Received: May 22, 2003

Dear Mr. Hartman:

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.

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); 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.

1

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

هاء سه سه سه مسه

INDICATIONS FOR USE

510(k) Application:	Special 510(k) Device Modification
Device Name:	E-Z-EM EmpowerCTA Injector System with optional EDA
Indications for Use:
	CT Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body.
	EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	KC31571

Prescription Use (Per 21 CFR 801.109)	OR	Over-the-Counter Use
---------------------------------------	----	----------------------

.

3

JUN 1 9 2003

K031571

ECEMI

Visualize a healthier world

EmpowerCTA Injector System 510(k) Summary

Submitter's Information:

Telephone Number: Fax Number: Contact: Date Prepared:

Trade Name: Common Name: Classification Name:

Predicate Device:

E-Z-EM, Inc. 717 Main Street Westbury, NY 11590 (516) 333-8230, ext. 2345 (516) 333-8278 Steven Hartman, Senior Project Engineer, CT Injectors May 19, 2003

EmpowerCTA Injector System (Trademark Pending) CT Iniector Injector, Syringe, Extra-Luminal Plethysmograph, Impedance

EmpowerCT Injector System, K011160 (Internal Project Name, and Name Used in the 510(k) Application: E-Z-EM PercuPump 2001 CT Injector)

Indications for Use:

CT Injector: Administration of nonionic and ionic compounds and flushing media in conjunction with computed tomography (CT) scanning of the body.

The EDA is intended to detect extravasations of ionic and non-ionic contrast media during powered CT contrast injections.

Device Description:

The EmpowerCTA Injector System is an injection system that uses one or two consumable syringe(s) to displace contrast media and flushing media to the patient. A motor driven linear actuator controls displacement of the syringe piston. This method of contrast injection is consistent with predicate devices from E-Z-EM for over 12 years. This new version of the EmpowerCT Injector family addresses the addition of a second syringe for the device for purposes of displacing flushing media.

A summary of the device as compared to the predicate device is as follows:

E-Z-EM EmpowerCTA 510(k) Submission Summary Page 1 of 9

4

Comparative Summary Tables

	Proposed Device	Predicate Device
	EmpowerCTA Injector	EmpowerCT Injector
(PercuPump 2001)
Indication for Use	Administration of nonionic
and ionic compounds and
flushing media in conjunction
with computed tomography
(CT) scanning of the body	Administration of
nonionic and ionic
compounds in
conjunction with
computed tomography
(CT) scanning of the
body
Design	Syringe type injector,
software controlled, venous
side, low pressure injector.	Same
Anatomical Sites	Inject contrast and flushing
media into a peripheral vein	Inject contrast media into
a peripheral vein
Radiation	No ionizing radiation emitted	Same
Thermal	No thermal energy introduced
into patient	Same

.

:

E-Z-EM EmpowerCTA 510(k) Submission Summary Page 2 of 9

5

| | Proposed Device
EmpowerCTA Injector | Predicate Device
EmpowerCT Injector
(Percupump 2001) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Injector Head | Located Adjacent to CT Scanner
Gantry via Floor or Overhead
Mounting | Same |
| Power Supply | Switching Power Supply in
Dedicated Enclosure | Switching Power Supply
in Dedicated Enclosure |
| Remote Control | Located Adjacent to CT Scanner
Console via Table or Wall
Mounting | Same |
| EDA (Extravasation
Detection Accessory) | Located in Dedicated Enclosure
mounted to same Floor or
Overhead Mounting as Injector
Head | Same |
| Pendant | Dedicated Single Button,
Start/Pause connected to Injector
Head and/or Remote | Same |

| | Proposed Device
EmpowerCTA Injector | Predicate Device
EmpowerCT Injector
(Percupump 2001) |
|----------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------|
| Syringe | Existing 200 ml, Proprietary E-Z-EM
Interface (Catalog No. 6720) | Same |
| EDA Electrode Patch | Existing Proprietary E-Z-EM
Electrode Patch (Catalog No. 7881) | Same |
| EDA Patient Cable
(Semi-Disposable) | Existing Patient Cable (Catalog No.
9871) | Same |

E-Z-EM EmpowerCTA 510(k) Submission Summary
Page 3 of 9

6

	Proposed Device	Predicate Device
Performance
(Injector)	EmpowerCTA Injector	EmpowerCT Injector
(Percupump 2001)
Flow Rate	0.1 to 10 ml/sec in user specified
increments of 0.1 ml/sec
Accuracy: ±5% of programmed
rate +0.1 ml/sec	0.1 to 10 ml/sec in user
specified increments of
0.1 ml/sec
Accuracy: ±5% of
programmed rate +0.1
ml/sec)
Delivery Volume	1 to 200 ml in user specified
increments of 1 ml
Accuracy: ±2% of programmed
volume +1ml)	1 to 200 ml in user
specified increments of 1
ml
Accuracy: ±2% of
programmed volume
+1ml
Maximum Pressure	50 to 300 psi in user specified
increments of 1 psi
Accuracy: ±10% of programmed
pressure limit + 10 psi)	20 to 300 psi in user
specified increments of 1
psi
Accuracy: ±10% of
programmed pressure
limit + 10 psi)
Pressure Limiting	Yes	Yes

100 - 100 -

E-Z-EM EmpowerCTA 510(k) Submission Summary Page 4 of 9 .

7

	Proposed Device	Predicate Device
Performance (EDA)	EmpowerCTA Injector	EmpowerCT Injector
(Percupump 2001)
Bio-Impedance Sensing	Range: 10 to 250
Resolution: 1/3 Ohm
Accuracy: +/-10%
Endpoints calibrated to 10 Ohm
+10% -0% and
250 Ohm -10% +0%	Same
Indicated Extravasation
Detection Threshold	20 ml	Same

E-Z-EM EmpowerCTA 510(k) Submission Summary Page 5 of 9

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

	Proposed Device	Predicate Device
Environmental
Requirements	EmpowerCTA Injector	EmpowerCT Injector
(Percupump 2001)
Operating Temperature
Operating Humidity,
Operating Altitude &
Storage Temperature	Meets Requirements set forth in
IEC/EN60601-1, Medical
Electrical Equipment Part 1:
General Requirements for Safety	Same
Electromagnetic
Compatibility (EMC)	Meets Requirements set forth in
IEC/EN 60601-1-2, Medical Electrical
Equipment Part 1: Collateral Standard,
Electromagnetic Compatibility
CISPR 11 (EN55011: 1998/1999)
IEC 60601-1-2: 1993/2001
EN61000-4-2: 1995
EN61000-4-3: 1996
EN61000-4-4: 1995
EN61000-4-5: 1995
EN61000-4-6: 1996
EN61000-4-8: 1993
EN61000-4-11: 1994	Meets Requirements set forth in IEC/EN
60601-1-2, Medical Electrical Equipment
Part 1: Collateral Standard,
Electromagnetic Compatibility
CISPR 11
IEC 801-2
IEC 801-3
IEC 801-4
IEC 801-5
UL/CSA	Medical Device Listing to UL
2601-1 / CSA C22.2 No. 601.1,
Electrical Class II, Type B Isolation
rating, Injector, Type CF, Isolation
rating, EDA	Same
Energy Requirements	100/240 VAC 50/60 Hz
Auto Seeking	Same
Shock and Vibration	International Safe Transit Authority
(ISTA), Project 3C	Same

:

60

E-Z-EM EmpowerCTA 510(k) Submission Summary Page 6 of 9

・・・・・・・・・

9

| Injector Head
Displays and
Controls | Proposed Device
EmpowerCTA Injector | Predicate Device
EmpowerCT Injector
(PercuPump 2001) |
|-------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------|
| Display | 240 x 180 Pixel
Electrolumenescent Display | Same |
| Syringe Advance
Slow | Membrane Key | Same |
| Syringe Advance
Fast | Membrane Key | Same |
| Syringe Retract
Slow | Membrane Key | Same |
| Syringe Retract Fast | Membrane Key | Same |
| Auto Initialize | Membrane Key | Same |
| Replace Syringe | Membrane Key | Same |
| Test Injection | Membrane Key | Same |
| Auto-Fill | Membrane Key | Same |
| Begin Fill | Membrane Key | Same |
| | Proposed Device | Predicate Device |
| Injector Head
Displays and Controls
"Continued" | EmpowerCTA Injector | EmpowerCT Injector
(PercuPump 2001) |
| Increase Flow Rate | Membrane Key | Membrane Key |
| Decrease Flow Rate | Membrane Key | Membrane Key |
| Hand Knob | Direct Connection to Drive
Mechanism | Same |
| Syringe Warmer | Snap On | Same |
| Illuminated
Stop/Arm/Run/Pause Status
Indicator | LED | LED |

E-Z-EM EmpowerCTA 510(k) Submission Summary Page 7 of 9

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E-Z-EM EmpowerCTA 510(k) Submission Summary Page 8 of 9

:

62

:

11

	Proposed Device	Predicate Device
Remote Control
Display and
Controls	EmpowerCTA Injector	EmpowerCT Injector
(PercuPump 2001)
Display	800 x 600 Color TFT LCD
with Touchscreen Overlay	800 x 600 Color TFT
LCD
with Touchscreen
Overlay
Maximum Number of
Injection Phases per
Protocol	8 (Contrast Only)
or
2 (1 Contrast followed by 1
Saline)
or
3 (2 Contrast followed by 1
Saline)	8
Maximum Number of
Stored Injection
Protocols	50	50
Programmed Pause	Yes	Yes
External CT Trigger
Port	Yes	Yes
Audio Speaker	Yes	Yes

| EDA Display and

Controls	Proposed Device	Predicate Device
EDA Display and
Controls	EmpowerCTA Injector	EmpowerCT Injector
(PercuPump 2001)
Display	EDA Function Supported
within Remote Control Display
and Touchscreen Field	Same

and the comments of the country of

E-Z-EM EmpowerCTA 510(k) Submission Summary
Page 9 of 9