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

Device Description

The EmpowerCT and EmpowerCTA Injector Systems have been modified for a software change only specific to the Empower Remote Control. They have been modified to add an optional calculator for glomerular filtration rate (GFR). This optional calculator is used as an additional screening tool for the use of a CT contrast injection in conjunction with a CT scan. This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system.

AI/ML Overview

The provided document describes a Special 510(k) submission for a software change to the EmpowerCT and EmpowerCTA Injector Systems, specifically adding an optional calculator for glomerular filtration rate (GFR). The core functionality of the injector systems (contrast and flushing media administration in CT scanning) remains unchanged.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a separate section for the GFR calculator. Instead, it focuses on demonstrating substantial equivalence to the predicate device, highlighting that the core injector performance metrics remain the same. The "Performance (Injector)" table compares the proposed device with the currently marketed device. Since the modification is only a software change for an optional GFR calculator, and "This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system," the implied acceptance criterion for the injector system performance is:

The performance of the injector system (flow rate, delivery volume, maximum pressure) must be identical to the predicate widely marketed device.

Performance (Injector) Parameter	Acceptance Criteria (Implied: Same as Predicate)	Reported Device Performance (Proposed Devices)
Design	Syringe type injector, software controlled, venous side, low pressure injector.	Syringe type injector, software controlled, venous side, low pressure injector.
Anatomical Sites	Inject contrast and flushing media into a peripheral vein.	Inject contrast and flushing media into a peripheral vein.
Flow Rate	0.1 to 10 mL/sec in user specified increments of 0.1 mL/sec.	0.1 to 10 mL/sec in user specified increments of 0.1 mL/sec.
Flow Rate Accuracy	±5% of programmed rate +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.	1 to 200 mL in user specified increments of 1 mL.
Delivery Volume Accuracy	±2% of programmed volume +1ml.	Accuracy: ±2% of programmed volume +1ml.
Maximum Pressure	40 to 300 psi in user specified increments of 1 psi.	40 to 300 psi in user specified increments of 1 psi.
Maximum Pressure Accuracy	±10% of programmed pressure limit + 10 psi.	Accuracy: ±10% of programmed pressure limit + 10 psi.
Pressure Limiting	Yes.	Yes.
Operating Principle	Electric Motor Linear Actuated Syringe Piston.	Electric Motor Linear Actuated Syringe Piston.
Power Supply	Medical Grade Switching Power Supply.	Medical Grade Switching Power Supply.
Remote Start Switch	Yes.	Yes.
Air Detection	User Observed.	User Observed.
Display	Color Touch screen.	Color Touch screen.
Max Number of Injection Phases	8 Contrast and Saline (CTA) / 8 Contrast (CT).	8 Contrast and Saline (CTA) / 8 Contrast (CT).
Max Number of Stored Protocols	50.	50.
Programmed Pause	Yes.	Yes.
Connectivity	Yes, either via a CT Trigger port or via a data communication method.	Yes, either via a CT Trigger port or via a data communication method.
Special Feature (GFR Calculator)	N/A (for predicate)	Optional GFR Calculator.
Target Population	Humans.	Humans.

For the GFR calculator itself: The document states, "This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system." This suggests that a specific clinical validation study for the GFR calculator's accuracy or impact on patient outcomes was not required for this 510(k) submission, as it's presented as an "optional calculator" that is an "additional screening tool" without affecting the device's fundamental function, safety, or efficacy. Therefore, there are no reported performance metrics for the GFR calculator and no specific acceptance criteria cited for it. The primary acceptance criterion for the overall device's performance is its equivalence to the predicate.

2. Sample size used for the test set and the data provenance:

The document describes a software modification to an existing injector system (adding a GFR calculator). It explicitly states that the modification "does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system."
There is no mention of a clinical test set or data for the GFR calculator or the injector system itself in the provided text. The submission relies on comparative data to predicate devices and likely non-clinical (e.g., software verification and validation, electrical safety, EMC testing, etc.) testing, which is not detailed in this summary for the GFR calculator. The core injector performance described above is based on the established performance of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a test set requiring expert-established ground truth within this summary.

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

Not applicable. There is no mention of a test set or adjudication process within this summary.

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:

Not applicable. This device is an injector system with an optional GFR calculator, not an AI-assisted diagnostic imaging tool that would typically undergo an MRMC study.

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

While the GFR calculator is an "algorithm only," the summary does not include any standalone performance study data (e.g., accuracy against a gold standard for GFR calculation) in terms of its output. The submission focuses on its nature as an "optional calculator" that does not impact the device's fundamental safety or efficacy.

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

Not applicable. The document does not describe studies that would require establishing a ground truth of this nature. The GFR calculator would typically use standard clinical formulas, but no validation against a ground truth for its accuracy is discussed here.

8. The sample size for the training set:

Not applicable. There is no mention of a training set, as the GFR calculator is likely based on established medical formulas, not a machine learning model trained on a dataset.

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

Not applicable. See point 8.

Summary

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K071378

EmpowerCT/EmpowerCTA Injector System Special 510(k) Summary

. . .

Contact Information:	Tracey CampbellE-Z-EM, Inc.Director - Regulatory Affairs1111 Marcus Avenue, suite LL-26Lake Success, NY 11042Phone: 516-333-8230, ext. 3407Fax: 516-302-2911JUN 1 3 2007
	Steven HartmanE-Z-EM, Inc.Director - Engineering750 Summa AvenueWestbury, NY 11590Phone: 516-333-8230, ext. 2345Fax: 516-333-2334
Trade Name:	EmpowerCT and EmpowerCTA Injector Systems
Common Name:	Radiographic CT Injector for Contrast Medium, Automatic
Classification:	System, X-Ray, Tomography, ComputedPlethysmograph, ImpedanceCardiovascular/Radiology/Injector, Contrast medium,Automatic21 CFR 892.1750 (Product Code JAK)21 CFR 870.2770 (Product Code DSB)21 CFR 870.1650 (Product Code IZQ)
Currently MarketedDevices:	EmpowerCTA Injector System (K031571) (K063029)EmpowerCT Injector System (K011160) (K063029)
New Indications for Use:	The EmpowerCTA Injector system is intended for thevascular administration of contrast and flushing media andthe EmpowerCT Injector system is intended for vascularadministration of contrast. Both injector systems are usedin conjunction with computed tomography (CT) scanning ofthe body with an optional interface to a CT scanner and anoptional calculator for glomerular filtration rate (GFR)

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Description of Modification:

Accessories:

There is no change to the accessories available with the CT or CTA Injector Systems.

The EmpowerCT is currently available with or without the E-Z-EM EDA . Device (K961845, K974621). The EmpowerCT Injector System is designed specifically for use with the following currently approved dedicated E-Z-EM disposables:
- . Fast*Load CT Syringe (K933846)
- EDA Electrode Patch (K961845, K974621) .
- Empower Transfer Set (K041178) .
- · The EmpowerCTA Injector System is also currently available with or without the E-Z-EM EDA device (K961845, K974621) The EmpowerCTA Injector System is designed specifically for use with the currently approved dedicated E-Z-EM disposables:
  - Fast*Load CT Syringe (K933846) ●
  - CTA Dual Pack (K933846 and K031571) .
  - EDA Electrode Patch (K961845, K974621) .
  - Empower Transfer Set (K041178) .
  - EmpowerCTA Connecting Tube (K031571)

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Comparative Summary:

A comparison between the proposed E-Z-EM EmpowerCTA and EmpowerCT Injector Systems against the currently marketed Injector System devices are presented in the following tables.

Performance (Injector)	Proposed DevicesE-Z-EM EmpowerCT andEmpowerCTA Injector withoptional GFR Calculator	Currently marketeddevicesE-Z-EM EmpowerCT(K011160)(K063029) andEmpowerCTA Injector(K031571)(K063029)
Design	Syringe type injector, softwarecontrolled, venous side, low pressureinjector.	Same as Proposed
Anatomical Sites	Inject contrast and flushing mediainto a peripheral vein	Same as Proposed
Flow Rate	0.1 to 10 mL/sec in user specifiedincrements of 0.1 mL/sec	Same as Proposed
	Accuracy: ±5% of programmed rate+0.1 mL/sec
Delivery Volume	1 to 200 mL in user specifiedincrements of 1 mL	Same as Proposed
	Accuracy: ±2% of programmedvolume +1ml)
Maximum Pressure	40 to 300 psi in user specifiedincrements of 1 psi	Same as proposed
	Accuracy: ±10% of programmedpressure limit + 10 psi
Pressure Limiting	Yes	Same as Proposed
Operating Principle	Electric Motor Linear ActuatedSyringe Piston	Same as Proposed
Power Supply	Medical Grade Switching PowerSupply	Same as Proposed
Remote Start Switch	Yes	Same as Proposed
Air Detection	User Observed	Same as Proposed
Display	Color Touch screen	Same as Proposed
Maximum Number of InjectionPhases per Protocol	8 Contrast and Saline (CTA)8 Contrast (CT)	Same as Proposed
Maximum Number of StoredInjection Protocols	50	Same as Proposed
Programmed Pause	Yes	Same as Proposed
Connectivity	Yes either via a CT Trigger port orvia a data communication method.	Same as Proposed
Special Feature	Optional GFR Calculator	No
Target Population	Humans	Same as Proposed

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three curved lines that resemble a bird in flight. The logo is black and white and appears to be of low resolution.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Steven Hartman Director Engineering E-Z-EM, Inc. 750 Summa Avenue WESTBURY NY 11590

机价1 3 2007

Re: K071378

Trade/Device Name: E-Z-EM EmpowerCT/CTA Injector System with Optional EDA Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II Product Code: JAK, DSB, and IZQ Dated: May 15, 2007 Received: May 17, 2007

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 (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The overall image appears to be a commemorative or celebratory design related to the FDA's centennial.

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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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its. toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C Hodgon

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

Enclosure

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INDICATIONS FOR USE

510(k) Number:	K071378
510(k) Application:	Special 510(k) Device Modification
Device Name:	E-Z-EM EmpowerCT/CTA Injector System with optional EDA
Indications for Use:
Injector:	Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner
EDA:	The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.
Prescription Use(Per 21 CFR 801.109)	(Yes)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓(Per 21 CFR 801.109)	OR Over-the-Counter Use
	(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K071378

EmpowerCT/CTA Injector System Special 510k Submission

Page 8 of 20

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.