(30 days)
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.
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.
This document is a 510(k) premarket notification for the E-Z-EM EmpowerCTA Injector System with Optional EDA. It demonstrates substantial equivalence to a predicate device, the E-Z-EM EmpowerCT Injector System (K011160). It is not a study report for an AI/ML device evaluating acceptance criteria through a clinical trial with human readers or AI standalone performance. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not applicable.
However, I can extract information related to the device's technical specifications and how its performance is compared to the predicate device to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a device modification and not an AI/ML device with clinical performance endpoints, "acceptance criteria" here refers to the performance specifications demonstrating substantial equivalence to the predicate device. The document explicitly outlines the performance characteristics of the proposed device and compares them to the predicate.
| Feature | Acceptance Criteria (Predicate Device K011160) | Reported Device Performance (EmpowerCTA Injector System) |
|---|---|---|
| Injector Performance | ||
| Flow Rate | 0.1 to 10 ml/sec in 0.1 ml/sec increments; Accuracy: ±5% of programmed rate +0.1 ml/sec | 0.1 to 10 ml/sec in 0.1 ml/sec increments; Accuracy: ±5% of programmed rate +0.1 ml/sec |
| Delivery Volume | 1 to 200 ml in 1 ml increments; Accuracy: ±2% of programmed volume +1ml | 1 to 200 ml in 1 ml increments; Accuracy: ±2% of programmed volume +1ml |
| Maximum Pressure | 20 to 300 psi in 1 psi increments; Accuracy: ±10% of programmed pressure limit +10 psi | 50 to 300 psi in 1 psi increments; Accuracy: ±10% of programmed pressure limit +10 psi |
| Pressure Limiting | Yes | Yes |
| EDA Performance | ||
| Bio-Impedance Sensing Range | Range: 10 to 250 Ohm; Resolution: 1/3 Ohm; Accuracy: +/-10%; Endpoints calibrated to 10 Ohm +10% -0% and 250 Ohm -10% +0% | Range: 10 to 250 Ohm; Resolution: 1/3 Ohm; Accuracy: +/-10%; Endpoints calibrated to 10 Ohm +10% -0% and 250 Ohm -10% +0% |
| Indicated Extravasation Detection Threshold | 20 ml | 20 ml |
| Power Supply | Switching Power Supply in Dedicated Enclosure | Switching Power Supply in Dedicated Enclosure |
| Display (Injector Head) | 240 x 180 Pixel Electroluminescent Display | 240 x 180 Pixel Electroluminescent Display |
| Display (Remote Control) | 800 x 600 Color TFT LCD with Touchscreen Overlay | 800 x 600 Color TFT LCD with Touchscreen Overlay |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a 510(k) submission for a medical device injector system, not an AI/ML diagnostic or prognostic device that typically relies on clinical test sets with patient data. The "testing" referred to here is primarily engineering verification and validation against technical specifications and predicate device performance, not a clinical study on a patient population.
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 is not applicable. Ground truth, in the context of clinical expert consensus for image interpretation or diagnosis, is not relevant for this device's 510(k) submission. The device performs automated contrast injection and extravasation detection, not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This 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 is not applicable. This document describes an automated medical device (contrast injector), not an AI-assisted diagnostic or treatment planning tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the AI/ML sense. The device itself operates "standalone" in its function of injecting contrast and detecting extravasation, but it is not an algorithm making diagnostic decisions. It performs physical and electronic functions. Performance is confirmed through engineering tests, not a "standalone algorithm" evaluation against ground truth in a clinical dataset.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, "ground truth" would relate to the accurate measurement of physical parameters like flow rate, volume, pressure, and bio-impedance, as well as the reliable detection of simulated extravasation events in a laboratory setting. This would be established by controlled experimental setups and validated measurement equipment, rather than clinical expert consensus or pathology. The document implies that the device's performance characteristics match those of the predicate, which would have undergone similar engineering validation.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML model that undergoes "training" on a dataset in the traditional sense. It is a control system with specific algorithms for injection and detection, likely developed through engineering design, mathematical modeling, and empirical testing.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of AI/ML for this device.
{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
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 nonionicand ionic compounds andflushing media in conjunctionwith computed tomography(CT) scanning of the body | Administration ofnonionic and ioniccompounds inconjunction withcomputed tomography(CT) scanning of thebody |
| Design | Syringe type injector,software controlled, venousside, low pressure injector. | Same |
| Anatomical Sites | Inject contrast and flushingmedia into a peripheral vein | Inject contrast media intoa peripheral vein |
| Radiation | No ionizing radiation emitted | Same |
| Thermal | No thermal energy introducedinto patient | Same |
.
:
:
:
E-Z-EM EmpowerCTA 510(k) Submission Summary Page 2 of 9
{5}------------------------------------------------
| Proposed DeviceEmpowerCTA Injector | Predicate DeviceEmpowerCT Injector(Percupump 2001) | |
|---|---|---|
| Injector Head | Located Adjacent to CT ScannerGantry via Floor or OverheadMounting | Same |
| Power Supply | Switching Power Supply inDedicated Enclosure | Switching Power Supplyin Dedicated Enclosure |
| Remote Control | Located Adjacent to CT ScannerConsole via Table or WallMounting | Same |
| EDA (ExtravasationDetection Accessory) | Located in Dedicated Enclosuremounted to same Floor orOverhead Mounting as InjectorHead | Same |
| Pendant | Dedicated Single Button,Start/Pause connected to InjectorHead and/or Remote | Same |
| Proposed DeviceEmpowerCTA Injector | Predicate DeviceEmpowerCT Injector(Percupump 2001) | |
|---|---|---|
| Syringe | Existing 200 ml, Proprietary E-Z-EMInterface (Catalog No. 6720) | Same |
| EDA Electrode Patch | Existing Proprietary E-Z-EMElectrode 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 specifiedincrements of 0.1 ml/secAccuracy: ±5% of programmedrate +0.1 ml/sec | 0.1 to 10 ml/sec in userspecified increments of0.1 ml/secAccuracy: ±5% ofprogrammed rate +0.1ml/sec) |
| Delivery Volume | 1 to 200 ml in user specifiedincrements of 1 mlAccuracy: ±2% of programmedvolume +1ml) | 1 to 200 ml in userspecified increments of 1mlAccuracy: ±2% ofprogrammed volume+1ml |
| Maximum Pressure | 50 to 300 psi in user specifiedincrements of 1 psiAccuracy: ±10% of programmedpressure limit + 10 psi) | 20 to 300 psi in userspecified increments of 1psiAccuracy: ±10% ofprogrammed pressurelimit + 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 250Resolution: 1/3 OhmAccuracy: +/-10%Endpoints calibrated to 10 Ohm+10% -0% and250 Ohm -10% +0% | Same |
| Indicated ExtravasationDetection Threshold | 20 ml | Same |
E-Z-EM EmpowerCTA 510(k) Submission Summary Page 5 of 9
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
{8}------------------------------------------------
| Proposed Device | Predicate Device | |
|---|---|---|
| EnvironmentalRequirements | EmpowerCTA Injector | EmpowerCT Injector(Percupump 2001) |
| Operating TemperatureOperating Humidity,Operating Altitude &Storage Temperature | Meets Requirements set forth inIEC/EN60601-1, MedicalElectrical Equipment Part 1:General Requirements for Safety | Same |
| ElectromagneticCompatibility (EMC) | Meets Requirements set forth inIEC/EN 60601-1-2, Medical ElectricalEquipment Part 1: Collateral Standard,Electromagnetic CompatibilityCISPR 11 (EN55011: 1998/1999)IEC 60601-1-2: 1993/2001EN61000-4-2: 1995EN61000-4-3: 1996EN61000-4-4: 1995EN61000-4-5: 1995EN61000-4-6: 1996EN61000-4-8: 1993EN61000-4-11: 1994 | Meets Requirements set forth in IEC/EN60601-1-2, Medical Electrical EquipmentPart 1: Collateral Standard,Electromagnetic CompatibilityCISPR 11IEC 801-2IEC 801-3IEC 801-4IEC 801-5 |
| UL/CSA | Medical Device Listing to UL2601-1 / CSA C22.2 No. 601.1,Electrical Class II, Type B Isolationrating, Injector, Type CF, Isolationrating, EDA | Same |
| Energy Requirements | 100/240 VAC 50/60 HzAuto 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 HeadDisplays andControls | Proposed DeviceEmpowerCTA Injector | Predicate DeviceEmpowerCT Injector(PercuPump 2001) |
|---|---|---|
| Display | 240 x 180 PixelElectrolumenescent Display | Same |
| Syringe AdvanceSlow | Membrane Key | Same |
| Syringe AdvanceFast | Membrane Key | Same |
| Syringe RetractSlow | 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 HeadDisplays 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 DriveMechanism | Same |
| Syringe Warmer | Snap On | Same |
| IlluminatedStop/Arm/Run/Pause StatusIndicator | LED | LED |
E-Z-EM EmpowerCTA 510(k) Submission Summary Page 7 of 9
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
61
{10}------------------------------------------------
E-Z-EM EmpowerCTA 510(k) Submission Summary Page 8 of 9
:
62
:
:
{11}------------------------------------------------
| Proposed Device | Predicate Device | |
|---|---|---|
| Remote ControlDisplay andControls | EmpowerCTA Injector | EmpowerCT Injector(PercuPump 2001) |
| Display | 800 x 600 Color TFT LCDwith Touchscreen Overlay | 800 x 600 Color TFTLCDwith TouchscreenOverlay |
| Maximum Number ofInjection Phases perProtocol | 8 (Contrast Only)or2 (1 Contrast followed by 1Saline)or3 (2 Contrast followed by 1Saline) | 8 |
| Maximum Number ofStored InjectionProtocols | 50 | 50 |
| Programmed Pause | Yes | Yes |
| External CT TriggerPort | Yes | Yes |
| Audio Speaker | Yes | Yes |
| EDA Display andControls | Proposed Device | Predicate Device |
|---|---|---|
| EDA Display andControls | EmpowerCTA Injector | EmpowerCT Injector(PercuPump 2001) |
| Display | EDA Function Supportedwithin Remote Control Displayand Touchscreen Field | Same |
and the comments of the country of
E-Z-EM EmpowerCTA 510(k) Submission Summary
Page 9 of 9
§ 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.