(31 days)
No
The device description focuses on mechanical control of injection parameters (volume, flow rate, pressure) and does not mention any AI/ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device administers contrast and flushing media for diagnostic imaging (CT scans), it does not directly treat a disease or condition.
No
The device is an injector system for administering contrast and flushing media during CT scans, which aids in imaging, but it does not analyze or interpret data to diagnose conditions itself.
No
The device description explicitly states it consists of four hardware components: Injector, Remote Control, EDA, and Power Supply, and describes a motor-driven linear actuator mechanism.
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 "vascular administration of contrast and flushing media" to a patient during CT scanning. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside of a living organism, typically on biological samples).
- Device Description: The device is an "injection system" that delivers substances directly into the patient's bloodstream.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to facilitate imaging by delivering contrast agents.
Therefore, the EmpowerCTA and EmpowerCT Injector Systems are medical devices used in conjunction with imaging procedures, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EmpowerCTA Injector system is intended for the vascular administration of contrast and flushing media and the EmpowerCT Injector system is intended for vascular administration of contrast. Both injector systems are used in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner.
Product codes
JAK, DSB, IZQ
Device Description
The EmpowerCT and EmpowerCTA Injector Systems have been modified to allow for connection to a CT scanner. This connection will allow data and state information to be synchronized between the scanner and injector systems. The EmpowerCT and EmpowerCTA Injector Systems are currently marketed as injection systems that use one or two consumable syringe(s) to displace contrast media and flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.
The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.
Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.
Volume- Volume is selectable from 1 ml to 200 ml in 1 ml increments.
Flow Rate- Flow rates are selectable from 0.1 to 10 ml/sec in increments of 0.1ml/sec.
Pressure- Maximum syringe pressure is selectable from 40-300 psi in increments of 1 psi
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:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT)
Anatomical Site
body, peripheral vein
Indicated Patient Age Range
Humans
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.)
Flow Rate Accuracy: ±5% of programmed rate +0.1 mL/sec
Delivery Volume Accuracy: ±2% of programmed volume +1ml)
Maximum Pressure Accuracy: ±10% of programmed pressure limit + 10 psi
Predicate Device(s)
Reference Device(s)
K961845, K974621, K933846, K041178
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K0630229
:
1
EmpowerCT/EmpowerCTA Injector System Special 510(k) Summary
-,
:
ﺚ ..
| Contact Information: | Tracey Campbell
E-Z-EM, Inc.
Director of Regulatory Affairs
1111 Marcus Avenue, suite LL-26
Lake Success, NY 11042
Phone: 516-333-8230, ext. 3407
Fax: 516-302-2911 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV - 2 2006 |
| | Steven Hartman
E-Z-EM, Inc.
Director of Engineering
750 Summa Avenue
Westbury, NY 11590
Phone: 516-333-8230, ext. 2345
Fax: 516-333-2334 |
| Trade Name: | EmpowerCT and EmpowerCTA Injector Systems |
| Common Name: | Radiographic CT Injector for Contrast Medium, Automatic |
| Classification: | System, X-Ray, Tomography, Computed
Plethysmograph, Impedance
Cardiovascular/Radiology/Injector, Contrast medium,
Automatic
21 CFR 892.1750 (Product Code JAK)
21 CFR 870.2770 (Product Code DSB)
21 CFR 870.1650 (Product Code IZQ) |
| Currently Marketed
Devices: | E-Z-EM EmpowerCTA Injector System (K031571)
EmpowerCT Injector System (K011160) |
| New Indications for Use: | The EmpowerCTA Injector system is intended for the
vascular administration of contrast and flushing media and
the EmpowerCT Injector system is intended for vascular
administration of contrast. Both injector systems are used
in conjunction with computed tomography (CT) scanning of
the body with an optional interface to a CT scanner. |
| Description of
Modification: | The EmpowerCT and EmpowerCTA Injector Systems have
been modified to allow for connection to a CT scanner.
This connection will allow data and state information to be
synchronized between the scanner and injector systems.
The EmpowerCT and EmpowerCTA Injector Systems are
currently marketed as injection systems that use one or
two consumable syringe(s) to displace contrast media and |
1
flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.
The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.
Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.
| Volume- | Volume is selectable from 1 ml to 200 ml in 1 ml increments. |
|---|---|
| Flow Rate- | Flow rates are selectable from 0.1 to 10 ml/sec in increments of |
| 0.1ml/sec. | |
| Pressure- | Maximum syringe pressure is selectable from 40-300 psi in |
| increments of 1 psi |
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:
Comparative Summary:
In the proposed device modification, the EmpowerCT and EmpowerCTA Injectors in addition to having a CT Trigger option, will now have a mechanism to synchronize data and state information communication between the CT Injector System and the CT Scanner. The connectivity is the only modification being made to the EmpowerCT and EmpowerCTA Injector Systems.
2
A comparison between the proposed E-Z-EM EmpowerCTA and EmpowerCT Injector A companser botwoon the proposeeed Injector System devices are presented in the following tables.
| Performance (Injector) | Proposed Devices
E-Z-EM EmpowerCT and
EmpowerCTA Injector with
optional scanner interconnect | Currently marketed
devices
E-Z-EM EmpowerCT
(K011160) and
EmpowerCTA Injector
(K031571) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Design | Syringe type injector, software
controlled, venous side, low pressure
injector. | Same as Proposed |
| Anatomical Sites | Inject contrast and flushing media
into a peripheral vein | Same as Proposed |
| Flow Rate | 0.1 to 10 mL/sec in user specified
increments of 0.1 ml/sec
A Accuracy: ±5% of programmed
rate +0.1 mL/sec | Same as Proposed |
| Delivery Volume | 1 to 200 mL in user specified
increments of 1 mL
Accuracy: ±2% of programmed
volume +1ml) | Same as Proposed |
| Maximum Pressure | 40 to 300 psi in user specified
increments of 1 psi
Accuracy: ±10% of programmed
pressure limit + 10 psi | Same as proposed |
| Pressure Limiting | Yes | Yes |
| Operating Principle | Electric Motor Linear Actuated
Syringe Piston | Same as Proposed |
| Power Supply | Medical Grade Switching Power
Supply | Same as Proposed |
| Remote Start Switch | Yes | Yes |
| Air Detection | User Observed | Same as Proposed |
| Display | Color Touch screen | Same as Proposed |
| 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) | Same as Proposed |
| Maximum Number of Stored
Injection Protocols | 50 | Same as Proposed |
| Programmed Pause | Yes | Yes |
| Connectivity | Yes either via a CT Trigger port or
via a data communication method.
The data communication method
was developed in accordance with
the CAN-CIA specification DSP 425. | Yes via a CT Trigger port
only. |
| Target Population | Humans | Same as Proposed |
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV - 2 2006
Ms. Tracey Campbell Director, Regulatory Affairs E-Z-EM, Inc. 750 Summa Avenue WESTBURY NY 11590
Re: K063029
Trade/Device Name: E-Z-EM Empower CT/CTA Injector System with optional EDA Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Codes: JAK, DSB and IZQ Dated: September 29, 2006 Received: October 2, 2006
Dear Ms. Campbell:
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 circular logo with the text "1906-2006 FDA Centennial" inside. The logo is surrounded by a ring of stars. The text "FDA" is prominently displayed in the center of the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
Protecting and Promoting Public St
4
Page 2 ---
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" (21CFR 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 yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| Number: | K063029 |
|---|---|
| 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. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
| 510(k) Number | K063029 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use | |
|---|---|---|---|
| --------------------------------------- | --------------------------------------------- | ---- | ---------------------- |