(27 days)
No
The description mentions a software change to add an optional GFR calculator, which is a standard medical calculation and does not indicate the use of AI or ML. There are no mentions of AI, DNN, or ML in the text.
No
The device administers contrast and flushing media for CT scanning and detects extravasations, which are diagnostic/supportive functions rather than therapeutic treatments.
No
The primary function of the device is for the administration of contrast and flushing media and for the detection of extravasations. While it adds an optional GFR calculator, this is explicitly stated to be an "additional screening tool" and does not affect the safety, efficacy, or indications for use of the system as an injector. It is not designed to diagnose a disease or condition.
No
The device description explicitly states it is a modification to an "Injector System," which is a hardware device. The software change is an optional calculator added to the remote control of this hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the administration of contrast and flushing media during CT scanning and the detection of extravasations. These are actions performed on the patient, not on a sample taken from the patient.
- Device Description: The description focuses on the injector system and an optional GFR calculator. While the GFR calculator uses patient data (presumably from a blood test, which is an IVD), the calculator itself is a tool for interpreting that data in the context of the injection procedure, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is procedural (administering substances) and safety-related (detecting extravasation).
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 and an optional calculator for glomerular filtration rate (GFR)
Product codes (comma separated list FDA assigned to the subject device)
JAK, DSB, IZQ
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.
Design: Syringe type injector, software controlled, venous side, low pressure injector.
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
Delivery Volume: 1 to 200 mL in user specified increments of 1 mL. Accuracy: ±2% of programmed volume +1ml)
Maximum Pressure: 40 to 300 psi in user specified increments of 1 psi. Accuracy: ±10% of programmed pressure limit + 10 psi
Pressure Limiting: Yes
Operating Principle: Electric Motor Linear Actuated Syringe Piston
Power Supply: Medical Grade Switching Power Supply
Remote Start Switch: Yes
Air Detection: User Observed
Display: Color Touch screen
Maximum Number of Injection Phases per Protocol: 8 Contrast and Saline (CTA) 8 Contrast (CT)
Maximum Number of Stored Injection Protocols: 50
Programmed Pause: Yes
Connectivity: Yes either via a CT Trigger port or via a data communication method.
Special Feature: Optional GFR Calculator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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.
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.
K961845, K974621, K933846, K041178
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
§ 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
K071378
:
EmpowerCT/EmpowerCTA Injector System Special 510(k) Summary
. . .
..
| Contact Information: | Tracey Campbell
E-Z-EM, Inc.
Director - Regulatory Affairs
1111 Marcus Avenue, suite LL-26
Lake Success, NY 11042
Phone: 516-333-8230, ext. 3407
Fax: 516-302-2911
JUN 1 3 2007 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Steven Hartman
E-Z-EM, Inc.
Director - 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: | EmpowerCTA Injector System (K031571) (K063029)
EmpowerCT Injector System (K011160) (K063029) |
| 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 and an
optional calculator for glomerular filtration rate (GFR) |
1
Description of Modification:
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.
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:
2
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 Devices
E-Z-EM EmpowerCT and
EmpowerCTA Injector with
optional GFR Calculator | Currently marketed
devices
E-Z-EM EmpowerCT
(K011160)(K063029) and
EmpowerCTA Injector
(K031571)(K063029) |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 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 | Same as Proposed |
| | Accuracy: ±5% of programmed rate
+0.1 mL/sec | |
| Delivery Volume | 1 to 200 mL in user specified
increments of 1 mL | Same as Proposed |
| | Accuracy: ±2% of programmed
volume +1ml) | |
| Maximum Pressure | 40 to 300 psi in user specified
increments of 1 psi | Same as proposed |
| | Accuracy: ±10% of programmed
pressure limit + 10 psi | |
| Pressure Limiting | Yes | Same as Proposed |
| 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 | Same as Proposed |
| Air Detection | User Observed | Same as Proposed |
| Display | Color Touch screen | Same as Proposed |
| Maximum Number of Injection
Phases per Protocol | 8 Contrast and Saline (CTA)
8 Contrast (CT) | Same as Proposed |
| Maximum Number of Stored
Injection Protocols | 50 | Same as Proposed |
| Programmed Pause | Yes | Same as Proposed |
| Connectivity | Yes either via a CT Trigger port or
via a data communication method. | Same as Proposed |
| Special Feature | Optional GFR Calculator | No |
| Target Population | Humans | Same as Proposed |
3
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.
4
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
5
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
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