(14 days)
Not Found
No
The description focuses on a communication protocol and hardware interface for synchronizing a CT scanner and an injector, with no mention of AI or ML capabilities.
No
The device is described as a "communication protocol and bus interface" that allows a CT system to communicate and synchronize with a compatible injector. It facilitates the use of a separate, 510(k) cleared injector, but it does not directly perform any therapeutic function itself.
No
Explanation: The device is described as a communication protocol and bus interface designed to synchronize a CT scanner with a compatible injector for contrast-enhanced CT imaging. It does not perform image analysis, diagnosis, or provide information for diagnosis of a disease or condition.
No
The device description explicitly states that the GE Xtream Injector Option is a "software and hardware option" and requires "software and hardware components" to be added to GE CT scanners.
Based on the provided text, the GE Xtream Injector Option is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE Xtream Injector Option's intended use and description clearly state that its purpose is to facilitate contrast-enhanced CT imaging by providing a communication interface between a CT scanner and a compatible injector. It synchronizes the start of the scan and the injection.
- No Specimen Analysis: The device does not analyze any biological specimens. It is a hardware and software option that enables communication and synchronization between two medical devices (CT scanner and injector).
Therefore, the GE Xtream Injector Option falls under the category of a medical device used in conjunction with imaging, but it is not an IVD.
N/A
Intended Use / Indications for Use
The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT system with a compatible injector. When used, it allows the user to synchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CiA425 standard, and allows approved injectors to operate with certain GE Healthcare CT scanners that have the modified software and hardware interface required for the CiA425 communication protocol. This device is only the communication protocol and bus interface needed to communicate with a 510(k) cleared Injector that is compatible with the CiA425 standard.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The GE Xtream Injector Option is a software and hardware option that is based on the CANopen Injector Interface Standard (CiA 425). The CANopen communication protocol allows integration and synchronization of the CT system with the iniector. This option is an extension to the functionality of the existing GE CT systems and is designed to facilitate contrast-enhanced CT imaging by connecting the CT system and a 510(k) cleared compatible injector. The addition of this option to a GE CT Scanner simply implements an interface between the CT scanner and the injector following the defined communication standard. By utilizing this design standard, it will allow the Xtream Injector to operate any 510(k) cleared Injector that is compatible the CiA 425 standard. This option is being developed to be compatible with multiple GE CT scanners by adding the software and hardware components. As the software is integrated and verification is completed on the GE CT systems, a commercial introduction plan will be determined including appropriate Pre-Market Notifications for the CT systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
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.
Toshiba Injector Synchronization Option (K061976), Siemens CARE CONTRAST CT (K043087)
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
§ 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
KOR29iO
OCT 1 7 2008
GE Healthcare
3000 N. Grandview Blvd. W-706
Waukesha, WI 53188
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
Submitter:
| Name: | GE Medical Systems, LLC (GE Healthcare) |
|---|---|
| Address: | 3000 N. Grandview Blvd., W-1140 |
| Waukesha, WI 53188 | |
| Contact: | Steven Kachelmeyer |
| Pre-Market Regulatory Affairs Program Manager | |
| Tel: 262-548-2432, Fax: 262-997-1080 | |
| e-mail: steven.kachelmeyer@med.ge.com | |
| Date Prepared: | August 11, 2008 |
PRODUCT IDENTIFICATION
| Name: | GE Xtream Injector Option |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| 21CFR892.1750, 90-JAK | |
| Manufacturer: | GE Yokogawa Medical Systems |
| 7-127 asahigaoka 4-chome | |
| Hino-shi, Tokyo, Japan 191-8503 | |
| Future Production may also be accomplished at one of our | |
| other registered CT Manufacturing facilities. | |
| Distributor: | GE Medical Systems, LLC (GE Healthcare) |
| 3000 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Marketed Devices: | The GE Xtream Injector Option is of a comparable type and |
| substantially equivalent to currently marketed Toshiba | |
| Injector Synchronization Option (K061976), and Siemens | |
| CARE CONTRAST CT (K043087) and complies with the | |
| same or equivalent standards and have similar intended | |
| uses. |
1
Predicate Device(s):
Toshiba Injector Synchronization Option (K061976) Siemens CARE CONTRAST CT (K043087)
DEVICE DESCRIPTION
The GE Xtream Injector Option is a software and hardware option that is based on the CANopen Injector Interface Standard (CiA 425). The CANopen communication protocol allows integration and synchronization of the CT system with the iniector. This option is an extension to the functionality of the existing GE CT systems and is designed to facilitate contrast-enhanced CT imaging by connecting the CT system and a 510(k) cleared compatible injector. The addition of this option to a GE CT Scanner simply implements an interface between the CT scanner and the injector following the defined communication standard. By utilizing this design standard, it will allow the Xtream Injector to operate any 510(k) cleared Injector that is compatible the CiA 425 standard. This option is being developed to be compatible with multiple GE CT scanners by adding the software and hardware components. As the software is integrated and verification is completed on the GE CT systems, a commercial introduction plan will be determined including appropriate Pre-Market Notifications for the CT systems.
Indications for Use:
The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT svstem with a compatible iniector. When used, it allows the user to svnchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CiA425 standard, and allows approved injectors to operate with certain GE Healthcare CT scanners that have the modified software and hardware interface required for the CiA425 communication protocol. This device is only the communication protocol and bus interface needed to communicate with a 510(k) cleared Injector that is compatible with the CiA425 standard.
Comparison with Predicate:
The GE Xtream Injector Option follows the same design standard as the Toshiba Iniector Synchronization Option (K061976) and Siemens CARE CONTRAST CT (K043087). The GE Xtream Injector Option uses similar operating principle as the Toshiba Injector Synchronization Option and the Siemens CARE CONTRAST CT, and is following the same design standard, as well as having similar indications for use. We believe the GE Xtream Injector Option is of comparable type and substantially equivalent to the currently marketed system listed above and complies with the same or equivalent standards and have the same intended uses.
2
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analysis) and controlled by:
- System verification and validation to ensure performance to specifications, . Federal Regulations, and user requirements.
- Adherence and certification to industry and international standards. (UL/CSA and . IEC).
The device is designed and manufactured under the Quality System Regulations of 21CFR820.
Conclusions:
The GE Xtream Injector Option is an evolutionary modification to our existing cleared CT systems. It does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the GE Xtream Injector Option to be equivalent to other marketed devices with similar indications for use and meeting similar standards.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
GE Medical Systems, LLC % Mr. Daniel Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K082960
Trade/Device Name: GE Xtream Injector Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 2, 2008 Received: October 3, 2008
Dear Mr. Lehtonen:
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 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.
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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
Joque M. Whang
Joyce M. Whang, Ph.D. Acting 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 (if known):
Device Name: GE Xtream Injector Option
Indications for Use:
The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT system with a compatible injector. When used, it allows the user to synchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CiA425 standard, and allows approved injectors to operate with certain GE Healthcare CT scanners that have the modified software and hardware interface required for the CiA425 communication protocol. This device is only the communication protocol and bus interface needed to communicate with a 510(k) cleared Injector that is compatible with the CiA425 standard.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
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