(38 days)
No
The description focuses on image synchronization with respiratory signals and user-driven phase selection, with no mention of AI/ML terms or processes.
No
The device is used for image acquisition and processing for evaluation of respiration-induced motion and target verification, not for treating any medical condition or disease.
No
The device is described as a software/hardware option that provides and displays CT images for evaluating respiration-induced motion and verifying target/treatment volumes. It does not perform a diagnosis.
No
The device description explicitly states it is a "software / hardware option" and mentions synchronizing CT images with a "respiratory signal coming from external device," indicating a hardware component is involved.
Based on the provided information, the Advantage 4D device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Advantage 4D's Function: The description clearly states that Advantage 4D is a software/hardware option used with CT imaging. Its purpose is to process and display CT images of a patient's internal anatomy during breathing. It helps in evaluating respiration-induced motion, selecting optimal image phases, and verifying treatment volumes.
- No Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body. The device works directly with imaging data acquired from the patient.
Therefore, Advantage 4D falls under the category of medical imaging software/hardware, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Advantage 4D is a non-invasive software / hardware option that can be used to provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and group images by the phase selected. Advantage 4D can also be used for target or treatment volume (DICOM Radiation Therapy Structure Sets) verification
Product codes
90 JAK
Device Description
Advantage 4D enables a patient to be scanned on a CT with normal breathing. CT data are acquired and images are reconstructed without image artifacts due to organ and tissue motion. CT Images are synchronized with respiratory signal coming from external device and organ/tissue motion within the CT data reflecting both the organ motions and the chest motion. The user can then visually determine the optimum phase to perform volume imaging and post processing [quantification, contouring, segmentation. The respiratory phase identification is also provided. In addition. Advantage 4D has the capability to display DICOM Radiation Therapy Structure Sets and can be used for target or treatment volume verification. This new capability comes from features derived from Advantage Sim 6.0 (K021780).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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GE Medical Systems 3000 N. Grandview Blvd 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 requirements of 21 CFR Part 807.87(h).
Larry A. Kroger, Ph.D. Submitter Senior Regulatory Program Manager Telephone: (262) 544-3894, FAX: (262) 548-4768 Date Prepared: August 8, 2002
PRODUCT IDENTIFICATION
| Name: | Advantage 4D option | ||||
|---|---|---|---|---|---|
| Classification Name: | Accessory to Computed Tomography System | ||||
| Classification Panel | 892 - Radiology | ||||
| Classification | |||||
| Number: | 892.1750 | ||||
| Manufacturer : | GE Medical Systems | ||||
| 3000 N. Grandview Blvd | |||||
| Waukesha, WI 53188, USA | |||||
| Distributor: | General Electric Medical Systems, Milwaukee, WI | ||||
| Marketed Devices: | Option is substantially equivalent to: | ||||
| Model: Smart Breath Respiratory Compensation | |||||
| Manufacturer: General Electric Medical Systems | |||||
| 510(k) #: K022919 | |||||
| Option also incorporates features derived from: | |||||
| Model: Advantage Sim 6.0. | |||||
| Manufacturer: General Electric Medical Systems | |||||
| 510(k) #: K021780 |
Device Description:
Advantage 4D enables a patient to be scanned on a CT with normal breathing. CT data are acquired and images are reconstructed without image artifacts due to organ and tissue motion. CT Images are synchronized with respiratory signal coming from external device and organ/tissue motion within the CT data reflecting both the organ motions and the chest motion.
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K032915
Page 2 of 2
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K∅32915
GE Medical Systems 3000 N. Grandview Blvd Waukesha, WI 53188
The user can then visually determine the optimum phase to perform volume imaging and post processing [quantification, contouring, segmentation. The respiratory phase identification is also provided.
In addition. Advantage 4D has the capability to display DICOM Radiation Therapy Structure Sets and can be used for target or treatment volume verification. This new capability comes from features derived from Advantage Sim 6.0 (K021780).
Indications for Use:
Advantage 4D is a non-invasive software / hardware option that can be used to provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and group images by the phase selected. Advantage 4D can also be used for target or treatment volume (DICOM Radiation Therapy Structure Sets) verification
Comparison with Predicate:
This device will use a similar technology to that already used by GE Medical Systems in our cleared devices Smart Breath Respiratory Compensation (K022919) and Advantage Sim 6.0 (K021780). Fundamentally, this device will use the same phase selection process that is used in Smart Breath Respiratory Compensation to group images based on respiratory phase. In addition, Advantage 4D will have the ability to display reformat images through a Cine Phase Movie, and to overlay RTSS (Radiotherapy Structure Sets) contours over multiphase CT slices. These additional features are inherited from the viewer of Advantage Sim 6.0 (K021780). A more detailed comparison is included in Attachment C of this submission.
| Device Name | FDA Clearance Number |
|---|---|
| Smart Breath Respiratory Compensation | K022919 |
| Advantage Sim 6.0 | K021780 |
Adverse Effects on Health :
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.
Conclusions:
Advantage 4D Option does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features and technology of the Advantage 4D Option to be equivalent to those of Smart Breath Respiratory Compensation []K022919 and Advantage Sim 6.0 [K021780.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
GE Medical Systems % Mr. Juergen Welte Responsible Third Party TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K032915
Trade/Device Name: Advantage 4D Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 14, 2003 Received: October 15, 2003
Dear Mr. Welte:
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.
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.
3
Page 2
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 vours.
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
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GE Medical Systems 3000 N. Grandview Blvd Waukesha, W1 53188
STATEMENT OF INTENDED USE
510(k) Number (if known): Ka32915
Device Name: Advantage 4D
Indications For Use:
Advantage 4D is a non-invasive software / hardware option that can be used to provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and group images by the phase selected. Advantage 4D can also be used for target or treatment volume (DICOM Radiation Therapy Structure Sets) verification
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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
K032915
510(k) Number