(9 days)
No
The summary describes standard image viewing and measurement tools, with no mention of AI/ML terms or capabilities.
No
The device is described as an analytical software tool for reviewing and reporting medical images, providing measurement tools to support a physician's determination of a diagnosis, rather than directly treating a condition.
No
The device is described as an "analytical software tool" that "provides reproducible tools for the review and reporting of medical images." It allows for display and measurement of images, and states that "When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis." This indicates it aids in analysis and reporting, but the ultimate diagnosis is made by the physician, not the device itself.
Yes
The device is described as a "Software Option" and an "analytical software application" that runs on a computer screen and imports images from an MR system. There is no mention of accompanying hardware being part of the device itself.
Based on the provided information, the GE Delta Software Option for MRI is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GE Delta Software Option for MRI is an analytical software tool that processes and analyzes medical images obtained from an MR system. It provides tools for viewing, measuring, and reporting on these images.
- Input: The input is medical images, not biological samples.
- Output: The output is analysis and measurements derived from the images, intended to support a physician's interpretation and diagnosis.
While the software provides tools that can be "useful in supporting the determination of a diagnosis," this is based on the analysis of images, not on the analysis of biological samples. The software is a tool for interpreting imaging data, which is distinct from performing a diagnostic test on a biological specimen.
N/A
Intended Use / Indications for Use
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
Product codes
90 LNH
Device Description
The GE Delta Software Option for MRI is an analytical software application intended to review and analyze medical images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
The Delta Option was evaluated to the IEC60601-1-4, the Programmable Electrical Medical Systems standard, and IEC 60601-2-33 International medical equipment safety standard for Magnetic Resonance Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUL 2 2003
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).
- ldentification of Submitter . Larry A. Kroger, Ph.D.,
- Phone: . 262-544-3464
- 트 Fax: 262-548-4768
- I Date Prepared: May 28, 2003
- Identification of the Product ● GE Delta Software Option for MRI
Manufactured by: GE Medical Systems 3200 N Grandview Blvd. Waukesha, WI 53188
- Common Name Software Option for MRI
- . Classification Name Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
- Device Description The GE Delta Software Option for MRI is an analytical software application intended to review and analyze medical images.
- Indications for Use .
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
1
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
- . Comparison with Predicate
The Delta Option is substantially equivalent to the features in currently marketed MEDIS Medical Imaging Systems FLOW (K994282) and MEDIS Medical Imaging Systems MASS (K994283). Both predicate devices are currently distributed by GE: Medical Systems and manufactured by MEDIS.
Summary of Studies .
The Delta Option was evaluated to the IEC60601-1-4, the Programmable Electrical Medical Systems standard, and IEC 60601-2-33 International medical equipment safety standard for Magnetic Resonance Systems.
Conclusions .
It is the opinion of GE that the Delta Option for MRI does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of an eagle with three stripes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2003
GE Medical Systems % Mr. Heinz Joerg Steneberg Primary Third Party Reviewer TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K031927 Trade/Device Name: GE Delta Software Option for MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: June 19, 2003 Received: June 23, 2003
Dear Mr. Steneberg:
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.
3
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/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number (if known): _ Ko3 19 27
Device Name: GE Delta Software Option for MRI
Indications For Use:
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ↓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices510(k) Number