(3 days)
Not Found
No
The document describes image processing software for segmentation but does not mention AI, ML, or related terms like deep learning.
No.
The device facilitates image segmentation for visualization and analysis, which is not a direct therapeutic action.
No
The device description states it "facilitates visualization of vessel features and assists in segmentation of bony structures" and "is intended to facilitate segmentation of bony structures." This indicates it is an image processing tool to aid in visualization and segmentation, not to diagnose medical conditions or determine a patient's health status. It is a utility for image analysis, not a diagnostic decision-making tool itself.
Yes
The device is described as a "software package" and an "optional software extension" that runs on existing hardware (Advantage Workstations). There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device 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 AutoBone software processes medical images (CT Angiography data) to segment bony structures. It does not analyze biological samples from the body.
- Intended Use: The intended use is to facilitate the visualization and segmentation of bony structures from imaging data, which is a function related to medical imaging analysis, not in vitro testing.
Therefore, AutoBone falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AutoBone option is a software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. It runs on Advantage Workstations, revision 4.1 or higher.
Product codes
90 JAK
Device Description
AutoBone is an optional software extension of the Volume Viewer application for Advantage Workstation. This software can be used in order to facilitate visualization of vessel features and assist in segmentation of bony structures
Mentions image processing
AutoBone is an image analysis software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Angiography data
Anatomical Site
abdominal and extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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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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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters are white against a black background, and the frame is also black. The logo is simple and recognizable, representing the well-known multinational corporation.
Ko3 1871
GE Medical Systems
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).
| Submitter | Larry A. Kroger, Ph.D. |
|---|---|
| Senior Regulatory Programs Manager | |
| Telephone: (262) 544-3894 | |
| Fax: (262) 548-4768 | |
| GE Medical Systems W-400 | |
| 3000 North Grandview Blvd. | |
| Waukesha, WI 53188 USA | |
| Date Prepared: March 25, 2003. |
PRODUCT IDENTIFICATION
| Name: | AutoBone |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Manufacturer : | General Electric Medical Systems |
| 283, rue de la Minière | |
| 78533 Buc Cedex, FRANCE | |
| Distributor: | General Electric Medical Systems, Buc, France. |
| Marketed Devices | The AutoBone is substantially equivalent to the devices listed below: |
| Model: | |
| Manufacturer: | |
| 510(k) #: | Volume Rendering |
| General Electric Medical Systems, Milwaukee, WI | |
| K972399 | |
| Model: | |
| Manufacturer: | |
| 510(k) #: | Vitrea 2 |
| Vital Images | |
| K002519 |
Device Description:
AutoBone is an optional software extension of the Volume Viewer application for Advantage Workstation. This software can be used in order to facilitate visualization of vessel features and assist in segmentation of bony structures
1
Indications for Use:
The AutoBone option is a software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. It runs on Advantage Workstations, revision 4.1 or higher .
Comparison with Predicate:
AutoBone is an image analysis software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. The functional features of this package are substantially equivalent to that of the following devices:
| Device Name | FDA Clearance Number |
|---|---|
| Volume Rendering | K972399 |
| Vitrea 2 | K002519 |
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:
The AutoBone does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AutoBone to be equivalent to those of Volume Rendering (K972399) and Vitrea 2 ( K002519).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems % Mr. Wolfram Gmelin Third Party Reviewer TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K031871
JUN 2 0 2003
Trade/Device Name: AutoBone Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II
Product Code: 90 JAK Dated: May 5, 2003 Received: June 17, 2003
Dear Mr. Gmelin:
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.
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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 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
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Ko31871
Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, contrasting with the white background.
General Electric Medical Systems
STATEMENT OF INTENDED USE
Device name: AutoBone
Intended Use:
The AutoBone option is a software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. It runs on Advantage Workstations, revision 4.1 or higher
(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 _________________________________________________________________________________________________________________________________________________________
David R. Ingram
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devi 510(k) Numb