(14 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on segmentation facilitation without indicating advanced learning algorithms.
No
The device is a software package intended to facilitate segmentation of bony structures and calcifications from CT Angiography data, which is an imaging-related function, not a therapeutic one.
No
The device is described as software that facilitates segmentation and visualization of bony structures and calcifications, which is an image processing function rather than a diagnostic one. It assists in visualization and segmentation, but does not identify or diagnose a disease state.
Yes
The device is described as a "software package" and an "optional software extension" of an existing application, with no mention of accompanying hardware components. Its function is solely focused on processing and segmenting existing CT Angiography data.
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 description clearly states that AutoBone 2 is a software package that facilitates the segmentation of bony structures and calcifications from CT Angiography data. This is image processing and analysis of medical images, not a test performed on a biological sample.
- Intended Use: The intended use is to facilitate visualization and assist in segmentation of structures within medical images. This is a diagnostic imaging aid, not an in vitro diagnostic test.
Therefore, based on the provided text, AutoBone 2 falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AutoBone 2 option is a software package that is intended to facilitate segmentation of bony structures and calcifications from abdominal and extremity CT Angiography data.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
AutoBone 2 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 and calcified structures
Mentions image processing
Not Found
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
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)
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.
0
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has decorative swirls or flourishes around its perimeter, giving it a classic and recognizable appearance.
JUN 2 6 2006
GE Healthcare 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 Tel: (262) 544-3894 Fax: (262) 544-3202 GE Healthcare W-440 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 13, 2006
PRODUCT IDENTIFICATION
Name: AutoBone 2 Classification Name: Accessory to Computed Tomography System per 21 CFR 892-1750 Product code: JAK
Manufacturer: GE Medical Systems SCS 283, rue de la Minière 78533 Buc Cedex, FRANCE
Distributor: GE Healthcare, P.O. Box 414, Milwaukee, WI 53210
Marketed Devices The AutoBone 2 is substantially equivalent to the devices listed below:
- . Model: AutoBone , 510(k) # K031871 Manufacturer: . GE Medical Systems SCS, Buc, France
Device Description:
- AutoBone 2 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 and calcified structures
Indications for Use:
The AutoBone 2 option is a software package that is intended to facilitate segmentation of bony structures and calcifications from abdominal and extremity CT Angiography data.
1
Comparison with Predicate:
AutoBone 2 is substantially equivalent to the predicate devices listed below:
| Device Name | FDA Clearance Number |
|---|---|
| AutoBone | K031871 |
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:
AutoBone 2 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 2 to be equivalent to AutoBone.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is black and white.
JUN 2 6 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
GE Healthcare % Mr. Daniel W. Lehtonen Responsible Third Party Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K061625
Trade/Device Name: AutoBone 2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 9, 2006 Received: June 12, 2006
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 (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/2/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a stylized font, with the word "Centennial" underneath. Above the letters "FDA" are the numbers "1906 - 2006". The text around the circle reads "FOOD AND DRUG ADMINISTRATION * PROTECTING AND PROMOTING YOUR HEALTH *".
oting Public .
3
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 liusting (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 100-1050.
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 10(x) marketed predicate device results in a classification for your device and thus, perrorts 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). You may obtain other general information on your responsibilites 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 Cbrogdon
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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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. There are three decorative swirls equally spaced around the outside of the circle.
GE Healthcare
Indications for Use
510(k) number if known: K 6 6 / 1 6 2 / 6 2
Device name: AutoBone 2
Indications For Use:
The AutoBone 2 option is a software package that is intended to facilitate segmentation of bonv structures and calcifications from abdominal and extremity CT Angiography data.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
i fancy Carden
(Division Sign-Off) Division of Reproductive, AF and Radiological Devices 510(k) Number