AUTOBONE2

K061625 · GE Healthcare · JAK · Jun 26, 2006 · Radiology

Device Facts

• Record ID: K061625
• Device Name: AUTOBONE2
• Applicant: GE Healthcare
• Product Code: JAK · Radiology
• Decision Date: Jun 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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.

Device Story

AutoBone 2 is an optional software extension for the GE Advantage Workstation; it processes abdominal and extremity CT Angiography data. The software facilitates the visualization of vessel features and assists in the segmentation of bony and calcified structures. It is intended for use by clinicians to aid in image analysis. By automating or assisting in the segmentation process, the device helps healthcare providers identify and isolate relevant anatomical structures, potentially improving the efficiency of clinical decision-making and diagnostic workflows.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by software development, validation, and verification processes to ensure performance to specifications and adherence to industry standards.

Technological Characteristics

Software-based application; extension of Volume Viewer for Advantage Workstation. Functions as an accessory to a Computed Tomography system (21 CFR 892.1750).

Indications for Use

Indicated for facilitating segmentation of bony structures and calcifications from abdominal and extremity CT Angiography data.

Regulatory Classification

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.

Predicate Devices

• AutoBone (K031871)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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.

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### 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.

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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.

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oting Public .

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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 [phone] or [phone]

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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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