OPTIMA CT660

K110227 · Ge Medical Systems, LLC · JAK · Jul 20, 2011 · Radiology

Device Facts

• Record ID: K110227
• Device Name: OPTIMA CT660
• Applicant: Ge Medical Systems, LLC
• Product Code: JAK · Radiology
• Decision Date: Jul 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Optima CT660 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Device Story

Multi-slice CT scanner system; includes gantry, patient table, operator console, PDU, and accessories. Inputs: X-ray transmission data. Processing: Computer reconstruction of data into cross-sectional images; includes optional ASiR advanced reconstruction technology. Outputs: Transaxial and reformatted images; post-processed analysis results. Used in clinical settings by trained medical professionals. Output assists clinicians in diagnosis of disease, trauma, or abnormality and in therapy planning, guidance, and monitoring. Benefits patients through diagnostic imaging capabilities.

Clinical Evidence

Bench testing only. Evidence includes module verification, system integration testing, performance testing, safety testing, and simulated use validation. Compliance with UL 60601-1, IEC 60601-1, and 21 CFR Subchapter J confirmed.

Technological Characteristics

Multi-slice CT scanner; gantry, table, console, PDU. Materials compliant with UL 60601-1 and IEC 60601-1. Employs X-ray transmission data acquisition and computer reconstruction. Includes optional ASiR (Adaptive Statistical Iterative Reconstruction) technology. Software-based image processing for transaxial/reformatted planes. Designed under 21 CFR 820 and ISO 13485.

Indications for Use

Indicated for head, whole body, cardiac, and vascular X-ray CT applications in patients of all ages for diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

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

• LightSpeed VCT (K082761)

Submission Summary (Full Text)

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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 letters are stylized and connected, creating a unique and recognizable design.

GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660

JUL 2 0 2011

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

Date:

May 3, 2011

Submitter:

GE Healthcare (GE Medical Systems, LLC) 3000 N. Grandview Blvd., W-1140 Waukesha, WI 53188

Primary Contact:

John Jaeckle Requlatory Affairs Manager MI & CT GE Healthcare (GE Medical Systems, LLC) Tel: [phone] e-mail: [e-mail]

Secondary Contact:

Tracey Ortiz Requlatory Affairs Leader MI & CT GE Healthcare (GE Medical Systems, LLC) Tel: [phone] Fax: [phone] e-mail: [e-mail]

Product Identification

Device Trade Name:

Common/Usual Name:

Computed Tomography X-ray System

Optima CT660

90-JAK

Classification Name:

Product Code:

Manufacturer: /Design Location: GE Healthcare Japan Corporation 7-127 Asahigaoka, 4-chome, Hino-shi Tokyo, 191-8503, Japan

Computed Tomography X-ray System per 21CFR 892.1750

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Image /page/1/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 frame has a swirling, decorative pattern around the letters. The logo is black and white.

GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660

Manufacturing Location(s): GE Healthcare Japan Corporation 7-127 Asahigaoka, 4-chome, Hino-shi Tokyo, 191-8503, Japan

> GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188

Distributor:

GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188

## Marketed Devices:

The Optima CT660 is of comparable type and substantially equivalent to GE Healthcare's currently marketed Computed Tomograhpy X-ray Systems that comply with the same standards. In addition, the system has similar indications for use as other GE Computed Tomograhpy X-ray Systems and identical indications as the unmodified device. The system is labeled as the Optima CT660 however the commercial names used for the configurations are Optima CT660 or Optima CT660 s.

### Predicate Device:

K082761 - LightSpeed VCT (GE LightSpeed 7.2 CT Scanner System)

### Device Description:

The Optima CT660 and its associated configurations/packages is a multi-slice CT scanner system consisting of a gantry, patient table, operator console, power distribution unit (PDU), associated accessories, and connections/interfaces to accessories. The system includes image acquisition hardware, imaqe acquisition & reconstruction software, associated accessories, and connections/interfaces to accessories. ASiR advanced reconstruction technology is also an option on this product and was cleared in K093581.

The Optima CT660 CT system is intended to be a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. Materials and construction are equivalent to our existing marketed products which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21 CFR Subchapter J. It has been developed under the same GE quality system and has completed all design controls, including risk management, verification and validation.

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Image /page/2/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 inner part of the circle are white, while the background is black.

# GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660

#### Indications for Use:

The Optima CT660 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

#### Technology:

The Optima CT660 employs the same fundamental scientific technology as its predicate device.

#### Adverse Effects on Health:

Potential electrical, mechanical and radiation hazards are identified in a risk management including hazard analysis and controlled by:

- System verification and validation to ensure performance to specifications, Federal . Requlations, and user requirements.
- Adherence and certification to industry and international standards. (UL/CSA and IEC). .
- Compliance to applicable CDRH 21CFR subchapter J requirements. .

The device is designed and manufactured under the Quality System Regulations of 21CFR820.

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Image /page/3/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 circle. There are decorative swirls or flourishes around the outer edge of the circle, adding a touch of elegance to the design. The logo is presented in black and white.

GE Healthcare / GE Medical Systems. LLC 510(k) Premarket Notification Submission Product Name: Optima CT660

#### Determination of Substantial Equivalence:

The Optima CT660 has completed testing and is in compliance IEC 60601-1 and associated collateral and particular standards, and 21 CFR Subchapter J. The device has completed all testing per our quality system as well as comparison testing to the unmodified device. It was designed and is manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system:

- Risk Analvsis .
- Requirement Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)

#### Conclusion:

The Optima CT660 does not raise in any new potential safety risks and performs as well as devices currently on the market. The Optima CT660 CT system has been certified in accordance with the same standards as the predicate device. GE Healthcare considers the Optima CT660 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Ms. Tracey Ortiz Regualtory Affairs Lead Engineer-MI & CT GE Healthcare, GE Medical Systems, LLC 3000 N. Grandview Blvd. W-1140 WAUKESHA WI 53188

Re: K110227

JUL 20 2011

Trade/Device Name: Optima CT660 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 3, 2011 Received: May 5, 2011

Dear Ms. Ortiz:

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 indictions for use stated in the enclosure) to legally marketed predicate devices market 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, Drig 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firther 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 or your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli inte [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters are stylized and connected, creating a distinctive and recognizable mark. The logo is black and white.

GE Healthcare / GE Medical Systems, LLC 510(k) Premarket Notification Submission Product Name: Optima CT660

. Indications for Use

510(k) Number (if known): K110227

Device Name: Optima CT660

#### Indications for Use:

The Optima CT660 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, quiding, and monitoring therapy.

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

K110227

610K